Center For Veterinary Medicine Adverse Drug Experience Reports

ADE Renorts Search Criteria
Prepared on 04/18/2011
DER PACKAGE DESCRIPTIONS
Document: N 141290 Sub Num:
ADEREVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Species:
Breed:
Gender:
Drug:
Source Report ID:
NDC:
Product Lot #:
Report Quality:
Age:
Weight:
Episode Date:
From To
Corr Date:
From To
Unit
Vet Opinion: Health Status: Reason for Use:
Route:
ADE CONCOMITANTS
Status: Description:
ADE ASSESSMENTS
Onset Value Onset Causality Assessment
Clinical Detail From To Denom From To
Number of Reviews Retrieved:
19
Drug Name: RACTOPAMINE
FDA/CVM - ADE Reports - CVM Response
Prepared on 04/ 18/2 0 11
Page: 1
Document ID: N 141290 Submission ID: L 7 Package ID: A 1 Corrsp Date: 01127/2009
Source:
Country:
State:
Report from sponsor or distibutor of drug
United States
VIRGINIA
Zip:
xx:xxx
Report Quality: Average
Episode Date:
01106/2009
Dosage: Recommended dose
Route: Oral (in dry feed)
Dose Description: 4.6 G/TON 116109- 1121109
Extra Label: None
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED WEIGHT GAIN; FEED EFFICIENCY
Health Status:
Good
Administered By:
Owner
Vet Opinion: Unknown
Concomitants: No
Evaluation Comments:
US200900139
N/A
#Treated:
152400
#Reacted: 134000
#Died:
0
Species: TURKEY
Breed: Not specified
Age: 17 WK
Weight:
UN
Gender: Group (m & f)
ON 116109, A FLOCK OF TURKEYS 13-20 WEEKS OLD WERE FED A RATION CONTAINING TOPMAX AT 4.6G/TON. CM:
W/IN 8 HOURS, TURKEYS WERE MORE EASILY EXCITED. 117/09 CM: INCREASED NUMBER OF GREEN WING TIPS,
SCRATCHES, LEG INWRIES DUE TO INCREASED EXCITABILITY AND INCREASED FIGHTING AMONG THE TURKEYS.
NO CMP; NO CONCOMITANTS. 1121109 UPDATE: 2 SEPARATE FLOCKS EXPERIENCED ADVERSE EFFECTS
DIFFERENT FROM WHAT WAS PREVIOUSLY REPORTED. THE FIRST FLOCK AFFECTED CONSISTED OF 13 WK OLD
HENS THAT BEGAN CONSUMING MORE WATER AND WERE PASSING BLACK FECES. THE SECOND FLOCK
AFFECTED CONSISTED OF 20 WEEK OLD TOMS THAT EXPERIENCE A SLIGHT INCREASE IN ACTIVITY AND SOME
FLIGHTINESS. THE THIRD FLOCK HAD 17 WK OLD HENS THAT DID NOT HAVE ANY SIGNS. AT THE TIME OF THE
UPDATE, THE FLOCKS HAD BEEN PROCESSED. NO FURTHER INFO. AVAILABLE. REVIEWER NOTE:
AGGRESSION/HYPERACTIVITY COULD BE ASSOCIATED W/ BETA ADRENERGIC RESPONSE.
Causality
Assessment
0
0
Drug Name:
Time
To Onset
UN
UN
8 HR
8 HR
RACTOP AMINE
Clinical Detail:
D STOOLABN
G POLYDIPSIA
N AGGRESSION
N HYPERACTIVITY
Document ID: N 141290 Submission ID: L 8
Source:
Country:
CVM _Report. rep
United States
Package ID: A 1 Corrsp Date: 02/02/2009
Source Report ld:
US2009004 72
NDC:
State:
Prepared on 04/ 18/20 11
NORTH CAROLINA Zip: 28938
Product Lot No:
N/A
Episode Date:
01/10/2009
#Treated:
#Reacted:
Route: Oral (in dry feed) #Died:
Dose Description: 4.6 G/ON 1110/09- 01/23/09
Species:
Extra Label: None
Breed:
Reason For Use:
INCREASED WEIGHT GAIN; FEED EFFICIENCY
Age:
Weight:
Health Status:
Gender:
Good
Administered By: Owner
Concomitants: No
Page: 2
13200
1000
0
TURK_EY
Not specified
19 WK
44 LB
Male
AFTER ADMINISTRATION OF TOPMAX (EXACT TIME TO ONSET NOT PROVIDED) , AN UNKNOWN NUMBER OF TOM
TURKEYS BEGAN EXHIBITING RUNWAY BEHAVIOR (HYPERACTIVITY), AND HAD AN INJURIES (SPRAINS, STRAINS
AND TWISTS) AND APPEARED TO DEVELOP THE BLUE COLOR ON THEIR HEADS MORE SLOWLY THAN EXPECTED
(SLOW TO REACH SEXUAL MATURITY)- CODED REPRODUCTION DISORDER. AT THE TIME OF THE REPORT, THE
TOMS HAD STOPPED EXHIBITING RUNWAY BEHAVIOR, HAD DEVELOPED THE BLUE COLOR IN HEADS AS
EXPECTED AND HAD BEEN PROCESSED. NO PRE-EXISTING CONDITIONS; NO CONCOMITANT.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
N HYPERACTIVITY
0 UN X REPRODUCTION DISORDER
Source:
Country:
State:
United States
IOWA
Zip:
52654
Episode Date:
02/01/2009
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Corrsp Date: 02/11/2009
US200900713
N/A
#Treated:
#Reacted:
#Died:
125000
625
625
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Prepared on 04118/2011
4.6 G/TON 1117/09 - 2/5/09
None
INCREASED RATE OF WEIGHT GAIN; FEED EFFICIENCY
Good
Owner
No attending veterinarian
No
Species:
Breed:
Age:
Weight:
Gender:
Page: 3
TURKEY
Not specified
Male
UN
UN
TOPMAX FED FOR 14 DAYS PRIOR TO TRANSPORTATION FOR PROCESSING. TRANSPORTATION MORTALITY RATE
WAS 0.5% HIGHER THAN THOSE NOT CONSUMING TOPMAX (EXPECTED MORTALITY 1 %). REVIEWER NOTE:
CALCULATIONS DON'T MATCH UP WITH GIVEN NUMBERS (MORTALITY RATE APPEARS TO BE 0.5%). THE FLOCK
HAD A HISTORY OF SERIOUS HEALTH PROBLEMS (DDX?); DETAILS NOT PROVIDED. NO CONCOMITANT
PRODUCTS; NO FURTHER INFO. FlU (2117/09; 10) AFTER RECHECKING RECORDS, OWNER REPORTED THAT THE
DEATH RATE WAS ACTUALLY LOWER (<1%) SINCE BEGINNING TOPMAX; HOWEVER THAT 5 BIRDS DIED ON
LOADING WHICH WAS 2 MORE DEATHS THAN EXPECTED NUMBER. REVIEWER NOTE: DEATH SCORED -9 SINCE
OVERALL MORTALITY RATE ACTUALLY LOWER FOR BIRDS FED TOPMAX AT THIS FARM.
Causality
Assessment
-9
Time
To Onset
14 DA
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
Episode Date:
02110/2009
Dose Description: 4.6 G/TON 2/ 10/09 - 2/27/09
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN; FEED EFFICIENCY
Health Status:
Good
Administered By:
Owner
Concomitants: No
CVM _Report. rep
US20090083 7
N/A
#Treated:
13400
#Reacted: 13400
#Died:
0
Species: TURKEY
Age: 18 WK
Weight: 38 LB
Gender: Male
Prepared on 04/ 18/2011
Page: 4
PRODUCER HAD TWO GROUPS OF BIRDS (13400 EACH GROUP). ONE GROUP WAS FED WI TOPMAX; THE OTHER
WAS NOT. 2/16/09: PRODUCER NOTED THAT THE BIRDS IN THE TOPMAX HOUSES WERE CALMER, MORE EASILY
MOVED AND HAD FEWER FRACTURES THAN NON TOP-MAX BIRDS. HE ASSESSED THIS AS POSITIVE. 3/4/09
UPDATE: ALTHOUGH THE TOPMAX FED BIRDS WERE MOSTLY CALM, THERE WERE SOME SIGNS THAT THEY
WERE MORE EXCITABLE. THE RATE OF CONDEMNS (PARTS OF BIRDS THAT CANNOT BE USED) AT PROCESSING
WAS 0.4%. THIS RATE IS NORMALLY 0.3%. THIS INCREASED RATE WAS REPORTEDLY DUE TO "GREEN WING TIPS"
CAUSED BY BIRDS FLAPPING THEIR WINGS MORE. BIRDS WERE PROCESSED AT THE END OF FEB. NO FURTHER
INFO.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
United States
State:
NORTH CAROLINA Zip:
PRODUCER REPORT
Episode Date:
03/25/2009
Dose Description: 8.2 G/TON 3/18/2009
Extra Label: None
28398
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED WEIGHT GAIN; IMPROVED FEED
EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
High
No
US20090 13 51
UNKNOWN
#Treated:
14000
#Reacted: 14000
#Died:
0
Species: TURKEY
Age: XX
Weight:
37 LB
Gender: Male
3/18/09: TOPMAX STARTED AT 8.2 G/TON WITH 1/2 OF FLOCK. (14000 BIRDS). BREED: NICHOLAS TURKEYS. AGE:
MARKET. THE TURKEY PRODUCER REP OR TED THAT THE TURKEYS CONSUMING THE TOP MAX WERE CALMER,
HAD LESS BLUE SKIN ON THEIR HEADS (DELAY IN SEXUAL MATURITY - REVIEWER NOTE: CODED AS
REPRODUCTIVE DISORDER AS NO SPECIFIC VEDRA CODE EXISTS FOR THIS CONDITION), AND WERE LESS
AGGRESSIVE. PRODUCER FELT THIS WAS A POSITIVE RESULT AND PLANS ON CONTINUING TOPMAX UNTIL THEIR
SLAUGHTER ON 4/1/09.
Causality
Assessment
0
Time
To Onset
UN
CVM _Report. rep
Clinical Detail:
X REPRODUCTION DISORDER
Prepared on 04118/20 11
Page: 5
Document ID: N 141290 Submission ID: L 13 Package ID: A 1
Source: Report from sponsor or distibutor of drug Source Report Id:
Country:
United States
NDC:
State:
INDIANA
Zip:
47501
Product Lot No:
Episode Date:
04115/2009
Dose Description: 8.2 G/TON 4/2/09 - 4115/09
Extra Label:
None
Reason For Use:
INCREASED RATE OF WEIGHT GAIN; IMPROVED FEED
EFFICIENCY
Health Status:
Good
Administered By:
Owner
Concomitants: No
US200901835
UNKNOWN
#Treated:
1600
#Reacted: 20
#Died:
0
Species: TURKEY
Age: 20 WK
Weight: 39 LB
Gender:
Male
4/2/09: A GROUP OF 1600 TOM TURKEYS (HYBRID) WERE FED A RATION CONTAINING TAOPMAX AT 8.2G/TON. AT
TIME OF PROCESSING, AN UNK NUMBER OF BIRDS WERE REPORTED TO HAVE "BREAST BLISTERS" (ESTIMATED
AT 20 FOR REPORTING PURPOSES, BUT ACTUAL NUMBER UNKNOWN). THE% OF BIRDS AFFECTED FROM BIRDS
NOT FED TOPMAX WAS ALSO REPORTED TO BE HIGHER THAN EXPECTED, BUT THE INCREASE IS NOT KNOWN
(CONFUSING). CMP- NO; CONCOMITANT PRODUCTS- NONE.
Causality
Assessment
0
Time
To Onset
13 DA
Clinical Detail:
G MEATABN
Source:
Country:
State:
United States
IOWA
Zip:
XX XXX
Episode Date:
04/20/2009
Dose Description: 4.6 G/TON 4/6/09- 4/20/09
CVM _Report. rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US20090 1834
UNK
#Treated:
#Reacted:
#Died:
Species:
13000
20
0
TURKEY
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
EFFICIENCY
Good
Owner
No
Breed:
Age:
Weight:
Gender:
Page: 6
Not specified
Male
20 WK
40 LB
4/20/09: AT TIME OF PROCESSING, FECAL CONTAMINATION OF THE CARCASS WAS REPORTED TO BE 17% RIGHTER
THAN EXPECTED. IT WAS NOT KNOWN IF THE FECAL CONTAMINATION WAS DUE TO "SPILLAGE" OR TEARING OF
THE GASTROINTESTINAL TRACT DURING PROCESSING. ANOTHER FLOCK OF THE SAME SIZE ON THE FARM WAS
NOT FED TOPMAX AND DID NOT EXPERIENCE THE INCREASE IN CONTAMINATION PROBLEMS. ACTUAL NUMBER
OF BIRDS AFFECTED WAS NOT PROVIDED; ESTIMATED AT 20 FOR REPORTING PURPOSES. CMP- NONE.
CON CO MIT ANT PRODUCT -NONE.
Causality
Assessment
-1
Time
To Onset
NA
Clinical Detail:
G MEATABN
Source:
Country:
State:
United States
INDIANA
Zip:
46140
POST APPROVAL STUDY T4V370819
Episode Date:
01/03/2009
Dosage: Various
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: FOUR TREATMENT GROUP AT VARIOUS LEVELS (SEE
NARRATIVE)
Extra Label: None
Reason For Use:
CLINCIAL RESEARCH STUDY
Health Status:
Fair
Administered By:
Veterinarian
Concomitants: No
POST APPROVAL STUDY# T4V370819. BREED: NICHOLAS TURKEYS.
Corrsp Date: 05112/2009
US200902151
NIA
#Treated:
590
#Reacted: 6
#Died:
6
Species: TURKEY
Age: 109 DA
Weight: 32 LB
Gender: Male
STUDY TITLE: POST APPROVAL STUDY: THE EVALUATION OF TOPMAX (RACTOPAMINE HCL) ADMINISTERED AT
4.6 G/TON- 11.8G/TON TO FINISHING TOM TURKEYS FOR THE LAST 14 DAYS PRIOR TO SLAUGHTER FOR IMPROVED
CVM _Report. rep
Prepared on 0411812011
WEIGHT GAIN AND FEED EFFICIENCY.
Page: 7
OBJECTIVE: DETERMINE THE CLINICAL EFFECTS OF 2% RACTOPAMINE HCL (RAC) TYPE A MEDICATED ARTICLE
GROWTH PERFORMANCE IN TOM FINISHING TURKEYS.
4129109: BLANCO HEALTH WAS MADE A WARE OF ADVERSE EVENTS OCCURRING IN THE RESEARCH STUDIES.
12131109: 794 FINISHING TURKEYS WERE PLACED ON ONE OF FOUR TREATMENTS (INCLUDING ONE CONTROL
GROUP) AT THE FOLLOWING EXPECTED LEVELS: 4.6GITON, 8.2GITON OR 11.8GITON (ASSAYS REVEALED LEVELS
TO BE 3.87GITON, 7.2GITON AND 10.05GITON, RESPECTIVELY. FROM THE 4.6 OlTON GROUP: 1 BIRD WAS REMOVED
FOR LAMENESS AT 5 DAYS, ONE NON AMBULATORY BIRD WAS REMOVED AT 10 DAYS; 1 NONAMBULATORY BIRD
REMOVED AT 14 DAYS. FROM THE 8.2 OlTON GROUP: 1 BIRD WAS REMOVED FOR A BROKEN WING AT 4 DAYS, 1
BIRD WAS REMOVED DUE TO LAMENESS AND CANNIBALIZATION AT 5 DAYS. FROM THE 11.8GITON GROUP: ONE
BIRD WAS REMOVED DUE TO CANNIBALIZATION.
Causality
Assessment
0
0
0
Time
To Onset
VA
VA
VA
Clinical Detail:
G BEHAVIOR DISORDER
G DEATH(SLAUGHTERED)
G LAMENESS
Source:
Country:
United States
State:
MINNESOTA
Report Quality: Fair
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0512012009
Not applicable
Product defect
Not applicable
Not applicable
Not applicable
Not applicable
No
Zip:
56288
Source Report Id:
NDC:
Product Lot No:
Corrsp Date: 0610112009
US200902532
A529175
#Treated:
0
#Reacted: 0
#Died:
0
Species: NOT APPLICABLE
Breed: Not applicable
Age: NA
Weight:
NA
Gender: Not applicable
ON AN UNKNOWN DATE, JENNY-0 TURKEY TOOK DELIVERY OF A PALLET OF TOPMAX FEED. SINCE RECEIVING
THE DELIVERY, THE FEED SAMPLES THAT HAVE BEEN TESTED HAVE CONSISTENL Y RESULTED IN BELOW
ACCEPTABLE LEVELS OF RACTOPAMINE IN THE FEED. JENNY-0 QUESTIONED THE CONCENTRATION OF THE
ENTIRE LOT OF TYPE A TOPMAX.
CVM _Report. rep
Page: 8
UPDATE: LOT NUMBER WAS A529175A AND SHIPMENT WAS RECEIVED ON APPROXIMATELY 11/26/08. QA
COMPLAINT INFORMATION IS AVAILABLE IN TRACKWISE RECORD TR#931266.
UPDATE: FEED ASSAY RESULTS REPORTED THAT TOPMAX WAS PRESENT IN THE RATION AT ACCEPT ABLE
LIMITS
Causality
Assessment
0
Time
To Onset
NA
Clinical Detail:
P PD-POTENCY, LO
Source:
Country:
State:
United States
IOWA
Zip:
50075
Episode Date:
04/29/2009
Dose Description: 4.6 G/TON 4/29/09- 5112/09
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE WEIGHT GAIN AND IMPROVED FEED
EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
US200903288
UNK
#Treated:
10000
#Reacted: 10000
#Died:
0
Species: TURKEY
Age: XX
Weight: 40 LB
Gender: Male
POTENTIAL LOE. 4/9/09: PRODUCER BEGAN A TOPMAS FEEDING DEMONSTRATION ON A FARM WITH 2 HOUSES
(1 0,000 BIRDDS/HOUSE) OF TURKEYS. CONTROL BIRDS WERE NOT FED TOPMAX. THE OTHER BIRDS WERE FED
TOPMAX AT 4.6 G/TON FOR 2 WEEKS AND THEN PROCESSED. THE PRODUCER REPORTED THAT THE TOPMAX FED
BIRDS DID NOT EAT AS MUCH FEED AS WAS EXPECTED . THE CONTROL BIRDS GAINED 1.2 LB. MORE THAN THE
TOPMAX FED BIRDS. THE PRODUCER DISCONTINUED FEEDING TOPMAX ON THE FARM. THERE WERE NO PRE-
EXISTING MEDICAL CONDITIONS AND NO CON CO MIT ANT PRODUCTS.
Causality
Assessment
0
Time
To Onset
2 WK
Clinical Detail:
E INEFFECT
Source: Report from sponsor or distibutor of drug
CVM _Report. rep
Source Report Id:
US200902739
Page: 9
Country:
United States
NDC:
State:
MISSING INFORMA' Zip: xxxxx
Product Lot No:
POST APPROVAL STUDY NO. T4VUS090003
Episode Date:
05/27/2009
Dose Description: 8.2 - 11.8 G/TON 5/26/09 - 6/22/09
Extra Label: Unknown
Reason For Use:
POST APPROVAL RESEARCH STUDY/ IMPROVED
WEIGHT GAIN AND FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Missing information
No
NOT PROVIDED
#Treated:
2760
#Reacted: 23
#Died:
23
Species: TURKEY
Age: 16 WK
Weight:
VA
Gender: Female
FROM 5/27/09- 6110/09, THERE WERE 23 IDENTIFIED DEAD BIRDS IN THIS POST APPROVAL STUDY (T4VUS090003).
THE STUDY WAS FOR THE EVALUATION OF TOPMAX ADMINISTERED AT 8.2G/TON- 11.8 G/TON TO FINISHING
HEAVY HEN TURKEYS FOR THE LAST 14 DAYS PRIOR TO SLAUGHTER FOR IMPROVED GAIN AND FEED
EFFICIENCY. THE LIVE MEDICATED PHASE OF TRIAL BEGAN ON 5/26/09. THREE DEAD TURKEYS WERE FOUND ON
5/27/09. FROM 5/27/09-6/ 10/09, A TOTAL OF 23 DEAD BIRDS WERE IDENTIFIED. THE AFFECTED (DEAD) BIRDS WERE
LOCATED IN PEN #5,7,17, 18,19 AS WELL AS LOADOUT AND TRANSPORTATION. THE WEIGHTS OF THE BIRDS
RANGED FROM 20.2-43 POUNDS. PRESUMED CAUSE OF DEATH INCLUDED: BROKEN LEG, CANNIBALISM, HEART
ATTACK, SUDDEN DEATH SYNDROME/AORTIC RUPTURE, HEAT EXHAUSTION, LACK OF OXYGEN AND DEAD ON
ARRIVAL. (REVIEWER NOTE: POSSIBLE HIGHER MORTALITY RATE ASSOC. W/ ELEV. ENVIRONMENTAL TEMPS
AND TOPMAX ADMIN IS LABELED; ONE OF CAUSES OF DEATH LISTED AS HEAT EXHAUSITON.)
Causality
Assessment
0
0
Time
To Onset
VA
VA
Clinical Detail:
C ARREST, HEART
G DEATH
Source:
Country:
State:
United States
MISSING INFORMA' Zip: XX XXX
RESEARCH STUDY# T4VUS090004
Episode Date: 06/03/2009
CVM _Report. rep
Package ID: A 1 Corrsp Date: 09117/2009
Source Report ld:
US200905309
NDC:
Product Lot No:
UNK
#Treated:
1950
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
4.6 - 8.2 G/TON 612109 - 6116109
None
RESEARCH STUDY
Good
Owner
Missing information
No
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 10
13
13
TURKEY
Not specified
18 WK
VA
Male
POST APPROVAL STUDY# T4VUS090004. BREED: HYBRID TURKEYS. THE EVALUATION OF TOPMAX
ADMINISTERED AT 4.6- 8.2 G/TON TO FINISHING HEAVY TOM TURKEYS FOR THE LAST 14 DAYS PRIOR TO
SLAUGHTER FOR IMPROVED GAIN AND FEED EFFICIENCY. 8/31/09: FROM 6/2/09-6/ 16/09 THERE WERE 13
IDENTIFIED DEAD BIRDS ADMINISTERED FEED CONTAINING TOPMAX. DOSE RANGED FROM 4.6 G/TON TO 8.2
G/TON. WEIGHTS RANGED FROM 24.3 - 43.7 LBS. REPORT LISTS PRESUMED CAUSES FO DEATH INCLUDE THE
FOLLOWING: BROKEN LEG, CANNIBALISM, HEART ATTACK, SUDDEN DEATH SYNDROME/AORTIC RUPTURE,
ASPERFILLOSIS AND PERICARDITIS. NO ADDITIONAL INFORMATION EXPECTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
MINNESOTA
Zip:
56551
Report Quality": Average
POST APPROVAL STUDYT4V270818
Episode Date:
04/0112009
Dose Description: 11.8 G/TON 3/23/09 - 416109
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
RESEARCH STUDY: CLINCIAL EFFECTS OF RAC TYPE A
ON GROWTH PERFORMANCE IN HEN FINISHING
TURKEYS
Health Status:
Good
CVM _ Repmi.rep
Corrsp Date: 11/ 10/2009
US200907229
UNK
#Treated:
936
#Reacted: 2
#Died:
2
Species: TURKEY
Age: 76 DA
Weight:
UN
Gender: Female
Administered By:
Owner
Concomitants: No
STUDY NUMBER: T4V270818.
Page: 11
POST APPROVAL STUDY: THE EVALUATION OF TOP AX ADMINISTERED AT 4.6 G/TON TO 1118 G/TON TO FINISHING
HEN TURKEYS FOR THE LAST 14 DAYS PRIOR TO SLAUGHTER FOR IMPROVED GAIN AND FEED EFFICIENCY.
OBJECTIVE: DETERMINE THE CLINICAL EFFECTS OF 2% RACTOMPAMINE HYDROCHLORIDE TYPE A MEDICATED
ARTICLE ON GROWTH PERFORMANCE OF FINISHING TURKEYS.
THREE BIRDS WERE REMOVED FROM THE STUDY DURING THE TREATMENT PHASE DUE TO PENDULOUS CROP.
ONE BIRD WAS IN THE CONTROL GROUP AND RECEIVED NO PRODUCT. THE OTHER TWO BIRDS WERE
ADMINISTERED PRODUCT AT 11.8 G/TON. PENDULOUS CROP REMOVED 4/1/09. NO MORTALITY OCCURRED
DURING THE TREATMENT PHASE. STUDY IS COMPLETE; NO FURTHER INFORMATION EXPECTED.
Causality
Assessment
0
Time
To Onset
8 DA
Clinical Detail:
D GI, ABNORMAL
-9 8 DA G DEATH(SLAUGHTERED)
Source:
Country:
State:
United States
VIRGINIA
Zip:
22802
Episode Date:
12/0112009
Dose Description: 8.2 G/TON 12/ 1109-?
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED WEIGHT GAIN AND IMPROVED FEED
EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
US20 1000630
UNK
#Treated:
2
#Reacted: 2
#Died:
0
Species: TURKEY
Age: UN
Weight: 20 LB
CARGILL TURKEYS STARTED ON PRODUCT 12/ 1109. SINCE THAT TIME, FINISHING TURKEYS PRODUCED "WETTER
LITTER" AND THERE WAS AN INCREASED NUMBER OF TENDER-LEGGED TURKEYS ATTRIBUTED TO SYNOVITIS
CVM _Report. rep
Page: 12
AMONG THE FINISHING HENS(# OF FINISHING HENS UNK; NUMBER PROVIDED IS AN ESTIMATE). THERE WERE NO
PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANTS.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D STOOLABN
M SYNOVITIS
Source:
Country:
State:
United States
VIRGINIA
Zip:
22802
Episode Date:
12/01/2008
Dose Description: 8.2 G/TON; 12/2008*
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN AND IMPROVED
FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
High
Yes
COBAN 54G/TON; PF; UNK DATES
US201001420
UNK
#Treated:
30000
#Reacted: 10000
#Died:
10000
Species: TURKEY
Age: 100 DA
Weight: 19 LB
Gender: Female
ON 03/23/09, AN ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING TOPMAX (RACTOPMAINE HYDROCHLORIDE) IN TURKEYS. THE ATTENDING
VETERINARIAN FOR A PRODUCTION FARM REPORTED THAT TURKEYS FED TOPMAX HAD AN INCREASE IN "WET
LITTER" (INCREASE IN WATER IN THE FECES) AND SYNOVITIS WAS FOUND IN THE HOCK JOINTS OF THE BIRDS AT
PROCESSING. THE FARM HAS BEEN FEEDING TOPMAX TO BIRDS SINCE APPROXIMATELY 12/08. THE NUMBER OF
BIRDS FED AND AFFECTED WAS NOT PROVIDED (NUMBER REPORTED IS AN ESTIMATE) . THERE WERE NO
CONCOMITANT PRODUCTS AND NO PRE-EXISTING MEDICAL CONDITIONS.
UPDATED 03/30/10: ON 03/30/10 THE ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT PROVIDED UPDATED
INFORMATION. THE ELAN CO ANIMAL HEALTH TECHNICAL CONSULTANT VISITED 2 OF THE COMPANY'S
PRODUCTION FARMS. ON THE FIRST FARM, (APPROXIMATELY 10,000 HENS, 113 DAYS OF AGE, 23 LB), THE LITTER
AND DROPPINGS WERE OBSERVED TO BE NORMAL. COBAN (54 G/TON) WAS DISCONTINUED IN THE DIET WHEN
THE BIRDS WERE STARTED ON TOPMAX (8.2 G/TON). THE CONSULTANT RETURNED TO THE FARM 4 DAYS AFTER
THE TOPMAX WAS ADDED AND OBSERVED NO DIFFERENCE IN THE LITTER OR DROPPINGS. ON THE SECOND
FARM (2 HOUSES, APPROXIMATELY 10,000 HENS/HOUSE, 73 DAYS IN AGE, 12-13 LB), THE LITTER AND DROPPINGS
WERE OBSERVED TO BE NORMAL. COBAN (54 G/TON) WAS DISCONTINUED IN THE DIET WHEN THE BIRDS WERE
CYM _Report. rep
Page: 13
STARTED ON TOPMAX (8.2 G/TON). THE CONSULTANT RETURNED TO THE FARM 3 DAYS AFTER THE TOPMAX WAS
ADDED AND OBSERVED NO DIFFERENCE IN THE LITTER OR DROPPINGS OF ONE HOUSE BUT THE SECOND HOUSE
HAD WETTER LITTER ESPECIALLY AROUND SOME OF THE FEEDERS. THE FARM OWNER STATED THAT THE BIRDS
WERE MORE HYPERACTIVE WHEN FED TOPMAX. THE BIRDS WERE NOT TREATED AND TOPMAX WAS CONTINUED
IN THE DIET OF BOTH FARMS. NO FURTHER INFORMATION IS EXPECTED.
REV NOTE: CHANGED #ANIMALS AFFECTED TO REFLECT NARRATIVE. ALSO, BOX 9 STATES THE BIRDS WERE FED
82 G/TON, HOWEVER THE NARRATIVE DISCUSSES A DOSE OF 8.2 G/TON, WHICH IS THE CORRECT DOSE. BOX 13
ALSO DOES NOT REFLECT THE FACT THAT THE BIRDS WERE SLAUGHTERED AND PROCESSED TO FIND DIAGNOSIS
OF SYNOVITIS; ESTIMATED A NUMBER AND CODED FOR SLAUGHTER.
Causality
Assessment
Time
To Onset Clinical Detail:
0 UN D DIARRHEA, WATERY
0 UN M SYNOVITIS
UN N HYPERACTIVITY
Source:
Country:
State:
United States
UTAH
Zip:
84646
Episode Date:
03/10/2010
Dose Description: 8.2 G/TON; 03/0112010-03110/2010
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Yes
COBAN 90 (200 G/KG); PF; 54 G/TON; 112010*-3110/2010
US201001291
UNK
#Treated:
100
#Reacted: 100
#Died:
0
Species: TURKEY
Age: 84 DA
Weight:
15 LB
Gender: Female
ON 03118/09, AN ELANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING TOP MAX (RACTOPMAINE HYDROCHLORIDE) IN TURKEYS. ON APPROXIMATELY 03/0 Ill 0,
AN UNKNOWN NUMBER (NUMBER PROVIDED IS AN ESTIMATE) OF TURKEY HENS WERE STARTED ON A TOPMAX
RATION. THE BIRDS WERE FED THE TOPMAX FOR 10 DAYS AND PROCESSED. AT THE TIME OF .PROCESSING, IT
WAS DISCOVERED THAT THERE WAS AN INCREASE IN THE PERCENTAGE OF DOWNGRADED CARCASSES. THE
SALES REPRESENTATIVE REPORTED THAT THERE WERE ALSO SOME "ISSUES AT THE PLANT" BUT NO DETAILS
CVM _ Report.rep
Page: 14
WERE PROVIDED. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND THE BIRDS WERE ALSO BEING FED
COBAN AT 54 G/TON.
REV NOTE: THE NUMBER OF ANIMALS AFFECTED IS CERTAINLY MORE THAN ONE TURKEY; CHANGED NUMBER
TO REFLECT A MORE REALISTIC QUANTITY
FlU (4/8/2010;36) ANOTHER LOAD OF TURKEYS FROM THE FARM WAS PROCESSED AND THE CARCASSES WERE
DOWNGRADED AS BEFORE.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G MEATABN
Source:
Country:
State:
Report from sponsor or distibutor of dmg
United States
MICHIGAN
Zip:
xxxxx
Episode Date:
09/24/2010
Dose Description: 8.2G/TON;ORAL 09110110- 9/24110
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
US20 1008525
UNKNOWN
#Treated:
9300
#Reacted: 319
#Died:
319
Species: TURKEY
Age: 133 DA
Weight: 40.3 LB
Gender: Male
ON 9/28/ 10, AN ELAN CO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXPERIENCE
INVOLVING TOPMAX (RACTOPAMINE HYDROCHLORIDE) IN TURKEYS. ON 9/ 1011 0, 9300 TOM TURKEYS WERE
STARTED ON A RATION THAT CONTAINED TOPMAX AT 8.2 G/TON. ON 9/24/ 10, THE FLOCK WAS SENT FOR
PROCESSING. ON ARRIVAL AT THE PROCESSING FACILITY, 319 TURKEYS WERE FOUND DEAD. THE PRODUCER
ASKED IF TOPMAX COULD HAVE CONTRIBUTED TO THE HIGH NUMBER OF DEAD TURKEYS. THERE WERE NO
PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANT PRODUCTS. NO FURTHER INFO IS EXPECTED.
CMP:UNK
Causality
Assessment
0
CVM _ Rep01t.rep
Time
To Onset
14 DA
Clinical Detail:
G DEATH
Drug N arne: RACTOP AMINE
Document ID: N 141290 Submission ID: L 41 Package ID: A 1 Corrsp Date: 11/29/2010
Source:
Country:
State:
United States
MICHIGAN
Zip:
49401
Episode Date:
04/29/2010
Route: Oral (all other)
Dose Description: 8.2 G/TON PER 8 DAYS; 4/ 1 0*
Source Report ld:
US201010107
NDC:
Product Lot No:
UNKNOWN
#Treated:
#Reacted:
#Died:
Species: TURKEY
Page: 15
Extra Label: None Breed: Not specified
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
INCREASED RATE OF WEIGHT GAIN ADN IMPROVED
FEED EFFICIENCY
Unknown
Owner
Unknown
No
Age:
Weight:
Gender: Male
UN
UN
ON 11111110, AN ELANCO ANIMAL HEALTH TECHNICIAN CONSULTANT REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING TOPMAX (RACTOP AMINE HYDROCHLORIDE) IN TURKEYS. A COMPARISON STUDY
PERFORMED AT A TURKEY FARM REPORTED THAT THERE WAS AN INCREASE IN THE NUMBER OF TURKEYS THAT
WERE DEAD ON ARRIVAL AT THE PROCESSING PLANT IN FLOCKS THAT WERE FED TOPMAX (23 FLOCKS)
COMPARED TO TURKEYS THAT WERE NOT FED TOPMAX ( 4 FLOCKS). THE TURKEYS WERE FED TOPMAX AT 8.2
G!TON FOR 8 DAYS INSTEAD OF THE LABEL INDICATED 14 DAYS. INFORMATION ON PRE-EXISTING MEDICAL
CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. REVIEWER NOTE: NO OTHER
INFO PROVIDED- EXACT NUMBER OF TURKEYS DIED OR% NOT PROVIDED.
CMP:UNK
12/28/2010: ELANCO TECHNICAL CONSULTANT HAD NO FURTHER INFO. NO FURTHER INFO EXPECTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
NORTH CAROLINA Zip: XX XXX
CVM _Report. rep
Source Report ld:
US201101108
NDC:
Product Lot No:
A579656
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
11107/2010
#Treated:
Recommended dose
#Reacted:
Oral (all other) #Died:
8.2 G/TON; 9/29110*- 11122110
Species:
None Breed:
RESEARCH STUDY
Age:
Weight:
Good
Gender:
Owner
Unknown
Yes
COBAN; PO; 54 G/TON; 10/25110*-11122110
Page: 16
528
528
528
TURKEY
Not specified
VA
UN
Female
ON 2/28/ 11, ELANCO ANIMAL HEALTH US AFFILIATE REPORTED A POTENTIAL ADE INVOLVING A RESEARCH
STUDY FOR RACTOPAMINE HCL IN TURKEYS.
STUDY TITLE
POST APPROVAL STUDY: THE EVALUATION OF TOPMAX (RACTOPAMINE HCL) ADM AT 8.2 G/TON TO FINISHING
HEN TURKEYS FOR THE LAST 14 DAYS PRIOR TO SLAUGHTER FOR IMPROVED GAIN AND FEED EFFICIENCY AT 3
DIFFERENT SLAUGHTER AGES; 12, 14, AND 17 WKS OF AGE(+/- 4 DAYS OF AGE).
TRIAL DATES:
RECEIPT OF ANIMALS AT DIAMOND K 8/27110
FINAL CARCASS MEASUREMENTS 11122/10
SPECIES AND SEX:
MELEAGRIDIS GALAPAVO, HYBRID CONVERTER STRAIN COMMERCIAL LARGE WHITE FEMALE TURKEYS
STUDY OBJECTIVE
THIS STUDY WAS CONDUCTED TO DETERMINE THE CLINICAL EFFECTS OF 2% RACTOP AMINE HCL (RAC)
TYPE A
MEDICATED ARTICLE ON GROWTH PERFORMANCE IN HEN FINISHING TURKEYS AT 3 DIFFERENT SLAUGHTER
AGES.
PURPOSE OF THE STUDY
THIS STUDY PROVIDED DATA IN SUPPORT OF THE FOLLOWING INDICATION: FOR INCREASED RATE OF WEIGHT
GAIN AND IMPROVED FEED EFFICIENCY (AS MEASURED BY FEED: GAIN) IN HEN FINISHING TURKEYS WHEN FED
FOR THE LAST 14 DAYS PRIOR TO SLAUGHTER AT 3 DIFFERENT SLAUGHTER AGES.
BIRD HEALTH AND LIVABILITY WERE EXCELLENT THROUGHOUT THE CONDUCT OF THE STUDY T4VUS10009.
ONLY 3 MORTALITIES OCCURRED DURING THE ACCLIMATION AND TX PHASES ACROSS ALL SLAUGHTER AGE
GROUPS. A TOTAL OF 10 BIRDS WERE REMOVED DURING THE ACCLIMATION AND TX PHASES; ALL DUE TO
CONGENITAL DEFECTS, WRONG SEX, OR INJURIES THAT OCCURRED FROM HANDLING BIRDS. THE FOLLOWING
TABLE PROVIDES INFO ON MORTALITY AND REMOVALS DURING THE ACCLIMATION AND TX PHASES OF THE
STUDY. THERE WAS NO APPARENT ASSOCIATION BETWEEN TXS AND MORTALITY OR BIRD REMOVALS.
NECROPSY RESULTS:
9115/ 10 A TOPMAX 35 2515 6.23 M SUSPECT ANEURYSM, DIED DURING RANDOMIZATION AS BIRDS WERE MOVED TO
CVM _Repmt.rep
ASSIGNED PENS.
9/22110 A CONTROL 32 2332 9.76 R BROKEN WING.
10/5110 T CONTROL 4 2340 10.89 R BREAST BLISTER AND LEFT HOCK DEFORMED
10/5/10 A TOPMAX 9 2764 12.58 R PENDULOUS CROP
10112/10 A CONTROL 40 2560 16.80 R BROKEN WING
10/12/ 10 A CONTROL 48 2720 15.58 R SUSPECT MALE
10/28/10 A TOPMAX 1 2867 19.50 R SUSPECT MALE
10/28110 A CONTROL 22 2734 19.32 R LEFT LEG INJURED, NON AMBULATORY
10/31110 A CONTROL 45 2851 18.27 R NON AMBULATORY
A TOPMAX 10 2983 22.86 R SUSPECT MALE, SM TESTES FOUND AT NECROPSY
1117110 T TOPMAX 16 2941 21.82 M UNDETERMINED, NO CLINICAL SIGNS
11111110 T TOPMAX 1 2896 20.45 M SLIGHT HEPATOMEGLIA, NO OTHER CLINICAL SIGNS
1 A= ACCLIMATION, T= TX
2M= MORTALITY, R=REMOVAL
NO FURTHER INFO WAS PROVIDED
CMP:UNK
Causality Time
Assessment To Onset Clinical Detail:
0 UN D DIGESTION DISORDER
0 UN G DEATH
-9 UN G DEATH(SLAUGHTERED)
0 UN G INTIJRY
0 UN L HEPATOMEGALY
0 UN N ATAXIA
CYM _Report. rep
Page: 17
Document: N 141221
ADE REVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Sub Num:
Species:
Breed:
Gender:
Drug:
Source Report ID:
NDC:
Product Lot#:
Report Quality:
Age:
Weight:
Episode Date:
From To
Corr Date:
From To
Unit
ADE CONCOMITANTS
Status:
ADE ASSESSMENTS
Clinical Detail
Route:
Description:
From To Denom From To
86
Page: 1
Source:
Country:
United States
State:
KANSAS
Zip:
OPT AFLEXX STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11/02/2003
Recommended dose
Oral (in dry feed)
200 MGIHDIDA Y
None
87401
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
OPT AFLEXX CONFIRMATION STUDY
Health Status:
Good
Administered By:
Other
Concomitants: No
T4V200321-003A
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
70
CATTLE
Mixed (cattle)
Male
1 YR
1420 LB
CALF WAS FOUND DEAD IN THE PEN. NECROPSY INDICATED BLOAT AS CAUSE OF DEATH.
Causality
Assessment
0
0
Time
To Onset
13 DA
13 DA
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
87401
CONFIRMATION STUDY
Episode Date:
10/28/2003
Dosage: Reconm1ended dose
Dose Description: 200 MG/HD/DA; 10/21-28/03
CVM _Report. rep
Source Report ld:
T4V200321-002A
NDC:
Product Lot No:
UNK
#Treated:
70
#Reacted:
#Died:
0
Species: CATTLE
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Breed:
OPT AFLEXX CONFIRMATION STUDY
Age:
Weight:
Unknown
Gender:
Other
Low
No
Page: 2
Mixed (cattle)
1 YR
UN
Unknown
REMOVED FROM THE STUDY AFTER PRESENTING WI DIARRHEA. TREATED WI NAXCEL AND RECOVERED.
Causality
Assessment
0
Time
To Onset
7 DA
Clinical Detail:
D DIARRHEA
Source:
Country:
United States
State:
KANSAS
Zip:
CLINICAL STUDY
Episode Date:
1112412003
87401
Dose Description: 200 MGIHDIDA Y; 11/19-24/03
Extra Label:
None
Reason For Use:
CLINICAL STUDY-T4V200321
Health Status:
Good
Vet Opinion: Low
Concomitants: No
Package ID: A 1 Corrsp Date: 1211712003
Source Report Id:
TAV200321-005
NDC:
Product Lot No:
UNK
#Treated:
70
#Reacted:
#Died:
0
Species: CATTLE
Breed: Mixed (cattle)
Age: YR
Weight:
UN
Gender: Male
CLIN STUDY-CALF #13710 FROM PEN #408 WAS REMOVED FROM STUDY DUE TO BLOAT.
Causality
Assessment
Time
To Onset
5 DA
CVM _Report. rep
Clinical Detail:
D BLOAT
Page: 3
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
11130/2003
46140
Dose Description: 200 MGIHDIDA Y; 11/19-30/03
Extra Label:
None
Reason For Use:
CLINSTUDY
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
Package ID: A 2 Corrsp Date: 12/ 17/2003
Source Report ld:
T4V200321-006
NDC:
Product Lot No:
UNK
#Treated:
70
#Reacted:
#Died:
0
Species: CATTLE
Age: 1 YR
Weight:
UN
Gender: Male
CALF #13741 FROM PEN #408 WAS REMOVED FROM THE STUDY DUE TO RESPIRATORY SIGNS. RTX: NAXCEL;
RECOVERED.
Causality
Assessment
Time
-1 11 DA R RESPIRATORYDISORDER
Source:
Country:
United States
State:
KANSAS
Zip:
Report Quality: Good
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
CVM _Report. rep
12/08/2003
Recommended dose
Oral (in dry feed)
200 MG/HD/DA Y
None
87401
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
T4V200321-007
UNK
#Treated:
70
#Reacted:
#Died:
0
Species: CATTLE
Age: 1 YR
Reason For Use:
CLINSTUDY
Weight:
Health Status:
Good
Gender:
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
REMOVED FROM STUDY AFTER PRESENTING WI BLOAT. CALF #13321 FROM PEN #404.
Causality
Assessment
0
Time
To Onset
19 DA
Clinical Detail:
D BLOAT
Page: 4
UN
Male
Source:
Country:
United States
State:
TEXAS
FEEDY ARD MANAGER
Episode Date:
02/13/2004
Dosage: Unknown
Zip:
Route:
Dose Description:
Oral (in dry feed)
2/ 11-17/04
Extra Label:
None
79092
Reason For Use:
IMPROVED GROWTH PERFORMANCE
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
Source Report ld:
OPTUS04001
NDC:
Product Lot No:
UNK
#Treated:
392
#Reacted: 392
#Died:
0
Species: CATTLE
Age: UN
Weight: 1000 LB
Gender: Male, neutered
4 PENS OF FINISHER CATTLE WERE STAR TED ON RACTOP AMINE. AFTER 2 DAYS THE NUTRITIONIST NOTED THE
MICRONUTRIENT MACHINE WAS SET FOR FEED INTAKE OF 26 LBS OF FEED/HD/DA AND THE ACTUAL FEED
INTAKE OF 3 OF THE 4 PENS OF CATTLE WAS GREATER THAN 26 LBS, GIVING THE CATTLE A LARGER DOSE OF
THE MICRO NUTRIENTS. THE CATTLE AVERAGED 28.3 LBS/HD/DA FROM 2/11-17/04. A VG CONSUMPTION FOR THESE
PENS FOR 2/7-10/04 (PRIOR TO RACTOPAMINE) WAS 29.13 LBS/HD/DA. IN THE REMAINING PEN, PRE-RACTOPAMINE
INTAKE AVERAGED 25.7 LBS/HD/DA AND AFTER RACTOPAMINE AVERAGED 24.7 LBS/HD/DA.
Causality
Assessment
CVM _Report. rep
Time
Page: 5
2 2 DA G ANOREXIA
Source:
Country:
United States
State:
TEXAS
Zip:
FARM MANAGER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
02/23/2004
Recommended dose
Oral (in dry feed)
22 G/TON
None
xxxxx
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
IMPROVED FEED EFFICIENCY, RATE OF GAIN
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Yes
MONENSIN- 24G/TON; SINCE 2/3/04
2 TYLOSIN PHOSPHATE - 7 GM/TON; SINCE 2/3/04
OPTUS04002
UNK
#Treated:
1000
#Reacted: 9
#Died:
0
Species: CATTLE
Age: VA
Weight: 1050 LB
27 ANIMALS PULLED FROM THE PEN DUE TO BLOAT; 9 OF THEM WERE ON RACTOPAMINE. A NUMBER OF THE
CATTLE WI BLOAT WERE FED 2 HOURS LATER IN THEDA Y THAN THE OTHERS. DDX: MONENSIN
Causality
Assessment
0
Time
To Onset
20 DA
Clinical Detail:
D BLOAT
Source:
Country:
United States
State:
INDIANA
CLINICAL STUDY
CVM _ Rep01t.rep
Zip:
46140
Source Report Id:
T4V160328-5765
NDC:
Product Lot No:
UNK
Page: 6
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0212812004
Recommended dose
Oral (in dry feed)
100 MGIHEADIDAY; 2122-28104
None
INC WEIGHT GAIN, FEED EFFICIENCY, RED MEAT
YIELD
Fair
Veterinarian
No
#Treated:
#Reacted:
#Died:
0
Species: CATTLE
Breed: Unknown (cattle)
Age: 18 MO
Weight: 1182 LB
STEER IN OPTAFLEXX STUDY DEVELOPED RESPIRATORY DISEASE WI TEMP=104.5. IT WAS REMOVED FROM THE
STUDY AND TREATED WI CEFTIOFUR.
Causality
Assessment
-1
Time
To Onset
6 DA
Clinical Detail:
G FEVER, BODY
-1 6 DA R RESPIRATORYDISORDER
Source:
Country:
United States
State:
INDIANA
Zip:
46140
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11/0212003
Recommended dose
Oral (in dry feed)
200 MGIHDIDAY; 10121-1112103
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
CLINICAL STUDY TO COMPARE V ARlO US LEVELS OF
OPTAFLEXX
Health Status:
Good
Administered By:
Other
Concomitants: No
CVM _Report. rep
T4V200321-003
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
70
CATTLE
Mixed (cattle)
Male
1 YR
1420 LB
Page: 7
CALF #15828 WAS FOUND DEAD IN THE PEN. NECROPSY: CALF DIED OF BLOAT.
Causality
Assessment
Time
13 DA D BLOAT
13 DA G DEATH
Source:
Country:
United States
State:
KANSAS
Zip:
87401
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/28/2003
Recommended dose
Oral (in dry feed)
200 MGIHDIDA Y; 10/21-28/03
None
OPT AFLEXX STUDY
Unknown
Other
Low
No
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
T4V200321-002
UNK
#Treated:
70
#Reacted:
#Died:
0
Species: CATTLE
Age: 1 YR
Weight:
UN
Gender: Unknown
CALF #15800 DEVELOPED DIARRHEAAND WAS REMOVED FROM THE STUDY AND TREATED WI 12 ML NAXCEL;
RECOVERED.
Causality
Assessment
Time
To Onset
7 DA
Clinical Detail:
D DIARRHEA
Source:
Country:
State:
United States
IDAHO
Zip:
XX XXX
CVM _Report. rep
Source Report ld:
OPTUS04003
NDC:
Product Lot No:
UNK
OWNER CALLED NAPCC
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0310712004
Reconm1ended dose
Oral (in dry feed)
200 MG/HD/DA; 2122104 TO 3/7104
None
INCREASE WEIGHT, FEED EFFICIENCY, INCREASE RED
MEAT YIELD
Unknown
Owner
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 8
0
CATTLE
Mixed (cattle)
Male
6 MO
1188 LB
BOVINE RESP DIS WI TEMP=106. REMOVED CALF FROM THE HERD AND TREATED WI CEFTIOFUR.
Causality
Assessment
0
Time
To Onset
14 DA
Clinical Detail:
G FEVER, BODY
0 14 DA R RESPIRATORY DISORDER
Source:
Country:
United States
State:
NEBRASKA
Zip:
FEEDLOT MANAGER
Episode Date:
0310512004
Dose Description: 200 MG/DAY
Extra Label:
None
Reason For Use:
GROWTH PRO MOT ANT
Health Status:
Good
Administered By:
Owner
Vet Opinion: No attending veterinarian
CVM _Report. rep
xxxxx
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200400 115
UNK
#Treated:
400
#Reacted: 400
#Died:
0
Species: CATTLE
Age: 12 MO
Weight:
1100 LB
Concomitants: Yes
RUMENSIN/TYLAN PREMIX
Page: 9
OPT AFLEXX FED CATTLE AT FEEDY ARD EATING LESS THAN THE OTHER CATTLE INTHE FIRST WEEK OF
CONSUMPTION.
Causality
Assessment
2
Time
To Onset
1 DA
Clinical Detail:
G ANOREXIA
Source:
Country:
State:
United States
ILLINOIS
Zip:
XX XXX
OWNER
Episode Date:
04119/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/DAY X 14, 21 OR 28 DAYS
Extra Label:
Reason For Use:
_ Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASE RATE OF GAIN AND CARCASS LEANNESS
Good
Owner
Unknown
US200400670
UNK
#Treated:
250
#Reacted: 167
#Died:
0
Species: CATTLE
Age: 16 MO
Weight: 1200 LB
A CONSULTANT REPORTED TO ELANCO A POTENTIAL ADE IN A FEEDLOT. CATTLE WERE PURCHASED FROM A
KNOWN SOURCE THAT HISTORICALLY GRADED 35,45 AND 55% CHOICE WHEN SLAUGHTERED AT DAY 14, 21 , AND
28. THIS GROUP WAS TREATED W/ RACTOPAMINE AT 100 MG/HD/DAY X 2 DAYS, THEN 150 MG/HD/DAY FOR 2 DAYS
THE 200 MG/HD/DAYFOR THE REMAINING 14,21 OR28 DAYS. THE CATTLE FED FOR 14 DAYS HAD 35% CHOICE, 21
DAYS HAD 25 % CHOICE(EXPECTED LEVEL WAS 45), AND THOSE FED FOR 28 DAYS HAD 15% (EXPECTED LEVEL
WAS 55%). THE ANIMALS WERE HEAVIER AT SLAUGHTER. THE NEXT GROUP TO BE SLAUGHTERED HAD GRADES
BACK TO EXPECTED LEVELS.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G MEATABN
Document ID: Submission ID:
CVM _ Repmi_ rep
Package ID: Corrsp Date:
Prepared on 04/18/20 11
Page: 10
N 141221 L 36
Source:
Country:
United States
State:
NEBRASKA
Zip:
OWNER
Episode Date:
04/13/2004
Dosage: Recmmnended dose
xxxxx
Dose Description: 200 MG/HD/DAY; 3/24/04 TO 4/ 13/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASE CARCASS LEANNESS
Good
Owner
Unknown
A 1 04/28/2004
Source Report ld:
US200400783
NDC:
Product Lot No:
UNK
#Treated:
1500
#Reacted: 60
#Died:
0
Species: CATTLE
Breed: Other (cattle)
Age: VA
Weight: 1200 LB
CM: STIFF HIND-END GAIT AFTER 20 DAYS ON RACTOP AMINE. CONTINUES TO FEED OPTAFLEXX.
Causality
Assessment
2
2
Time
To Onset
20 DA
20 DA
Clinical Detail:
G LOCOMOTION DISORDER
G STIFFNESS, HIND LIMB(S
Source:
Country:
State:
United States
KANSAS
Zip:
66506
OWNER
Episode Date:
05/0112004
Dose Description: 300 MG/HD/DA Y; 4/23-4/30/04
Extra Label:
None
CVM _ Rep01t.rep
Source Report Id:
NDC:
Product Lot No:
US200401273
UNK
#Treated:
2
#Reacted: 2
#Died:
0
Species: CATTLE
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
RESEARCH STUDY T4V200332
Age:
Good
Veterinarian
Low
Unknown
Weight:
Gender:
Page: 11
15 MO
1200 LB
Male, neutered
BREED: HOLSTEIN-FRIESIAN. ONE STEER BLOATED ON 511104 AND ANOTHER ON 512104. THEY WERE BOTH
TREATED WI STOMACH TUBE AND RECOVERED.
Causality
Assessment
Time
8 DA D BLOAT
Source:
Country:
United States
State:
TEXAS
Zip:
79109
STUDY #T4V200324
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0510512004
Recommended dose
Oral (in dry feed)
200, 33 GITON; 90 MG; 514-5104
None
STUDY #T4V200324
Good
Veterinarian
Low
Unknown
Source Report Id:
US200401279
NDC:
Product Lot No:
101PC1
#Treated:
550
#Reacted: 3
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1100 LB
3 STEERS WERE REMOVED FROM THE STUDY. 2 HAD RESPIRATORY DISEASE. ONE WAS TREATED WI CEFTIOFUR
AND RECOVERED. THE OTHER WAS REMOVED FROM THE PEN, RECOVERED WIOUT TX AND WAS RETURNED TO
THE STUDY. ONE STEER WAS REMOVED DUE TO DIGESTIVE PROBLEMS. FlU: LOT# ADDED.
Causality
Assessment
CVM _ Repmt.rep
Time
1 DA D DIGESTION DISORDER
1 DA D GI, ABNORMAL
0 1 DA R RESPIRATORY DISORDER
Page: 12
Source:
Country:
United States
State:
KANSAS
Zip:
RESEARCH STUDY
Episode Date:
05/14/2004
67401
Dose Description: 200 MG/HD/DAY; 5/11-15/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
POST MARKETING STUDY
Good
Veterinarian
Missing information
Unknown
Source Report Id:
US200401488
NDC:
Product Lot No:
101PC1
#Treated:
#Reacted:
#Died:
0
Species: CATTLE
Age: 15 MO
Weight:
1150 LB
A STEER (ID#8341) WAS REMOVED FROM THE STUDY DUE TO PNEUMONIA. FlU: LOT# ADDED.
Causality
Assessment
0
Time
To Onset
3 DA
Clinical Detail:
R PNEUMONIA
Source:
Country:
State:
United States
COLORADO
Zip:
80644
Episode Date:
05/03/2004
CVM _ Report.rep
Source Report ld:
US200402213
NDC:
Product Lot No:
UNK
#Treated:
1500
Page: 13
#Reacted: 180
0
Dose Description: 200 MGIHDIDA
Species: CATTLE
Extra Label: None Breed: Mixed (cattle)
Reason For Use:
INCREASE FEED EFFICIENCY
Age: 24 MO
Weight: 1350 LB
Health Status:
Good
Administered By:
Owner
Concomitants: Unknown
REDUCTION IN QUALITY GRADE AT SLAUGHTER. 8-12% OF THE HIGH GRADE CATTLE MARKETED WERE GRADED
AS SELECT RATHER THAN CHOICE GRADE.
Causality
Assessment
Time
1 MO G MEATABN
Source:
Country:
United States
State:
IOWA
Zip:
Report Ouality: Average
REPORTED BY NUTRITIONIST
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
06/01 /2004
Recommended dose
Oral (in dry feed)
200 MG/HD/DA
None
51525
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infonnation
Owner
Missing infonnation
Unknown
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
2 STEERS HAVE DIED. NECROPSY: CAUSE OF DEATH WAS ENTEROTOXEMIA.
CVM _ Repmt. rep
US20040402140
UNK
#Treated:
800
#Reacted: 2
#Died:
2
Species: CATTLE
Age: UN
Weight:
1200 LB
Causality
Assessment
0
0
0
Time
To Onset
UN
UN
UN
Clinical Detail:
D ENTERITIS
D GI, ABNORMAL
D PR-INTEST, LESION(S)
Page: 14
Source:
Country:
State:
United States
TEXAS
Zip:
78638
RMPDC
Episode Date:
06/01/2004
Dosage: Not applicable
Route: Topical (all other)
Source Report ld:
NDC:
Product Lot No:
Dose Description: EXPOSED WHILE WORKING AT FEEDLOT
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species
ACCIDENTAL
Missing infonnation
Not applicable
Not applicable
Unknown
US200402760
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
Male
44 YR
UN
FEEDLOT WORKER HAD BEEN USING RACTOP AMINE FOR 1 MONTH. CM: ACHES AND PAINS IN THE ARM
SHOULDER. THE MAN STATED THAT RACTOP AMINE HAD BEEN DETECTED IN HIS BLOOD AT THE HOSPITAL.
HOSPITAL TOLD HIM HE HAD CIRCULATORY PROBLEMS AND WAS REFERRED TO A CARDIOLOGIST. MAN HAD
USED A DUST MASK WHEN HANDLING RACTOPAMINE. H/0: LIFE LONG SMOKER. UNK IF HE HAS SEEN A
CARDIOLOGIST.
Causality
Assessment
-9
-9
Time
To Onset
1 MO
NA
NA
1 MO
CVM _Report. rep
Clinical Detail:
c CIRCULATORY DISORDER
G ACCIDENTAL EXPOSURE
G HUMAN EXPOSURE
G PAIN, LIMB(S)
Page: 15
Source:
Country:
United States
State:
KANSAS
Zip:
ATUDY T4V200332
Episode Date:
06115/2004
Dose Description: 5/25/04 TO 6/15/04
Extra Label:
None
Reason For Use:
STUDY T4V200332
Health Status:
Good
Administered By:
Veterinarian
Vet Opinion: Missing information
Concomitants: Yes
TYLOSIN 9 G/TON
2 MONENSIN 27 G/TON
66502
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
US200402788
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
CATTLE
Mixed (cattle)
18 MO
1310 LB
Male, neutered
RACTOPAMINE 18G/TON, MONENSIN AT 27 G/TON, TYLOSIN 9G/TON. STEER 217 FROM PEN 504 WAS FOUND DEAD.
NECROPSY: SEVERE RUMINAL FROTHY BLOAT AND RUMINAL ACIDOSIS. CAUSE OF DEATH FROTHY BLOAT
Causality
Assessment
Time
To Onset
21 DA
21 DA
Clinical Detail:
D ACIDOSIS, RUMEN
D BLOAT
21 DA D PR-STOMACH, LESION(S)
21 DA G DEATH
Source:
Country:
United States
State:
CALIFORNIA
POST MARKET STUDY
CVM _ Repmt.rep
Zip:
93422
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200403255
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0611912004
#Treated:
Recommended dose
#Reacted:
Oral (in dry feed) #Died:
Species:
None Breed:
STUDY T4V060406
Age:
Weight:
Good
Gender:
Veterinarian
Missing infonnation
Yes
MONENSIN FROM 611 4104
2 TYLOSIN FROM 6114104
Page: 16
65
0
CATTLE
Mixed (cattle)
14 MO
1200 LB
Male, neutered
STEER 426 FROM PEN #4 BLOATED. RTX: WATER/MIN OIL DRENCH SEVERAL TIMES; POLOXALENE. THE STEER
HAD BLOATED 2 PREVIOUS TIMES AND RECOVERED WI TREATMENT. ON 6123 THE STEER BLOATED AGAIN; AGAIN
TREATED WI WATER/MIN OIL. 711104 BLOATED AGAIN-TREATED WI WATER, POLOXALENE. HE WAS REMOVED
FROM THE STUDY PEN FOR TREATMENT BUT RETURNED ON 712104. FlU: 718104: STEER CONTINUES TO BLOAT EVERY
FEW DAYS BUT HAS REMAINED ON STUDY. NOW BEING TREATED WI WATER, MIN OIL, THERABLOAT.
Causality
Assessment
Time
5 DA D BLOAT
Source:
Country:
United States
State:
INDIANA
Zip:
ELANCO SALES REP
Episode Date:
0312412004
Route: Topical (all other)
Dose Description: UNK AMT; 3123104
Extra Label:
Species
Reason For Use:
ACCIDENTAL
Health Status:
Missing information
CVM_Report.rep
46140
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200403294
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
48 YR
UN
Female
Page: 17
Administered By:
Vet Opinion:
Concomitants:
Not applicable
Not applicable
No Value
WOMAN TOUCHED UNOPENED BAGS OF RACTOPAMINE TO SMELL THE PRODUCT THEN TOUCHED HER NOSE
WITH HER HANDS. WITHIN ONE DAY THE AREA AROUND HER NOSE BROKE OUT IN PIMPLES. HER NOSE
REMAINED SORE FOR 10 DAYS.
Causality
Assessment
-9
-9
Time
To Onset
NA
1 DA
NA
Clinical Detail:
G APPLICATION SITE PAIN
G HUMAN EXPOSURE
-9 NA G HUMAN EXPOSURE, HAND(S
-9 NA G HUMAN EXPOSURE, TOPICA
1 DA ERUPTION(S)
Drug Name: RACTOP AMINE
Source:
Country:
United States
State:
CALIFORNIA
Zip:
POST MARKET STUDY
Episode Date:
06/1 6/2004
93422
Dose Description: 300 MG/DA Y; FROM 6115/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
STUDY T4V060406
Good
Veterinarian
Yes
MONENSIN
2 TYLOSIN
CVM _Report. rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200402955
102PC1, 101PC1
#Treated:
65
#Reacted:
#Died:
0
Species: CATTLE
Age: 14 MO
Weight: 1224 LB
Page: 18
STEER #437 IN PEN 9 HAD SIGNS OF RESP DISEASE. TREATED W/ CEFTIOFUR HCL AND REMAINED ON THE STUDY.
7/1/04 FlU CALL-STEER RECOVERED AND REMAINED ON STUDY. FlU: LOT# ADDED.
Causality
Assessment
Time
1 DA G ANOREXIA
1 DA G FEVER, BODY
1 DA R DISCHARGE, NOSE
1 DA R RESPIRATORY DISORDER
Source:
Country:
United States
State:
INDIANA
Zip:
46140
Episode Date:
07/05/2004
Dosage: Reconunended dose
Dose Description: 230 MG/HD/DA; 6/1-7/6/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
IMPROVED FEED EFFICIENCY
Good
Owner
Low
Yes
MONENSIN
2 TYLOSIN
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200404170
UNK
#Treated:
150
#Reacted: 2
#Died:
2
Species: CATTLE
Age: UN
Weight:
UN
Gender: Female
FEEDLOT MANAGER REPORTED THAT 1 COW HAD BLOAT. THE CAUSE OF DEATH IN THE OTHER COW WAS
UNDETERMINED.
Causality
Assessment
CVM _Report. rep
Time
To Onset
34 DA
34 DA
RACTOP AMINE
Clinical Detail:
D BLOAT
G DEATH
Page: 19
Drug Name:
Source:
Country:
United States
State:
NEBRASKA
ANONYMOUS NUTRITIONIST
Episode Date:
07/ 13/2004
Dosage: Unknown
Zip:
Route:
Dose Description:
Oral (in dry feed)
7/13/04
Extra Label:
Unknown
XX XXX
Reason For Use:
IMPROVE FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infonnation
Owner
Unknown
Source Report ld:
US200404267
NDC:
Product Lot No:
UNK
#Treated:
190
#Reacted: 190
#Died:
190
Species: CATTLE
Age: UN
Weight:
UN
Gender: Unknown
ANONYMOUS NUTRITIONIST CALLED TO OBTAIN VERIFICATION OF A RUMOR THAT 190 CATTLE ON
RACTOP AMINE HAD DIED OF HEAT STROKE. NEBRASKA EXTENSION NUTRITIONIST HAD NOT HEARD OF THE
INCIDENT. ELANCO WAS UNABLE TO CONFIRM THE RUMOR.
Causality
Assessment
Time
-8 UN G DEATH
Source:
Country:
United States
State:
UNKNOWN
Zip:
OWNER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
CVM _Report. rep
07/10/2004
Recommended dose
Oral (in dry feed)
200 MG/HD/DA
xxxxx
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200404317
UNK
#Treated:
#Reacted:
#Died:
Species:
66000
112
112
CATTLE
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Missing information
Owner
Medium
Yes
Breed:
Age:
Weight:
Gender:
MONENSIN
2 TYLOSIN
Page: 20
Unknown (cattle)
UN
UN
Male, neutered
DEATH RATES IN STEERS FED RACTOPAMINE WERE TWICE THAT OF STEERS NOT FED RACTOPAMOINE OVER THE
LAST 25 DAYS, AN INCREASE OF 0.17%. CATTLE WERE FED 3 TIMES PER DAY.
Time Causality
0 UN G DEATH
Source:
Country:
United States
State:
NEBRASKA
Zip:
OWNER
Episode Date:
07/27/2004
69127
Dose Description: 200 MG/HD/DA; 6/24-7/27/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASED RATE OF GAIN
Good
Owner
Unknown
Source Report Id:
US200404818
NDC:
Product Lot No:
101PC1
#Treated:
66
#Reacted: 66
#Died:
0
Species: CATTLE
Age: UN
Weight:
1276 LB
OWNER REPORTED THERE WAS NO INCREASE IN WEIGHT GAIN WITH THIS GROUP OF CATTLE AFTER 33 DAYS ON
RACTOP AMINE. THEY HAVE BEEN SENT TO SLAUGHTER.
CVM _Report. rep
Causality
Assessment
0
0
Time
To Onset
NA
NA
Clinical Detail:
E INEFFECT, PRODUCTION (MEAT)
E INEFFECT, WEIGHT INC
Document ID: N 141221 Submission ID: L 56 PackageiD: A 1 Corrsp Date: 08/25/2004
Source:
Country:
State:
United States
MISSING INFORMA Zip: xxxxx
INFO MISSING
Episode Date:
Dosage:
Route:
Dose Description:
08/1 6/2004
Unknown
Oral (in dry feed)
TOPDRESSED; UNK DATES
Source Report ld:
US200405004
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
Page: 21
363
363
0
Extra Label:
Unknown Breed: Unknown (cattle)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infom1ation
Owner
Unknown
Age: UN
Weight:
UN
Gender: Unknown
NO INFORMATION REGARDING DOSAGE OR DURATION OF ADMINISTRATION. FEEDY ARD REPORTED A SHIFT IN
MEAT GRADE FROM CHOICE TO SELECT IN CALVES FED RACTOP AMINE. THESE CALVES ALSO CONSUMED MORE
FEED AND GAINED MORE WEIGHT THAN NON RACTOPAMINE FED CATTLE. ON 8/23/04 ELANCO RECEIVED
INFORMAL EVALUATIONS FROM THE FEEDY ARD. IN THE FIRSAT EVALUATION THE RACTOP AMINE CATTLE
GAINED 20 LBS MORE AND HAD 36% DISCOUNTED BEEF VS 18% IN THE CONTROL GROUP. IN THE SECOND
EVALUATION THE RACTOPAMINE FED CATTLE GAINED 5 LBS MORE AND HAD 7.6% DISCOUNTED BEEF VS 3.3% IN
THE CONTROLS. THE FEEDY ARD DOES NOT INTEND TO USE RACTOPAMINE AGAIN AS THEY SEE NO ADVANTAGE
TO IT.
Causality
Assessment
0
Time
To Onset
NA
Clinical Detail:
G MEATABN
Source:
Country:
CYM _Report. rep
United States
Source Report ld:
US200405089
NDC:
State:
KANSAS
Zip:
67842
Product Lot No:
206PC4
OWNER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/12/2004
Recommended dose
Oral (in dry feed)
200MG/DA
None
Good
Owner
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 22
365
365
0
CATTLE
Unknown (cattle)
UN
1280 LB
Male, neutered
ON FARM FEEDING DEMONSTRATION. 365 FED RACTOPAMINE AND 365 IN CONTROL GROUP, NOT FED
RACTOPAMINE. DECREASE IN FEED INTAKE BY 2 LB/HD/DA Y FOR 3 DAYS IN BOTH GROUPS. INTAKE RETURNED TO
NORMAL (32-33 LB/HD/DA Y) 3 DAYS AFTER INTRODUCTION OF THE NEW FEED. STEERS ON RACTOP AMINE
RETURNED TO NORMAL INTAKE FASTER. MILL MANAGER FELT THAT WEIGHING THE CATTLE CAUSED THE
REDUCED INTAKE. ALSO STATED THAT THE RACTOPAMINE CONTAINING FEED SMELLED SWEETER THAN THE
CONTROL RATION.
Causality
Assessment
0
Time
To Onset
1 DA
Clinical Detail:
G ANOREXIA
Source:
Country:
United States
State:
IOWA
PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
CVM _Report. rep
Zip:
XX :XXX
07112/2004
Recommended dose
Oral (in dry feed)
200 MG/DA; 6/04 TO 7/04
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
US2004051 00
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
800
800
5
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
Breed:
Age:
Weight:
Gender:
Page: 23
Mixed (cattle)
UN
UN
Male, neutered
FINISHING STEERS WENT OFF FEED FOR A FEW DAYS AFTER VERY HOT AND HUMID TEMPERATURES. THE
STEERS RECEIVING RACTOPAMINE BACKED OFF FEED FOR A LONGER PERIOD AND WERE DOWN 3-4 LBS PER
ANIMAL AFTER THE PERIOD OF ANOREXIA. ALSO HAD 8 STEERS DIE OF BLOAT; 5 WERE ON RACTOP AMINE. ONE
WAS IDENTIFIED AS A DIGESTIVE DEAD AND WAS NECROPSIED-RESULTS WERE INCONCLUSIVE. PRODUCER IS
STILL USING RACTOPAMINE.
Causality
Assessment
Drug Name:
Time
To Onset
1 MO
1 MO
1 MO
RACTOP AMINE
Clinical Detail:
D BLOAT
G ANOREXIA
G DEATH
Source:
Country:
United States
State:
KANSAS
Zip:
FEEDYARD
Episode Date:
08/29/2004
XX XXX
Dose Description: 200 OR 250 MG/HD/DA X 28 DAYS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CYM _Report. rep
None
INCREASEDRA TE OF GAIN
Missing information
Owner
Unknown
Source Report ld:
US200405377
NDC:
Product Lot No:
UNK
#Treated:
1200
#Reacted: 1200
#Died:
0
Species: CATTLE
Age: UN
Weight: UN
Gender: Female
Page: 24
DECREASED FEED INTAKE WITH NO GAIN RESPONSE. FEED CONSUMPTION DROPPED AFTER 3RD DAY AND
REMAINED ERRATIC THROUGH DAY 28. A VG DROP OF 1 TO 1.5 LBS/DA Y COMPARED TO CONTROLS. HALF WERE
ON 200 AND HALF ON 250 MG/HD/DA FOR 28 DAYS.
Causality
Assessment
Time
2 3 DA G ANOREXIA
Source:
Country:
United States
State:
UNKNOWN
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
09/0112004
Recommended dose
Oral (in dry feed)
200 MG/HD/DA
None
XX XXX
Reason For Use:
INCREASED FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Yes
TYLOSIN PHOSPHATE 8G/TON
2 MONENSIN 23 G/TON
Source Report Id:
US200405461 .
NDC:
Product Lot No:
UNK
#Treated:
1600
#Reacted: 70
#Died:
0
Species: CATTLE
Age: 13 MO
Weight:
1200 LB
SLIGHT INCREASE IN FEED CONSUMPTION DURING THE FIRST 10 DAYS. CM: HYPERACTIVE AND A BIT STIFF
GAITED. THE CATTLE WERE ON CONCRETE AND HAD AN INCREASED INCIDENCE OF LEG PROBLEMS.
Causality
Assessment
2
2
2
Time
To Onset
17 DA
1 DA
17 DA
17 DA
CYM _Report.rep
Clinical Detail:
G LEG DISORDER
G POLYPHAGIA
G STIFFNESS, LIMB(S)
N HYPERACTNITY
Page: 25
Source:
Country:
United States
State:
MISSOURI
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
10/04/2004
Unknown
Oral (in dry feed)
UNK; 9/24/04
Unknown
XX :XXX
Reason For Use:
INCREASED FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Fair
Owner
Unknown
Source Report ld:
US200405609
NDC:
Product Lot No:
UNK
#Treated:
35
#Reacted: 35
#Died:
2
Species: CATTLE
Age: UN
Weight: 1300 LB
Gender: Unknown
GROSS NECROPSY-SIGNIFICANT LUNG DAMAGE IN BOTH ANIMALS. THE GROUP IN THIS PEN HAD CHRONIC RESP
DISEASE AND THERE WERE OTHER ANIMALS W/ LABORED BREATHING.
Causality
Assessment
-1
Time
To Onset
11 DA
Clinical Detail:
G DEATH
-1 11 DA R PR-LUNG(S), LESION(S)
Source:
Country:
State:
United States
TEXAS
Zip:
79241
VET
Episode Date:
1110112004
Dose Description: 200 MG/HD/DA: 1111104 TO 12/2/04
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200406379
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
1000
1000
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
Breed:
Age:
Weight:
Gender:
Page: 26
Mixed (cattle)
UN
1050 LB
Female
FEED CONSUMPTION WAS APPROX 0.5 TO 1 LB LESS/DAY/ANIMAL SINCE STARTING RACTOPAMINE. FIU:3/17/05.
SALES REP UPDATE. NO FURTHER INFO.
Causality
Assessment
3
Time
To Onset
12 HR
Clinical Detail:
G ANOREXIA
3 12 HR G UNPALATABLE, WON'T EAT
Source:
Country:
United States
State:
GEORGIA
Zip:
39861
OWNER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01114/2005
Unknown
Oral (in dry feed)
UNK CONCENTRATION, 1114/05
Unknown
Good
Owner
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200500221
UNK
#Treated:
5
#Reacted: 5
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1200 LB
SHOW CATTLE, 4 STEERS, 1 HEIFER. SOON AFTER STARTING THE OWNER NOTICED THE CATTLE ACTING MORE
AGGRESSIVE AND CONSUMING ALL THE FEED THEY WERE OFFERED.
Causality
Assessment
CVM _Report. rep
Time
Page: 27
1 DA G POLYPHAGIA
2 1 DA N AGGRESSION
Document ID: N 141221 Submission ID: S 75
Source:
Country:
State:
Foreign
Zip:
PRODUCER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11102/2004
Recommended dose
Oral (all other)
300 MGIHDIDA Y
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED DAILY INTAKE, FEED EFFICIENCY AND
CARCASS WEIGHT
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
MX200500002
UNKNOWN
#Treated:
68
#Reacted: 68
#Died:
0
Species: CATTLE
Age: 2 YR
Weight: 450 KG
Gender: Unknown
CM: PRODUCER DID NOT SEE ANY IMPROVEMENT, PHYSICAL CONFORMATION OF CATTLE WAS VERY BAD.
CARCASS WEIGHT IN SOME OF THE 68 TREATED WAS LESS COMPARED TO OTHER ANIMALS ON THE RANCH.
Causality
Assessment
Time
NA E INEFFECT, LEAN CARCASS
Source:
Country:
United States
State:
KANSAS
2/ 1105
CVM _Report. rep
Zip:
67502
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Corrsp Date: 03/21 /2005
US200500640
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
02/0112005
Recommended dose
Oral (in dry feed)
NOV, 2004 APPROX
None
Good
Owner
Missing information
Yes
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
MONENSIN
2 TYLOSIN
Page: 28
5000
11
11
CATTLE
Unknown (cattle)
UN
1100 LB
Male
FEEDY ARD HAD INCREASE IN DIGESTIVE RELATED DEATHS. 2.111000 HD (11 OUT OF 5000). DEATH RATE HAD
BEEN LOWER PRIOR TO RACTOPAMINE.
Causality
Assessment
Time
To Onset
2 MO
2 MO
Clinical Detail:
D GI, ABNORMAL
G DEATH
Source:
Country:
United States
State:
TEXAS
Zip:
79015
FEED LOT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
CVM _Report. rep
02/28/2005
Recommended dose
Oral (in dry feed)
200 MG/HD/DA
None
Missing infom1ation
Source Report ld:
US200500648
NDC:
Product Lot No:
UNK
#Treated:
6
#Reacted: 6
#Died:
6
Species: CATTLE
Age: UN
Weight:
UN
Gender: Unknown
Administered By:
Vet Opinion:
Concomitants:
Owner
Yes
MONENSIN, TYLOSIN
Page: 29
2 FEEDLOTS HAD HIGHER THAN NORMAL DEATH LOSS RATES. DURING THE WEEK OF 2/28/05 THEY EACH
EXPERIENCED 3 DEATHS.
Causality
Assessment
Time
0 UN G DEATH
Source:
Country:
United States
State:
ILLINOIS
POST APPROVAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
03/03/2005
Unknown
Oral (all other)
2114-3/4/05
None
Zip:
61802
Reason For Use:
POST APPROVAL STUDY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing information
Unknown
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200500677
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
CATTLE
Angus (include red)
16 MO
1150 LB
Female
A HEIFER WAS REMOVED FROM THE POST APPROVAL STUDY DUE TO A HEMATOMA ON THE LEFT SHOULDER
AND ANOREXIA.
Causality
Assessment
0
0
Time
To Onset
17 DA
17 DA
CVM _Report. rep
Clinical Detail:
G ANOREXIA
G BLD(HEMATOMA)
Page: 30
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
04111/2005
Recommended dose
Oral (in dry feed)
200 MG/HD/DA STARTING 4/ 11/05
None
INCREASE RATE OF GAIN
Good
Owner
Yes
MONENSIN 300 MGIHDIDA
Source Report ld:
US20050 1170
NDC:
Product Lot No:
UNK
#Treated:
240
#Reacted: 240
#Died:
0
Species: CATTLE
Age: UN
Weight: 1100 LB
OWNER NOTED INCREASED FEED INTAKE BY 2 LBS/DA AS FED ON A 60-70% DRY MATTER RATION.
Causality
Assessment
0
Time
To Onset
10 DA
Clinical Detail:
G POLYPHAGIA
Source:
Country:
State:
Episode Date:
Dosage:
Route:
United States
MINNESOTA
Zip:
56164
0511112005
Overdose
Oral (in dry feed)
Dose Description: 22.7 G; 5/10/05
Extra Label:
Overdose
CVM _Report. rep
Source Report Id:
US200501334
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: CATTLE
Breed: Angus (include red)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
SHOW STEER
Good
Owner
High
Unknown
Age:
Weight:
Gender:
Page: 31
UN
1100 LB
Male, neutered
OWNER FED HALF A POUND OF TYPE A RACTOPAMINE TO A SHOW STEER. 22.7 GAT ONE FEEDING. CM:
SWEATING PROFUSELY, RECUMBENT, PANTING. NEXT DAY THE STEER WAS STANDING, DRINKING(APPROX 30
GAL) AND EATING BUT STILL SWEATING SLIGHTLY AND APPEARED A LITTLE STIFF. RECOVERED BY 5/ 18/05.
Causality
Assessment
5
5
5
5
Time
To Onset
1 DA
2 DA
1 DA
1 DA
Clinical Detail:
G RECUMBENCY
G STIFFNESS
SWEATING
R POLYPNEA
Source:
Country:
State:
Foreign
Zip:
MEXICO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/28/2004
Recommended dose
Oral (in dry feed)
300 MG/HD/DA: DEC 2004 APPROX
None
UNK
Poor
Owner
Unknown
Source Report ld:
MX20050000 1
NDC:
Product Lot No:
UNK
#Treated:
250
#Reacted: 250
#Died:
0
Species: CATTLE
Age: 2.5 YR
Weight: 350 KG
Gender: Unknown
DECREASED AVG DAILY CONSUMPTION, 1-2 KG/HD/DA. REPORT FROM MEXICO.
CVM _Report. rep
Prepared on 04/1 8/20 11
Page: 32
Causality
Assessment
Time
UN G ANOREXIA
UN G UNPALATABLE, WON'T EAT
Drug ~ a r n e : RACTOPAMINE
Document IQ: N 141221 Submission ID: L 93
Source:
Country:
State:
Foreign
Zip:
MEXICO
Episode Date:
03/1112005
Dose Description: 300 MG/HD/DA: 2/7/05 TO 3/9/05
Extra Label: None
PackageiD: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Medium
Unknown
MX200500009
UNK
#Treated:
74
#Reacted: 14
#Died:
14
Species: CATTLE
Age: 2 YR
Weight: 410 KG
Gender: Male
REPORT FROM MEXICO. SOME HAD POOR WEIGHT GAIN; ABOUT 0.7 KG/HD/DA. SLAUGHTERED 30 DAYS AFTER
RACTOPAMINE STOPPED. CARCASS DATA: 60% SUPREME, 22% GOOD, 19% STANDARD.
Causality
Assessment
Time
0 NA E INEFFECT, PRODUCTION (MEAT)
Source:
Country:
State:
United States
INDIANA
Zip:
46140
CVM _Report. rep
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
US200500422
lOIPCl
Page: 33
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
02110/2005
Not applicable
Product defect
Not applicable
Not applicable
Not applicable
Not applicable
No
#Treated:
0
#Reacted: 0
#Died:
0
Age: NA
Weight: NA
FEED ASSAY SHOWED THAT POTENCY OF RACTOPAMINE IN SOME TYPE C FEEDS POTENTIALLY DECREASES W/IN
24 TO 96 HRS OF MIXING. FlU: 10/7/05-#109-FURTHER EVAL AT BLANCO AND EUROFINS- RESULTS WITHIN
PERMITTED VARIATION FOR RACTOP AMINE.
Causality
Assessment
0
Time
To Onset
NA
Clinical Detail:
P PD-POTENCY, LO
Source:
Country:
State:
Foreign
Zip:
MEXICO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _ Repmi.rep
06/02/2005
Recommended dose
Oral (in dry feed)
300 MG/HD/DA; 6/2/05 TO 6/6/05
None
CARCASS LEANNESS
Good
Owner
High
Unknown
Package ID: A 1 Corrsp. Date: 06/23/2005
Source Report ld:
MX200500036
NDC:
Product Lot No:
UNK
#Treated:
80
#Reacted: 80
#Died:
0
Species: CATTLE
Age: 1.5 YR
Weight: 500 KG
Gender: Unknown
Page: 34
REPORT FROM MEXICO. CATTLE HAD BEEN FED ZILPATEROL FOR 5 DAYS THEN SWITCHED TO RACTOPAMINE.
CATTLE REJECTED THE FOOD FOR 3 DAYS. THE OWNER STOPPED RACTOPAMINE AND CONTINUED WI
ZILPATEROL. INTAKE RETURNED TO NORMAL.
Causality
Assessment
Time
3 NA G UNPALATABLE, WON'T EAT
Source:
Country:
Foreign
State: Zip:
VET REPORT-MEXICO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/28/2005
Recommended dose
Oral (in dry feed)
400 MGIHDIDA; 12112/04
Other
INCREASED CARCASS LEANNESS
Good
Owner
High
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
MX200500041
212PC4
#Treated:
350
#Reacted: 80
#Died:
0
Species: CATTLE
Age: 1.5 YR
Weight:
430 KG
Gender: Missing information
MEXICO. DID NOT GET DESIRED RESULTS IN 30 DAYS SO THE OWNER FED FOR ADDITIONAL 10 DA YS(40 DAYS
TOTAL). OWNER FEELS THAT RACTOPAMINE IS TOO EXPENSIVE CONSIDERING THE LACK OF RESULTS. LABEL:
FEED FOR 28 DAYS.
Causality
Assessment
Time
NA E INEFFECT, PRODUCTION (MEAT)
Source:
Country:
State:
United States
Zip:
xxxxx
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US2005021 07
UNK
Page: 35
Episode Date:
07/25/2005
#Treated:
#Reacted:
Route: Oral (all other) #Died:
0
Dose Description: 6-8 PELLETS; 7/25/05 Species: DOG
Extra Label:
Species Breed: Australian cattle dog
Reason For Use:
ACCIDENTAL
Age: 2 YR
Weight: 35 LB
Health Status:
Good
Gender: Female, neutered
Administered By:
Not applicable
Concomitants: No
DOG CONSUMED 6-8 PELLETS CONTAINING RACTOPAMINE. CM: HR=180-200 BPM. DOG REMAINED LETHARGIC
THE REST OF THEDA Y; RECOVERED W/IN 24 HRS.
Causality
Assessment
4
-9
4
Time
To Onset
12 HR
NA
12 HR
Clinical Detail:
C TACHYCARDIA
G DEPRESSION/LETHARGY
Source:
Country:
State:
Foreign
Zip:
MEXICO REPORT
Episode Date:
06/21/2005
Dosage:
Overdose
Dose Description: 30 PPM 6/18-7/8/05
Extra Label:
Overdose
Reason For Use:
GROWTH PRO MOT ANT
Health Status:
Good
CVM _Report. rep
Source Report ld:
NDC:
Product Lot No:
MX200500050
UNK
#Treated:
103
#Reacted: 103
#Died:
0
Species: CATTLE
Age: 2 YR
Weight: 430 KG
Gender: Female
Administered By:
Vet Opinion:
Concomitants:
Owner
High
No Value
PTX: RACTOPAMINE ADDED TO RATION AT 8.6 KG/HD. CM: DECR FEED INTAKE.
Causality
Assessment
3
Time
To Onset
6 HR
Clinical Detail:
G ANOREXIA
Document ID: N 141221 Submission ID: L 106 Package ID: A 2 Corrsp Date: 09/01 /2005
Page: 36
Foreign
Source Report ld:
MX200500051
Country:
State: Zip:
MEXICO REPORT
Episode Date:
07/20/2005
Dose Description: 300 MG/HD/DA Y 7/20-7/27/05
Extra Label: None
Reason For Use:
UNKNOWN
Health Status:
Good
Administered By:
Owner
Vet Opinion: High
Concomitants: No Value
NDC:
Product Lot No:
213PC4
#Treated:
240
#Reacted: 240
#Died:
0
Species: CATTLE
Age: 18 MO
Weight:
450 KG
Gender: Missing infonnation
CM: DECR FEED INTAKE. RTX: DECR DOSE TO HALF AND RECOV. DDX: BAD WEATHER ALSO.
Causality
Assessment
2
Time
To Onset
6 HR
Clinical Detail:
G ANOREXIA
Source:
Country:
State:
CYM _Report. rep
United States
Zip:
Source Report ld:
US200502565
NDC:
IOWA
APSS CASE
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/17/2005
Not applicable
Inhalation
52339
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
INHALED AND POSS LICKED PRODUCT
Species:
Species
ACC
Good
Not applicable
High
No
Breed:
Age:
Weight:
Gender:
Page: 37
2
0
DOG
Unknown (dog)
9 YR
70 LB
Female, neutered
CM: ACC ACCESS TO RACTOPAMINE PRESENT IN YARD. BOTH SNIFFED AND POSS LICKED. 4 HRS LATER
ANOREXIA AND PANTING WITH HI HR. RTX: ATENOLOL Q 8 HRS FOR 3 DOSES AND RECOV.
Causality
Assessment
2
Time
To Onset
60 MN
Clinical Detail:
C TACHYCARDIA
-9 NA G ACCIDENTAL EXPOSURE
2 60 MN G ANOREXIA
2 60 MN R POLYPNEA
Source:
Country:
State:
Report from sponsor or di stibutor of drug
United States
NEBRASKA
Zip:
68864
Episode Date:
11101/2005
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200503064
UNK
#Treated:
#Reacted:
#Died:
540
216
0
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
200 MGIHDIDA Y
None
INCT WT GAIN, CARCASS LEANNESS AND IMPROVE
FEED EFF
Good
Owner
Missing infonnation
Yes
SYNOVEX PLUS TRENBOLONE I ESTRADIOL IMPLANTS
CM: 30-40% OF HERD WERE CLASSIFIED AS DARK CUTTERS AND NOT GRADED.
Causality
Assessment
0
Time
To Onset
28 DA
Clinical Detail:
G MEAT, ABNCOLOR
Species:
Breed:
Age:
Weight:
Gender:
Page: 38
CATTLE
Mixed (cattle)
2 YR
XX
Male, neutered
Document ID: N 141221 Submission ID: L 117 Package ID: A 1 Corrsp Date: 0110512006
Source:
Country:
United States
State:
PENNSYLVANIA
Zip:
19438
Episode Date:
0910212005
Dose Description: NOT REPORTED
Extra Label:
Species subgroup
Reason For Use:
NOT REPORTED
Health Status:
Good
Administered By:
Owner
Vet Opinion: Missing information
Concomitants: No
Source Report ld:
US200502711
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
CATTLE
Mixed (cattle)
Male
136 DA
469 LB
BREED: HOLSTEIN I FRIESIAN. CM: VEAL SLAUGHTERED AND HAD RACTOPAMINE RESIDUE. VET STATED THAT
THE CALF HAD NO KNOWN EXPOSURE TO RACTOPAMINE. FlU (123) 1124106: SAMPLES WERE TESTED BY FSIS AT
WESTERN LABS INCA; PROCESSING PLANT WAS IN PA. VET REPORTED THAT FSIS REPORTED 7 SAMPLES
POSITIVE DURING 2005(APPROX 40 SAMPLES ARE COLLECTED PER MONTH). ON 1124106, FSIS STATED THAT THESE
RESULTS WERE FALSE POSITIVES FROM AN EXPERIMENTAL ASSAY.
CYM _Report. rep
Causality
Assessment
-1
Time
To Onset
UN
Clinical Detail:
G RESIDUE, MEAT
Page: 39
Source:
Country:
United States
State:
COLORADO
Zip:
81052
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/27/2007
Recommended dose
Oral (in dry feed)
200MGIHDIDA Y, UNK DATES
None
UNKNOWN
Unknown
Veterinarian
Missing information
Unknown
. Source Report ld:
US200703057
NDC:
Product Lot No:
UNKNOWN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
Mixed (cattle)
UN
820 LB
Female
ON 8/23/07 DR. REPORTED A POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING OPTAFLEXX IN
A CLINICAL STUDY. DURING STUDYT4V080604, HEIFER # 5313 WAS TREATED FOR RESPIRATORY SYMPTOMS AND
PINKEYE AND REMOVED FROM THE STUDY ON 9/14/06. THIS HEIFER WAS FOUND DEAD ON 9/ 15/06 AND WAS
NECROPSIED BY THE ONSITE VET. SEVERE FIBRIN AND SERUM WAS NOTED IN THE PLEURAL CAVITY.
INTERSTIAL PNEUMONIA WAS NOTED TO BE AFFECTING 90% OF THE LUNG. A NECROPSY DIAGNOSIS OF
ATYPICAL INTERSTITIAL PNEUMONIA WAS MADE. THE OBJECTIVE OF THE STUDY IS TO EVALUATE THE
CUMULATIVE RESPONSE OF OPT AFLEXX WHEN FED TO BEEF HEIFERS THOUGHOUT THE LAST 42 DAYS OF THE
FINISHING PHASE, IMMEDIATELY PRIOR TO SLAUGHTER. A COMPLETE SUMMARY OF AE, SERIOUS AND NON
SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT.
Causality Time
0 UN G DEATH
0 UN R PNEUMONIA
0 UN R PR-LUNG(S), LESION(S)
0 UN R RESPIRATORY DISORDER
0 UN s EYE DISORDER
CVM _Report. rep
Page: 40
Source:
Country:
State:
United States
TEXAS
Zip:
79106
Report Quality: Poor
NON SPECIFIC INFORMATION
Episode Date:
09/05/2007
Dose Description: 200 MG/HD/D; ORAL, 2004
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN, IMPROVED FEED
EFFICIENCY AND INCREASED CARCASS LEANNESS
Health Status:
Unknown
Administered By:
Owner
US200703205
REQUESTED, NOT PROV.
#Treated:
500000
#Reacted: 0
#Died:
0
Species: CATTLE
Age: UN
Weight:
UN
Gender: Unknown
ON SEPTEMBER 5, 07, MS , REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN CATTLE. BEGINNING
IN 04, CACTUS FEEDERS BEGAN FEEDING A RATION INTENDED TO DELIVER RACTOP AMINE AT 200 MG/HG/DA Y.
SINCE THAT TIME, 500,000 HEAD HAVE BEEN FED THE RACTOP AMINE RATION AND 500,000 HEAD HAVE NOT BEEN
FED RACTOPAMINE. CACTUS FEEDER NOTED THAT THE PENS IN WHICH THE CATTLE WERE BEING FED
RACTOPAMINE AVERAGED 1 MORE DEATH LOSS THAN THOSE PENS THAT WERE NOT BEING FED RACTOPAMINE.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
02/05/2007
CVM_ Report. rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200703221
NOT PROVIDED
#Treated:
#Reacted:
200
2
Page: 41
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
200MG HEAD DAY ORAL UNKNOWN DATE
None
RESEARCH STUDY
Missing information
Unknown
Missing infonnation
Yes
ZILMAX 7.4 PPM AS FED BASIS 1217/06-2/5/07
#Died:
0
Species: CATTLE
Age: UN
Weight: 463 LB
POST APPROVAL STUDY TITLE: COMPARATIVE EFFECTS OF RACTOP AMINE AND ZILP ATEROL ON GROWTH
PERFORMANCE, CARCASS TRAITS, SENSORY CHARACTERISTICS, AND CARCASS CUTOUT YIELDS OF FINISHING
STEETS.
STUDY NUMBER: T4VME0605
PERSON RESPONSIBLE: DR. CONSULTANT
WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING
DURING RESEARCH STUDY T4VME0504, FOUR POTENTIAL ADVERSE DRUG
EXPERIENCES OCCURRED DURING THE COURSE OF THE STUDY, FROM DECEMBER 7 06 THOUGH FEBRUARY 5 07.
THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE COMPARATIVE EFFECT OF OPTAFLEXX (200MG/HD/DA Y)
AND ZILMAX (7.5 PPM AS FED BASIS) WHEN FED TO BEEF STEERS DURING THE LAST 33 DAY OF THE FINISHING
PHASE, IMMEDIATELY PIROR TO SLAUGHTER.
THREE HUNDRED STEER CAL YES (APPROXIMATELY 6 TO 9 MONTHS OF AGE) WERE SELECTED FROM THREE
DIFFERENT SOURCES FOR USE IN THIS STUDY. DURING THE COURSE OF THE STUDY FOUR STEERS WERE
REMOVED DURING THE TREATMENT PERIOD. IT WAS REPORTED THAT 2 STEERS, RECEIVING OTPAFLEXX, WERE
REMOVED DUE TO FRACTURED LIMBS. IT WAS ALSO REPORTED THAT 2 ADDITIONAL STEERS DIED DURING THE
STUDY HOWEVER, THESE ANIMAL WERE MEMBERS OF THE CONTROL GROUP AND DID NOT RECEIVE ANY
OPT AFLEXX DURING THE COURSE OF THE STUDY. A NECROPSY DIAGNOSIS OF RESPIRATORY DISEASE WAS
MADE IN THE BOTH OF THESE ANIMAL..
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G LEG DISORDER
M BONE, ABN
Source:
Country:
State:
United States
COLORADO
Zip:
80808
Episode Date:
09/07/2007
CYM _Report. rep
Source Report ld:
US200703265
NDC:
Product Lot No:
MISSING INFORMATION
#Treated:
320
#Reacted:
Dose Description: ORAL- 7/2005
Species:
Extra Label: None Breed:
Reason For Use:
RESEARCH STUDY
Age:
Weight:
Health Status:
Critical
Gender:
Administered By: Veterinarian
Vet Opinion: Missing infom1ation
Concomitants: Yes
TYLAN 100 PREMIX; PO; LABEL DOSE; NOV-2004*- JUL-2005*
2 RUMENSIN 80; PO; LABEL DOSE; NOV-2004*- JUL-2005*
3 MICOTIL 300; INJECTION; 10MG/KG BW; UNKNOWN
Page: 42
18
6
CATTLE
Unknown (cattle)
UN
VA
Male
POST REGISTRATION STUDY-THE EFFECTS OF MET APHYLACTIC TREATMENT WITH MICOTIL OR EX CEDE ON THE
INCIDENCE OF BOVINE RESPIRATORY DISEASE (BRD) AND THERAPEUTIC RESPONSE OF BAYTRIL OF DRAXXIN IN
THE TREATMENT OF BRD IN FEEDER CATTLE.
STUDY NO. T5C080529
PERSON RESPONSIBLE, MARILYN CORBIN
THIS STUDY'S OBJECTIVES ARE TO COMPARE THE EFFECTS OF MET APHYLACTIC ADMINISTRATION OF MICOTIL
AND EXCEDE WHEN COMPARED TO A NEGATIVE CONTROL ON BOVINE RESPIRATORY DISEASE (BRD) AND
ANIMAL PERFORMANCE IN NEWLY RECEIVED FEEDLOT CATTLE, AND TO COMPARE THE THERAPEUTIC
RESPONSE OF BA YTRIL OR DRAXXIN FOLLOWING MET APHYLACTIC TREATMENT WITH EITHER MICOTIL OR
EXCEDE. THESE CATTLE WERE ALSO FED WITH RUMENSIN AND TYLAN THROUGHOUT THE STUDY AN
OPT AFLEXX AT THE LAST 28-35 DAYS OF THE STUDY.
A TOTAL OF EIGHT HUNDRED STEERS WERE USED FOR THIS STUDY. CATTLE WERE PLACED IN 20 PENS, 40 HEADS
PER PEN. ONE HUNDRED SIXTY WERE RANDOMLY ASSIGNED TO THE NEGATIVE CONTROL TREATMENT GROUP,
AND 320 CALVES WERE RANDOMLY ASSIGNED TO EACH MICOTIL AND EX CEDE MET APHYLACTIC TREATMENT
GROUP.
AMONG THE 22 ANIMALS REMOVED FROM THE STUDY, TWELVE OF THEM WERE IN THE MICOTIL TREATMENT
GROUP. THEY WERE EITHER LAME, HAD CHRONIC BLOAT OR GOT BRD.
A TOTAL OF 18 CATTLE WERE DEAD. SIX OF THEM WERE IN THE MICOTIL TREATMENT GROUP. ONE DIED FROM
HARDWARE, ONE DIED FROM BRD AND FOUR DIED FROM BLOAT.
OVERALL, NO DIFFERENCES WERE OBSERVED ON BRD MORBIDITY, MORTALITY OR ANIMAL PERFORMANCE IN
CATTLE TREATED WITH MICOTIL OR EXCEDE DURING ARRIVAL PROCESSING. IN ADDITION, THERE WERE NO
DIFFERENCES ON HEALTH OUTCOMES WHEN EITHER BA YTIL OR DRAXXIN WAS ADMINISTERED FOLLOWING
MICOTIL OR EX CEDE MET APHLAXIS.
Causality
Assessment
0
0
CVM _Report. rep
Time
To Onset
UN
UN
Clinical Detail:
D BLOAT
G LAMENESS
0 UN
R RESPIRATORYDISORDER
Page: 43
Source:
Country:
Report from sponsor or distibutor of chug
United States
State:
WISCONSIN
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01128/2008
Not applicable
Oral (all other)
ORAL; 01-28-08*
Species
53114
Reason For Use:
ACCIDENTAL ANIMAL EXPOSURE
Health Status:
Good
Administered By:
Not applicable
Source Report ld:
NDC:
Product Lot No:
US200800804
REQ-NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
DOG
Shepherd, australian
3 YR
55 LB
Female, neutered
ADVERSE EXPERIENCES ON JANUARY 28,2008, THE ANIMAL PRODUCT SAFETY SERVICE (APSS) CONTACTED
ELAN CO ANIMAL HEALTH REGARDING A POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE
HYDROCHLORIDE IN AN AUSTRALIAN SHEPHERD DOG. ON THE MORNING OF JANUARY-28-2008, AN
AUSTRALIAN SHEPHERD DOG DEVELOPED ANOREXIA, DEPRESSION, LETHARGY, TREMBLING AND VOMITED A
DARK SUBSTANCE. LATER ON JANUARY-28-2008, DR , REGULAR VETERINARIAN, EXAMINED THE
DOG AND RAN UNKNOWN BLOOD TESTS. DR. WEIDMAN FOUND THE DOG TO BE TACHYCARDIC (180 BPM) AND
HYPOKALEMIC (2.7MEQ/L). THE OWNER OF THE DOG REPORTED THAT HE HAD FOUND EVIDENCE THAT THE DOG
HAD EATEN AN UNKNOWN AMOUNT OF A TYPE B SUPPLEMENT CONTAINING RACTOPAMINE AT AN UNKNOWN
LEVEL. DR. ADMINISTERED CIMETIDINE TO THE DOG AND DISCHARGED THE DOG.
UPDATE RECEIVED ON JANUARY-31-2008: ON JANUARY-30-2008, THE APSS CONTACTED DR. CLINIC
FOR ADDITIONAL INFORMATION. THE DOG WAS TREATED WITH ATENOLOL (ORALLY) AND INTRA VENOUS FLUID
THERAPY WHICH INCLUDED POT AS SlUM CHLORIDE (DILUTED). THE DOG WAS ALSO GIVEN AN ENEMA BUT IT
WAS NON PRODUCTIVE. THE DOG HAD RETURNED TO NORMAL BY JANUARY-29-2008, AND WAS DISCHARGED
THAT DAY. ATENOLOL WAS DISPENSED TO THE OWNER TO TREAT THE DOG ATHOMEFORANUNKNOWN
NUMBER OF DAYS. THE APSS CLOSED THE CASE FOLLOWING THE CALL.
REVIEWER: ONSET PUT AS UNKNOWN BECAUSE NO MENTION IN NARRATIVE OF TIME FRAME FOR WHEN DOG
MAY HAVE INGESTED PRODUCT.
Causality
Assessment
CVM _ Repmt.rep
Time
To Onset
Clinical Detail:
Page: 44
0 UN c TACHYCARDIA
0 UN D VOMITING
0 UN G ANOREXIA
0 UN G DEPRESSION/LETHARGY
0 UN G KLO, BLD
0 UN N TREMBLING
Source:
Country:
State:
United States
TEXAS
Zip:
79494
Episode Date:
12/01/2007
Dose Description: 200MG/HD/DA Y; ORAL, 12/ 1/07-2/18/08
Extra Label:
None
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
US200801471
REQSTED, NT PROVIDED
#Treated:
900
#Reacted: 900
#Died:
0
Species: CATTLE
Age: 1.5 YR
Weight:
1150 LB
Gender: Female
ON FEBRUARY 18, 2008, MR. , ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN BEEF HEIFERS. IN
APPROXIMATELY DECEMBER 2007, LUBBOCK FEED YARDS BEGAN FEEDING A GROUP OF 900 FINISHING HEIFERS
A RATION INTENDED TO DELIVER RACTOPAMINE AT 200 MGIHDIDAY. IN FEBRUARY 2008, THE GROUP WAS
SLAUGHTERED AND MR. BOBBY SWIFT, OF LUBBOCK FEEDY ARDS REPORTED THAT THE GROUP OF HEIFERS
CONSUMED, ON AVERAGE, 1 TO 2 POUNDS LESS OF FEED THAN EXPECTED WHILE ON THE RACTOP AMINE RATION.
CVM _Report. rep
Page: 45
Causality
Assessment
0
Time
To Onset
NA
Clinical Detail:
Source:
Country:
State:
United States
IOWA
Zip:
51050
Episode Date:
03113/2008
Dose Description: 200MG/HD/DA Y; PO; 3110/08*
Extra Label:
None
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE RATE OF WEIGHT GAIN, IMPROVED FEED
EFFICIENCY, INCREASED CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Yes
RUMENSIN 80 PO 250 MG/HD/DA Y DATES UNK
US200802709
REQ, NOT PROVIDED
#Treated:
138
#Reacted: 104
#Died:
0
Species: CATTLE
Age: 1 YR
Weight:
1100 LB
Gender: Female
ON 3/24/08, DR. , BLANCO ANIMAL HEALTH TECHNICAL CONSULTANT, REPORTED A POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN FINISHING HEIFERS. ON
APPROXIMATELY 3/10/08, HEIFERS AT AN UNK FEEDYARD, WERE STARTED ON FEED CONTAINING RACTOPAMINE
TO BE FED AT 200 MG/HD/DAY. ON APPROXIMATELY 3/ 13/08, IT WAS OBSERVED THAT THE HEIFERS
(APPROXIMATLEY 75% OF THEM) HAD A SMALL AMOUNT OF WHITE FOAM AROUND THEIR MOUTHS. THERE
WERE NO OTHER SIGNS AND THEIR FEED INTAKE AND PERFORMANCE SCORES WERE NORMAL. RACTOPAMINE
WAS CONTINUED IN THE FEED.
BLANCO ANIMAL HEALTH HAS MADE SEVERAL ATTEMPTS TO OBTAIN UPDATE INFO (4/ 11/08, 411 5/08 AND 4/22/08),
AND HAD NO SUCCESS. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
Time
To Onset
3 DA
Clinical Detail:
G FROTH, MOUTH/LIP(S)
Source:
CVM _ Rep01t.rep
Page: 46
Country:
State:
United States
MINNESOTA
Zip:
56175
Episode Date:
07110/2008
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200MG/HEAD/DAY; ORAL; 07-01-08* TO 07-10-08*
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASED WEIGHT GAIN, IMPROVED FEED
Good
Owner
Unknown
Unknown
US200808698
NOT PROVIDED
#Treated:
10
#Reacted: 10
#Died:
10
Species: CATTLE
Age: UN
Weight: 1000 LB
ON 07-22-08, MR , ELANCO ANIMAL HEALTH SALES REP, REPORTED A POTENTIAL ADE
INVOLVING OPTAFLEXX (RACTOPAMINE HCL) IN CATTLE. ON APPROX 07-01-08, ANUNKPRODUCERBEGAN
FEEDING AN UNK # OF FEEDER CATTLE A RATION THAT PROVIDED OPTAFLEXX AT 2200MG/KG/DA Y. ON APPRO X
07-10-08, 10 OF THE ANIMALS DIED. AN ATTENDING VET (NAME UNK) FROM THE BROCKWAY-BROWN VET
CLINIC PERFORMED A POST MORTEM EXAM ON AN UNK # OF CATTLE; REPORTEDLY, THE CAUSE OF DEATH
APPEARED TO BE DUE TO BLOAT. THE OPTAFLEXX WAS DISCONTINUED IN THE RATION.
Causality
Assessment
0
0
Time
To Onset
9 DA
9 DA
Clinical Detail:
D BLOAT
G DEATH
DrugName: RACTOPAMINE
Source:
Country:
State:
United States
TEXAS
Zip:
79081
Episode Date:
06/01/2008
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200809369
UNKNOWN
#Treated:
#Reacted:
#Died:
9028
24
24
Page: 47
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
200MG/HEAD/DAY; ORAL; 6/1/08*--7117/08*
None
Good
Owner
Yes
RUMENSIN 80; PO; 33 G/TON; UNK DATES
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
Unknown (cattle)
UN
1300 LB
Unknown
ON 8/ 1/2008, MS. 6 , ELANCO ANIMAL HEALTH SALES REP , REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING OPTAFLEXX ( RACTOP AMINE HYDROCHLORIDE) AND RUMENSIN ( MONENSIN
SODIM) IN CATTLE. FROM 6/ 1/2008 TO 711 7/2008, CANADIAN FEEDYARD DOCUMENTED 24 DEATHS ATTRIBUTED TO
BLOAT IN A GRP OF CATTLE ( 9028 HD) CONSUMING A RATION INTENDED TO DELIVER OPTAFLEXX AT
200MG/HD/DAY. MR 6 , REPORTED THAT DURING THAT SAME TIME, 21 , 190
HD OF CATTLE THAT WERE CONSUMING A RATION THAT CONTAINED NO OPT AFLEXX HAD ONLY 18 DEATHS
ATTRIBUTED TO BLOAT. MR INDICATED THAT OPTAFLEXX INCREASED THE# OF BLOAT CASES IN
CATTLE. MR THRASHER PLANNED TO INCREASE THE LEVEL OF RUMENSIN FROM 33G/TON TO 38G/TON IN THE
OPTAFLEXX RATION TO HELP DECREASE THE # OF BLOAT CASES. NO FURTHER INFO IS EXPECTED
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
MINNESOTA
Zip:
56175
Episode Date:
07/1 0/2008
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200MG/HEAD/DAY; PO- 7/ 1/08-7/10/08
Extra Label:
Reason For Use:
Health Status:
CYM _Report. rep
None
Good
US200808698
REQ, NOT PROVIDED
#Treated:
1600
#Reacted: 11
#Died:
11
Species: CATTLE
Age: UN
Weight:
1000 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Yes
RUMENSIN 80; PO IN FEED; 25OM/TON; UNK DATES OF ADM
Page: 48
ON 7/22/08, MR. , ELANCO ANIMAL HEALTH SALES REP, REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN CATTLE. ON APPROXIMATELY
7/01/08, AN UNKNOWN PRODUCER BEGAN FEEDING AN UNKNOWN NUMBER OF FEEDER CATTLE A RATION THAT
PROVIDED OPTAFLEXX AT 200MG/HD/DAY. ON APPROXIMATELY 711 0/08, 10 OF THE ANIMALS DIED. AN ATTENDING
VET (NAME UNKNOWN) FROM THE BROCKWAY-BROWN VET CLINIC PERFORMED A POST MORTEM
EXAMINATION ON AN UNKNOWN NUMBER OF THE CATTLE; REPORTEDLY, THE CAUSE OF DEATH APPEARED TO
BE DUE TO BLOAT. THE OPT AFLEXX WAS DISCONTINUED IN THE RATION.
UPDATE 8/5/08: ON 8/5/08 FOLLOW -UP INFORMATION WAS OBTAINED. DR. JUSTINE HOMM, ELAN CO ANIMAL
HEALTH TECHNICAL CONSULT ANT, REPORTED THAT MR. WAS THE OWNER OF THE CATTLE
AND THAT HE FED 1600 HEAD OPTAFLEXX DURING THE FINISHING PERIOD. THE 10 ANIMALS THAT DIED HAD
BEEN RECUMBENT FOR AN UNSPECIFIED PERIOD BEFORE DEATH. ONE ADDITIONAL ANIMAL WAS RECUMBENT
AND WAS SACRIFICED; POST MORTEM FINDINGS INCLUDED GASTRIC LESIONS. THE OPTAFLEXX WAS REMOVED
FROM THE RATION AND THE REMAINING CATTLE WERE SLAUGHTERED.
UPDATE 8/11/08: FEED ASSAY RESULTS REPORTED THAT OPTAFLEXX WAS PRESENT IN THE RATION AT 531 G/TON.
THE RESULT WAS WITHIN ACCEPTABLE LIMITS.
UPDATE 8/26/08: FEED ASSAY RESULTS REPORTED THAT RUMENSIN WAS PRESENT IN THE RATION AT 833 G/TON.
THE RESULT WAS WITHIN ACCEPTABLE LIMITS. NO FURTHER INFORMATION IS EXPECTED.
FlU (224): NO ADD'L INFO.
Causality
Assessment
0
0
Time
To Onset
UN
10 DA
Clinical Detail:
D PR-GI, LESION(S)
G DEATH
0 UN G DEATH(EUTHANIZED)
0 UN G RECUMBENCY
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
08117/2008
Dosage:
Recommended dose
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US20081 0969
A400381
#Treated:
72
#Reacted:
#Died:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
400MG/HEAD/DAY; PO- 7116/08-8/16/08 Species:
None Breed:
RESEARCH STUDY
Age:
Weight:
Good
Gender:
Owner
Low
Unknown
Page: 49
CATTLE
Other (cattle)
Male
16 MO
1270 LB
ON 8/28/08 ELANCO ANIMAL HEALTH WAS MADE AWARE OF A POTENTIAL ADVERSE EVENT IN RESEARCH STUDY
T4V080806. THIS POTENTIAL ADVERSE EVENT WAS REPORTED BY AN EXECUTIVE TECHNICAL ADVISOR FOR
ELAN CO ANIMAL HEALTH.
STUDY TITLE: CLINICAL STUDY (GCP): EFFECTIVENESS OF RACTOPAMINE HYDROCHLORIDE (OPTAFLEXX 45)
WHEN FED AS A TOP DRESS APPLICATION I BEEF CATTLE. STUDY NUMBER: T4080806
STUDY OBJECTIVE: TO EVALUATE AND CONFIRM THE CLINICAL EFFECTIVENESS OF RACTOPAMINE HCL (RAC)
FOR IMPROVING GROWTH PERFORMANCE WHEN FED TO BEEF CA TILE (STEERS) FOR THE LAST 42 DAYS
IMMEDIATELY PRIOR TO SLAUGHTER.
STEER NUMBER 6038, PEN 505- WHITE TREATMENT FOUND DEAD IN PEN AT MORNING OBSERVATIONS, STEER
WAS OK THE EVENING BEFORE WHEN THE LAST OBSERVATIONS WERE TAKEN. NO INDICATION OF DISTRESS
PRIOR TO ANIMAL BEING FOUND DEAD. THERE HAD BEEN SEVERAL DAYS OF LATE AFTERNOON
THUNDERSTORMS THAT HAD INTERRUPTED ANIMAL INTAKES AND NORMAL FEEDING PATTERNS. BASED ON THE
NATURE OF THE OCCURRENCE AND RECENT WEATHER EVENTS- THE INVESTIGATOR INDICATED THIS WEATHER
DISRUPTION THAT CAN CAUSE INTERRUPTIONS IN FEED INTAKE WAS TYPICAL OF A FEEDLOT DIGESTIVE
DISRUPTION ASSOCIATED DEATHS OR SUDDEN DEATH DUE TO SUDDEN DIGESTIVE DISORDERS SUCH AS
ENTEROTOXAEMIA OR ACUTE ACIDOSIS/BLOAT.
NECROPSY OF ANIMAL ON 8117/08 DETERMINED SIGNS OF ACUTE ENTEROTOXAEMIA-DUODENUM WAS BRIGHT
RED, LOCALIZED TISSUE DETER! ORATION. NO INDICATIONS OF PROBLEMS WITH THE ANIMAL THE EVENING
BEFORE AND AT PREVIOUS OBSERVATION TIME.
ANIMAL HAD BEEN ON TEST FEED SINCE 7116/08 WITH NO ADVERSE EVENTS NOTED. INVESTIGATOR STATED
THERE HAVE BEEN NO OBSERVATIONS THAT SUGGEST ANY DRUG RELATED INVOLVEMENT IN THE STUDY.
USUALLY FEED LOT BLOAT AND DIGESTIVE DISORDER IF ASSOCIATED WITH BLOAT CAN BE INTERVENED WITH
RELIEVING THE BLOAT RELATED PRESSURE IN THE RUMEN BY WALKING THE ANIMAL TO ALLOW ERUCTATION.
IN SEVERE CASES THE RUMEN MAY BE PUNCTURED WITH A TROCAR. IN CASES WITH ACUTE ENTEROTOXAEMIA
OR ACUTE DIGESTIVE DISRUPTION FOLLOWED BY BLOAT FOLLOWED BY DEATH- NO INTERVENTION IS
USUALLY POSSIBLE. MOST ACUTE DEATHS OF THIS TYPE HAPPEN DURING THE EVENING.
UPDATE 9/3/08: PER A PHONE CONVERSATION WITH THE EXECUTIVE TECH ADVISOR FOR ELANCO ANIMAL
HEALTH IT WAS CONFIRMED THE LIVE PHASE FOR THIS STUDY IS COMPLETE. OTHER THAN A CONTROL ANIMAL
(WHICH DID NOT RECEIVE ELANCO ANIMAL HEALTH PRODUCT) THERE WERE NO OTHER ADVERSE EVENTS
REPORTED WITHIN THE LIVE PHASE. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
0
CVM _Report. rep
Time
To Onset
UN
UN
Clinical Detail:
D GASTROENTERITIS
G DEATH
0 UN G TOX
Source:
Country:
State:
United States
KANSAS
Zip:
67502
Episode Date:
09/22/2008
Dose Description: 200MG/HEAD/DA Y 8/23/08-09/22/08
Source Report ld:
US200812822
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species: CATTLE
Page: 50
900
900
0
Extra Label:
None Breed: Unknown (cattle)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No
Age: UN
Weight: UN
ON 26-SEP-2008, MR. , BLANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL LACK OF EFFECTIVENESS INVOLVING OPT AFLEXX(RACTOP AMINE HYDROCHLORIDE) IN BEEF
CATTLE. ON APPROXIMATELY 22-AUG-2008, OTT A W COUNTY CATTLE FEEDERS BEGAN FEEDING A GROUP OF
HEIFERS AND ANOTHER GROUP (SEX UNKNOWN) OF FINISHING CATTLE A RATION THAT WAS INTENDED TO
DELIVER OPT AFLEXX AT 200 MG/HD/DA Y. ON APPROXIMATELY 23-SEP-2008, THE 2 GROUPS WERE PROCESSED. AT
THE TIME OF PROCESSING THE HEIFER GROUP'S DRESSING PERCENTAGE WAS 60% AS OPPOSED TO THE
EXPECTED 61 % AND THE OTHER GROUP'S DRESSING PERCENTAGE WAS 62.2% AS OPPOSED TO THE EXPECTED
62.7%. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
Time
0 NA E INEFFECT, WEIGHT INC
Source:
Country:
CVM _ Report.rep
United States
Package ID: A 1
Source Report ld:
NDC:
US200812825
Page: 51
State:
Product Lot No:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0811112008
Recommended dose
Oral (in dry feed)
280MG/HEAD/DAY, PO (IN FEED) 7-1-2008 TO 8-11-2008
None
Good
Owner
No
ADVERSE EXPERIENCES
NOT PROVIDED
#Treated:
400
#Reacted: 400
#Died:
0
Species: CATTLE
Age: UN
Weight: 1230 LB
ON 26-SEP-2008, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL LACK OF EFFECTIVENESS INVOLVING OPT AFLEXX (RACTOP AMINE HYDROCHLORIDE) IN BEEF
CATTLE. ON APPROXIMATELY 0 1-JUL-2008, BEGAN FEEDING 400 FINISHING
CATTLE RATION THAT WAS INTENDED TO DELIVER OPT AFLEXX AT APPROXIMATELY 280 MG/HD/DA Y. ON 11-
AUG-2008, THE CATTLE WERE PROCESSED. REPORTED THAT THE CATTLE'S
FINISHING WEIGHTS RANGED FROM 1230 LBS TO 1280 LBS. YANKTON LAND AND CATTLE REPORTED THAT THE
CATTLE WERE EXPECTED TO FINISH AT HEAVIER WEIGHTS (WEIGHT NOT SPECIFIED).
UPDATED 06-0CT-2008: FEED ASSAY RESULTS REPORTED THAT OPTAFLEXX WAS PRESENT IN THE SUPPLEMENT
AT 1140 G/TON (EXPECTED LEVEL 1135 G/TON). THE RESULT WAS WITHIN ACCEPTABLE LIMITS. NO FURTHER
INFORMATION IS EXPECTED.
Causality
Assessment
Time
To Onset
Clinical Detail:
Source:
Country:
State:
United States
TEXAS
Zip:
79015
Episode Date:
10/03/2008
CYM _ Repmt.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Corrsp Date: 10/1 3/2008
US200813220
REQ, NOT PROVIDED
#Treated:
Page: 52
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (all other)
200 MG/HEAD/DAY; PO; 10/3/08*
None
Good
Owner
Yes
RUMENSIN PO 30 G/TON 10/3/08*
2 TYLAN PO 9 G/TON 10/3/08*
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
Unknown (cattle)
UN
1200 LB
Unknown
ON 10/3/08, AN ELANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING OPT AFLEXX (RACTOP AMINE HYDROCHLORIDE) IN FEEDLOT CATTLE. A CONSULTING
NUTRITIONIST, WHO CONSULTS W/ FEEDY ARDS IN TEXAS, COLORADO, AND KANSAS, REPORTED THAT THE
NUMBER OF DEATHS, DUE TO A DIGESTIVE DISORDER (BLOAT), IN FINISHING CATTLE THAT WERE FED
OPTAFLEXX ARE 2 TIMES THE NUMBER OF DEATHS IN CATTLE NOT FED OPT AFLEXX. THE NUMBERS OF ANIMALS
AFFECTED AND THE PERIOD OF TIME WHEN THESE EVENTS OCCURRED WAS NOT PROVIDED. THE OPT AFLEXX
FED CATTLE RECEIVED THE OPTAFLEXX THE LAST 30 DAYS THEY WERE ON FEED. THEY WERE ALSO BEING FED
RUMENSIN (MONENSIN SODIUM) AT 30 G/TON AND TYLAN (TYLOSIN PHOSPHATE) AT 9 G/TON (ACUTAL START
DATE OF RATIONS IS UNK, DATE REPORTED IS AN ESTIMATE). THE SALES REPRESENTATIVE ALSO REPORTED
THAT THE NUTRITIONIST WAS COMPARING RATIONS FOR FINISHING CATTLE TO THE RATIONS OF ALL OTHER
CATTLE IN THE FEEDLOT WHEN HE STATED HIS OBSERVATIONS. THERE WERE NO PRE-EXISTING MEDICAL
CONDITIONS AND NO NON ELANCO CONCOMITANT PRODUCTS. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
80634
Episode Date:
07/0112008
Dosage:
Recommended dose
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200813160
NOT PROVIDED
#Treated:
#Reacted:
#Died:
11600
31
31
Page: 53
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
200 MG/HEAD/DAY; ORAL, 07/01/2008*- 10/01/2008
None
INCREASED RATE WEIGHT GAIN, IMPROVED FEED
Good
Owner
Unknown
Yes
RUMENSIN 80; PO; 40G/TON; 2008*
2 TYLAN 40; PO; 90MG/HEAD/DA Y; 2008*
Species: CATTLE
Age: UN
Weight: 1250 LB
EXPERIENCE INVOLVING OPT AFLEXX (RACTOP AMINE HYDROCHLORIDE) IN FEEDLOT CATTLE. BEGINNING ON
07/01108, FINISHING CATTLE AT A FEED YARD WERE STARTED ON A RATION THAT INCLUDED OPTAFLEXX AT 200
MG/HD/DAY. DURING THE MONTH OF 07/08, 10 OPTAFLEXX FED ANIMALS DIED DUE TO BLOAT. IN 08/08, 12
OPTAFLEXX FED ANIMALS DIED AND IN 09/08, 9 DIED. THE RATE OF DEATHS DUE TO BLOAT DURING THIS TIME
PERIOD WAS 0.2% (4 TIMES THE EXPECTED LEVEL). ON 10/01/08, OPTAFLEXX WAS REMOVED FROM THE RATION.
RUMENSIN 80 WAS ADMINISTERED AT 40 G/TON AND TYLAN 40 WAS ADMINISTERED AT 90 MG/HD/DA Y ON
UNKNOWN DATES. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND NO NON ELANCO CONCOMITANT
PRODUCTS. AT THE TIME OF THE REPORT, IT WAS NOT KNOWN IF DEATHS WERE STILL OCCURRING.
FlU 11/25/08 (238): AFTER OPTAFLEXX WAS REMOVED FROM THE RATION, THE NUMBER OF DEATHS RELATED TO
BLOAT DECREASED. DEATH RATES AT THE FEEDLOT RETURNED TO THE EXPECTED LEVEL. OPT AFLEXX WAS
NOT PUT BACK INTO THE RATION.
Causality
Assessment
0
0
Time
To Onset
9 DA
9 DA
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
67855
NO SPECIFIC DATES
Episode Date:
10/03/2008
CVM _Rep01t.rep
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200813293
NOT PROVIDED
#Treated:
#Reacted:
#Died:
0
0
0
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
200 MG/HEAD/DA Y; ORAL, 10/03/2008*
None
INCREASED RATE WEIGHT GAIN, IMPROVED FEED
Unknown
Owner
Unknown
Yes
Species:
Breed:
Age:
Weight:
Gender:
RUMENSIN PO; UNK DOSE; UNK DATES
2 TYLAN PO; UNK DOSE; UNK DATES
Page: 54
CATTLE
Unknown (cattle)
Unknown
UN
UN
ON 10/03/08, AN BLANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING OPT AFLEXX (RACTOPAMINE HYDROCHLORIDE) IN CATTLE. BEGINNING ON AN
UNKNOWN DATE, THREE FEED YARDS, TRISTATE, CATTLE CO. AND 5 N FEEDERS, BEGAN OBSERVING AN
INCREASED NUMBER OF BLOATED CATTLE IN THE HERDS BEING FED A RATION THAT CONTAINED OPTAFLEXX,
RUMENSIN (MONENSIN SODIUM) AND TYLAN (TYLOSIN PHOSPHATE) AS OPPOSED TO THE HERDS THAT WERE
BEING FED A RATION THAT CONTAINED RUMENSIN AND TYLAN ONLY (ACTUAL START DATE OF RATIONS IS
UNKNOWN, DATE REPORTED IS AN ESTIMATE). ALL OPTAFLEXX RATIONS WERE FORMULATED BY PMS
NUTRITION AND WERE INTENDED TO DELIVER 200 MG/HD/DA Y OF OPTAFLEXX. INFORMATION ON PRE-EXISTING
MEDICAL CONDITIONS AND CON CO MIT ANT PRODUCTS WAS REQUESTED, NO PROVIDED.
FOLLOW UP (SUB #236) UPDATED 10/28/08: BLANCO ANIMAL HEATH HAS MADE SEVERAL ATTEMPTS TO OBTAIN
UPDATE OR FOLLOW UP INFO WITH NO SUCCESS.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
D BLOAT
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
09/27/2008
Dosage: Underdose
Dose Description: 400 MG/KG; PO; 9/23/08-9/26/08
Extra Label:
Underdose
CVM _ Rep01t.rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200813529
A400381
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
80
C A T T L ~
Other (cattle)
17 MO
Page: 55
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
RESEARCH STUDY
Good
Veterinarian
Missing infom1ation
Unknown
Weight: 1396 LB
Gender: Male
ON 10/8/08, ELAN CO ANIMAL HEALTH WAS MADE AWARE OF A POTENTIAL ADVERSE EVENT IN RESEARCH STUDY
T4V160805 BY A COMPANY EMPLOYEE.
STUDY TITLE: CLINICAL STUDY (GCP): EFFECTIVENESS OF RACTOPAMINE HYDROCHLORIDE (OPTALFEXX 45)
WHEN FED AS A TOP DRESS APPLICATION IN BEEF CATTLE.
STUDY OBJECTIVE: THE OBJECTIVE OF THIS STUDY IS TO EVALUATE AND CONFIRM THE CLINICAL
EFFECTIVENESS OF RACTOPAMINE HC1 (RAC) FOR IMPROVING GROWTH PERFORMANCE WHEN FED TO BEEF
CATTLE (STEERS) FOR THE LAST 42 DAYS IMMEDIATELY PRIOR TO SLAUGHTER.
STEER 5061 , PEN 110 WAS FOUND DEAD IN PEN AT MORNING OBSERVATION ON 9/27/08. THERE ARE 10 ANIMALS
PER PEN IN THIS STUDY, ALL ANIMALS HAVE AMPLE BUNK SPACE FOR EATING. NECROPSY DETERMINED CAUSE
OF DEATH WAS ACUTE FEEDLOT BLOAT. IT WAS NOTED BY THE DOCTORS PERFORMING THE NECROPSY, A VERY
CLASSIC AND WELL DELINEATED EXAMPLE OF ACUTE FEEDLOT BLOAT. NO FURTHER INFO EXPECTED.
Causality
Assessment
0
0
Time
To Onset
4 DA
4 DA
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
80654
Episode Date:
07117/2008
Dose Description: 200 MG/HEAD/DA Y 07117/08
Extra Label: None
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
CVM _Report. rep
US200809754
REQUESTED NOT PROVID
#Treated:
626
#Reacted: 626
#Died:
0
Species: CATTLE
Age: UN
Weight: 1200 LB
Page: 56
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Yes
RUMENSIN; PO (IN FEED); 30G/TON; 7117/08
ON 07-AUG-2008, MR. BLANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING OPTAFLEXX (RACTOP AMINE HYDROCHLORIDE) AND
RUMENSIN (MONENSIN SODIUM) IN CATTLE. ON 17-JUL-2008, BEGAN FEEDING FINISHING
CATTLE A RATION INTENDED TO DELIVER OPTAFLEXX AT 200 MG/HD/DAY; THE CATTLE HAD ALSO BEEN ON
RUMENSIN AT 30 G/TON. IMMEDIATELY AFTER BEGINNING THE OPT AFLEXX RATION, THE CATTLE DECREASED
THEIR DRY MATTER INTAKE BY 2LBS. MR. 4 , OF 15 FELT THE OPTAFLEXX WAS
CAUSING PALATABILITY ISSUES.
UPDATED 28-0CT-2008: ON 28-0CT-2008, AN BLANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED
THAT THERE WAS NO FURTHER INFORMATION EXPECTED.
Causality
Assessment
0
0
Time
To Onset
1 DA
NA
Clinical Detail:
G ANOREXIA
G UNPALATABLE
Source:
Country:
State:
United States
TEXAS
Zip:
X XXX X
Episode Date:
01/01/2007
Dose Description: 200 MG/HEAD/DA Y; ORAL, 03/2007*
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
US20090 194 2
NOT PROVIDED
#Treated:
30000
#Reacted: 10
#Died:
10
Species: CATTLE
Age: UN
Weight:
UN
CYM _Report. rep
Page: 57
EXPERIENCE INVOLVING OPT AFLEXX (RACTOPAMINE HYDROCHLORIDE) IN FEEDLOT CATTLE. IN
APPROXIMATELY THE SPRING OF 2007, CIRCLE 3 FEED YARDS BEGAN FEEDING THEIR FINISHING CATTLE
OPT AFLEXX AT 200 MG/HD/DA Y (ACTUAL START DATE UNKNOWN, DATE REPORTED IS AN ESTIMATE). THE
OWNER OF THE FEED YARD REPORTED THAT DURING THE LAST 30 DAYS PRIOR TO SLAUGHTER, HE NOTICED AN
INCREASE IN THE NUMBER OF "DIGESTIVE DEADS"-DEATHS DUE TO BLOAT-(ACTUAL START DATE UNKNOWN,
DATE REPORTED IS AN ESTIMATE) AS COMPARED TO ANY TIME BEFORE THAT FEEDING PERIOD. THE OWNER OF
THE FEED YARD WAS NOT SURE IF THERE WAS AN ACTUAL INCREASE AND REQUESTED ASSISTANCE FROM THE
ELANCO ANIMAL HEALTH SALES REPRESENTATIVE IN CALCULATING THE INCIDENCE OF DIGESTIVE DEADS.
INFORMATION ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT
PROVIDED.
UPDATED 05112/09: ON 05112/09, AN ELANCO ANIMAL HEALTH SALES REPRESENTATIVE PROVIDED UPDATE
INFORMATION AND REPORTED THAT ADDITIONAL INFORMATION ON THE POTENTIAL EVENT WAS NOT
AVAILABLE. NO FURTHER INFORMATION IS EXPECTED.
**REVIEWERS NOTE** ON THE REPORT THE NUMBER OF ANIMALS LISTED AS REACTED AND DIED WERE ZERO,
THE NUMBER 10 IS JUST AN ESTIMATE ON MY PART.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
NEBRASKA
Zip:
68643
Episode Date:
05/24/2009
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HEAD/DA Y; ORAL, 04/2112009-05/24/2009
Extra Label:
Reason For Use:
Uealth Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Yes
RUMENSIN 300MG/HD/DA Y 12/ 1108*-5/24/09
2 TYLAN 90MG/HD/DA Y 1211/08*-5/24/09
CVM _ Repmt. rep
US200902815
NOT PROVIDED
#Treated:
284
#Reacted: 284
#Died:
4
Species: CATTLE
Age: UN
Weight: 1400 LB
Page: 58
EXPERIENCE INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN FEEDLOT CATTLE. ON 04/21/09, A
PRODUCER STARTED 284 RED CROSSBRED STEERS ON A RATION THAT INCLUDED OPTAFLEXX (200 MG/HD/DAY).
THE CATTLE HAD BEEN OF FEED FOR 150 DAYS AND WERE BEING FED A RATION THAT INCLUDED RUMENSIN (300
MG/HD/DAY) AND TYLAN (90 MG/HD/DAY). ON 05/24/09, THE CATTLE WERE SHIPPED TO A PROCESSING PLANT. ON
ARRIVAL, 1 ANIMAL WAS DEAD ON THE TRUCK AND 3 ANIMALS HAD TO BE EUTHANIZED (THE CONDITION OF
ANIMALS WAS NOT REPORTED). THE PRODUCER REPORTED THAT THE GROUP HAD AN AVERAGE CARCASS YIELD
OF 66.27% WHICH WAS LOWER THAN WHAT HE EXPECTED FROM OPT AFLEXX FED CATTLE. THERE WERE NO PRE-
EXISTING MEDICAL CONDITIONS. NO FURTHER INFORMATION IS EXPECTED
Causality
Assessment
Time
0 150 DA E INEFFECT, LEAN CARCASS
0 150 DA G DEATH
0 150 DA G DEATH(EUTHANIZED)
Source:
Country:
State:
United States
IOWA
Zip:
51248
Episode Date:
05/01/2009
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HEAD/DA Y; ORAL, 05/2009*-06/09*
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Yes
TYLAN UNK. DOSE, ROUTE 2009* SOME CATTLE
2 IMPLANT, UNK TYPE DATE, SOME CATTLE
3 RUMENSIN, UNK DOSE, IN FEED, 2009* SOME CATTLE
US200903387
UNK
#Treated:
139
#Reacted: 25
#Died: 0
Species: CATTLE
Breed: Holstein (include red)
Age: UN
Weight:
1350 LB
EXPERIENCE INVOLVING OPT AFLEXX (RACTOP AMINE HYDROCHLORIDE) IN FINISHING CATTLE. IN
APPROXIMATELY 05/09 THROUGH 06/09, HOLSTEIN STEERS WERE STARTED ON A RATION THAT INCLUDED
OPTAFLEXX FED AT 200 MG/HD/DAY. THE STEERS WERE STARTED ON THE OPTAFLEXX AND ON DAY 21 OF 28
CV M _ Repmt.rep
Page: 59
DAYS ON FEED, SOME ANIMALS EXHIBITED SIGNS OF "BULLING". LATER, AT THE TIME OF PROCESSING, THE
PRODUCER REPORTED THAT 18-20% OF CATTLE WERE "DARK CUTTERS". SOME OF THE CATTLE MAY HAVE BEEN
FED RUMENSIN (MONENSIN SODIUM) AND TYLAN (TYLOSIN) (ACTUAL START DATE UNKNOWN, DATE REPORTED
IS AN ESTIMATE) AND SOME MAY HAVE HAD IMPLANTS BUT THE DOSAGES AND THE IMPLANT TYPES WERE NOT
KNOWN TO THE REPORTER. THE TOTAL NUMBER OF ANIMALS THAT WERE FED OPTAFLEXX AND REACTED WAS
UNKNOWN BUT THE REPORTER STATED THAT IN ONE GROUP, 25 OF 139 HEAD WERE AFFECTED. INFORMATION
ON PRE-EXISTING MEDICAL CONDITIONS WAS NOT PROVIDED.
Causality
Assessment
Time
0 UN G BEHAVIOR DISORDER
0 UN G MEAT, ABN COLOR
Source:
Country:
United States
State:
COLORADO
Zip:
XX XXX
Episode Date:
01/01/2009
Dosage: Unknown
Dose Description: ORAL, 2009*
Extra Label:
Unknown
Reason For Use:
UNK
Health Status:
Good
Administered By:
Owner
Concomitants: No
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200903340
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
Angus (include red)
Female
UN
UN
EXPERIENCE INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN FINISHING CATTLE. ON 06/1 8/09, AN
ANIMAL BEHAVIORIST MADE THE OBSERVATION THAT SHE SAW SOME "PERFECT, ANGUS HEIFERS UNLOAD OFF
A CATTLE TRUCK AT A PACKING PLANT, AND ONE OF THOSE HEIFERS WAS DEAD ON THE TRUCK." THE
BEHAVIORIST ALSO COMMENTED THAT THE HEIFER" DIED DUE TO BEING PUSHED TOO HARD BY IMPLANTS AND
RACTOPAMINE." THE COMMENTS WERE MADE AT A SYMPOSIUM ON BEEF CATTLE AND DETAILS ON THE
NUMBER OF ANIMALS IN THE TRUCK, WHEN THE EVENT OCCURRED, AND THE PRODUCTS INVOLVED WERE NOT
PROVIDED. THE DATE OF EXPOSURE TO OPTAFLEXX WAS NOT KNOWN (ACTUAL START DATE UNKNOWN, DATE
REPORTED IS AN ESTIMATE) AND NO POST MORTEM EXAMINATION WAS PERFORMED ON THE HEIFER. NO
FURTHER INFORMATION IS EXPECTED.
QC NOTE: NOT SURE THIS ONE SHOULD NOT BE NO SIGNS - DID THE BEHAVIORIST EVEN KNOW WHAT MEDS THE
CATTLE WERE ON.
CVM _Report. rep
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
XX :XXX
Episode Date:
01/01/2009
Dosage: Unknown
Dose Description: ORAL, 2009*
Source Report ld:
US20090481 0
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
Page: 60
100
100
0
Extra Label:
Unknown Breed: Unknown (cattle)
Reason For Use:
UNK
Age: UN
Weight:
UN
Health Status:
Unknown
Gender: Unknown
Administered By:
Owner
Concomitants: No
ON 08/12/09, AN ELANCO ANIMAL HEALTH EMPLOYEE REPORTED A POTENTIAL ADVERSE DRUG EXPERIENCE
INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN CATTLE. WHILE ATTENDING A CATTLE SHOW, AN
ELAN CO EMPLOYEE WAS TOLD THAT OPT AFLEXX MAKES CATTLE DIFFICULT TO HANDLE (THERE WERE NO
SPECIFICS PROVIDED). INFORMATION ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS
WAS REQUESTED, NOT PROVIDED. NO FURTHER INFORMATION IS EXPECTED.
QC NOTE: ENTERED 100 CATTLE TREATED EFFECTED - NO NUMBERS WERE LISTED
Causality
Assessment
Time
Source:
Country:
State:
CVM _ Rep01t.rep
United States
UNKNOWN
Zip:
xxxxx
Poor
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200905286
UNKNOWN
Report Quality:
Episode Date:
08/31/2009
Dosage: Unknown
Dose Description: PO; 2009*
Extra Label:
Unknown
Reason For Use:
UNKNOWN
Health Status:
Unknown
Administered By:
Unknown
Concomitants: No
SEE ALSO CASE US200904859
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 61
CATTLE
Unknown (cattle)
Unknown
UN
UN
ON 08/31/2009, CONTACTED ELANCO ANIMAL HEALTH WAS CONTACTED
REGARDING A POTENTIAL ADE INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN CATTLE. AT A
CONFERENCE THAT TOOK PLACE ON 08/11 AND 08/12/2009, THE FOLLOWING COMMENTS WERE MADE
CONCERNING BET A-AGONISTS INCLUDING OPT AFLEXX. A PRODUCER WAS QUESTIONING IF SACRIFICING MEAT
QUALITY FOR WEIGHT GAIN WAS THE BEST TRADE OFF AND A SPEAKER REPORTED THAT BETA-AGONISTS
CAUSE STRESS, DEATH AND LEG PROBLEMS. THE SPEAKER WENT ON TO STATE THAT SHE HAD SEEN PERFECTLY
HEALTHY STEERS FALL OVER DEAD BECAUSE OF OPTAFLEXX (ACTUAL START DATES AND ANIMAL NUMBERS
UNKNOWN, ALL DATES AND NUMBERS REPORTED ARE ESTIMATES). THERE WAS NO DETAILED INFORMATION ON
THE EVENTS MENTIONED.
UPDATED 09/02/2009: BLANCO ANIMAL HEALTH HAS MADE 2 ATTEMPTS TO OBTAIN UPDATE OR FOLLOW-UP
INFORMATION (08/31/2009 AND 09/01/2009), AND HAD NO SUCCESS. NO FURTHER INFORMATION IS EXPECTED.
**REVIEWERS NOTE** I RELUCTANTLY CODED DEATH BECAUSE THAT WAS THE ONLY INFORMATION THAT I
COULD GET FROM THE NARRATIVE, WHICH IS REALLY NOTHING MORE THAN HEARSAY.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
MINNESOTA
Zip:
55038
Episode Date:
06/01/2009
CVM _Report. rep
Source Report ld:
US200906467
NDC:
Product Lot No:
UNKNOWN
#Treated:
25
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Prepared on 0411 8/2011
Recommended dose
Oral (in dry feed)
200MG/HEAD/DA Y; PO; 2009*
None
Good
Owner
No
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 62
5
0
CATTLE
Holstein (include red)
16 MO
VA
Male, neutered
ON 10/09/2009, AN ELANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A POTENTIAL ADE INVOLVING
OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN HOLSTEIN CATTLE. BEGINNING IN 06/2009, A PRODUCER
OBSERVED AN INCREASED NUMBER OF BLOATS OCCURRING IN A PEN OF CATTLE BEING FED OPTAFLEXX AT
200MGIHDIDAY (ACTUAL START DATE UNKNOWN, DATE REPORTED IS AN ESTIMATE). THE PEN HOUSED 25
CATTLE AND APPRO X 20% OF THE CATTLE BLOATED. AN UNKNOWN NUMBER OF BLOATS WERE TREATED BY
DECOMPRESSION VIA A STOMACH TUBE. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND NO
CONCOMITANT PRODUCTS.
UPDATED 10/26/2009: ON 10/26/2009, THE BLANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED THAT
THERE WERE NO RESENT PROBLEMS CATTLE WITH BLOATING AND THAT FOLLOW UP WITH THE PRODUCER
CONCERNING THE PREVENTION OF THE PROBLEM IN THE FUTURE WOULD NOT BE CONDUCTED. NO FURTHER
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
D BLOAT
Source:
Country:
State:
United States
UNKNOWN
Zip:
xxxxx
Episode Date:
11120/2009
Route: Inhalation
Dose Description: INHALATION; 11120/2009
Extra Label:
Species
Reason For Use:
ACCIDENTAL HUMAN EXPOSURE
CVM _ Repmt. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200907 63 7
UNKNOWN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
0
HUMAN
Not specified
19 YR
150 LB
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Not applicable
Not applicable
No
Gender: Male
Page: 63
ON 11123/2009, THE ROCKY MOUNTAIN POISON AND DRUG CENTER (RMPDC) CONTACTED ELANCO ANIMAL
HEALTH REGARDING A POTENTIAL ADE INVOLVING TYLAN INJECTION (TYLOSIN) AND OPTAFLEXX
(RACTOPAMINE HYDROCHLORIDE) IN A HUMAN. ON 11120/2009, AN EMPLOYEE FROM THE KANSAS POISON
CENTER CONTACED THE RMPDC AND REPORTED THAT SHE RECEIVED A CALL FROM A KANSAS CITY
EMERGENCY ROOM ABOUT A PATIENT WHO HAD BEEN EXPOSED TO TYLAN. AT THE TIME OF THE CALL, AN
UNKNOWN TIME POST EXPOSURE, THE PATIENT WAS EXPERIENCING NAUSEA. LATER ON 11120/2009, THE KANSAS
POISON CENTER CONTACTED THE RMPDC AND REPORTED A RECEIVED CALL, REGARDING THE SAME PATIENT
WHO HAD INHALED OPTAFLEXX ON 11120/2009. AT THE TIME OF THE 2ND CALL, APPRO X 4 HOURS POST EXPOSURE,
THE PATIENT WAS EXPERIENCING NAUSEA. LATER ON 11120/2009, THE RMPDC CONTACTED ANOTHER EMPLOYEE
FROM THE KANSAS POISON CENTER WHO REPORTED THAT THE PATIENT HAD BEEN GIVEN ZOFRAN FOR NAUSEA,
THE NAUSEA HAD RESOLVED, AND THE PATIENT HAD BEEN DISCHARGED. ON 11/2112009, THE RMPDC CONTACTED
ANOTHER EMPLOYEE FROM THE KANSAS POISON CENTER AND RECEIVED THIS SAME INFORMATION.
INFORMATION ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS NOT PROVIDED.
THE RMPDC CLOSED THE CASE FOLLOWING THE CALL. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
Time
To Onset
4 HR
Clinical Detail:
D NAUSEA
-9 NA G HUMAN EXPOSURE, INHALA
Source:
Country:
State:
United States
UNKNOWN
Zip:
XX XXX
Episode Date:
10/28/2008
Dosage: Various
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 0, 9.1, 18.2 OR 27.3 G/TON ALL ON 100% DMB; 8/28/08-
2118/09
Extra Label:
Various
Reason For Use:
UNKNOWN
CVM _ Rep01t.rep
US200907364
UNKNOWN
#Treated:
1895
#Reacted: 3
#Died:
2
Species: CATTLE
Age: VA
Weight:
VA
Health Status: Unknown
Administered By:
Veterinarian
Vet Opinion: Low
Concomitants: Yes
RUMENSIN 80 33.3G/TON, PF, 8/28/08-2/18/09
2 TYLAN 100 PREMIX 8.9G/TON, PF, 8/28/08-2/ 18/09
POST APPROVAL RESEARCH STUDY: TITLE UNKNOWN
STUDYNUMBER: T4V80811.
Gender: Male
ON 11112/2009, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADE INVOLVING
RUMENSIN, TYLAN AND OPTAFLEXX IN CATTLE.
Page: 64
THIS IS THE END OF THE STUDY# T4V 480811. AN ELAN CO EMPLOYEE IS REPORTING ALL REMOVALS AND DEAD
ANIMALS ON THE STUDY. THIS STUDY CONTAINED 1,895 STEERS THAT STARTED THE TRIAL.
DURING THE PRE-TREATMENT PHASE, 53 ANIMALS WERE REMOVED FOR THE FOLLOWING REASONS: BULLERS
(30), BOVINE RESPIRATORY DISEASE (BRD: 15), INJURY (6), LAME (1), SLOW GROWTH (1). DURING THE TREATMENT
PHASE, ONE ANIMAL WAS REMOVED FROM THE STUDY FOR BRD.
DURING THE PRE-TREATMENT PHASE, WE HAD 14 ANIMALS DIE FOR THE FOLLOWING REASONS: BRD (7),
DIGESTIVE (4), TRAUMA (EUTHANIZED 2), UNKNOWN (1). DURING THE TREATMENT PHASE, WE HAD 2 ANIMALS
DIE FOR MECHANICAL RELATED DEATH.
ALL ANIMALS WERE NECROPSIED BY A VET. ALL REMOVALS AND DEATHS WERE AT OR LOW INDUSTRY
AVERAGE AND THE RESEARCH SITE AND VET ARE NOT CONCERNED OR BLAME ELANCO ANIMAL HEALTH
PRODUCTS.
WHEN EVENTS APPEARED, THE DOSES OF RUMENSIN/TYLAN/OPT AFLEXX WAS NOT CHANGED SINCE THIS RATE
WAS EXPECTED.
OPTAFLEXX DOSING WAS 0, 9.1, 18.2 OR 27.3 G/TON ALL ON 100% DMB.
NO FURTHER INFORMATION WAS PROVIDED.
2 ANIMALS DIED FROM MECHANICAL RELATED DEATHS.
**REVIEWERS NOTE** MOST OF THE ANIMALS LISTED IN THE NARRATIVE, WERE REMOVED BEFORE
TREATMENT. I CODED THE 2 DEATHS (EUTH.) HOWEVER, I WAS UNABLE TO FIND A THIRD ANIMAL THAT
REACTED (AS LISTED IN BOX 13B.) DO TO THE VAGUE STATEMENTS IN THE NARRATIVE.
Causality
Assessment
Time
Source: Report from sponsor or distibutor of drug Source Report ld:
CYM _Report. rep
US20 1000942
Country:
United States
State:
TEXAS
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/01/2010
Not applicable
Product defect
Not applicable
Not applicable
Not applicable
Not applicable
No
NDC:
Zip:
XX XXX
Product Lot No:
A632073
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 65
0
0
0
NOT APPLICABLE
Not applicable
NA
NA
Not applicable
ON 3/0112010, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL PRODUCT DEFECT INVOLVING AN
OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) BAG. ON 3/01/2010, A SHIPMENT OF OPTAFLEXX WAS RECEIVED
BY A CUSTOMER. ONE BAG, AT THE BOTTOM OF A PALLET OF 20 BAGS, WAS FOUND TO HAVE BROKEN OPEN. THE
BAG WAS FROM LOT # A632073, BOX #7. NO FURTHER INFO IS EXPECTED.
ON 3/04/2010 UPDATED INFO WAS PROVIDED BY ELANCO US COMPLAINT MANAGEMENT QA: COMPLAINT INFO IS
AVAIL IN TRACKWISE RECORD TR#1210228. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
Time
0 NA P PD-CONT AINER(S), DAMAG
Source:
Country:
State:
United States
COLORADO
Zip:
XX XXX
Episode Date:
05/06/2008
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US201001323
UNK
#Treated:
#Reacted:
#Died:
2053
38
3
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
300 MG/HEAD/DA Y;PO; 5/6/2008 - 9/25/2008
Species:
None Breed:
UNK
Age:
Weight:
Good
Gender:
Owner
Unknown
No
Page: 66
CATTLE
Mixed (cattle)
12 MO
1080 LB
Male, neutered
ON 3/19/2010, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADE INVOLVING
COMPONENT (ESTRADIOL AND TRENBOLONE ACETATE) AND OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE).
FROM 5/6/2008 TO 9/25/2008, 2 GROUPS OF CATTLE WERE TREATED WITH COMPONENT IMPLANTS. ONE GROUP WAS
FED A RATION INTENDED TO PROVIDE OPT AFLEXX AT 300 MGIHDIDA Y AND THE OTHER WAS FED A RATION THAT
CONTAINED A ZILMAX. FROM 5/6/2008 TO 9/25/2008, 3 CATTLE FED THE OPT AFLEXX RATION DIED AS A RESULT OF
LAMENESS, BLOAT AND ACUTE INTERSTITIAL PNEUMONIA WHILE 4 CATTLE FED THE ZILMAX RATION DIED.
DURING THAT SAME TIME PERIOD, 35 CATTLE FED THE OPTAFLEXX RATION WERE REMOVED FROM THE STUDY
DUE TO LAMENESS, UNSPECIFIED RESPIRATORY PROBLEMS AND FOR BEING "BULLERS", WHILE 17 OF THE
CATTLE FED THE ZILMAX RATION WERE REMOVED FROM THE STUDY. A TOTAL OF 2053 CATTLE WERE PLACED
IN THE STUDY AT INITIATION AND 1994 CATTLE FINISHED THE STUDY. THE LOSSES WERE CONSIDERED
ACCEPTABLE LEVELS OF MORBIDITY AND MORTALITY UNDER INDUSTRY CONDITIONS. NO FURTHER INFO IS
EXPECTED.
CMP- UNK
Causality
Assessment
0
0
0
0
Time
To Onset
UN
UN
UN
UN
Clinical Detail:
D BLOAT
G DEATH
G LAMENESS
R PNEUMONIA
0 UN X ESTRUS BEHAVIOR
Source:
Country:
State:
United States
COLORADO
Zip:
XX XXX
Episode Date:
10/01/2008
CVM _Report. rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US20 1002261
UNKNOWN
#Treated:
1275
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (all other)
SEE NARRATIVE; ORAL, 10/17/2008-03118/2009
None
Unknown
Unknown
Unknown
Yes
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
COMPONENT TE-S W/ TYLAN IMPLANT; IMPLANT, UNK DOSAGE & DATE
ADVERSE EXPERIENCES
Page: 67
106
8
CATTLE
Unknown (cattle)
UN
UN
Male, neutered
ON 04/27/ 10, AN BLANCO STEER HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN STEERS. FROM 10/17/08 TO 03118/09, A
STUDY OF THE EFFECT OF OPT AFLEXX LEVELS ON GROWTH PERFORMANCE AND CARCASS CHARACTERISTICS
OF FEEDLOT STEERS WAS CONDUCTED DURING WHICH TIME ALL CATTLE WERE FED RATIONS THAT INCLUDED
TYLAN (TYLOSIN PHOSPHATE) AT 90 MGIHDIDAY AND RUMENSIN (MONENSIN SODIUM) AT 33.3 G/TON. ON
ARRIVAL, EACH STEER WAS TREATED WITH A COMPONENT TE-S WITH TYLAN (ESTRADIOL, TRENBOLONE
ACETATE, TYLOSIN TARTRATE) IMPLANT. THE TREATMENT GROUPS WERE BASED ON THE LEVELS OF
OPTAFLEXX FED AND ADVERSE EFFECTS AND DEATHS REPORTED FOR EACH GROUP WERE AS FOLLOWS.
THE FOLLOWING WERE REMOVED FROM THE OPTAFLEXX FREE GROUP: 21 STEERS DESCRIBED AS BULLERS, 4
STEERS DESCRIBED AS MECHANICAL, 1 STEER DESCRIBED AS OTHER- BULL, AND 1 STEER WITH A RUPTURED
SCROTUM. ALSO, 2 STEERS DIED OF UNSPECIFIED RESPIRATORY ISSUES AND 1 STEER DIED OF HEART F AlLURE.
THE FOLLOWING WERE REMOVED FROM THE OPTAFLEXX AT 9.1 G/TON GROUP: 13 STEERS DESCRIBED AS
BULLERS, 3 STEERS DESCRIBED AS MECHANICAL, 4 STEERS DESCRIBED AS RESPIRATORY, 2 STEERS DESCRIBED
AS OTHER-RAILER, 1 STEER REMOVED AS OTHER- STRAY, AND 1 STEER REMOVED AS A OTHER- DOWNER. ALSO,
1 STEER DIED OF UNSPECIFIED DIGESTIVE PROBLEMS.
THE FOLLOWING WERE REMOVED FROM THE OPTAFLEXX 18.2 GROUP: 19 STEERS DESCRIBED AS BULLERS, 3
STEERS DESCRIBED AS MECHANICAL, 1 STEER DESCRIBED AS OTHER-STRAY, 1 STEER DESCRIBED AS A
DIGESTIVE, AND 1 STEER DESCRIBED AS RESPIRATORY. ALSO, 2 STEERS DIED OF UNSPECIFIED DIGESTIVE
PROBLEMS AND 1 STEER DIED OF UNSPECIFIED RESPIRATORY PROBLEMS.
THE FOLLOWING WERE REMOVED FROM THE OPTAFLEXX 27.3 GROUP: 15 STEERS DESCRIBED AS BULLERS, 3
STEERS DESCRIBED AS MECHANICAL, 3 STEERS DESCRIBED AS OTHER- RAILER, 1 STEER DESCRIBED AS OTHER-
STRAY. ALSO, 1 STEER DIED OF UNSPECIFIED RESPIRATORY PROBLEMS. NO FURTHER INFORMATION IS
EXPECTED.
CMP- UNK
Causality
Assessment
CVM _Report. rep
Time
0 UN
0 UN
0 UN
0 UN
0 UN
G
G
G
R
X
DEATH
DIFFICULTY RISING
RECUMBENCY
DISTRESS, RESP
ESTRUS BEHAVIOR
Page: 68
Source:
Country:
State:
United States
OHIO
Zip:
XX XXX
Episode Date:
04/0112007
Dosage: Overdose
Dose Description: 4 OZ/DA Y; 4/2007* - 5/2007*
Extra Label:
Overdose
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
US201003048
UNKNOWN
#Treated:
#Reacted:
#Died:
0
Species: CATTLE
Age: UN
Weight: 1250 LB
ON MAY 20, 2010, ELAN CO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADE INVOLVING
OPT AFLEXX (RACTOP AMINE HYDROCHLORIDE) IN A SHOW STEER. IN APPROXIMATELY APRIL OR MAY, 2007, AN
ANIMAL OWNER BEGAN FEEDING OPTAFLEXX (TYPE A) TO HIS STEER AT A RATE OF 4 OZ/DA Y (ESTIMATED 11.25
G/DA Y) FOR 40 DAYS BEFORE FINISHING. AT AN UNK TIME, THE STEER BECAME "UNSOUND" SHOWING SIGNS OF
STIFF JOINTS AND TIGHTNESS. THE OWNER DECREASED THE AMOUNT OF OPTAFLEXX BY 0.5 OZ (TO 3.5 OZ/DAY)
AND THE STEER RECOVERED. INFO ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS
WAS NOT PROVIDED. NO FURTHER INFO IS EXPECTED.
CMP: UNKNOWN
Causality
Assessment
0
CVM _Report. rep
Time
To Onset
4 WK
Clinical Detail:
G STIFFNESS
Page: 69
Document ID: N 141221 Submission ID: L 301 Package ID: A 1 Corrsp Date: 06/ 16/2010
Source:
Country:
State:
United States
COLORADO
Zip:
80701
Episode Date:
05/16/2010
Dose Description: 200 MG/HEAD/DAY; 4/20/2010
Extra Label:
None
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
EFFICIENCY AND INCREASED CARCASS LEANNESS;
4/20/2010
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Yes
RUMENSIN 80 (80 G/LB); 23.4 G/TON; ORAL; 04/2010*
2 TYLAN 100 (100 G/LB); 90 MG/HEAD/DAY; ORAL; 04/2010*
US201003349
UNKNOWN
#Treated:
14059
#Reacted: 11
#Died:
11
Species: CATTLE
Age: 15 MO
Weight:
1050 LB
ON MAY 28,2010, AN ELANCO ANIMAL HEALTH TECH CONSULTANT REPORTED A POTENTIAL ADE INVOLVING
OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN FEEDLOT CATTLE. ON APRIL 20, 2010, FEEDLOT CATTLE WERE
STARTED ON A RATION THAT INCLUDED OPT AFLEXX FED AT 200 MG/HD/DA Y. AT THE TIME THE OPTAFLEXX WAS
ADDED, THE CATTLE WERE ALSO BEING FED RUMENSIN AT 23.36 G/TON (ON AN AS-FED BASIS) AND TYLAN AT 90
MG/HD/DAY. ON MAY 16, 2010 THROUGH MAY 18, 2010, 5 ANIMALS DEVELOPED BLOAT AND DIED. THERE WERE NO
PRE-EXISTING MEDICAL CONDITIONS.
UPDATE JUNE 8, 2010: FEED ASSAY RESULTS REPORTED THAT RUMENSIN WAS PRESENT IN THE RATION AT 26.8
G/TON (EXPECTED LEVEL WAS 23.4 G/TON). THE RESULT WAS WITHIN ACCEPT ABLE LIMITS.
UPDATED JUNE 8, 2010: ON JUNE 8 ~ 2010 UPDATE INFO WAS OBTAINED. THE ELANCO ANIMAL HEALTH TECHNICAL
CONSULTANT REPORTED THAT 6 MORE ANIMALS DIED (3 FROM THE OPTAFLEXX FED GROUP AND 3 FROM THE
NON:OPT AFLEXX FED GROUP).
UPDATED JUNE 10,2010: FEED ASSAY RESULTS REPORTED THATRUMENSIN WAS PRESENT IN THE RATION AT 29.2
G/TON (EXPECTED LEVEL WAS 23.4 G/TON). THE RESULT WAS ABOVE ACCEPT ABLE LIMITS.
FEED ASSAY DETAILS- JUNE 9, 2010 02
RESULT: 29.2 G/TON
RESULT ABNORMALLY HIGH.
6/09/2010 02 - FEED ASSAY 29.2 G/TON RESULT ABNORMALLY HIGH
617/2010 01- FEED ASSAY 26.8 G/TON NORMAL
01: US201003349B; EXPECTED LEVEL 23.4 G/TON
CVM _Report. rep
Page: 70
02: US201003349A; EXPECTED LEVEL 23.4 G/TON
CMP: UNKNOWN
Causality
Assessment
0
0
Time
To Onset
4 WK
4 WK
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
TEXAS
Zip:
79116
Episode Date:
05/1 9/2008
Dose Description: 200 MG/HEAD/DA Y; PO; 5/1 9/08*
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
Concomitants: Yes
RUMENSIN 31 G/TON PO DATE UNK
2 TYLAN 10G/TONPO DATE UNK
US200807 513
REQ, NOT PROVIDED
#Treated:
15000
#Reacted: 39
#Died:
39
Species: CATTLE
Age: UN
Weight: 1350 LB
ON 01-JUL-2008, MS. , ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING OPT AFLEXX (RACTOP AMINE HYDROCHLORIDE) IN
FEEDLOT CATTLE. ON APPROXIMATELY 19-MAY-2008, THE BEGAN FEEDING
OPT AFLEXX TO 15,000 HEAD OF FINISHING CATTLE. OVER A PERIOD OF 30 DAYS (FROM APPROXIMATELY 19-
MA Y -2008 UNTIL 18-JUN-2008), THERE WAS AN INCREASE IN THE NUMBER OF BLOAT RELATED DEATHS IN THE
OPT AFLEXX FED CATTLE. THE NORMAL BLOAT RELATED DEATH RATE IN THE FEEDY ARD WAS 0.16%; IN THE
OPTAFLEXX FED CATTLE IT WAS 0.26%. RUMENSIN (MONENSIN SODIUM) WAS ALSO IN THE RATION AT 31 G/TON;
TYLAN (TYLOSIN PHOSPHATE) WAS IN THERA TION AT 10 G/TON. NO FURTHER INFORMATION IS EXPECTED.
MEDICAL HISTORY
NONE
CVM _Report. rep
Causality
Assessment
0
0
CVM _Report. rep
Time
To Onset
VA
VA
Clinical Detail:
D BLOAT
G DEATH
Page: 71
ADE Reoorts Search Criteria
Document: N 141225
ADE REVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Sub Num: Drug:
Source Report ID:
NDC:
Product Lot#:
Report Quality:
Species: Age:
Breed: Weight:
Gender: Episode Date:
From To
Corr Date:
From To
Unit
ADE CONCOMITANTS
Status:
ADE ASSESSMENTS
Clinical Detail
Route:
Description:
14
Page: 1
Drug Name: MONENSIN, RACTOPAMINE
Source:
Country:
United States
State:
INDIANA
Zip:
CLIN STUDY
Episode Date:
04/15/2004
Dose Description: 200 MG/HD/DA Y
Extra Label: None
Reason For Use:
STUDY T4V310333
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
. Evaluation Comments:
46140
PackageiD: A 1 Corrsp Date: 05/05/2004
Source Report ld:
US20040080 1
NDC:
Product Lot No:
101PC1
#Treated:
24
#Reacted:
#Died:
0
Species: CATTLE
Age: 13.5 MO
Weight:
1200 LB
STEER WAS REMOVED FROM POST MARKETING STUDY ON 4/15/04 DUE TO FOOT PROBLEMS. CEMENT FLOORING
MAY BE A FACTOR. SIGNS NOTICED 4111 , STARTED ON PRODUCT 4112/04. STEER WAS ON MONENSIN PRIOR TO
STARTING RACTOPAMINE. THE STEER WAS MOVED TO A DIRT LOT. MONENSIN AND RACTOPAMINE WERE
DISCONTINUED. F/U: LOT# ADDED.
Causality
Assessment
0
Time
To Onset
3 DA
Clinical Detail:
G HOOF DISORDER
Source:
Country:
State:
United States
PENNSYLVANIA
Zip:
17545
OWNER
Episode Date:
03/23/2004
Dose Description: 200 MGIHDIDA; 3/23/04 TO 4113/04
CVM _ Report.rep
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200400874
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
68
5
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
FDA/CVM- ADE Reports - CVM Response
None
Good
Owner
Unknown
Breed:
Age:
Weight:
Gender:
Page: 2
Mixed (cattle)
16 MO
1400 LB
Missing information
CATTLE EXHIBITED STIFF REAR LIMBS AND CRAMPING AFTER 21 DAYS ON RACTOPAMINE. THE CATTLE HAD
BEEN KEPT ON SLATS FOR 200+ DAYS. FARM CONTINUES TO USE RACTOPAMINE. FlU: ELANCO CONSULTANT
OBSERVED CATTLE AT THE FARM. CONCLUDED THAT THE PROBLEMS WERE DUE TO PRESSURE SORES FROM
BEING ON SLATS. HE REPORTED THAT THE ATTENDING VET HAD THE SAME OPINION. THE PROBLEMS HAVE
SUBSIDED.
Causality
Assessment
Time
To Onset
21 DA
Clinical Detail:
G SPASM
21 DA G STIFFNESS, HIND LIMB(S
Source:
Country:
United States
State:
COLORADO
Zip:
STUDY T4V31 0333
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/26/2004
Recommended dose
Oral (in dry feed)
200 MG/HD/D
None
STUDY
Missing infom1ation
Owner
Low
Unknown
80863
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US20040 1241
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
3
CATTLE
Unknown (cattle)
14 MO
1200 LB
Male, neutered
STEER #8276 WAS FOUND DEAD. NECROPSY INDICATED DEATH WAS DUE TO ACUTE, FREE GAS BLOAT. FlU: LOT#
ADDED.
CVM _Report. rep
Page: 3
Causality
Assessment
Time
6 DA D BLOAT
6 DA G DEATH
Source:
Country:
State:
United States
TEXAS
Zip:
78877
STUDY
Episode Date:
05/02/2004
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/DA Y RACTOP AMINE; 30 G/TON MONENSIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
FEEDING STUDY
Good
Owner
Unknown
US20040 1567
UNK
#Treated:
530
#Reacted: 530
#Died:
0
Species: CATTLE
Age: UN
Weight:
1100 LB
FEEDYARD STARTED A FEEDING TRIAL ON MARCH 23,2004. STEERS FED RACTOPAMINE AND MONENSIN
AVERAGED A DAILY FEED TNT AKE OF 1.78 LB/HD MORE THAN THE GROUP THAT RECEIVED ONLY MONENSIN.
Causality
Assessment
3
Time
To Onset
UN
Clinical Detail:
G POLYPHAGIA
Source:
Country:
State:
United States
PENNSYLVANIA
Zip:
17545
INFO IS UNCLEAR
CYM _Report. rep
Source Report ld:
US200402404
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05/15/2004
Recommended dose
Oral (all other)
4 OZ IHDIDA; FROM 5/3/04
Other
INC CARCASS LEANNESS
Good
Owner
Yes
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
MONENSIN "REGULAR DOSE"
2
Page: 4
136
68
0
CATTLE
Mixed (cattle)
12 MO
1300 LB
Male, neutered
REPORT STATES STEERS ADMINISTERED RACTOPAMINE AT 4 OZ/HD/DA AND MONENSIN SODIUM AT THE
"REGULAR DOSE". PREMIX SHOULD BE THOROUGHLY MIXED WI FEED. ALSO READS AS IF MONENSIN FED
SEP ARA TEL Y. UNCLEAR IF DOSE IS APPROPRIATE IN THIS INCIDENT. CM: WHITE HAIR ON LATERAL ASPECT OF
HIND LEGS. SORES AND SCABS DEVELOPED IN SAME AREA. NO RUBBING OR SCRATCHING OBSERVED. FlU: NO
FURTHER INFORMATION.
Causality
Assessment
0
0
0
Time
To Onset
UN
UN
UN
Clinical Detail:
HAIR, ABN COLOR
SKIN, SCAB(S)
I SORE(S)
Source:
Country:
United States
State:
TEXAS
FEEDYARD
Episode Date: 10/01 /2004
Dosage: Unknown
Zip:
Route:
Dose Description:
Oral (in dry feed)
STARTED 9/27/04
CYM _ Report.rep
79015
Source Report ld:
US200405660
NDC:
Product Lot No:
UNK
#Treated:
3800
#Reacted: 1900
#Died:
0
Species: CATTLE
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
Age:
Weight:
Gender:
Page: 5
14 MO
1100 LB
Female
HALF THE CATTLE HAD REDUCED FEED CONSUMPTION BY 1 TO 1.5 LBS/DA Y FOR ABOUT 4 DAYS.
Causality
Assessment
2
Time
To Onset
7 DA
Clinical Detail:
G ANOREXIA
Source:
Country:
United States
State:
IOWA
OWNER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
01/30/2005
Recommended dose
Oral (all other)
200 MGIHDIDA Y
None
XX XXX
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED WEIGHT GAIN AND FEED EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
US200500808
UNKNOWN
#Treated:
118
#Reacted: 118
#Died:
0
Species: CATTLE
Age: XX
Weight: 868 LB
2 GROUPS OF STEERS TREATED WITH MONENSIN SODIUM, 180 STARTED 9114/04, 118 STARTED 9/18/04 FOR 140 DAYS.
FOR THE LAST 25 DAYS, RACTOPAMINE ADDED TO THIS SECOND GROUP. THE RACTOPAMINE GROUP WAS SOLD
FOR SLAUGHTER 1/30/05, THE OTHER GROUP ON 211 /05. CM: AVERAGE DAILY WEIGHT GAIN FOR THE
RACTOPAMINE GROUP WAS 3.53 LBS/DAY, FOR THE OTHER GROUP WAS 3.46 LB/DA Y (MONENSIN ONLY). THE
DRESSING PERCENTAGE WAS 61.2% FOR THE RACTOPAMINE GROUP AND 61.75% FOR THE MONENSIN ONLY
GROUP. HIDES MUDDY IN BOTH GROUPS.
Causality
Assessment
CVM _ Report.rep
Time
Page: 6
NA E INEFFECT, WEIGHT INC
Drug N arne: MONENSIN, RACTOPAMINE
Source:
Country:
United States
State:
IOWA
Zip:
FEEDYARD
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
04/03/2005
Recommended dose
Oral (in dry feed)
4/ 1/05; 290 MGIHDIDA
None
XX :XXX
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200501104
UNK
#Treated:
1400
#Reacted: 3
#Died:
3
Species: CATTLE
Age: UN
Weight:
UN
3 ANIMALS IN 2 LOCATIONS DIED FROM BLOAT. 2 STEERS, 1 HEIFER. CONTINUES TO FEED RACTOPAMINE.
Causality
Assessment
Time
To Onset
2 DA
2 DA
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
ILLINOIS
Zip:
61071
Episode Date:
04/27/2005
CVM_Rep01t.rep
Package ID: A 1 Corrsp Date: 05/1 2/2005
Source Report ld:
US200501214
NDC:
Product Lot No:
UN
#Treated:
4000
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
200 MG/DA RACTOP AMINE, 225 MG/DA MONENSIN
None
Good
Owner
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 7
212
0
CATTLE
Mixed (cattle)
UN
1250 LB
Unknown
THE PRODUCER TARGETED RACTOPAMINE AT 200 MG/HD, MONENSIN RATE WAS 225 MG/HD/DA. OTHER CATTLE
ON THE FEEDLOT RECEIVED ONLY MONENSIN AT 250-275 MG/HD/DA. THE GROUP FED BOTH RACTOPAMINE AND
MONENSIN HAD AN OUTBREAK OF COCCIDIOSIS. THE CATTLE FED THE HIGHER MONENSIN DOSE DID NOT
EXPERIENCE A COCCIDIOSIS OUTBREAK. FlU SUBM 13, 5/20/05: FEED ASSAY W/IN EXPECTED RANGE. THE DOSE
THAT THE ANIMALS RECEIVED WAS ADJUSTED AND ALL HAVE RECOVERED.
Causality
Assessment
0
Time
To Onset
NA
Clinical Detail:
E INEFFECT, COCCIDIA
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
08116/2005
Dosage: Unknown
Source Report Id:
NDC:
Product Lot No:
Dose Description: 7/30/05 TO 8/ 16/05; 200 MG/HD/DA RACTOPAMINE, 260
MG/HD/DA MONENSIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
None
Good
Owner
Missing information
Unknown
US200501501
UNK
#Treated:
142
#Reacted:
#Died:
0
Species: CATTLE
Age: UN
Weight:
1150 LB
STUDY T4V190410. ONE STEER WAS REMOVED FROM THE STUDY DUE TO LAMENESS.
Causality
Assessment
Time
To Onset
17 DA
Clinical Detail:
G LAMENESS
Page: 8
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
06/01/2005
Source Report ld:
NDC:
Product Lot No:
Dose Description: RACTOP AMINE @ 200 MG/HD/DA, MONENSIN @ 300
MGIHDIDA; 51?/05 TO 6/15/05
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
Concomitants: No
US200502031
UNK
#Treated:
322
#Reacted: 6
#Died:
6
Species: CATTLE
Age: 12.5 MO
Weight:
1250 LB
1 OF THE DEATHS WAS ON THE TRUCK. STEERS WERE FROM 3 DIFFERENT YARDS. NECROPSY DX-DEATH DUE TO
HEART ATTACKS; THERE WAS FOAM FROM THE NOSTRILS AT TIME OF DEATH. OWNER ALSO STATED THAT
THESE STEERS WERE HYPERACTIVE. DISCONTINUED RACTOP AMINE AT THIS FARM.
Causality
Assessment
0
0
0
Time
To Onset
2 WK
2 WK
2 WK
2 WK
Clinical Detail:
c HEART F AlLURE
G DEATH
N HYPERACTIVITY
R FROTH, NOSE
Source:
CVM _Report. rep
Country:
United States
State:
IOWA
Zip:
52761
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/30/2005
Recommended dose
Oral (in dry feed)
7/30/04 TO 9/2/04
None
Good
Veterinarian
Missing information
Unknown
Source Report Id:
US200502166
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 9
72
3
0
CATTLE
Mixed (cattle)
UN
1000 LB
Male, neutered
STUDY OBJECTIVE WAS TO DETERMINE THE EFFECTS OF CRUDE PROTEIN CONCENTRATION AND THE FEEDING
OF RACTOPAMINE @ 200 MG/HD/DA FOR 34 DAYS PRIOR TO SLAUGHTER ON STEER GROWTH AND CARCASS DATA.
ONE STEER FROM THE CONTROL GROUP(NO RACTOPAMINE) WAS FOUND DEAD WI A BROKEN NECK. ONE FROM
THE TREATMENT GROUP WAS REMOVED FROM THE STUDY DUE TO LAMENESS. 1 WAS REMOVED FOR
TREATMENT OF PINKEYE AND ONE FOR A PUNCTURE-UNK WHICH GROUP THEY WERE FROM. THEY BOTH
RETURNED AFTER TX.
Causality
Assessment
-3
-3
Time
To Onset
UN
Clinical Detail:
G INJURY
UN G LAMENESS
UN S CONJUNCTIVITIS
Source:
Country:
State:
United States
WISCONSIN
Zip:
XX XXX
Episode Date:
07115/2006
CVM _Repmi.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US20060 1792
UNK
#Treated:
#Reacted:
73
73
Page: 10
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
200 MG/HD/DA; STARTED 711 4/06
None
INCREASED RATE OF GAIN, IMPROVED FEED
EFFICIENCY AND CARCASS LEANNESS
Good
Owner
No
#Died:
0
Species: CATTLE
Age: 2 YR
Weight: 1300 LB
SHORTLY AFTER THERA TION WAS STARTED THE STEERS WERE OBSERVED TO BE HYPERACTIVE, JUMPING AND
RIDING EACH OTHER. CF: STEERS HAD BEEN PULLED FORM OTHER PENS AND RE-SORTED. RACTOPAMINE IS
STILL BEING FED.
Causality
Assessment
2
Time
To Onset
1 DA
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
State:
United States
NEBRASKA
Zip:
68116
Episode Date:
04/01/2008
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200MG/HD/DA Y OPT AFLEXX; 28 G/TON RUMENSIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASED RATE OF WEIGHT GAIN IMPROVED FEED
Good
Owner
No
Corrsp Date: 0611 2/2008
US200806065
RQST BUT NOT PRVD
#Treated:
700
#Reacted: 2
#Died:
2
Species: CATTLE
Age: 18 MO
Weight: 1200 LB
Gender: Unknown
ON 06-JUN-2008, MS. , ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING OPT AFLEXX (RACTOPAMINE HYDROCHLORIDE) AND
RUMENSIN (MONENSIN SODIUM) IN FEED LOT CATTLE. IN APPROXIMATELY APR-2008, AN UNK PRODUCER
CVM _Report. rep
Page: 11
BEGAN FEEDING A GROUP OF 700 HEAD OF FINISHING CROSSBRED CATTLE A RATION MANUFACTURED BY KENT
FEEDS INTENDED TO PROVIDE OPTAFLEXX AT 200MG/HD/DAY AND CONTAINING RUMENSIN AT 28 G/TON.
APPROXIMATELY 10 DAYS AFTER BEGINNING THE RATION, 2 ANIMALS DIED OF BLOAT. MR. ALAN SANDBULTE,
SALES REPRESENTATIVE AT DELUXE FEEDS (KENT FEEDS SUBSIDIARY), REPORTED THAT CATTLE ON
OPTAFLEXX HAVE HIGHER MORTALITY RATES. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
0
CVM _Report. rep
Time
To Onset
10 DA
10 DA
Clinical Detail:
D BLOAT
G DEATH
ADEREVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Species:
Breed:
Gender:
Drug:
Source Report ID:
NDC:
Product Lot#:
Report Quality:
Age:
Weight:
Episode Date:
From To
Corr Date:
From To
Unit
ADE CONCOMITANTS
Status:
ADE ASSESSMENTS
Clinical Detail
Route:
Description:
71
Page: 1
Drug Name: MONENSIN, RACTOPAMINE, TYLOSIN
Source:
Country:
United States
State:
TEXAS
Zip:
CLIN TRIAL T4V480326
Episode Date:
03/24/2004
79013
Dose Description: 20 G/TON; 3/23/04 TO 3/24/04
Extra Label:
None
Reason For Use:
CLINTRIAL
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
RUMENS IN
2 TYLOSIN
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200400258
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
87
CATTLE
Mixed (cattle)
15 MO
1180 LB
Male, neutered
ONE STEER WAS FOUND DEAD IN THE PEN. VET FELT THAT IT DIED OF BLOAT UNRELATED TO OPTAFLEXX. FlU:
LOT#ADDED.
Causality
Assessment
Time
1 DA D BLOAT
1 DA G DEATH
Drug N arne: MONENSIN, RACTOPAMINE, TYLOSIN
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
03/08/2004
CVM _Report. rep
Source Report Id:
US200400285
NDC:
Product Lot No:
101PC1
#Treated:
72
#Reacted:
#Died:
Dose Description: 275 MG/HD/DA; 3/8-3/26/04 Species:
Extra Label:
None Breed:
Reason For Use:
CLINTRIAL
Age:
Weight:
Health Status:
Good
Gender:
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
RUMENS IN
2 TYLOSIN
Page: 2
CATTLE
Mixed (cattle)
15 MO
1500 LB
Male, neutered
BREED: HOLSTEIN-FRIESIAN. STEER WAS FOUND DEAD IN THE PEN AFTER 18 DAYS ON OPTAFLEXX. FlU: LOT 3
ADDED.
Causality
Assessment
Time
0 18 DA G DEATH
Source:
Country:
United States
State:
TEXAS
Episode Date:
03/30/2004
Zip:
Dosage:
Recommended dose
Dose Description: 10-20 GM/TON
Extra Label:
None
Reason For Use:
CLINTRIAL
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
CVM _Report. rep
79013
Source Report ld:
US200400 513
NDC:
Product Lot No:
101PC1
#Treated:
3
#Reacted: 3
#Died:
3
Species: CATTLE
Age: 14 MO
Weight: 1150 LB
RUMENS IN
2 TYLOSIN
Page: 3
ON 3/30/0/4, 2 STEERS WERE REMOVED FROM THE STUDY AFTER SHOWING SIGNS OF RIDING AND AGGRESSIVE
SEXUAL BEHAVIOR. ON 411 /04, ONE STEER WAS REMOVED DUE TO AN INJURED FRONT LEG THAT RESULTED
FROM AGGRESSION OF ANOTHER STEER. VET DID NOT FEEL THE BEHAVIOR WAS RELATED TO OPTAFLEXX. ALL
3 WERE SENT TO SLAUGHTER. F/U: LOT NUMBER ADDED.
Causality
Assessment
Time
UN G DEATH(SLAUGHTERED)
UN N AGGRESSION
Source:
Country:
United States
State:
NEBRASKA
Episode Date:
03/31/2004
Dosage: Unknown
Zip:
Dose Description: 3/31/04
Extra Label: None
Reason For Use:
CLINTRIAL
Health Status:
Fair
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
RUMENS IN
2 TYLOSIN
68583
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
US200400543
101PC1
#Treated:
#Reacted:
#Died:
0
Species: CATTLE
Age: 13.5 MO
Weight:
1500 LB
ONE STEER ON A CONTROL DIET OF MONENSIN (320 MG/H/D) AND TYLOSIN (90 MG/H/D) SHOWED RESP SIGNS ON
4/6/04. ANOTHER STEER WAS STARTED RACTOPAMINE AT 100 MG/HD/DAY, MONENSIN AT 320 MG/HD !DAY AND
TYLOSIN AT 90 MGIHDIDA ON 3/31/04 AND AT THAT TIME WAS SHOWING SIGNS OF DIPTHERIA. THE STEER'S SIGNS
WERE MORE SIGNIFICANT AFTER PROCESSING AND HE WAS REMOVED FROM THE STUDY ON 4/6/04 AND TREATED.
FlU: LOTNUMBERADDED.
CVM _ Rep01t.rep
Page: 4
Causality
Assessment
Time
-1 NA R RESPIRATORY DISORDER
Source:
Country:
United States
State:
TEXAS
Zip:
Episode Date:
04/08/2004
79013
Dose Description: 10 GM/TON; 3/23/04 TO 4/8/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
CLINTRIAL
Good
Owner
Low
Unknown
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200400729
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
1700
CATTLE
Mixed (cattle)
14 MO
1100 LB
Male, neutered
ONE STEER WAS FOUND DEAD IN THE PEN 15 DAYS AFTER STARTING OPTAFLEXX. VET FELT THE ANIMAL DIED
OF BLOAT UNRELATED TO OPT AFLEXX. FlU: LOT NUMBER ADDED.
Causality
Assessment
0
0
Time
To Onset
15 DA
15 DA
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
United States
State:
TEXAS
CVM _ Rep01t.rep
Zip:
79013
Source Report Id:
US200400731
NDC:
Product Lot No:
101PC1
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/ 13/2004
#Treated:
Recommended dose
#Reacted:
20 GM/TON; 3/23-4/8/04
Species:
None Breed:
CLINTRIAL
Age:
Weight:
Good
Gender:
Owner
Low
Yes
RUMENS IN
2 TYLOSIN
Page: 5
1700
CATTLE
Mixed (cattle)
14 MO
1600 LB
Male, neutered
FOUND DEAD IN THE PEN ON 4/8/04. VET FELT THE STEER DIED OF BLOAT, UNRELATED TO TREATMENT. FlU: LOT
NUMBER ADDED.
Causality
Assessment
0
0
Time
To Onset
15 DA
15 DA
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
NEBRASKA
Zip:
xxxxx
FEEDLOT
Episode Date:
04/24/2004
Dose Description: 200, 20, 6; ORAL; 4/7/04-4/24/04
Reason For Use:
Health Status:
Good
CVM _Rep01t.rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US20040 1102
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
400
CATTLE
Unknown (cattle)
Male
UN
1225 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Page: 6
DOSAGE REPORTED AS 200, 20, 6 WITH NO OTHER DESCRIPTION. FEEDYARD FOUND ONE CALF DEAD. ENLARGED
HEART WI SIGNIFICANT FAT AROUND IT WAS SEEN AT NECROPSY. HEART FAILURE SUSPECTED.
Causality
Assessment
Time
To Onset
17 DA
17 DA
17 DA
Clinical Detail:
C CARDIOMEGALY
C HEART F AlLURE
G DEATH
Source:
Country:
United States
State:
SOUTH DAKOTA
Zip:
Episode Date:
04/24/2004
57007
Dose Description: 200, 285, 185 G/TON; 4/1 3/04-4/24/04
Extra Label:
None
Reason For Use:
STUDY T4V460339
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
MONENSIN
2 TYLAN
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
US20040 1 01 0
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
Other (cattle)
15 MO
UN
Male, neutered
STEER WAS FOUND DEAD IN THE PEN ON 4/24/04. BLOAT WAS SUSPECTED AS THE CAUSE OF DEATH. FlU: 5/ 14/04:
NECROPSY: STEER DIED DUE TO ACUTE RUMENAL TYMPANY(BLOAT). FlU: LOT NUMBER ADDED.
Causality
Assessment
CYM _ Repmt.rep
Time
Page: 7
11 DA D BLOAT
11 DA G DEATH
Source:
Country:
United States
State:
NEBRASKA
STUDY T4V310338
Episode Date:
04/21/2004
Zip:
Dose Description: 200, 300, 90 G/TON
Extra Label:
None
Reason For Use:
STUDY T4V310338
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
MONENSIN
2 TYLOSIN
68583
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
US200400914
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
Mixed (cattle)
15 MO
1250 LB
Male, neutered
STEER NUMBER 1830 WAS FOUND DEAD IN THE PEN. NECROPSY: CAUSE OF DEATH DETERMINED TO BE
ATYPICAL INTERSTITIAL PNEUMONIA. FlU: LOT NUMBER ADDED.
Causality
Assessment
-1
-1
Time
To Onset
16 DA
16 DA
Clinical Detail:
G DEATH
R PNEUMONIA
Source:
Country:
CVM _ Repott. rep
United States
Source Report ld:
US200401398
NDC:
State:
KANSAS
Zip:
67401
Product Lot No:
101PC1
POST MARKET STUDY T4V200324
Episode Date:
05111/2004
#Treated:
#Reacted:
Dose Description: 200, 33 G/TON; 5/4-12/04
Species:
Extra Label:
None Breed:
Reason For Use:
Age:
Weight:
Health Status:
Gender:
Good
Administered By:
Veterinarian
Vet Opinion: Low
Page: 8
360
CATTLE
Other (cattle)
15 MO
1020 LB
Unknown
ANIMAL #8640 WAS FOUND DEAD ON 5112/03 AFTER HAVING DIGESTIVE PROBLEMS 5/ 11/04. POST MORTEM EXAM:
DIGESTIVE PROBLEM DETERMINED TO BE THE CAUSE OF DEATH. FlU: 917/04-LOT NUMBER ADDED.
Causality
Assessment
Time
0 7 DA D DIGESTION DISORDER
0 8 DA G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
81052
POST MARKETING STUDY T4V080325
Episode Date:
05/07/2004
Dose Description: 100 MG/HD; 21.1, 6.4; 4/26-5/7/04
Extra Label:
None
CVM _ Repmt.rep
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
US20040 1395
101PC1
#Treated:
66
#Reacted:
#Died:
0
Species: CATTLE
Age: 24 MO
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Missing information
Unknown
Weight:
Gender:
Page: 9
1220 LB
Male, neutered
ANIMAL APPEARED TO HAVE BROKEN ITS SHOULDER. IT WAS TREATED AND REMOVED FROM THE STUDY
BECAUSE IT WAS NOT ABLE TO WALK. FlU: 9/7/04: LOT# ADDED.
Causality
Assessment
-1
-1
Time
To Onset
11 DA
11 DA
Clinical Detail:
G INJURY
G LAMENESS
Source:
Country:
State:
United States
NEBRASKA
Zip:
68583
STUDY T4V310338
Episode Date:
05/10/2004
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
Dose Description: 115, 300, 90 MG/HD/D; 4/5/04 TO 5/10/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
STUDY T4V310338
Good
Owner
Missing infom1ation
Unknown
US200401324
101PC1
#Treated:
9
#Reacted:
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1326 LB
STEER WENT DOWN IN A CHUTE DURING A WEIGH IN. HEW AS DOWN FOR A SHORT TIME, EVENTUALLY GOT UP,
LEFT THE CHUTE AND HAD NO OTHER REPORTED PROBLEMS. THE STEER WAS REMOVED FROM THE STUDY
BECAUSE THE WEIGHT RECORDED MAY HAVE BEEN INACCURATE. REVIEWER COMMENT: RECUMBENCY IS SEEN
IN PIGS FED RACTOPAMINE. FlU: 9/7/04: LOT NUMBER ADDED.
Causality
Assessment
CVM _ Repmt.rep
Time
Page: 10
0 35 DA G COLLAPSE
0 35 DA G RECUMBENCY
Source:
Country:
State:
United States
KANSAS
Zip:
67401
STUDY T4V200324
Episode Date:
05/06/2004
Package ID: A 4
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200, 33 G/TON; 90 MG/H; 5/4/04 TO 5/6/04
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Veterinarian
Vet Opinion: Low
US200401306
101PC1
#Treated:
180
#Reacted: 2
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1054 LB
2 STEERS WERE REMOVED FROM THE STUDY DUE TO RESPIRATORY DISEASE. THEY WERE TREATED WI NAXCEL
AND RECOVERED. NEITHER ANIMAL WILL RETURN TO THE STUDY. FlU: LOT NUMBER ADDED.
Causality
Assessment
Time
2 DA R RESPIRATORYDISORDER
Source:
Country:
United States
State:
COLORADO
STUDY T4V080336
CVM _ Rep01t.rep
Zip:
80523
Package ID: A 6
Source Report ld:
NDC:
Product Lot No:
US20040 1224
101PC1
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05/03/2004
#Treated:
Recommended dose
#Reacted:
200, 20, 4; 4/26-5/3/04
Species:
None Breed:
STUDY T4V080336
Age:
Weight:
Good
Gender:
Veterinarian
Low
Unknown
Page: 11
200
0
CATTLE
Other (cattle)
14 MO
1100 LB
Male, neutered
A STEER EXHIBITED CLINICAL SIGNS OF RESPIRATORY DISEASE (BRD) ON 5/3/04. STEER WAS REMOVED FROM
THE STUDY AND TREATED WI A180. ON 5/18/04 THE STEER WAS REPORTED TO HAVE RECOVERED. FlU: LOT#
ADDED.
Causality
Assessment
Time
7 DA R RESPIRATORYDISORDER
Source:
Country:
United States
State:
ARIZONA
Zip:
STUDY T4V040334
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _ Report.rep
05/04/2004
Recommended dose
Oral (in dry feed)
15.3 GM/TON; 4/28-5/4/04
None
STUDY T4V040334
Good
Veterinarian
Missing information
Unknown
85721
Package ID: A 7
Source Report ld:
NDC:
Product Lot No:
US200401292
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
294
CATTLE
Mixed (cattle)
17 MO
1100 LB
Male, neutered
Page: 12
THE STEER WAS FOUND DEAD. NECROPSY INDICATED DEATH WAS DUE TO BLOAT. F/U: LOT NUMBER ADDED
Causality
Assessment
Time
6 DA D BLOAT
6 DA G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
81052
STUDT
Episode Date:
05/24/2004
Package ID: A 7
Source Report ld:
NDC:
Product Lot No:
Dose Description: 100 MG/HD/DAY RACTOPAMINE, MONENSIN: 21.1 G/TON,
TYLOSIN: 6.4 G/TON.
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
STUDY T4V080325
Good
Veterinarian
Missing information
Unknown
US20040 1 799
101PC1
#Treated:
70
#Reacted:
#Died:
0
Species: CATTLE
Age: 24 MO
Weight:
1160 LB
STEER WAS REMOVED FROM THE STUDY DUE TO BLOAT. ID # 2449. STEER WAS TREATED WI CEPHALOSPORIN
AND AN ESOPHAGEAL TUBE WAS PASSED TO LET OFF RUMINAL GAS. FlU: 9/7/04: ADDED LOT#
Causality
Assessment
-1
Time
To Onset
28 DA
Clinical Detail:
D BLOAT
Source:
Country:
State:
United States
NEBRASKA
Zip:
68154
CVM _ Rep01t.rep
Source Report ld:
US200401458
NDC:
Product Lot No:
101PC1
STUDY T4V200324
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05/13/2004
Recommended dose
Oral (in dry feed)
200, 33, 90; 5111-13/04
None
STUDY T4V200324
Good
Veterinarian
Low
Yes
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
TYLOSIN
2 RUMENSIN
Page: 13
350
0
CATTLE
Mixed (cattle)
16 MO
1068 LB
Male, neutered
ANIMAL# 7843 WAS REMOVED FROM THE STUDY DUE TO RESPIRATORY DISEASE. FlU, SUBM 26: NO NEW INFO.
Causality
Assessment
Time
2 DA R RESPIRATORY DISORDER
Source:
Country:
State:
United States
COLORADO
Zip:
81052
STUDY
Episode Date:
05112/2004
Package ID: A 9
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/D RACTOPAMINE, 29.1 G/TON MONENSIN, 88
MG/HD/DA TYLOSIN; 4/19-5112/04
Extra Label:
None
Reason For Use:
STUDY T4V080325
Health Status:
Good
CVM _ Report.rep
US20040 1460
101PC1
#Treated:
276
#Reacted:
#Died:
0
Species: CATTLE
Age: 24 MO
Weight: 1000 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Low
Yes
TYLOSIN
2 MONENSIN
Page: 14
STEER WAS REMOVED FROM THE STUDY DUE TO RESPIRATORY DISEASE WI A FEVER OF 105.3. FlU: SUBM26, NO
NEW INFO.
Causality
Assessment
-1
Time
To Onset
23 DA
Clinical Detail:
G FEVER, BODY
-1 23 DA R RESPIRATORY DISORDER
Source:
Country:
United States
State:
KANSAS
Zip:
STUDY T4V200324
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
05/23/2004
Recommended dose
Oral (in dry feed)
5/4/04 TO 5/23/04
None
67401
Reason For Use:
RESEARCH STUDY #T4V200324
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing information
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200402037
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
350
CATTLE
Mixed (cattle)
15 MO
1520 LB
Male, neutered
STEER# 8233 IN STUDY #T4V200324 WAS FOUND DEAD IN THE PEN. NECROPSY: BLOAT FOUND TO BE CAUSE OF
DEATH. WAS ON RACTOPAMINE 100 MG/DA, MONENSIN 33 G/TON, TYLOSIN 90 G/TON. FlU: 917/04: ADDED LOT#.
Causality
Assessment
0
CVM _Report. rep
Time
To Onset
19 DA
Clinical Detail:
D BLOAT
Page: 15
0 19 DA G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
67401
RESEARCH STUDY TV 4200324
Episode Date:
0610312004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MGIHID RACTOPAMINE, 33 GITON MONENSIN, 9.1
GITON TYLOSIN; 5111-613104
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
STUDY T4V200324
Good
Veterinarian
Missing information
Unknown
US200402343
101PC1
#Treated:
150
#Reacted:
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1180 LB
STEER 7762 WAS REMOVED FROM THE STUDY AFTER 23 DAYS. DX WI ACUTE INTERSTITIAL PNEUMONIA AND
TREATED WI CEPHALOSPORIN. WAS ON RACTOPAMINE 200 MGIHDI DA, MONENSIN 33 GITON, TYLOSIN 9.1 GITON.
FlU: 917104: ADDED LOT#.
Causality
Assessment
0
Time
To Onset
23 DA
Clinical Detail:
R PNEUMONIA
Source:
Country:
United States
State:
TEXAS
FEEDYARD
Episode Date:
CVM _Report. rep
Zip:
79015
Source Report ld:
US200403 654
NDC:
Product Lot No:
UNK
Page: 16
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/01/2004
Recommended dose
Oral (in dry feed)
200 MG/H/D; FROM 6/ 1104
None
INC RATE OF GAIN
Good
Owner
Missing information
Yes
MONENSIN 270 MG/HD/DA Y
2 TYLOSIN 90 MG/HD/DA
#Treated:
16000
#Reacted: 100
#Died:
0
Species: CATTLE
Age: 15 MO
Weight:
UN
FEEDYARD. 16000 TO 20000 HEAD OF CATTLE. THE FEEDING SCHEDULE RECENTLY CHANGED FROM 3 TO 2 TIMES
PER DAY AND THERE HAS BEEN A SIGNIFICANT AMOUNT OF RAIN. THE RACTOPAMINE FED CATTLE ARE
EXPERIENCING A HIGHER RATE OF BLOATS. THE CATTLE ARE ALSO FED MONENSIN SODIUM AT 270 MG/HD/DA
AND TYLOSIN PHOSPHATE AT 90 MG/HD/DA Y. THE CATTLE ARE IN V ARlO US STAGES OF A 0 TO 28 DA FEEDING
SCHEDULE. THE NUMBER OF CATTLE AFFECTED WAS NOT REPORTED.
Causality
Assessment
Time
UN D BLOAT
Source:
Country:
United States
State:
CALIFORNIA
Episode Date:
06/1 5/2004
Zip:
Dose Description:
Extra Label:
None
Reason For Use:
STUDY T4V060406
Health Status:
Good
CVM _Report. rep
93422
Source Report Id:
US200403 719
NDC:
Product Lot No:
102PC1, 101PC1
#Treated:
13
#Reacted:
#Died: 0
Species: CATTLE
Age: 14 MO
Weight: 1450 LB
Page: 17
Administered By:
Vet Opinion:
Concomitants:
Veterinarian
Missing infom1ation
No Value
STEER #157, PEN #15 BLOATED. TREATED WI 1 QT MIN OIL, 1 LB MAGNESIUM HYDROXIDE AND RETURNED TO THE
PEN. THE STEER WAS IN THE CONTROL GROUP AND DID NOT RECEIVE RACTOPAMINE. IT WAS GETTING
MONENSIN 28 G/TON AND TYLOSIN 7G/T.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
D BLOAT
Source:
Country:
State:
United States
CALIFORNIA
Zip:
93422
STUDY T4V060406
Episode Date:
06/28/2004
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MGIHID RACTOPAMINE, 28 G/TON MONENSIN, 7
G/TON TYLOSIN; FROM 6115/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Veterinarian
Missing information
Unknown
US200403 720
102PC1, 101PC1
#Treated:
13
#Reacted:
#Died:
0
Species: CATTLE
Age: 14 MO
Weight:
1150 LB
STEER #204 IN PEN #1 HAD A RECTAL PROLAPSE. RTX: IT WAS REDUCED AND THE STEER RETURNED TO THE PEN.
STILL NORMAL AS OF 6/29/04. FlU: 917/04: NO FURTHER INFO.
Causality
Assessment
0
Time
To Onset
13 DA
Clinical Detail:
D PROLAPSE, RECTUM
Source: Report from sponsor or distibutor of dmg
CVM _Report. rep
Source Report ld:
Page: 18
Country:
United States
State:
KANSAS
Episode Date:
06117/2004
Zip:
Dose Description:
Extra Label: None
66502
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing infonnation
No Value
US0200403492
NDC:
Product Lot No:
101PC1
#Treated:
24
#Reacted:
#Died:
0
Species: CATTLE
Age: 18 MO
Weight:
1266 LB
STEER# 322 FROM PEN # 505 HAD A LEFT REAR HOCK SWELLING AND LAMENESS. TREATED W/ DEX, REMOVED
FROM THE PEN. NOT RECEIVING RACTOP AMINE BUT WAS GETTING MONENSIN @ 27 G/TON AND TYLOSIN AT
9G/TON. FlU: 9/7/04: ADDED LOT#.
Causality
Assessment
-9
-9
Time
To Onset
NA
NA
Clinical Detail:
G LAMENESS
M SWELLING, JOINT(S)
Source:
Country:
State:
United States
COLORADO
Zip:
80610
Report Oualitv: Average
FEEDLOT
Episode Date:
06/24/2004
Dose Description: 200 MG/DA RACTOP AMINE
Extra Label:
None
CVM _ Rep01t.rep
Source Report ld:
US200403529
NDC:
Product Lot No:
UNK
#Treated:
128
#Reacted: 128
#Died:
0
Species: CATTLE
Page: 19
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
FEED EFFICIENCY
Good
Owner
Missing information
Yes
TYLOSIN
2 MONENSIN
Age:
Weight:
Gender:
UN
1250 LB
Male, neutered
RACTOP AMINE DEMONSTRATION AT FEEDLOT. 256 CATTLE. 128 WERE FED RACTOPAMINE FOR 28 DAYS AT 200
MG/HD/DA. ALL ANIMALS WERE WEIGHED AT THE BEGINNING AND THE END. RACTOPAMINE FED CATTLE WERE
MORE HYPERACTIVE AND DIFFICULT TO KEEP ON THE SCALES AYT THE END OF THE STUDY. NO BEHAVIOR
PROBLEMS WHEN ANIMALS WERE WEIGHED AT THE BEGINNING OF THE PROJECT, PRIOR TO RACTOP AMINE.
Causality
Assessment
2
Time
To Onset
28 DA
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
State:
United States
KANSAS
Zip:
66502
STUDY T4V200332
Episode Date:
06/17/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 300 MG/HD/D RACTOP AMINE, 27 G/TON MONENSIN,
9G/TON TYLOSIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Missing information
Veterinarian
Missing infom1ation
Unknown
US200403499
101PC1, AF063025BAM
#Treated:
24
#Reacted:
#Died:
0
Species: CATTLE
Age: 18 MO
Weight: 1170 LB
STEER #132 FROM PEN# 506 HAD A RR HOCK LAMENESS AND SWELLING. HE WAS REMOVED FROM THE PEN ON
6/24/04 AND TREATED WITH 20 MG DEXAMETHASONE. FlU: 9/7/04: LOT NUMBER ADDED.
CVM _ Repmt.rep
Page: 20
Causality
Assessment
0
0
0
Time
To Onset
23 DA
23 DA
23 DA
Clinical Detail:
G LAMENESS
M PAIN, JOINT(S)
Source:
Country:
United States
State:
TEXAS
Zip:
NUTRITIONIST REPORT
Episode Date:
07/01 /2004
79015
Dose Description: 100 MG/HD/DA Y; 5119-6/22/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
Source Report ld:
US200404067
NDC:
Product Lot No:
UNK
#Treated:
270
#Reacted: 270
#Died:
0
Species: CATTLE
Age: 15 MO
Weight:
1350 LB
NUTRITIONIST REPORTED THAT CATTLE INCREASED THEIR FEED INTAKE BY 2 LBS/DAY AT AN UNK POINT
DURING THE FINISHING PERIOD.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G POLYPHAGIA
Source:
Country:
State:
United States
TEXAS
Zip:
xxxxx
CVM _Report. rep
Source Report ld:
US200403654
NDC:
Product Lot No:
UNK
FEEDYARD
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/0112004
Recommended dose
Oral (in dry feed)
200 MG/HD/DA
None
Good
Owner
High
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 21
17109
57
57
CATTLE
Unknown (cattle)
15 MO
UN
Male, neutered
FEEDING SCHEDULE RECENTLY CHANGED FROM 3 TIMES ADA Y TO 2 TIMES ADA Y AND THERE HAD BEEN A
SIGNIFICANT AMOUNT OF RAIN. THE RACTOPAMINE FED CATTLE ARE EXPERIENCING A GREATER RATE OF
BLOATS. THE CATTLE ARE AT VARIOUS TIMES IN THEIR 28 DAY FEEDING SCHEDULE. 7/29/04: OVER A 45 DAY
PERIOD THERE WERE 17,109 ANIMALS ON RACTOP AMINE AND 57 DIGESTIVE DEADS. THERE WERE 17,533 NOT FED
RACTOPAMINE AND ONLY 21 DIGESTIVE DEATHS IN THAT GROUP. THE NUMBER OF DEATHS HAS DECREASED; IT
APPEARS TO INCREASE WITH WEATHER EVENTS SUCH AS RAIN. THE YARD ALSO WENT TO ONE LESS FEEDING
PER DAY(2 VS 3) AND THAT MAY HAVE CONTRIBUTED TO THE PROBLEM. FlU: NO FURTHER INFO
Causality
Assessment
Time
2 VA D DIGESTION DISORDER
2 VA G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
66502
STUDY T4V200332
Episode Date:
07/22/2004
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Dose Description: 300 MG/HD/DA RACTOPAMINE, 27 G/TON MONENSIN, 9
GM/TON TYLOSIN
Extra Label:
None
Reason For Use:
CVM _Report. rep
Corrsp Date: 08/ 1112004
US200404557
UNK
#Treated:
219
#Reacted:
#Died:
0
Species: CATTLE
Age: 22 MO
Health Status: Good
Administered By:
Veterinarian
Vet Opinion: Low
Concomitants:
Unknown
Weight:
Gender:
Page: 22
1268 LB
Male, neutered
STEER #95 WAS REMOVED FROM THE STUDY DUE TO SEROMA OF THE RIGHT FLANK, POSSIBLY DUE TO TRAUMA.
TREATED WI CEPHALOSPORIN AND DEXAMETHASONE INJECTIONS. 8/1 6/04: IT WAS REPORTED THAT THE CALF
RECOVERED. FlU: 8/16/04: CALF RECOVERED.
Causality
Assessment
-1
Time
To Onset
6 DA
Clinical Detail:
G INJURY
Source:
Country:
State:
United States
TEXAS
Zip:
79027
Episode Date:
06/24/2004
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MGIHDIDA RACTOPAMINE, MONENSIN, TYLOSIN; X
34 DAYS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Missing information
Unknown
Corrsp Date: 08/ 1112004
US200404 781
UNK
#Treated:
324
#Reacted: 2
#Died:
2
Species: CATTLE
Age: 18 MO
Weight:
1375 LB
ON FARM FEEDING DEMONSTRATION. 40 STEERS WERE SHIPPED APPRO X 700 MILES TO PHOENIX, AZ ON 6/24/04. 2
WERE DOA. NO NECROPSY.
Causality
Assessment
CVM _Report. rep
Time
To Onset
34 DA
Clinical Detail:
G DEATH
Page: 23
Source:
Country:
United States
Source Report Id:
US200404745
NDC:
State:
KANSAS
Zip:
66502
Product Lot No:
UNK
TRIAL T4V200332
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/28/2004
#Treated:
Recommended dose
#Reacted:
7113-7/28/04; 300 MG/HD/DA RACT, 27 G/TON MONENSIN, 9 Species:
GM/TON TYLOSIN.
None Breed:
POST MARKETING TRIAL Age:
Good
Veterinarian
Missing information
Unknown
Weight:
Gender:
219
CATTLE
Mixed (cattle)
24 MO
1160 LB
Male, neutered
BREED: HOLSTEIN-FRIESIAN. STEER #632 IN PEN #501 WAS FOUND DEAD IN THE PEN. SLIGHTLY INCREASED
RESP RATE THAT MORNING. NECROPSY: 1) DIFFUSE PERITONITIS, SEVERE, SUBACUTE. 2) RUPTURED OMENTAL
ABSCESS 3) FIBRINOUS PLEURITIS. DEATH PROBABLY DUE TO PERITONITIS, BLOAT OCCURRING POST MORTEM.
STEER HAD A H/0 BLOATING SINCE FEB, 2004.
Causality
Assessment
0
-1
Time
To Onset
15 DA
15 DA
Clinical Detail:
G DEATH
G PERITONITIS
-1 15 DA G PR-PERITONEUM, LESION(
-1 15 DA G PR-PLEURA, LESION(S)
-1 15 DA R HYPERPNEA
Source:
Country:
State:
United States
KANSAS
Zip:
66502
CVM _ Repott.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200404907
UNK
OWNER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/ 11/2004
Recommended dose
Oral (in dry feed)
7113/04 TO 8/10/04; 200 AND 300 MG/HD/DA RACTOPAMINE
None
POST MARKETING STUDY #T4V200302
Good
Owner
Low
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 24
3
3
3
CATTLE
9 MO
1300 LB
Male, neutered
3 STEERS WERE REMOVED FROM THE STUDY DUE TO FOOT ROT. EACH HAD BEEN TREATED FOR 3 SUCCESSIVE
DAYS ON 2 OCCASIONS SINCE THE START OF THE TRIAL. STEER #475 AND #417 WERE RECEIVING 300 MG/HD/DA
RACTOP AMINE AND STEER #363 RECEIVED 200 MG/HD/DA. MONENSIN AT 27 G/TON AND TYLOSIN AT UNK
CONCENTRATION WERE ALSO IN THERA TION. 8116/04-THE STEERS NEVER RECOVERED AND WERE TO BE
PROCESSED. F/U: 8/25/04: DID NOT RECOVER AND WERE PROCESSED.
Causality
Assessment
Time
-1 NA G DEATH(SLAUGHTERED)
-1 NA G HOOF DISORDER
Source:
Country:
State:
United States
NEBRASKA
Zip:
X XXX X
OWNER
Episode Date:
04/08/2004
Dose Description: 200 MG/HD/DA; 3/24/04 TO 4/8/04
Extra Label:
None
Reason For Use:
Health Status:
Good
CYM _ Repmt.rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200400784
UNK
#Treated:
200
#Reacted: 60
#Died:
0
Species: CATTLE
Age: UN
Weight:
1200 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Page: 25
ADULTS. INCREASED FEED CONSUMPTION AFTER 15 DAYS. PRODUCER CONTINUES FEEDING RACTOPAMINE.
Causality
Assessment
Time
2 15 DA G POLYPHAGIA
Source:
Country:
United States
State:
KANSAS
Zip:
67880
Episode Date:
08/23/2004
Dose Description: 200 MG/HD/DA STARTED 7/26/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASEFEED EFFICIENCY
Good
Owner
Missing information
Yes
MONENSIN 360 MG/HD/DA Y
2 TYLOSIN 9 G/TON
Source Report ld:
US200405119
NDC:
Product Lot No:
UNK
#Treated:
11000
#Reacted: 29
#Died:
29
Species: CATTLE
Age: VA
Weight: VA
2.5 TIMES THE EXPECTED LEVEL OF DIGESTIVE DEADS AND BLOATS AT THE FEEDYARD. NO NECROPSY. FlU,
SUBM 25, 9/20/04: REVIEW OF RECORDS FROM 7/24/04 TO 8/24/04: 14 DIGESTIVE DEATHS OUT OF 29 TOTAL DEAD.
THIS FEEDLOT TYPICALLY HAS 0.048% DIGESTIVE DEATH LOSS BUT THIS GROUP EXPERIENCED 0.083% DIGESTIVE
DEATH LOSS.
Causality
Assessment
2
2
CVM _Report. rep
Time
To Onset
3 WK
3 WK
Clinical Detail:
D BLOAT
D GI, ABNORMAL
Page: 26
2 3 WK G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
66506
STUDY T4V200332
Episode Date:
08/18/2004
Dose Description: 200 OR 300 MGIHDIDA; 7/13-8/18/04
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE GAIN; POST MARKETING STUDY #T4V200332
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing information
Yes
TYLOSIN 9 G/TON
2 MONENSIN 27 G/TON
US200405067
101PC1
#Treated:
219
#Reacted: 5
#Died:
0
Species: CATTLE
Age: 24 MO
Weight: 1444 LB
5 STEERS WERE REMOVED FROM THE STUDY FOR LAMENESS AND FOOT ROT. 4 RECEIVED 200 MG/DA Y AND 1
RECEIVED 300 MG/DA. SHIPPED FOR SLAUGHTER ON 8/19/04. STEERS WERE NOT TREATED. F/U: 917/04-NO FURTHER
INFO.
Causality
Assessment
Time
To Onset
35 DA
35 DA
Clinical Detail:
G HOOF DISORDER
G LAMENESS
Source:
Country:
State:
CVM _Report. rep
United States
Zip:
Source Report ld:
US200405099
NDC:
Product Lot No:
KANSAS 66502
Episode Date:
07/22/2004
Dose Description:
Extra Label:
None
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Yes
TYLOSIN 9 GM/TON
2 MONENSIN 27 G/TON
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 27
219
3
0
CATTLE
24 MO
1340 LB
Male, neutered
LAMENESS AND FOOT ROT IN 3 STEERS AT THE CONCLUSION OF THE STUDY. STEER 368 RECEIVED 200
MG/HD/DA, HAD FOOT ROT SINCE 7/20/04. IT WAS NOT TREATED, WAS KEPT ON STUDY AND WAS SHIPPED 8119/04.
STEER 93 RECEIVED 300 MG/HD/DA, WAS TREATED FOR FOOT ROT 7/22, 23, 24. SEEMED TO RECOVER UNTIL 8119/04.
JUST BEFORE SHIPPING HE WAS LAME AGAIN. STEER 123 REC'D 300 MG, SHOWED LAMENESS SIGNS 8119/04, WAS
SLIGHTLY OFF FEED, NOT TREATED.
Causality
Assessment
0
Time
To Onset
36 DA
Clinical Detail:
G ANOREXIA
7 DA G HOOF DISORDER
7 DA G LAMENESS
Source:
Country:
State:
United States
MISSOURI
Zip:
64102
PRODUCER
Episode Date:
06/29/2004
CVM_ Report. rep
Source Report Id:
US200405287
NDC:
Product Lot No:
UNK
#Treated:
180
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
200 MG/HD/DA; 611 /04 TO 6/29/04
None
INC RATE OF GAIN
Good
Owner
Yes
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
TYLOSIN
2 MONENSIN
Page: 28
180
0
CATTLE
Mixed (cattle)
UN
1160 LB
Male, neutered
MARKET AGE. 1 GROUP OF MEXICAN CATTLE AND 1 GROUP OF DOMESTIC. EQUAL NUMBER AND TYPE IN
CONTROL GROUPS. MEXICAN CATTLE ONLY GAINED 1 LB/HD MORE THAN MEXICAN CONTROLS (17 LBS
EXPECTED). DOMESTIC CATTLE GAINED 19 LBS MORE THAN CONTROL DOMESTIC CATTLE AND PRODUCED A
HEAVIER CARCASS THAT WAS DISCOUNTED. RACTOPAMINE FED CATTLE HAD HIGHER NUMBERS OG GRADE 4
(34%) COMPARED TO DOMESTIC CONTROLS (12.5%) . LEVEL OF MONENSIN AND TYLOSIN UNK. PRODUCER IS NOT
LIKELY TO USE RACTOPAMINE AGAIN.
Causality
Assessment
Time
2 28 DA G MEATABN
Source:
Country:
State:
United States
KANSAS
Zip:
67401
FEEDLOT
Episode Date:
05/06/2004
Dose Description: 100 AND 200 MGIHDIDA 5/4- 6/8/04
Extra Label: None
CVM _ Repmi.rep
PackageiD: A 2
Source Report Id:
NDC:
Product Lot No:
US200405365
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
CATTLE
727
6
0
Mixed (cattle)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Weight:
Good
Gender:
Veterinarian
Low
No Value
Page: 29
UN
1167 LB
Male, neutered
REVIEW OF FINAL REPORT FOR STUDY T4V200324. ALL SERIOUS ADES WERE REPORTED AS 15 DAY REPORTS. 6
NON-SERIOUS ADES WERE REPORTED. CM: DIGESTIVE. RTX: GAS REMOVED VIA TUBE THROUGH THE MOUTH
INTO THE RUMEN. ALL CATTLE WERE RETURNED TO THE PEN AND REMAINED ON STUDY.
Causality
Assessment
Time
2 DA D BLOAT
2 DA D GI, ABNORMAL
Source:
Country:
United States
State:
KANSAS
Zip:
POST MARKET RESEARCH STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
05/18/2004
Recommended dose
Oral (in dry feed)
100/200 MG
None
67401
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Missing information
Unknown
Package ID: A 9
Source Report Id:
NDC:
Product Lot No:
US200401599
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
360
2
Mixed (cattle)
UN
1560 LB
Male, neutered
ANIMAL #6915 DIED 5/18/04 DUE TO DIGESTIVE EVENT. IT HAD RECEIVED 100 MG/HD/DA. ANIMAL #8311 RECEIVED
200 MG/HD/DA DVELOPED DIGESTIVE PROBLEMS ON 5/ 18/04. IT WAS TREATED FOR BLOAT. THIS PKG WAS
SUBMITTED AS FOLLOW UP BUT NO INITIAL WAS FOUND. ENTERED AS ORIGINAL.
Causality
Assessment
CVM _Rep01t.rep
Time
Page: 30
14 DA D BLOAT
14 DA G DEATH
Source:
Country:
United States
State:
ARIZONA
Zip:
STUDY T4V040334
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
05117/2004
Recommended dose
Oral (in dry feed)
25.4, 4/28-5117/04
None
85721
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing infonnation
Unknown
Source Report ld:
US200401513
NDC:
Product Lot No:
101PC1
#Treated:
25
#Reacted:
#Died:
0
Species: CATTLE
Age: 18 MO
Weight: 1200 LB
STEER WAS FOUND DOWN AND UNDER THE FENCE IN PEN #50 AND WAS DEHYDRATED. THE STEER WAS LED TO
WATER AND HE DRANK. NO OTHER TREATMENT. WAS REMOVED FROM THE STUDY. LOOKING BETTER BY 5/18.
THIS REPORT WAS SENT AS A FOLLOW UP BUT THE ORIGINAL WAS NEVER FOUND SO THIS WAS ENTERED AS AN
ORIGINAL REPORT.
Causality
Assessment
-1
-1
Time
To Onset
19 DA
19 DA
Clinical Detail:
G DEHYDRATION
G RECUMBENCY
Source:
Country:
State:
CVM _Report. rep
United States
KANSAS
Zip:
67401
Source Report ld:
US20040 1508
NDC:
Product Lot No:
101PC1
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05/17/2004
Recommended dose
Oral (in dry feed)
100 MG; 33 G; 90 MG; 5/4-17/04
None
RESEARCH
Good
Veterinarian
Missing infonnation
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 31
360
2
0
CATTLE
Other (cattle)
15 MO
1140 LB
Male, neutered
ORIGINAL REPORT. ANIMAL #8544 RECEIVED RACTOPAMINE AT 100 MG/DA AND DEVELOPED LAMENESS IN THE
LEFT FRONT FOOT.
Causality
Assessment
0
Time
To Onset
13 DA
Clinical Detail:
G LAMENESS
Source:
Country:
United States
State:
NEBRASKA
Zip:
VET REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
05112/2004
Recommended dose
Oral (in dry feed)
411 2/04 TO 5112/04
Unknown
68583
Package ID: A 14
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
POST MARKETING STUDY T4V31 0338
Health Status:
Good
Administered By:
Veterinarian
Vet Opinion: Low
CVM _ Rep01t .rep
US200401451
101PC1
#Treated:
11
#Reacted:
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1119 LB
Concomitants:
Unknown
Page: 32
STEER #2512 IN PEN 316 DEVELOPED SWELLING AT THE RIGHT FRONT ELBOW AND BECAME NON-WEIGHT
BEARING. STEER WAS REMOVED FROM THE PEN AND GIVEN NO TREATMENT. STEER IS SCHEDULED TO BE
MARKETED.
Causality
Assessment
Time
0 30 DA G LAMENESS
0 30 DA G SWELLING, LIMB(S)
Source:
Country:
United States
State:
NEBRASKA
Zip:
OWNER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/05/2004
Recommended dose
Oral (in dry feed)
200 MG/DA; 3/5/04
None
GROWTH PROMOTANT
Good
Owner
Unknown
XX XXX
Source Report ld:
US200400 115
NDC:
Product Lot No:
UNK
#Treated:
400
#Reacted: 400
#Died:
0
Species: CATTLE
Age: 12 MO
Weight: 1100 LB
ORIGINAL REPORT. OPTAFLEXX FED CATTLE WERE NOT CONSUMING AS MUCH FEED AS THE OTHER CATTLE;
THIUS WAS NOTED IN THE FIRST WEEK ON RACTOP AMINE. 3/26/04: CATTLE RETURNED TO NORMAL AFTER 3-4
DAYS ONRACTOPAMINE.
Causality
Assessment
2
2
Time
To Onset
1 DA
1 DA
Clinical Detail:
G ANOREXIA
G UNPALATABLE, WON'T EAT
CVM _Report. rep
Corrsp Date:
Page: 33
N 141224 L 28 Package ID: A 1
Country:
United States NDC:
State:
COLORADO
Zip:
80634
Product Lot No:
Episode Date:
02113/2004
Dose Description: 200 MG RACTOP AMINE, 30.3 G/TON MONENSIN, 8.1
G/TON TYLOSIN.
Extra Label:
None
Reason For Use:
POST MARKET STUDY T4V060405
Health Status:
Good
Administered By:
Veterinarian
Vet Opinion: Low
10/12/2004
US200405483
101PC1
#Treated:
291
#Reacted:
#Died:
0
Species: CATTLE
Age: UN
Weight: 1243 LB
1 STEER RECEIVED RACTOPAMINE, MONENSIN, TYLOSIN. THE OTHER ONLY MONENSIN AND TYLOSIN. BOTH
HAD A TUBE PASSED TO RELIEVE GAS; RECOVERED AND WERE RETURNED TO THE PEN.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
D BLOAT
Source:
Country:
State:
United States
COLORADO
Zip:
80634
FEEDING DEMONSTRATION
Episode Date:
06/01 /2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: RACTOP AMINE 200 MG/HD/DA, MONENSIN 300
MGIHDIDA, TYLOSIN 90 MG/HD/DA X 30-37 DAYS.
Extra Label:
None
CVM _Report. rep
US200405801
UNK
#Treated:
1000
#Reacted: 3
#Died:
3
Species: CATTLE
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Missing infonnation
Unknown
Age:
Weight:
Gender:
Page: 34
UN
1250 LB
Male, neutered
1000 STEERS ON RACTOPAMINE DEMONSTRATION; 1000 STEERS IN CONTROL GROUP. STARTED FEEDING IN MAY,
2004. CATTLE WERE MARKETED IN JUNE. 3 STEERS IN THE RACTOPAMINE GROUP DIED OF BLOAT DURING
DEMONSTRATION; NONE DIED IN THE CONTROL GROUP.
Causality
Assessment
Time
To Onset
4 WK
4 WK
Clinical Detail:
D BLOAT
G DEATH
Source:
Country:
State:
United States
TEXAS
Zip:
79409
Episode Date:
10112/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: RACTOPAMINE 200 MG/DA; MONENSIN 30 G/TON;
TYLOSIN 8 G/TON; 9/28/04 TO 10112/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
RESEARCH STUDY
Good
Veterinarian
Missing information
Unknown
US200405728
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
90
CATTLE
Mixed (cattle)
12 MO
1211 LB
Male, neutered
STEER 1177 DIED. NECROPSY-CAUSE OF DEATH DETERMINED TO BE ACUTE ACIDOSIS W/ SECONDARY
PULMONARY CONGESTION. LOT# OF TYLOSIN WAS 337GC4, LOT# OF MONENSIN WAS 02H112, 03H101.
NECROPSY: SIGNIFICANT LESIONS WERE PULMONARY CONGESTION AND VERY PASTY (ACIDOTIC TYPE) RUMEN,
ABOMASAL AND INTESTINAL CONTENTS. MARKED AUTOLYSIS.
CVM _ Repott.rep
Page: 35
Causality
Assessment
Time
To Onset
14 DA
14 DA
14 DA
14 DA
14 DA
Clinical Detail:
D ACIDOSIS, RUMEN
D PR-STOMACH, LESION(S)
G DEATH
R CONGESTION, LUNG(S)
R PR-LUNG(S), LESION(S)
Document ID: N 141224 Submission ID: L 31 PackageiD: A 1
Source:
Country:
United States
State:
KANSAS
Zip:
STUDY T4V200332
Episode Date:
05/01/2004
66506
Dose Description: 300 MG/HD/DA; 4/23/04 TO 4/30/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
POST APROV AL STUDY T4V200332
Good
Veterinarian
Low
Unknown
Source Report ld:
NDC:
Product Lot No:
US200401273
101PC1
#Treated:
2
#Reacted: 2
#Died:
0
Species: CATTLE
Age: 15 MO
Weight: 1200 LB
STEER# 146 IN PEN 511 BLOATED ON 5/ 1/04. STEER# 58 IN PEN 511 BLOATED ON 5/2/04 BOTH WERE TREATED WI
GASTRIC TUBE AND RECOVERED.
Causality
Assessment
2
Time
To Onset
8 DA
Clinical Detail:
D BLOAT
Source:
Country:
CVM _Report. rep
United States
Source Report ld:
US200402788
NDC:
State:
KANSAS
Zip:
STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
06115/2004
Recommended dose
Oral (in dry feed)
5/25/04 TO 6115/04
None
66502
Product Lot No:
Reason For Use:
POST APPROVAL RESEARCH STUDY T4V200332
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing information
Unknown
101PC1
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 36
220
CATTLE
Holstein (inClude red)
18 MO
1310 LB
Male, neutered
ORIGINAL REPORT. STEER #217 FROM PEN 504 WAS FOUND DEAD ON 6/ 15/04. POST MORTEM EXAM-FROTHY
BLOAT AND RUMINAL ACIDOSIS. H/0 FOOT ROT IN MARCH 2004. RACTOPAMINE 18 G/TON; MONENSIN 27 G/TON;
TYLOSIN 9 G/TON.
Causality
Assessment
Time
To Onset
21 DA
21 DA
21 DA
Clinical Detail:
D ACIDOSIS, RUMEN
D BLOAT
G DEATH
Source:
Country:
State:
United States
TEXAS
Zip:
XX XXX
Episode Date:
11105/2004
CVM _ Report.rep
Source Report ld:
US200406070
NDC:
Product Lot No:
101PC1
#Treated:
15
#Reacted:
#Died:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
RACTOPAMINE 200 MG/HD/DA, MONENSIN 30 G/TON,
TYLOSIN 8 G/TON; 10/21104 TO 1115/04
None
RESEARCH STUDY
Good
Veterinarian
Missing information
Unknown
Species:
Breed:
Age:
Weight:
Gender:
Page: 37
CATTLE
Mixed (cattle)
1 YR
1080 LB
Male, neutered
STEER WAS FOUND DEAD. POST MORTEM EXAM: CAUSE OF DEATH ENTEROTOXEMIA DUE TO GRAIN OVERLOAD.
LOT# RUMENSIN-165DE4, TYLOSIN 01H124.
Causality
Assessment
0
Time
To Onset
15 DA
15 DA
Clinical Detail:
D ACIDOSIS, RUMEN
G DEATH
Source:
Country:
State:
United States
NEBRASKA
Zip:
XX XXX
Episode Date:
03115/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MGIHDIDA RACTOP AMINE, 90 MGIHDIDA TYLOSIN,
320-340 MGIHDIDA MONENSIN
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Owner
Concomitants:
No Value
US200406114
UNK
#Treated:
4171
#Reacted: 9
#Died:
9
Species: CATTLE
Age: UN
Weight:
UN
FINISHING CATTLE. INCREASE IN DEATH LOSS ABOVE THE EXPECTED RATE OF 0.5 %. DEATHS SUPECTED DUE TO
ENTEROTOXEMIA AND DIGESTIVE DISORDERS. THE CATTLE WERE FOUND DEAD IN GROUPS OF 2-3. ALSO
RECEIVED TYLOSIN AT 90 MGIHDIDA ANDMONENSIN AT 320 MG/HD/DA. IN CATTLE FED OPT AFLEXX. OCCURRED
CVM _ Repmt.rep
Page: 38
FROM MARCH TO NOVEMBER 2004. ANIMAL NUMBERS NOT REPORTED. FlU: 2/ 1105: MULTIPLE ATTEMPTS TO
OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL. FlU: 3/7/05: RECORDS REVIEWED FOR THIS
PERIOD(MARCH 2004). DEATH LOSS FOR CATTLE FED RACTOPAMINE IN THE LAST 50 DAYS ON FEED WAS .22% (9
OUT OF 4171 ON RACTOP AMINE). DEATH LOSS IN GROUP NOT FED RACTOPAMINE WAS 0.3%. RACTOPAMINE
CONTINUES TO BE FED AT THE FEEDYARD. FlU: DEATH LOSS WAS 0.22 %, 9 OUT OF 4171 CATTLE ON
RACTOPAMINE. DEATH LOSS IN GROUP NOT FED RACTOPQAMINE WAS 0.3%. RACTOPAMINE CONTINUES TO BE
FED AT THIS FEEDYARD. A 1300 LB STEER DIED ON 4/30/05. PR: GAS BLOAT, HEMORRHAGES IN THE SPLEEN
THOUGHT TO BE DUE TO POST MORTEM CHANGES. VET REPORTED THERE WERE NO DIGESTIVE PROBLEMS
DURING THE WINTER MONTHS BUT W/ THE WEATHER CHANGE THEY WERE SEEING DIGESTIVE DEATHS.
Causality
Assessment
0
-1
Time
To Onset
UN
UN
Clinical Detail:
D ACIDOSIS, RUMEN
G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
66868
PRODUCER
Episode Date:
1110112004
PackageiD: A 2
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MGIHDIDA RACTOPAMINE, 26 OlTON MONENSIN, 8
G/TON TYLOSIN; 9/25/04 TO 1111104
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
No Value
US200406115
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
1388
344
Mixed (cattle)
17 MO
1300 LB
Male, neutered
DIFFICULTY LOADING STEERS TO SHIP TO PACKING PLANT 40-45 MILES AWAY. 1 STEER WAS DOA AT THE
PLANT. PRODUCER HAS NEVER HAD AN ANIMAL DIE ON THE TRUCK BEFORE. ANOTHER LOAD OF STEERS THAT
HAD RECEIVED RACTOPAMINE HAD SHIPPED W/0 INCIDENT ON 10/25/04. EACH LOAD CONTAINED 344 STEERS.
Causality
Assessment
2
2
CVM _Report. rep
Time
To Onset
36 DA
36 DA
Clinical Detail:
G BEHAVIOR DISORDER
G DEATH
Page: 39
2 36 DA N HYPERACTIVITY
Source:
Country:
United States
State:
MINNESOTA
Zip:
RESEARCH TRIAL
Episode Date:
10118/2004
Dose Description: 0-200 MGIHDIDA
Extra Label:
None
55343
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE RATE OF GAIN; POST APPROVAL STUDY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing infom1ation
Yes
ESTROGEN/TRENBOLONE ACETATE PRODUCT IMPLANTED
SUMMARY OF 6 FIELD TRIALS. SLIGHT INCREASE IN MORTALITY NOTED.
Causality
Assessment
Time
To Onset
32 DA
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
KANSAS
Zip:
67880
FEEDYARD
Episode Date:
06115/2004
CYM _ Rep01t.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200406436
UNK
#Treated:
4582
#Reacted: 9
#Died:
9
Species: CATTLE
Age: UN
Weight: 1200 LB
US200500607
#Treated:
80000
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
FOR 28 TO 35 DAYS; JUN/2004 TO FEB/2005;
APPROXIMATE
None
Good
Owner
Missing infonnation
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 40
400
400
CATTLE
Unknown (cattle)
UN
1300 LB
Group (m & f)
200 MG/HD/DA RACTOPAMINE, 30 G/TON MONENSIN, 9 G/TON TYLOSIN. DURING THE SUMMER OF 2004 THERE WAS
AN INCREASED DEATH LOSS DUE TO DIGESTIVE PROBLEMS IN FINISHING CATTLE. DEATH LOSSES DECREASED
WHEN THE ROUGHAGE IN THE RATION WAS INCREASED. IN DEC/2004, JAN/2005 AND FEB/2005 DEATH LOSS
INCREASED AGAIN DUE TO DIGESTIVCE PROBLEMS. THE CATTLE WERE STILL BEING FED RACTOPAMINE,
MONENSIN, TYLOSIN. DDX: NUTRITION MANAGEMENT.
Causality
Assessment
Time
UN D GI, ABNORMAL
UN G DEATH
Source:
Country:
State:
Renort Qualit:y:
FEEDYARD
Episode Date:
Dosage:
Route:
United States
NEBRASKA
Zip:
68850
Average
03/02/2005
Reconunended dose
Oral (in dry feed)
Dose Description: 2/ 15/05 TO 3/2/05
Extra Label:
None
Reason For Use:
Health Status:
Good
CVM _Rep01t.rep
Source Report ld:
US200500721
NDC:
Product Lot No:
#Treated:
120
#Reacted: 4
#Died:
0
Species: CATTLE
Age: UN
Weight:
UN
Page: 41
Administered By:
Vet Opinion:
Concomitants:
Owner
Missing infom1ation
Unknown
4 STEERS FROM A PEN OF 120 WERE PULLED DUE TO BLOAT. HAY FED AT 1%. RACTOPAMINE FED AT 200
MGIHDIDA, MONENSIN @ 22 G/TON, TYLOSIN @ 9 G/TON. THE REMAINING STEERS CONTINUED TO BE FED THIS
RATION.
Causality
Assessment
Time
To Onset
15 DA
Clinical Detail:
D BLOAT
Source:
Country:
State:
United States
KANSAS
Zip:
67502
SALES REP REPORT
Episode Date:
02/0112005
Dosage: Unknown
PackageiD: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/DA Y RACTOPAMINE, UNKNOWN AMOUNTS
OF MONENSIN/TYLOSIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Good
Owner
Missing infom1ation
Unknown
US200500640
UNKNOWN
#Treated:
5000
#Reacted: 11
#Died:
11
Species: CATTLE
Age: 2 YR
Weight: 1100 LB
Gender: Male
FED TO FINISHING CATTLE (AGE ESTIMATED). CM: ON REVIEW OF RECORDS, INCREASE IN DIGESTIVE DEATHS
NOTED, APPROX 2.1 / 1000 HEAD. 11 DEAD IN 5000. DEATH RATES PRIOR TO INTRODUCTION OF THIS PRODUCT
WAS LOWER. NO OTHER SIGNS DETAILED, "DIGESTIVE" SIGNS NOT SPECIFIED, MAY MEAN BLOAT, DID NOT ADD
BECAUSE NOT SPECIFIED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
CVM _ Repmt.rep
Source:
Country:
State:
United States
TEXAS
Zip:
79015
SALES REP REPORT
Episode Date:
03/02/2005
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/DA Y RACTOP AMINE; 2/ 1105 TO 317/05
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Missing infonnation
Owner
Unknown
US200500648
UNKNOWN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 42
17065
16
16
CATTLE
Mixed (cattle)
2 YR
UN
Unknown
NUMBER TREATED NOT GIVEN, ONLY SAYS "2 HERDS" AND NUMBERS IN BOX 13 WERE LEFT AS O'S ON REPORT.
CM: INCREASED DEATH RATES, 3 DEATHS PER HERD. NO OTHER CM LISTED. FlU: 3/21105: TYLOSIN DOSE WAS 6-8
G/TON, MONENSIN WAS 26 G/TON. DEATHS OCCURRED FROM FEB, 2005 THRU THE FIRST WEEK IN MARCH, 2005.
ANIMAL NUMBERS REPORTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
TEXAS
Zip:
XX XXX
Episode Date:
03/2112005
Dose Description: 200 MG/HD/DA; 3/21105
Extra Label:
Other
CVM _ Repmt.rep
PackageiD: A 1
Source Report ld:
NDC:
Product Lot No:
US20050 1022
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
CATTLE
1000
3
3
Mixed (cattle)
Page: 43
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
FEED EFFICIECY
Good
Owner
Unknown
Weight:
Gender:
UN
1150 LB
Unknown
3 ANIMALS BLOATED AND DIED W/IN 3 DAYS OF ADDING RACTOPAMINE. HAD ALREADY BEEN ON TYLOSIN,
MONENSIN UNK DOSE/DURATION. CONTINUED TO FEED RACTOPAMINE.
Causality
Assessment
Time
2 7 DA D BLOAT
2 7 DA G DEATH
Source:
Country:
United States
State:
NEBRASKA
VET REPORT
Episode Date:
04/ 13/2005
Zip:
Route:
Dose Description:
Extra Label:
Oral (all other)
4/12/05
None
68583
Reason For Use:
POST MARKING STUDY T4V31 0340
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Veterinarian
Missing infonnation
No Value
Source Report ld:
US20050 1071
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
167
#Reacted: 3
#Died:
0
Species: CATTLE
Age: XX
Weight:
1200 LB
CM: 3 CATTLE DEVELOPED FOOT ROT. RTX: CEFTIOFUR SODIUM AND DEXAMETHASONE. FlU: 4/20/05: STEER 6230
WAS REMOVED FROM PEN 410 FOR DIPTHERIA AND COUGHING.
Causality
Assessment
CYM _ Report.rep
Time
1 DA I INFLAM, SKIN
Page: 44
Source:
Country:
State:
United States
COLORADO
Zip:
XX :XXX
FEEDLOT
Episode Date:
04/05/2005
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/DA-RACTOPAMINE; MONENSIN AT 300
MGIHDIDA; TYLOSIN @ 90 MG/HD/DA
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Missing information
Owner
No
US20050 1286
210PC4
#Treated:
979
#Reacted: 47
#Died:
0
Species: CATTLE
Age: 15 MO
Weight:
1350 LB
FINISHING CATTLE. FEEDLOT. SINCE FEEDING RACTOPAMINE, 2-3% OF THE ANIMALS WERE DARK CUTTERS AT
SLAUGHTER. GROUP 1 HAD 6 OUT OF 221 HEAD AFFECTED AFTER 28 DAYS ON SUPPLEMENT, 6 AFFECTED; GRP 2
HAD 3 OUT OF 226 AFFECTED AFTER 35 DAYS ON SUPPLEMENT AND GROUP 3 HAD 6 OUT OF 242 AFFECTED AFTER
36 DAYS ON SUPPLEMENT. FlU: ON 7118/05 32 OF 290 STEERS WERE SCORED AS DARK CUTTERS. RACTOPAMINE
WAS REMOVED FROM THERA TION AT THAT TIME. CF: HIGH TEMPS-95+. EARLIER GROUPS WERE SLAUGHTERED
IN COOLER WEATHER(APRIL 5TH TO MAY 3RD).
Causality
Assessment
Time
To Onset
28 DA
Clinical Detail:
G MEAT, ABN COLOR
Source:
Country:
State:
United States
MISSOURI
Zip:
64112
Episode Date:
05/09/2005
CVM _Report. rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200501301
UNK
#Treated:
#Reacted:
15000
15000
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
200 MG/HD/DA; OCT, 2004
Species:
None Breed:
Age:
Weight:
Good
Gender:
Owner
No
Page: 45
0
CATTLE
Unknown (cattle)
15 MO
1250 LB
Male, neutered
DID NOT SEE EXPECTED LEVELS OF AVERAGE DAILY GAIN. CONTINUES TO FEED RACTOP AMINE.
Causality
Assessment
Time
Source:
Country:
United States
Source Report ld:
US20050 1627
NDC:
State:
KANSAS
Zip:
XX XXX
Product Lot No:
UNK
NUMBER TREATED/REACTED NOT ACCURATE
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05/15/2005 #Treated:
Reconm1ended dose #Reacted:
Oral (in dry feed) # Died:
RACTOP AMINE 200 MG/HD/DA; MONENSIN 300 Species:
MG/HSD/DA, TYLOSIN 90 MG/HD/DA. PTX FOR BRD(UNK
TX). NOT ALL ANIMALS THAT DIED RE EIVED
RACTOP AMINE, NOT KNOW
Unknown Breed:
INCREASED RATE OF WEIGHT GAIN Age:
Missing information
Owner
No Value
Weight:
Gender:
15000
26
26
CATTLE
Mixed (cattle)
UN
UN
Group (m & f)
HIGHER DEATH RATE IN RACTOPAMINE FED CATTLE. NORMAL WAS 13/MONTH; THERE WERE 26 DEATHS IN THE
MAY 2005. THE FACILITY MAINTAINS APPROX 42,000 HEAD ON FEED; IN MAY THERE WERE 8000 HEIFERS FED
CVM _ Repmt.rep
Prepared on 0411 8/20 11
Page: 46
MONENSIN AND TYLOSIN BUT NO RACTOPAMINE AND 34,000 STEERS( SOME ON RACTOP AMINE, MONENSIN AND
TYLOSIN; SOME ON ruST TYLOSIN AND MONENSIN). PTX: UNK TX FRO BRD. SOME ANIMALS THAT DIED HAD
NOT RECEIVED RACTOPAMINE-NUMBER UNKNOWN. ALL FEED ASSAYS W/IN TOLERANCE. #OF ANIMALS FED
RACTOPAMINE IS NOT PROVIDED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
NEBRASKA
Zip:
68154
NO ANIMAL NUMBERS
Episode Date:
06/0112005
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Dose Description: 7/1104 TO 6/1105 (APPRO X); 200 MG/HD/DA RACTOPAMINE
X 40 DAYS, 10.6 GM/TON TYLOSIN, 29.5 G/TON
MONENSIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
UNK
Missing infom1ation
Owner
No
US20050 1593
UNK
#Treated:
0
#Reacted: 0
#Died:
0
Species: CATTLE
Age: UN
Weight:
1200 LB
ANIMALS WERE FED RACTOP AMINE FOR THE LAST 40 DAYS PRIOR TO SLAUGHTER. 70% OF THE LIVERS WERE
CONDEMNED DUE TO LNER ABSCESSES. THE CATTLE HAD SWELLINGS AROUND THE HEART SAC AND
INFLAMMATION IN THE TRIPE AREA. GAINS AND EFFICIENCY WERE BELOW NORMAL FOR THIS PRODUCER. FlU:
SUBM 49: 7/8/05: FEED ASSAY INDICATED TYLOSIN WAS PRESENT AT 135 G/TONNOT THE EXPECTED LEVEL OF 180
G/TON. FlU SUBM 51 , 8/ 11105: ON 8/4, 34 ANIMALS WERE SLAUGHTERED. 2 OF THE LIVERS WERE RATED A-.
MONENSIN AND TYLOSIN WERE CONTINUED IN THE RATIONS.
Causality
Assessment
-1
-1
Time
To Onset
UN
UN
Clinical Detail:
L PR-LIVER, LESION(S)
CVM _Report. rep
Source:
Country:
State:
United States
UNKNOWN
Zip:
XX XXX
Episode Date:
05/30/2005
Source Report ld:
NDC:
Product Lot No:
Dose Description: RACTOPAMINE @ 200 MGIHDIDA 5/24-30/05; MONENSIN
AT 32 G/TON, TYLOSIN @ 10 G/TON SINCE AT THE
FEEDLOT
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
US200501837
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 47
130
2
2
CATTLE
Mixed (cattle)
UN
1150 LB
Male, neutered
FINISHING CATTLE. 2 STEERS IN ONE PEN DIED OF DIGESTIVE PROBLEMS W/IN 2 HRS OF EACH OTHER. HAD BEEN
A RECENT RATION CHANGE. A PELLETED PRODUCT HAD BEEN ADDDED TO THE TMR. RACTOPAMINE CONTINUES
TO BE FED AT THE FEEDLOT.
Causality
Assessment
0
0
Time
To Onset
6 DA
6 DA
Clinical Detail:
D GI, ABNORMAL
G DEATH
Document ID: N 141224 Submission ID: S 52
Source:
Country:
State:
United States
KANSAS
Zip:
67601
Episode Date:
Dosage:
Route:
Dose Description:
CVM _Report. rep
03/31/2004
Missing information
Oral (all other)
NOT REPORTED
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200400430
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
391
300
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infom1ation
IMPROVED FEED EFF
Good
Owner
Unknown
Breed:
Age:
Weight:
Gender:
Page: 48
Mixed (cattle)
XX
1350 LB
Male, neutered
CM: DRAMATIC INCR IN FEED INTAKE DURING RACTOPAMINE TRIAL. PERSISTED THRU DAY 25 OF TRIAL WHEN
SOME HAVE FEED INTAKE OF 5#/HD/DA Y.
Causality
Assessment
2
Time
To Onset
NA
Clinical Detail:
E INEFFECT
2 NA E INEFFECT, PRODUCTION (MEAT)
Source:
Country:
State:
United States
OKLAHOMA
Zip:
73942
Episode Date:
07115/2005
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: RAC-200 MG/HD/DA Y FOR 32 DAYS; MONENSIN 360
MGIHDIDA Y, TYLOSIN 90 MG/HD/DA Y FOR 3 MO.
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCR FEED EFF
Good
Owner
No
US200503265
UNK
#Treated:
574
#Reacted: 17
#Died:
0
Species: CATTLE
Age: XX
Weight:
1300 LB
BREED: HOLSTEIN I FREISIAN- MARKET AGE. CM: 3% OF TREATED ANIMALS RATED AS DARK CUTTERS.2.1 % NOT
TREATED RATED AS DARK CUTTERS.
Causality
Assessment
CVM_Report.rep
Time
Page: 49
0 UN G MEAT, ABNCOLOR
Source:
Country:
United States
State:
TEXAS
Zip:
Episode Date:
06/0112005
Route:
Dose Description:
Extra Label:
Oral (all other)
LABEL DOSE
None
79106
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infonnation
Owner
Missing infonnation
No
Source Report Id:
US200501733
NDC:
Product Lot No:
UNK
#Treated:
59
#Reacted: 59
#Died:
59
Species: CATTLE
Age: XX
Weight: XX
CM: STUDY FROM 6 FEEDLOTS TO DETERMINE DIFFERENCES IN CAUSE OF DEATH IN TREATED AND UNTREATED
ANIMALS. 1 GROUP OF 25 FED CONTROL RATION OF MONENSIN AND TYLOSIN. GROUP 2 OF 34 ANIMALS FED
OPT AFLEX. NO DIFFERENCES IN CAUSE OF DEATH IN 2 GROUPS.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
Source:
Country:
State:
United States
KANSAS
Zip:
XX XXX
Episode Date:
01109/2006
CYM _ Report.rep
Source Report ld:
US200600228
NDC:
Product Lot No:
UNK
#Treated:
15000
Page: 50
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
200 MG/HD/DA; 119/06
None
EFFICIENCY
Good
Owner
No
#Reacted: 125
#Died:
0
Species: CATTLE
Age: UN
Weight: 1250 LB
FEED CONSUMPTION DROPPED FROM 29 TO 26 LBS. INTAKE FLUCTUATED. CF: FLUCTUATING WEATHER
CONDITIONS. CONTINUES TO FEED RACTOPAMINE. DURATION APPROX 16 DAYS.
Causality
Assessment
Time
1 DA G ANOREXIA
Source:
Country:
State:
United States
IOWA
Zip:
51346
Episode Date:
08/14/2007
Dosage: Unknown
Dose Description: SEE NARRATIVE; ORAL
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
REDUCTION OF INCIDENCE OF LIVER ABSCESSES
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No Value
US200703178
REQ, NOT PROVIDED
#Treated:
174
#Reacted: 0
#Died:
0
Species: CATTLE
Age: UN
Weight:
1300 LB
ON SEPTEMBER 4, 07, MS. ( , ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL LACK OF EFFECT INVOLVING MONENSIN SODIUM, TYLOSINE PHOSPHATE, AND RACTOP AMINE
CVM_Report.rep
Page: 51
HYDROCHLORIDE IN STEERS. ON APPROXIMATELY AUG 14, 07, 174 HOLSTEIN STEERS BELONGING TO SAM BORN
WERE PROCESSED AT TYSON FOODS IN SIOUX CITY, lA. THE STEERS REPORTEDLY HAD AN EXCESSIVE NUMBER
OF LIVER ABSCESSES BUT IT WAS NOT KNOWN HOW MANY ANIMALS WERE AFFECTED AND HOW THE LIVERS
WERE RATED. THE STEERS HAD BEEN ON A RATION OF MONENSIN (250 MG/HD/DAY) TYLOSIN (90 MG/HD/DA Y)
AND RACTOPAMINE (200 MG/HD/DA Y) PRIOR TO SLAUGHTER AND IT WAS SUGGESTED THAT THE TYLOSIN HAD
NOT BEEN EFFECTIVE. NO CHANGES WERE MADE TO THE RATION.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
L LIVER DISORDER
Source:
Country:
State:
United States
NEBRASKA
Zip:
68116
Episode Date:
04/01 /2008
Dose Description: 200 MG/HD/DA Y 4/08*
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED WEIGHT GAIN, FEED EFFICENCY, LEANESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Yes
RUMENSIN 28G/TON, 4/08*-?
2 TYLAN PREMIX 90 MG/HD/DAY 4/08*-?
US200806064
NOT PROVIDED
#Treated:
400
#Reacted: 3
#Died:
3
Species: CATTLE
Age: 18 MO
Weight:
1400 LB
ON JUNE 6 2008, MS. , ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING OPTIFLEXX (RACTOPAMINE HYDROCHLORIDE), RUMENSIN
(MONENSIN SODIUM) AND TYLAN PREMIX (TYLOSIN PHOSPHATE) IN FEEDLOT CATTLE. IN APPROXIMATELY
APRIL 2008, AN UNKNOWN PRODUCER BEGAN FEEDING 2 GROUPS (200 HEAD EACH) OF FINISHING HOLSTEIN
STEERS A RATION MANUFACTURED BY KENT FEEDS INTENDED TO DELIVER OPTAFLEXX AT 200 MG/HD/DA Y,
TYLAN AT 90MG/HD/DA Y AND RUMESIN 28 G/TON. APPROXIMATELY 10 DAYS AFTER BEGINING THERA TION, 1
STEER FROM GROUP 1 AND 2 STEERS FROM THE SECOND GROUP DIED OF BLOAT. MR. , SALES
REP. AT KENT FEEDS, REPORTED THAT CATTLE ON OPTIFLEXX HAVE A HIGHER MORTALITY RATES. NO FURTHER
INFO IS EXPECTED.
CVM _ Repott.rep
Causality
Assessment
0
0
Time
To Onset
10 DA
10 DA
Clinical Detail:
D BLOAT
G DEATH
Page: 52
Source:
Country:
State:
United States
KANSAS
Zip:
67530
Episode Date:
06/01/2009
Dose Description: SEE NARRATIVE; ORAL- 6/1/09-8/1/09
Extra Label:
None
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
FOR INCREASED RATE OF WEIGHT GAIN, IMPROVED
FEED EFFICIENCY, INCREASED CARCASS LEANNESS
Health Status:
Good
Administered By:
Owner
Concomitants: Yes
HEIFERMEX (MELENGESTROL ACETATE) PO UNK REGIMEN 6/ 1/09*
ADVERSE EXPERIENCES
US200905039
UNK
#Treated:
7000
#Reacted: 7
#Died:
7
Species: CATTLE
Age: UN
Weight:
VA
EXPERIENCE INVOLVING OPTAFLEXX (RACTOPAMINE HYDROCHLORIDE) IN FEEDLOT CATTLE. FROM 6/1/09 TO
8/ 1/09, FORD COUNTY FEEDER REPORTED A 1 IN 1000 HEAD INCREASE IN SUDDEN DEATHS OF FINISHING CATTLE
(70% HEREFORD, 30% CROSS BRED). DURING THAT TIME, THE STEERS WERE CONSUMING A RATION THAT
DELIVERED OPTAFLEXX AT 200 MG/HD/DAY, TYLAN AT 90 MG/HD/DAY AND CONTAINED RUMENSIN AT 30 G/TON
AND THE HEIFERS WERE CONSUMING A RATION THAT DELIVERED OPT AFLEXX AT 200 MG/HD/DA Y, TYLAN AT 90
MG/HD/DA Y, CONTAINED RUMENSIN AT 30 G/TON AND MELENGESTROL ACETATE AT AN UNK LEVEL (ACTUAL
START DATE UNK, DATE REPORTED IS AN ESTIMATE). ALSO DURING THAT TIME, THE AREA EXPERIENCED
HIGHER THAN NORMAL TEMPERATURES. FORD COUNTY FEEDER QUESTIONED IF OPTAFLEXX COULD CAUSE THE
INCREASE SEEN IN THE DEATH RATE. ON 8/1/09, FORD COUNTY FEEDER DISCONTINUED THE USE OF OPTAFLEXX
AND THE DEATH RATE APPEARED TO RETURN TO NORMAL. INFO ON PRE-EXISTING MEDICAL CONDITIONS AND
CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED.
UPDATE 9/2/09: ON 9/2/09, THE BLANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED THAT ADDITIONAL
INFO IS NOT EXPECTED.
CVM _ Repmt.rep
Causality
Assessment
0
Time
To Onset
8 WK
Clinical Detail:
G DEATH
Page: 53
Source:
Country:
United States
State:
TEXAS
Zip:
79013
Episode Date:
03/31/2010
Dose Description: 200 MGIHDIDAY, 3/25/10
Extra Label:
None
Reason For Use:
RESEARCH STUDY
Health Status:
Unknown
Administered By:
Veterinarian
Vet Opinion: Low
Concomitants: Yes
RUMENSIN, PO, 33 G/TON, 11/09 ...
2 TYLAN, PO, 9 G/TON, 11/09 .. .
Source Report ld:
US201001570
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
198
3
Mixed (cattle)
Male
VA
UN
EXPERIENCE INVOLVING RUMENSIN (MONENSIN SODIUM), TYLAN (TYLOSIN PHOSPHATE) AND OPTAFLEXX
(RACTOP AMINE HYDROCHLORIDE) IN CATTLE. ON 3/25/10, A RESEARCH STUDY BEGAN WITH 91 CATTLE FED A
RATION THAT WAS INTENDED TO PROVIDE OPT AFLEXX AT 200 MGIHDIDA Y, RUMENS IN AT 33 G/TON AND TYLAN
AT9 G/TON.
ON 3/31/10, STEER #532342 (18 MONTH OLD, 1087 LBS) FROM TX GROUP 200C WAS REMOVED FROM THE STUDY DUE
TO HIND END ATAXIA AND THE INABILITY TO RISE. THE SIGNS WERE CONSISTENT WITH DISTAL SPINAL CORD
TRAUMA.
UPDATED 4/20/ 10: ON 4/23/10, THE ELAN CO ANIMAL HEALTH TECHNICAL CONSULTANT PROVIDED UPDATE INFO.
THE STUDY STARTED IN 11/09 WITH 107 CATTLE IN THE CONTROL GROUP THAT WERE FED A RATION THAT
CONTAINED RUMENS IN AT 33 G/TON AND TYLAN AT 9 G/TON. ON 4/15/10, STEER #576488 (22 MONTH OLD, 1300 LBS)
FROM TX GROUP CON WAS REMOVED FROM THE STUDY DUE TO HIND END ATAXIA. THE SIGNS WERE
CONSISTENT WITH DISTAL SPINAL CORD TRAUMA. ON 4/19/10, STEER #572167 (22 MONTH OLD, 1250 LBS) FROM TX
GROUP 200TDI WAS FOUND DEAD. ON NECROPSY, BLOOD WAS FOUND IN THE GI TRACT FROM THE ABOMASUM
TO THE ANUS WITH LYMPH NODE ENLARGEMENT THROUGHOUT THE ABDOMEN. THE CAUSE OF DEATH WAS
CONSIDERED INFECTIOUS ENTERITIS.
CVM _Report. rep
CMP:UNK
Causality Time
Assessment To Onset
0 25 DA
0 25 DA
0 25 DA
0 25 DA
0 25 DA
0 25 DA
0 21 DA
0 21 DA
CVM _ Repmt.rep
Clinical Detail:
D ENTERITIS
D PR-STOMACH, LESION(S)
G BLD
G DEATH
G INFECTION
H PR-L YMPH NODE(S), LESI
N ATAXIA
N PARESIS, HIND LIMB(S)
Page: 54
Document: N 141233
ADEREVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Sub Num:
Species:
Breed:
Gender:
Drug:
Source Report ID:
NDC:
Product Lot#:
Report Quality:
Age:
Weight:
Episode Date:
From To
Corr Date:
From To
Unit
Route:
ADE CONCOMITANTS
ADE ASSESSMENTS
3
Page: 1
Drug Name: MELENGESTROL, MONENSIN, RACTOPAMINE, TYLOSIN
Source:
Country:
State:
United States
COLORADO
Zip:
80610
FEEDLOT
Episode Date:
10/ 12/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: RACTOP AMINE @ 200 MG/HD/DA, TYLOSIN @ 90
MG/HD/DA, MONENSIN @ 300 MG/HD/DA,
MELENGESTROL ACETATE @ 4.5 G/TON; STARTING
10/6/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
FEEDLOT HEIFERS WERE RIDING EACH OTHER.
Causality
Assessment
2
Time
To Onset
6 DA
Clinical Detail:
X ESTRUS BEHAVIOR
Source:
Country:
State:
United States
COLORADO
Zip:
80863
FEEDLOT
Episode Date:
10/15/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 200 MG/HD/DA RACTOP AMINE, 300 MG/HD/DA
CVM _ Repmt.rep
US200405817
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
CATTLE
1000
1000
0
Mixed (cattle)
UN
1200 LB
Female
US200406069
UNK
#Treated:
#Reacted:
#Died:
Species: CATTLE
280
280
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
MONENSIN, 90 MGIHDIDA TYLOSIN, 4.5 OlTON
MELENGESTROL ACETATE; FROM 9/12/04
None
Good
Owner
Missing infom1ation
Unknown
Breed:
Age:
Weight:
Gender:
Page: 2
Mixed (cattle)
UN
1110 LB
Female
ON FARM DEMOSTRATION AT A FEEDLOT STARTING 9/ 12/04. CONTROL GROUP HAD SAME RATION WITHOUT
RACTOPAMINE. ALL WERE SLAUGHTERED ON 10/15/04. THE HEIFERS ON THE RACTOPAMINE RATION GAINED
AVO OF 6LB/HD LESS THAN CONTROLS ON RATION W/ MGA, TYLOSIN AND MONENSIN ONLY. THE PRODUCER
DISCONTINUED USE OF RACTOPAMINE.
Causality
Assessment
Time
Source:
Country:
United States
State:
KANSAS
Zip:
FEED TRIAL
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
12/10/2004
Recommended dose
Oral (in dry feed)
200 MGIHDIDA
None
66506
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
IMPROVED RATE OF GAIN; RESEARCH TRIAL
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infom1ation
Veterinarian
Missing infom1ation
Unknown
US200406505
UNK
#Treated:
187
#Reacted: 151
#Died:
0
Species: CATTLE
Age: UN
Weight:
UN
Gender: Female
UNIV TRIAL. 144 HEAD IN 12 PENS. NO GAIN OR CARCASS RESPONSE COMPARED TO HEIFERS NOT CONSUMING
RACTOPAMINE. THERE WAS ANOTHER TRIAL WHERE HEIFERS WERE FED INDIVIDUALLY VS IN PENS WHERE
THERE WAS A POSITIVE RESPONSE. FlU: 12/21104:302 HEIFERS IN FIRST STUDY GROUP; HALF CONTROL, HALF FED
CVM _Report. rep
Page: 3
RACTOP AMINE. RACTOP AMINE GROUP SHOWED A RESPONSE OF 4 EXTRA LBS OF GAIN AT THE END OF TX. THE
SECOND GROUP HAD 72 HEIFERS, HALF CONTROL, HALF RACTOPAMINE FED. RACTOP AMINE GROUP SHOWED A
16 LB GAIN ADVANTAGE OVER CONTROLS.
Causality
Assessment
-1
CVM _Report. rep
Time
To Onset
NA
Clinical Detail:
Document : N 140863
ADE REVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Sub Num:
Species:
Breed:
Gender:
Drug:
Source Report ID:
NDC:
Product Lot#:
Report Quality:
Age:
Weight:
Episode Date:
From To
Corr Date:
From To
Unit
Route:
ADE CONCOMITANTS
ADE ASSESSMENTS
N urn ber of Reviews Retrieved:
376
Page: 1
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
xxxxx
03/24/2000
Recommended dose
Oral (in dry feed)
18 G/TON OF FEED, FROM 2/2000
None
IMPROVED GROWTH
Good
Owner
Unknown
Source Report ld:
PAYUS00001
NDC:
Product Lot No:
UN
#Treated:
186
#Reacted: 15
#Died:
3
Species: PIG
Breed: Unknown (pig)
Age: 5 MO
Weight: 270 LB
*CM: PIGS WERE DOA AFTER TRANSPORT FROM SOUTH DAKOTA, OTHERS SHOWED CM DURING MOVEMENT AT
FACILITY. *AEC: PORCINE STRESS SYNDROME-SUSPECTED TO BE CARRIERS OF GENE FOR PST. F/U: CONFIRMED
PSS CARRIERS PRESENT. DOWNERS AND DEADS DECREASED 50% IN SUBSEQUENT STUDIES(ASSUME THEY
REDUCED/ELIMINATED PSS ANIMALS); ALSO INCREASED LYSINE IN RATION AND DECREASED RACTOPAMINE.
Causality
Assessment
Drug Name:
Time
To Onset
6 WK
6 WK
6 WK
6 WK
RACTOP AMINE
Clinical Detail:
G DEATH
G RECUMBENCY
G WEAKNESS
R DYSPNEA
Source:
Country:
State:
United States
INDIANA
Zip:
46041
CVM _Report. rep
Source Report Id:
PAYUS00002
NDC:
Product Lot No:
UN
Page: 2
Episode Date:
04118/2000
#Treated:
1000
#Reacted: 5
5
Dose Description: 9 OR 18 G/TON FEED, 3/21/00 TO 4118/00
Species: PIG
Extra Label: None Breed: Mixed (pig)
Reason For Use:
IMPROVE GROWTH
Age: 6 MO
Weight: 240 LB
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
*CM: DIED DURING MOVEMENT TO THE WEIGHING SCALES AT UNITED FEEDS (CONDUCTING RESEARCH FOR
ELANCO). 4 WERE IN GROUP RECEIVING 18 G/TON RACTOPAMINE, 1 RECEIVED 9 G/TON.
*SIGNS CONSISTENT WI PORCINE STRESS SYNDROME. ANALYSIS OF TISSUE SAMPLES PENDING. FlU: 4 OUT OF 5
PIGS TESTED WERE POSITIVE FOR THE PSS GENE.
Causality
Assessment
Time
0 28 DA G DEATH
Source:
Country:
United States
State:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
04/04/2000
Recommended dose
Oral (in dry feed)
18 G/TON
None
IMPROVED GAIN, LEANESS
Good
Owner
Medium
Yes
Source Report ld:
PAYUS00003
NDC:
Product Lot No:
#Treated:
1856
#Reacted: 158
#Died:
44
Species: PIG
Breed: Mixed (pig)
Age: 6 MO
Weight:
240 LB
CHLORTETRACYCLINE IN DRINKING WATER
Page: 3
*RACTOPAMINE FED FOR 2 MONTHS. DURING THAT TIME NUMEROUS GROUPS OF PIGS WERE SHIPPED TO
HARVESTING FACILITY. 114 BECAME RECUMBENT DURING TRANSPORT AND LATER RECOVERED. AN
ADDITIONAL 44 WERE DOA. *CM: SIGNS ASSOC WI PORCINE STRESS SYNDROME-SHORTNESS OF BREATH AND
MUSCLE TREMORS. ANALYSIS OF BLOOD AND TISSUES PENDING. FlU: 10/ 10/00: IN A LATER STUDY INVOLVING 914
PIC SWINE AND 964 NEWSHAM DEATH LOSS WAS 7 AND 2 RESPECTIVELY. # DEAD WAS W/IN NORMAL RANGE FOR
THIS OPERATION. OF 52 PIGS REMAINING ON THE FARM 43% CARRIED ONE COPY OF THE STRESS GENE. 9/30/02:
OPERATION HAS MADE CHANGES IN HANDLING, TRUCK DENSITY AND LOAD OUT PROCEDURES. THEY
CONTINUE TO SEE DOWNERS. THEY ALSO FEEL RACTOP AMINE MAKES PIGS MORE DIFFICULT TO HANDLE.
Causality
Assessment
Time
UN G BEHAVIOR DISORDER
6 WK G DEATH
UN G RECUMBENCY
6 WK N TREMBLING
6 WK N TWITCH
6 WK R DYSPNEA
Source:
Country:
United States
State:
OHIO
Zip:
43502
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
08/02/2000
Unknown
Oral (in dry feed)
UNKAMT
Unknown
INCREASE GAIN, LEANESS
Good
Owner
Medium
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS00005
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Breed: Duroc
Age: 5 MO
Weight:
275 LB
Gender: Female
Page: 4
ELU: POSSIBLE OD; NOT LABELED TO BE FED IN PRE MIX FORM. RTX: REMOVE RACTOPAMINE AND ADMIN 50%
DEXTROSE SOLN IP; RECOVERED.
Causality
Assessment
Time
2 20 DA G DEPRESSION/LETHARGY
2 20 DA N ATAXIA
2 20 DA R DYSPNEA
Source:
Country:
United States
State:
INDIANA
Zip:
46947
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
11/09/2000
Recommended dose
Oral (in dry feed)
9 GM/TON X 21 DAYS
None
INCREASED WEIGHT GAIN
Good
Owner
No Value
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
PAYUS00007
UNK
#Treated:
308
#Reacted: 91
#Died:
7
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight: 280 LB
BREED: PIC 337. CM OCCURRED FOLLOWING SHIPMENT TO HARVESTING FACILITY. 7 WERE EUTHANIZED ON THE
TRAILER DUE TO INABILITY TO MOVE; 61 WERE ASSISSTED TO THE FACILITY BY MECHANICAL MEANS; 23
WALKED FROM THE TRAILER BUT BECAME RECUMBENT 3 TO 4 HOURS AFTER ARRIVAL AND WERE THEN MOVED
MECHANICALLY. 84 ANIMALS WERE SLAUGHTERED NORMALLY.
FlU: BARN RECORDS FROM THE INTEGRATOR THAT SUPPLIES PIGS TO THIS CONTRACT PRODUCER SHOWING
THAT RATE OF DOWN AND DEADS WENT UP IN PIC 337 SIRED PIGS B/4 PA YLEAN USE. RATE INCREASED MORE
WITH P A YLEAN USE. USE OF PIC 280 SIRES RESULTED IN LOWER D&D RATE. 9/19/02 F /U: CHANGES IN HANDLING
AND IN BOAR GENETICS;# OF DEAD AND DOWNERS IS LOWER THAN PRE-RACTOPAMINE LEVELS.
Causality
Assessment
CYM _ Rep01t. rep
Time
1 MO G DEATH(EUTHANIZED)
Prepared on. 04/18/2011
Page: 5
1 MO G RECUMBENCY
1 MO N ATAXIA
1 MO R DYSPNEA
Source:
Country:
United States
State:
INDIANA
Zip:
47108
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09115/2000
Not applicable
Inhalation
PRODUCT IN INHALED DUST
Species
ACCIDENTAL
Good
Not applicable
Not applicable
No Value
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
PAYUS00006
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
35 YR
190 LB
Male
CM: NOSE BLEED LASTED 1-2 HRS AFTER HAND FEEDING HIS SHOW PIGS +/OR CONTACT WITH DUST FROM A
BULK BIN FEEDER AS IT WAS MIXING A TON OF FEED WI RACTOP AMINE. NO RTX.
Causality
Assessment
-9
-9
0
Time
To Onset
NA
NA
8 HR
Clinical Detail:
G HUMAN EXPOSURE, INHALA
R EPISTAXIS
Source:
Country:
CVM _Report. rep
United States
Package ID: A 1
Source Report Id:
NDC:
PAYUS01001
State:
INDIANA
Zip:
47240
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/24/2000
Recommended dose
Oral (in dry feed)
4.5 AND 9 GM/TON
None
INCREASE GAIN/LEANMEAT
Good
Owner
High
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 6
1549
27
14
PIG
Mixed (pig)
6 MO
256 LB
Group (m & f)
CM: DEAD AND DOWNER PIGS ON ARRIVAL AT SLAUGHTER PLANT. DOWNERS RECOVERED AND WERE
PROCESSED. CF: FED LOWER L YSINE(0.7%) AND PROTEIN(l5%) LEVELS THAN RECOMMENDED WI RACTOPAMINE:
0.9 TO 1.2 % LYSINE; AT LEAST 16% PROTEIN. 800 HOGS WERE FED 9 GM/TON AND 800 WERE FED 4.5 GM/TON. 4
DOWN AND 8 DEAD IN THE GROUP FED AT 9 GM/TON. 9 DOWN AND 6 DEAD IN THE GROUP FED AT 4.5 GM/TON.
FlU: 9118/02: PRODUCER INCREASED LYSINE LEVEL FROM 0.68% TO 0.95 %; PROBLEMS WENT AWAY.
Causality
Assessment
Drug Name:
Time
To Onset
1 MO
1 MO
1 MO
1 MO
1 MO
RACTOP AMINE
Clinical Detail:
G DEATH
G RECUMBENCY
G WEAKNESS
N TREMBLING
R POLYPNEA
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
02/07/2001
CVM _ Repmt.rep
Source Report ld:
PAYUS01002
NDC:
Product Lot No:
UNK
#Treated:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
4.5 TO 18 GM/TON
None
EXPERIMENTAL. MODEL
Fair
Owner
High
No Value
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
Page: 7
280
44
13
Mixed (pig)
5 MO
222 LB
Male, neutered
EXPERIMENT DESIGNED TO EVALUATE HANDLING STRESS AS A FACTOR IN THE INCIDENCE OF DOWNER PIGS. OF
THE 88 PIGS THAT WERE FED 4.5, 9 OR 18 GM/TON BUT NOT SUBJECTED TO HANDLING TREATMENTS, NONE WERE
AFFECTED. IN THE GROUP OF 36 THAT WERE GENTLY HANDLED, 2 WERE AFFECTED, 1 WAS EUTHANIZED. IN THE
AGGRESSIVELY HANDLED GROUPS(36 IN EACH), THERE WERE MORE DOWNERS AND DEATHS IN THE GROUP FED
18 GM/TON(22 DOWNERS, 7 EUTHANIZED) THAN IN THE GROUP FED 4.5 GM/TON(9 DOWNERS, 3 EUTHANIZED).
FASTED ANIMALS(LOW LIVER GLYCOGEN) APPEARED MORE SUSCEPTIBLE THAN FED PIGS(NORMAL LIVER
GLYCOGEN).
PIGS WERE SOURCED FROM A FARM WI A HI INCIDENCE OF DOWNER PIGS AND A H/0 SWINE RESPIRATORY
DISEASE.
TOTAL DEATHS: 12 EUTHANIZED, 1 NON-EUTHANIZED DEATH.
INCREASED SERUM LACTATE AND DECREASED BLOOD PH IN DOWN PIGS.
Causality
Assessment
Time
To Onset
1 MO
1 MO
Clinical Detail:
G ACIDOSIS
G DEATH
1 MO G DEATH(EUTHANIZED)
1 MO G RECUMBENCY
Source:
Country:
State:
United States
GEORGIA
Zip:
X XXX X
Episode Date:
02/22/2001
Dosage: Unknown
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS01005
UNK
#Treated:
#Reacted:
#Died:
1300
23
19
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
UNKDOSE
Unknown
Species:
Breed:
INCREASE GAIN/LEAN MEAT
Age:
Weight:
Good
Gender:
Owner
Medium
Unknown
Page: 8
PIG
Various (pig)
5.5 MO
246 LB
Group (m & f)
JUNIOR NATIONAL LIVESTOCK SHOW PIGS. SUSPECT THAT MOST OR ALL RECEIVED RACTOPAMINE; POSSIBLY
OVERDOSED. CM: 5 BECAME RECUMBENT DURING SHOW, 1 DIED, 3 RECOVERED AFTER BEING DOUSED W/
WATER, 5TH WAS NOT NORMAL THE NEXT DAY, UNK IF IT RECOVERED. ALL WERE SHIPPED TO PROCESSING
PLANT. 18 DEAD AT ARRIVAL, HIGHER NUMBER OF DOWNERS THAN EXPECTED. 50-90% OF THE LIVERS WERE
CONDEMNED. FlU: 3/7/01-USDA VET AT PLANT SAID A LARGE# OF LIVERS CONDEMNED, >50%. CONDEMNED
EITHER FOR PARASITE SCARS OR BECAUSE THEY APPEARED "VISUALLY ABNORMAL". HE ATTRIBUTED THESE
ABNORMALITIES TO USE OF A "HIGH POWERED DIET" WHICH HE SAYS HAS BEEN PREVIOUSLY OBSERVED IN
SHOW PIGS. HE DID NOT ATTRIBUTE THE LIVER ABNORMALITIES TO RACTOPAMINE. FlU: 9/18/02-NO FURTHER
TESTING WAS DONE.
Causality
Assessment
Time
UN G DEATH
UN G RECUMBENCY
0 UN L PR-LIVER, LESION(S)
Source:
Country:
State:
United States
MICHIGAN
Zip:
XX XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
CVM _Report. rep
02/28/2001
Reconm1ended dose
Oral (in dry feed)
9 GM/TON
None
INCREASE GAIN, LEAN MEAT
Good
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
PAYUS01003
UNK
#Treated:
1200
#Reacted: 31
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight:
257 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
No Value
Page: 9
BREED: DEKALB GENETICS. AT ARRIVAL, 14 WERE DOWN AND "WINDED", UNABLE TO RISE. CF: SOME PIGS AT
FARM OF ORIGIN WERE RELUCTANT TO LOAD, 17 WENT DOWN; UNK IF THESE RECOVERED AND/OR WERE
SHIPPED. FlU: 9/19/01 -HAS SINCE FED RACTOPAMINE TO SEVERAL GROUPS AT 4.5 GM/TONW/0 PROBLEMS.
Causality
Assessment
2
2
Time
To Onset
1 MO
1 MO
Clinical Detail:
G RECUMBENCY
R POLYPNEA
Source:
Country:
United States
State:
TEXAS
NO DATES PROVIDED
Episode Date:
04/02/2001
Dosage: Unknown
Zip:
Dose Description:
Extra Label:
Unknown
XX XXX
Reason For Use:
INCREASE GAIN AND LEAN MEAT
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Medium
Unknown
Source Report ld:
PAUUS01004
NDC:
Product Lot No:
UNK
#Treated:
25
#Reacted: 25
#Died:
25
Species: PIG
Breed: Mixed (pig)
Age: 5.5 MO
Weight: 248 LB
PIGS TAKEN FROM JUNIOR LIVESTOCK SHOW IN SAN ANTONIO. CM: INCREASE# OF DEAD PIGS: 5 DEAD ON THE
TRUCK, 10 DIED IN THE LOT AND 10 DIED ON THE WAY TO A PACKING PLANT. TOTAL# PIGS NOT KNOWN. SHOW
VET SUSPECTS 80% SUPPLEMENTED W/ RACTOPAMINE. DOSE AND TIME SUPPLEMENTED UNK. F/U: SHOW VET
FEELS THAT PEOPLE HAVE LEARNED HOW TO USE THE PRODUCT, HAVE STOPPED OVERFEEDING IT AND NO
LONGER HAVE PROBLEMS.
Causality
Assessment
CVM _ Rep01t.rep
Time
UN G DEATH
Page: 10
Source:
Country:
United States
State:
TEXAS
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
04/03/2001
Unknown
Oral (in dry feed)
UNKNOWN
Unknown
79336
Reason For Use:
INCREASE GAIN, LEANESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Low
Unknown
Source Report ld:
PAYUS01007
NDC:
Product Lot No:
UNK
#Treated:
1000
#Reacted: 130
#Died:
130
Species: PIG
Breed: Mixed (pig)
Age: 5.5 MO
Weight:
240 LB
# ANIMALS NOT REPORTED. PURCHASES BARROWS FROM LIVESTOCK SHOWS THEN FEEDS THEM OR SHIPS THEM
TO CA TO BE FED AND MARKETED. CM: 10-16 % DIED DURING TRANSPORTATION OR SHORTLY AFTER ARRIVAL.
HAS LOST THIS YEAR DUE TO DEATHS. UNKNOWN HOW MANY OF THESE PIGS WERE FED RACTOPAMINE
BUT IT'S ASSUMED THAT A LARGE# OF SHOW ANIMALS ARE SUPPLEMENTED. FlU: 9/20/02-VET REPORTS THAT
THE PRODUCER NO LONGER IN BUSINESS; OTHER PRODUCERS IN AREA HAVE LEARNED HOW TO MANAGE THE
PRODUCT.
Causality
Assessment
Time
UN G DEATH
Source:
Country:
State:
United States
GEORGIA
Zip:
30752
Episode Date:
03/24/2001
Dosage: Unknown
CYM _Report. rep
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
PAYUS01009
UNK
#Treated:
#Reacted:
#Died:
5
3
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
FDA/CVM- ADE Reports- CVM Response
Oral (in dry feed)
8-9 WEEKS
Unknown
INCREASE GAIN AND LEAN MEAT
Good
Owner
Missing information
Unknown
Species:
Breed:
Age:
Weight:
Gender:
Page: II
0
PIG
Mixed (pig)
1 YR
325 LB
Female
HAMPSHIRE CROSS. HAD BEEN FED RACTOP AMINE IN A SHOW RATION DURING AUGUST AND SEPT/00. BRED IN
NOVEMBER; FARROWED 3/24/01. 18 PIGS WERE BORN DEAD (MUMMIES OR DEFORMED) OR DIED A SHORT TIME
AFTER DELIVERY. F/U: 9/20/02-PRODUCER HAS DISCONTINUED USE DUE TO REPRODUCTIVE PROBLEMS AND
DISCOLORED(GRA Y) LIVERS. HAD ONE GILT THAT NEVER CONCEIVED AND A LITTERMATE THAT DID CONCEIVE
BUT ALL PIGLETS WERE MUMMIES.
Causality
Assessment
0
0
0
0
Drug Name:
Time
To Onset
UN
6 MO
6 MO
UN
RACTOPAMINE
Clinical Detail:
L PR-LIVER, LESION(S)
X DEATH(NEWBORN)
X DEATH(STILLBORN)
X FERTILITY, LACK OF
Source:
Country:
United States
State:
MISSISSIPPI
Zip:
XX XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
CVM _Report. rep
03/04/2001
Unknown
Oral (in dry feed)
SUSPECTED EXPOSURE
Unknown
INCREASE GAIN, LEAN MEAT
Good
Source Report ld:
NDC:
Product Lot No:
PA YUS01008
UNK
#Treated:
9550
#Reacted: 302
#Died:
210
Species: PIG
Breed: Mixed (pig)
Age: 5.5 MO
Weight:
255 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Page: 12
PIGS SHIPPED FROM 2 LIVESTOCK SHOWS. FROM SAN ANTONIO SHOW: 2000 SHIPPED; 56 WERE DOA OR DIED
SHORTLY AFTER ARRIVAL, 39 WERE DOWN. THIS NUMBER IS MUCH HIGHER THAN PREVIOUS YEARS. 23 DIED IN
1999 AND 24 DIED IN 2000 OUT OF 2000 SHIPPED. FROM HOUSTON SHOW: 2000 SHIPPED; 95 DOA, 34 WERE DOWN.
PURCHASER BELIEVES PIGS WERE FED RACTOPAMINE BECAUSE THEY WERE VERY HEAVILY MUSCLED. THEY
ALSO HAD SHRUNKEN ABDOMENS AS IF OFF FEED BEFORE SHIPPING. CF: EXPOSURE TO RACTOP AMINE
SUSPECTED, UNK HOW MANY EXPOSED, DOSE, LENGTH OF TX.
FlU: 10/ 1102: CHANGES IN SHOW PROCEDURES, SHIPPING AND HANDLING WERE RECOMMENDED. DEAD AND
DOWNERS FROM LIVESTOCK SHOWS WERE DECREASED IN 2002 COMPARED TO 2001 NUMBERS. 3448 EXHIBITED
AT SAN ANTONIO; 20 DEAD, 12 DOWN AFTER TRANSPORT TO SLAUGHTER. AT HOUSTON SHOW 2102 PIGS
EXHIBITED; 39 DEAD AND 7 DOWN.
Causality
Assessment
Time
2 UN G DEATH
2 UN G RECUMBENCY
Source:
Country:
United States
State:
ILLINOIS
Zip:
61238
Episode Date:
04/08/2001
Dose Description: 4.5 GM/TON X 3 DAYS
Extra Label: None
Reason For Use:
Health Status:
Fair
Administered By:
Owner
Vet Opinion: Low
Source Report Id:
PAYUS01010
NDC:
Product Lot No:
UNK
#Treated:
198
#Reacted: 30
#Died:
30
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight: 260 LB
BREED: DEKALB GENETICS. CM: 25 DEAD ON TRUCK AT ARRIVAL AT PROCESSING PLANT, 5 DIED ON WAY TO
SCALES. TRUCKER REPORTED A NOTICEABLE INCREASE IN DEAD AND SLOW PIGS ARRIVING THAT DAY. NEXT
GROUP SHIPPED (150 HD) HAD NO DOA'S. SUPPLEMENT SAMPLE ASSAYED: 309 GM/TON. *THESE PIGS WERE
SUPPLEMENTED ONLY 3 DAYS; REPORTEDLY A VERY HOT DA Y(APRIL IN IL). FlU: 9/24/02-NO FURTHER PROBLEMS
CVM _ Report.rep
Page: 13
AFTER HANDLING PROCEDURES CHANGED. PRODUCER IS NOT USING RACTOPAMINE AT THIS TIME DUE TO LOW
PIG PRICES.
Causality
Assessment
Time
2 3 DA G DEATH
Source:
Country:
United States
State:
INDIANA
Zip:
46539
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/0112001
Recommended dose
Oral (in dry feed)
4.5 GM/TON; 2/2 TO 311 /01
None
Good
Owner
No Value
Source Report ld:
PAYUS01006
NDC:
Product Lot No:
UNK
#Treated:
1000
#Reacted: 5
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 26 WK
Weight:
286 LB
CM: 191 PIGS SHIPPED; DURING UNLOADING 5 BECAME DYSPNEIC, SHAKY THEN WENT DOWN AND WERE UNABLE
TO RISE. THEY WERE MECHANICALLY MOVED AND PROCESSED. CUSTOMER USUALLY HAS 1-3 PIGS AFFECTED
IN GROUP OF 190. FlU: 9/ 18/02-FARM CONTINUES TO USE RACTOPAMINE. THEY HAVE REDUCED THE NUMBER OF
ANIMALS ON A LOAD.
Causality
Assessment
2
2
2
Time
To Onset
1 MO
1 MO
1 MO
Clinical Detail:
G RECUMBENCY
N TREMBLING
R DYSPNEA
Source:
Country:
CVM _Report. rep
United States
Source Report Id:
PAYUS01011
NDC:
State:
INDIANA
Zip:
47616
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05/23/2001
Recommended dose
Oral (in dry feed)
4.5 GM/TON; 5/ 10-23/01
None
Good
Owner
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 14
535
11
11
PIG
Mixed (pig)
6 MO
260 LB
Male, neutered
SHIPPED 185 PIGS, 2 HRS AWAY. AFTER UNLOADING AT THE PLANT 11 PIGS WENT DOWN, WERE DYSPNEIC AND
HAD BLOTCHY SKIN. RTX: ATTEMPTED TO MOVE TO A RECOVERY PEN; ALL DIED. THIS PRODUCER USUALLY
HAS 2-3 PIGS DIE DURING TRANSPORT. TEMPERATURE WAS HIGH THAT DAY. FlU: 9/19/02-WERE NOT ABLE TO
REDUCE THE NUMBER OF "SLOWS". HANDLING ISSUES ON THE TRUCK AND AT THE PLANT. PRODUCER NO
LONGER USES RACTOPAMINE.
Causality
Assessment
2
2
2
2
Drug Name:
Time
To Onset
13 DA
13 DA
13 DA
13 DA
RACTOP AMINE
Clinical Detail:
G DEATH
G RECUMBENCY
I CONGESTION, SKIN
R DYSPNEA
Source:
Country:
State:
United States
NEBRASKA
Zip:
XX XXX
Episode Date:
06/09/2001
CVM _Report. rep
Source Report Id:
PAYUS01012
NDC:
Product Lot No:
MISSING
#Treated:
#Reacted:
Route: Vaginal #Died:
0
Dose Description: DERMAL AND INHALED Species: HUMAN
Extra Label:
Secondary exposure Breed: Not specified
Reason For Use:
ACCIDENTAL
Age: 40 YR
Weight:
XX
Health Status:
Good
Gender: Male
Administered By:
Owner
CM: GOT PRODUCT ON HANDS AND POSSIBLY INHALED. 4 DAYS LATER HEADACHE AND FEVER. WENT TO
HEALTH CARE FACILITY AND WAS DISCHARGED AND RETURNED THAT PM DT WORSENING SIGNS. HOSP IN
INTENSIVE CARE OVERNIGHT. NO CARDIOVASCULAR SIGNS. FlU: 9/26/02-6115/01-0UT OF ICU, STILL HAS NECK
AND BACK ACHE, MUSCLE ACHES, SEVERE HEADACHES AND FLU-LIKE SYNDROME. DDX: VIRAL MENINGITIS
Causality
Assessment
-9
-2
-2
-9
-9
-2
-2
-2
Drug Name:
Time
To Onset
NA
4 DA
4 DA
NA
NA
4 DA
4 DA
4 DA
RACTOP AMINE
Clinical Detail:
G FEVER, BODY
G HEADACHE
G HUMAN EXPOSURE, HAND(S
G PAIN, BACK
G PAIN, NECK
M PAIN, MUSCLE(S)
Source:
Country:
State:
United States
MINNESOTA
Zip:
55936
Episode Date:
06/ 13/2001
Dose Description: 4.5 GM / TON
CVM _ Rep01t.rep
Source Report ld:
NDC:
Product Lot No:
PAYUS01013
MISSING
#Treated:
#Reacted:
#Died:
Species: PIG
300
5
5
Page: 16
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
No Value
Breed:
Age:
Weight:
Gender:
Other (pig)
UN
250 LB
Female
CM: PRODUCER FED 600 PIGS AND SENT THEM TO MARKET. HALF WERE FED RACTOPAMINE. 5 OF THAT GROUP
WERE DEAD ON ARRIVAL AT PLANT. USUALLY LOSES 1 OR 2 PER SHIPMENT. ALSO THOUGHT THEY WERE VERY
STRESSED. NO NECROPSY. FlU: 9/20/02-CUSTOMER "WORKED THROUGH THE PROBEM", IS STILL FEEDING
RACTOPAMINE AND HAD NO ADDITIONAL CONCERNS.
Causality
Assessment
Time
2 4 WK G DEATH
Source:
Country:
United States
State:
KANSAS
Zip:
67530
Episode Date:
06/ 18/2001
Dose Description: 9 GM/TON X 3 WEEKS
Extra Label: None
Reason For Use:
INCREASED DAILY GAIN
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
TYLOSIN 40 G/TON 5/28 - 6/ 18/ 1
Source Report ld:
PAYUS01014
NDC:
Product Lot No:
MISSING
#Treated:
300
#Reacted: 14
#Died:
7
Species: PIG
Breed: Other (pig)
Age: 8 MO
Weight: 230 LB
Gender: Male
PIC GENETICS. CM: 300 PIGS SENT TO SLAUGHTER IN 2 SHIPMENTS. 7 DOWN, 7 DEAD. AEC: TEMP 93-98 DEGREES
W DEWPOINT 61- HEAT STRESS. NO NECROPSY. CF: CONCURRENT TYLOSIN. FlU: 9/ 19/02-NO FURTHER
PROBLEMS; NOT MUCH PRODUCT BEING USED IN THE AREA.
CVM _ Report.rep
Page: 17
Causality
Assessment
Time
3 WK G DEATH
3 WK G RECUMBENCY
Source:
Country:
United States
State:
IOWA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/15/2001
Recommended dose
Oral (in dry feed)
4.5 G/TON X 4-5 WEEKS
None
INCREASE GAIN
Good
Owner
No
51027
Source Report Id:
PAYUS01015
NDC:
Product Lot No:
UNK
#Treated:
185
#Reacted: 2
#Died:
2
Species: PIG
Breed: Mixed (pig)
Age: 7.5 MO
Weight:
265 LB
Gender: Female
PIC X DEKALB GENETICS. SHIPPED GILTS TO PROCESSING PLANT ON A COOL DAY. CM: DOA AT PLANT.
USUALLY HAS NO DEAD ANIMALS IN A TRUCKLOAD. FlU: HAVE CHANGED HANDLING TECHNIQUES; NO
FURTHER PROBLEMS.
Causality
Assessment
2
Time
To Onset
4 WK
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
81240
CVM _Report. rep
Source Report Id:
PAYUS01016
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/ 10/2001
#Treated:
Recommended dose
#Reacted:
18 G/TON X 3-4 WEEKS
Species:
None Breed:
INCREASE WEIGHT GAIN
Age:
Weight:
Good
Gender:
Owner
Medium
No Value
Page: 18
9
6
0
PIG
Mixed (pig)
5 MO
200 LB
Female
HAMPSHIRE CROSS SHOW GILTS. CM: ACTED A "LITTLE OFF", TREMBLING, DIFFICULTY WALKING, WEAK IN HIND
END. AMBIENT TEMP IN 100S. 2 GILTS WERE MORE AFFECTED THAN THE OTHERS. RTX: 7/5/01-D/C
RACTOPAMINE; PPG-IMPROVED. OWNER NOTICED HOOF SPLITTING AND YELLOW MUCOUS, VAGINAL
DISCHARGE. DDX: POSSIBLE THAT FEED NOT MIXED WELL. FlU: 10/3/02- THIS YEAR HAD 4 PIGS THAT WERE FED
RACTOP AMINE. ONE HAD A HOOF CRACK THAT WAS TRIMMED AND TREATED; PIG IMPROVED AND WAS SHOWN.
OTHER 2 HAD NO PROBLEMS. THEY USED A LOWER DOSE OF RACTOP AMINE THIS YEAR.
Causality
Assessment
2
0
2
2
2
2
0
Drug Name:
Time
To Onset
9 DA
1 MO
9 DA
9 DA
9 DA
9 DA
1 MO
RACTOPAMINE
Clinical Detail:
G FEVER, BODY
G HOOF DISORDER
G WEAKNESS
N PARE SIS, HIND LIMB(S)
N TREMBLING
X DISCHARGE, VULVA
Source:
Country:
State:
United States
ILLINOIS
Zip:
61801
Episode Date:
11127/2000
CVM_Rep rt.rep
Source Report ld:
NDC:
Product Lot No:
PAYUS01017
UNK
#Treated:
#Reacted:
1687
46
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
4.5 G/TON X 4 WK
None
INCREASE GAIN, LEAN CARCASS
Good
Owner
Yes
#Died:
Species:
Breed:
Age:
Weight:
Gender:
MAGNESIUM SULFATE
Page: 19
19
PIG
Unknown (pig)
6 MO
UN
Group (m & f)
U OF IL STUDY GROUP TO EVALUATE EFFECTS OF RACTOP AMINE WITH MAGNESIUM SULFATE. NO DESCRIPTION
OF DOSE OR# TREATED W/ MAG SULFATE. SHIPMENTS TO PROCESSING PLANT OVER 2 DAYS RESULTED IN 19
DOA AND 27 DEMONSTRATING SIGNS OF STRESS INCLUDING IMMOBILITY, RAPID BREATHING, SEVERE REDNESS
OF SKIN AND MUSCLE TREMORS. FlU: 9/20/02-NO FURTHER INFO.
Causality
Assessment
2
2
2
2
2
Drug Name:
Time
To Onset
4 WK
4 WK
4 WK
4 WK
4 WK
RACTOP AMINE
Clinical Detail:
G DEATH
G RECUMBENCY
CONGESTION, SKIN
N TREMBLING
R POLYPNEA
Source:
Country:
United States
State:
PENNSYLVANIA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
CVM _ Repmt.rep
08/ 18/2001
Recommended dose
Oral (in dry feed)
8/GM/TON; 8/13-18/01
None
INCREASE GAIN
15330
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
PAYUS01018
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
5
0
PIG
Mixed (pig)
UN
Health Status: Good
Administered By:
Vet Opinion:
Concomitants:
Owner
Missing information
Unknown
Weight:
Gender:
Page: 20
250 LB
Unknown
HAMPSHIRE CROSS SHOW PIG. CM: LEG STIFFNESS. DEVELOPED POST PARESIS AND WAS UNABLE TO WALK
AFTER RACTOPAMINE D/C. A LITTER MATE ALSO FED RACTOPAMINE WAS UNAFFECTED.
Causality
Assessment
2
2
2
Time
To Onset
14 DA
14 DA
5 DA
Clinical Detail:
G ANOREXIA
G RECUMBENCY
2 14 DA N PARALYSIS, HIND LIMB(S
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
08/24/2001
Recommended dose
Oral (all other)
4.5 G/TON
None
INCREASE DAILY GAIN
Good
Owner
No Value
50629
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS01019
UNK
#Treated:
275
#Reacted: 5
#Died:
5
Species: PIG
Age: XX
Weight: 220 LB
CM: STARTED TO FEED PA YLEAN 8/20. 4 DAYS LATER 1 DEAD. LOST 4 MORE OVER NEXT 4 DAYS. CALLED DVM-
SAID PROBABLY HEM BOWEL DZ. NO NECROPSY. DDX: OVERCROWDED, HOT TEMPS. NO FURTHER DEATHS
DESPITE NO DECHAL.
CVM _ Rep01t.rep
Page: 21
Causality
Assessment
Time
0 4 DA G DEATH
Source:
Country:
United States
State:
MINNESOTA
Zip:
56345
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
11115/2001
Not applicable
Unknown
SECONDARY EXPOSURE
Secondary exposure
SECONDARY EXPOSURE
Good
Not applicable
Not applicable
No Value
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
PAYUS01020
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
49 YR
UN
Male
CONTRACT GROWER EXPERIENCED CHEST PAIN AND BURNING SENSATION IN ARMS UPON ENTERING FINISHER
BARN. FEED W/ RACTOPAMINE HAD JUST BEEN DELIVERED THAT DAY. MD EXAM-NR. MD CONCLUDED SIGNS
DUE TO ALLERGIC REACTION TO RACTOPAMINE. HAS RECOVERED AND RETURNED TO WORK. SIMILAR SIGNS
AND DIZZINESS THIS SPRING IN FINISHER BARN; ATTRIBUTED IT TO A SINUS INFECTION.
Causality
Assessment
Time
To Onset
5 MN
5 MN
5 MN
Clinical Detail:
G ANAPHYLAXIS/TOlD
G PAIN, BRISKET/CHEST
G PAIN, LIMB(S)
Source:
Country:
State:
CVM _ Report.rep
United States
MINNESOTA
Zip:
56002
Source Report ld:
NDC:
Product Lot No:
PAYUS02001
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/01/2001
Recommended dose
Oral (in dry feed)
9 GM/TON X 3 TO 4 WEEKS
None
INCREASE WEIGHT GAIN AND CARCASS LEANNESS
Good
Owner
Yes
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
TYLOSIN PHOSPHATE 100 G/TON, PERIODICALLY IN 2001
Page: 22
5340
156
50
PIG
Other (pig)
UN
260 LB
Group (m & f)
BREED: PIC. PRODUCER COMPARED 5 GROUPS OF HOGS THAT HAD BEEN FED RACTOP AMINE AND SHIPPED TO
THE PROCESSING PLANT FROM 3/ 1/01 TO 11/30/01 TO 5 GROUPS THAT WERE NOT FED RACTOPAMINE DURING THE
SAME PERIOD IN 2000. HOGS NOT FED RACTOP AMINE HAD A DEATH LOSS ON ARRIVAL AT THE PLANT OF 0.54%
AND A SUBJECT RA TE(BELOW STANDARD) OF 0.84%. THE HOGS FED RACTOPAMINE HAD A DEATH RATE OF 0.8%
AND A SUBJECT RATE OF 1.68%. ALSO FOUND SOME HIGHER DEATH NUMBERS IN THE BARNS OF THE HOGS FED
RACTOPAMINE IN 2001. ALL THE HOGS WERE ON THE SAME SITE FEEDING FARM. FlU: 9/25/02-SAME RATE OF
DEAD AND DOWNERS AT 9 GM/TON DOSAGE, DECREASED RATE AT 4.5 GM/TON. 10/6/02: PERCENTAGE OF DEAD
AND SUBJECTS RANGED FROM 1.7% IN MARCH/2001 TO 3.45% IN NOV/2001. NUMBERS DECLINED AFTER
NOVEMBER FOR BOTH 4.5 AND 9 GM/TON DOSAGES TO 2.1 % IN JAN/2002, AND 0.41 % IN MAY/2002. CURRENT RATE
AT 1.7% AT 9 GM/TON DOSE.
Causality
Assessment
Time
To Onset
4 WK
4 WK
4 WK
Clinical Detail:
G DEATH
G DIFFICULTY RISING
G RECUMBENCY
Source:
Country:
State:
United States
TEXAS
Zip:
75954
Episode Date:
0311 9/2002
CVM_Report.rep
Package ID: A 1 Corrsp Date: 04/01 /2002
Source Report ld:
PAYUS02002
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
2.25 GM/2 #, ( 4 OZ), TOP DRESSED
Other
INCREASE A VG WEIGHT GAIN
Good
Owner
Unknown
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 23
0
PIG
Mixed (pig)
6 MO
220 LB
Female
MAX LABEL DOSE= 18 GM/TON FEED(9 MG/# FEED). DOSE FED: 4 OZ TOP DRESSED-2250 MG/PIG; 5 LB/TON OF FEED-
45 GM/TON. ELU: TOP DRESSED AND OVERDOSED; SHOULD BE USED AS A PRE MIX. CM: WOULD GET UP ONLY WI
URGING AND WAS A LITTLE "TIGHT". RTX: REMOVED PAYLEAN, ADMINISTERED ANTIBIOTICS AND BANAMINE.
RECOVERED. FlU: 9/27/02-RMPCC REC'D A CALL FROM THIS PRODUCER'S VET. HE REPORTED A MIXING ERROR
WHERE BY 5 LBS/TON OF PA YLEAN WAS MIXED INSTEAD OF 4 OZ/TON. CM: PIGS WERE DOWN AND SHAKING.
Causality
Assessment
3
3
3
Time
To Onset
12 HR
12 HR
12 HR
Clinical Detail:
G ANOREXIA
G RELUCTANT TO MOVE
G STIFFNESS
Source:
Country:
State:
United States
TEXAS
Zip:
75488
Episode Date:
09/28/2001
Dosage: Unknown
Dose Description: 3 TO 4 LBS/DAY-UNK CONCENTRATION
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, IMPROVE LEAN CARCASS
Health Status:
Good
Administered By:
Owner
CVM _Report. rep
PAYUS02004
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Breed: Duroc
Age: 6 MO
Weight:
239 LB
Gender: Female
Concomitants:
No Value
Page: 24
OWNER REPORT TO NAPCC. OWNER FED 3 TO 4 LBS/DA Y(UNK FORMULATION), THEN 2-3 LBS IDA Y FROM 8/30/01
TO 10/10/01. CM: MODERATELY RECUMBENT WHILE AT STATE FAIR, EDEMA, RIGIDITY AND WEAKNESS. STOPPED
RACTOPAMINE ON 10110/01 AND APPLIED LINAMENT TO PIG'S LEGS. ALSO WALKED THE PIG EVERY 2-3 HRS.
RECOVERED BY 10/1 1/01.
Causality
Assessment
2
3
3
3
Drug Name:
Time
To Onset
1 MO
1 MO
1 MO
1 MO
RACTOP AMINE
Clinical Detail:
G EDEMA
G RECUMBENCY
G SPASM
G WEAKNESS
Source:
Country:
State:
United States
SOUTH DAKOTA Zip: XX XXX
Episode Date:
04/02/2002
Route: Unknown
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Dose Description: CONTACT WI PIGS FED RACTOPAMINE
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Secondary exposure
SECONDARY EXPOSURE
Good
Not applicable
Not applicable
Unknown
PAYUS02005
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
52 YR
165 LB
Male
SUBJECT LOADED TRUCK WI MARKET 154 HOGS THAT HAD BEEN FED RACTOPAMINE. HE COMMENTED THAT THE
AROMA OF THE MANURE WAS DIFFERENT IN THIS GROUP THAN THOSE LOADED IN THE PRIOR TWO WEEKS. CM:
CHEST PAINS. NEXT DAY HE HAD A CHEST COLD. UNK RTX.
Causality
Assessment
CYM_Report.rep
Time
To Onset
12 HR
Clinical Detail:
G PAIN, BRISKET/CHEST
Page: 25
24 HR R RESPIRATORY DISORDER
Source:
Country:
United States
State:
IOWA
Zip:
51250
Episode Date:
03/22/2001
Dosage: Unknown
Dose Description: UNK
Extra Label:
Species subgroup
Reason For Use:
ACCIDENTAL
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
Package ID: A 3
Source Report Id:
NDC:
Product Lot No:
PAYUS02003
UNK
#Treated:
420
#Reacted: 80
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: 64 DA
Weight: 45 LB
BREED: PIC. H/0: E COLI DIARRHEA. SUSPECTED THAT THE NURSERY RATION INADVERTENTLY CONTAINED
RACTOPAMINE DUE TO MIXING ERROR AT CO-OP. CM: HUGE HAMS, CURVING BACK LEGS, BUCKLIING FRONT
LEGS, EXERCISE INTOLERANCE. FEED SAMPLES SUBMITTED CONTAINED NO RACTOPAMINE. OWNER AGREES
THAT PIGS WERE NOT EXPOSED.
Causality
Assessment
-9
-9
-9
-9
-9
Time
To Onset
13 DA
13 DA
13 DA
13 DA
13 DA
Clinical Detail:
G EXERCISE INTOLERANCE
G PAIN, LIMB(S)
G SWELLING, LIMB(S)
Source:
CVM _ Repmt.rep
Country:
United States
State:
ILLINOIS
Zip:
xxxxx
Episode Date:
04/23/2002
Dose Description: 4.5 GM/TON X 1 WEEK
Extra Label:
None
Reason For Use:
INCREASE ADG, LEAN CARCASS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
Source Report ld:
PAYUS02006
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 26
200
10
10
PIG
Unknown (pig)
UN
240 LB
Group (m & f)
TRUCK CARRYING PIGS TO MARKET WAS DELAYED FOR 3 HRS WI NO COOLING DEVICES AND AMBIENT TEMP OF
90 DEGREES. 10 PIGS WERE FOUND DEAD WHEN TRUCK WAS UNLOADED; NO DOWNERS SEEN. FlU CONTACT
4/24/02-PIGS HAD NOT BEEN FED RACTOP AMINE.
Causality
Assessment
Time
-9 NA G DEATH
Source:
Country:
United States
State:
COLORADO
Zip:
80523
Episode Date:
12115/2001
Extra Label:
None
Reason For Use:
INCREASE
CVM _Report. rep
Source Report Id:
PAYUS02007
NDC:
Product Lot No:
UNK
#Treated:
200
#Reacted: 200
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Health Status: Good
Administered By:
Owner
Vet Opinion: Medium
Weight:
Gender:
Page: 27
275 LB
Group (m & f)
PIGS WERE RELUCT ANT TO UNLOAD FROM A "POTBELLY TRAILER". AN EXCESSIVE AMOUNT OF PRODDING AND
HOT SHOT USE WAS NECESSARY. THEY SEEMED TO HAVE NO ENERGY. PIGS HAD RECEIVED THE HIGH END DOSE
OF RACTOPAMINE; DURATION OF TX NOT KNOWN. AFTER UNLOADING ALL PIGS WERE PROCESSED NORMALLY.
Causality
Assessment
2
2
Time
To Onset
UN
UN
Clinical Detail:
G RELUCTANT TO MOVE
Source:
Country:
United States
State:
UNKNOWN
Zip:
XX XXX
VERY LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/18/2002
Missing information
Oral (in dry feed)
UN
Unknown
CARCASS LEANNESS, INC GAIN
Good
Owner
No Value
Source Report Id:
NDC:
Product Lot No:
PAYUS02008
UNK
#Treated:
50
#Reacted: 50
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
UN
BREED: PIC. UNK NUMBER EXPOSED/REACTED. CHANGE IN THE MEAT COLOR SCORES OF SLAUGHTERED PIGS.
OWNER HAS DECIDED TO REMOVE RACTOPAMINE FROM THE FEED.
Causality
Assessment
CVM_Report.rep
Time
Prepared on 04/18/2 0 11
Page: 28
0 UN G MEAT, ABN COLOR
Source:
Country:
State:
United States
WISCONSIN
Zip:
53533
Episode Date:
05/07/2002
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 GMS/TON X 5 DAYS PRIOR TO SLAUGHTER.
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Yes
TETRACYCLINE PO
PAYUS02009
UNK
#Treated:
18
#Reacted: 18
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 250 LB
BREED: ILLINI. ONLY 15 % OF THE HOGS WERE IN THE PACKER'S PREMIUM ZONE FOR CARCASS WEIGHT AND
BACK FAT. PRODUCER'S HOGS USUALLY AVERAGE ABOUT 50%. RATION WAS 16% PROTEIN; LYSINE LEVEL UNK.
CF: 5 DAYS NOT ENOUGH TIME TO SEE CARCASS BENEFITS. FlU: 9/1 8/02: PRODUCER SATIAFIED WI RESULTS, IS
FEEDING 9 GM/TON. HAS AN OCCASIONAL SLOW PIG.
Causality
Assessment
-9
-9
0
Time
To Onset
NA
NA
5 WK
Clinical Detail:
E INEFFECT, LEAN CARCASS
G RELUCTANT TO MOVE
Source:
Country:
CVM _ Repmt. rep
United States
Package ID: A 3
Source Report ld:
NDC:
PAYUS02010
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
52163
04/25/2002
Recommended dose
Oral (in dry feed)
4.5 GM/TON X 2 WKS; 9 GM/TON X 3 WKS
None
INCREASE GAIN; LEAN CARCASS
Good
Owner
No Value
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 29
1000
50
0
PIG
Other (pig)
UN
265 LB
Group (m & f)
BREED: SEAGHER. UNK # REACTED. WITHIN A WEEK OF INCREASING TO 9 GM/TON, MANY PIGS DEVELOPED
FOOT PROBLEMS SUCH AS CRACKED PADS AND INTERDIGITAL BLEEDING. PIGS WERE STIFF IN THE LEGS WHEN
SHIPPED TO PACKER. FlU: 10/03/02-STILL USING RACTOPAMINE, PIGS ARE NO LONGER STIFF. CF: BROKEN
CONCRETE SLATS IN FINISHING FACILITY WERE CONTRIBUTING TO PROBLEM.
Causality
Assessment
Drug Name:
Time
To Onset
5 WK
5 WK
5 WK
5 WK
RACTOP AMINE
Clinical Detail:
G BLD, FEET/DIGIT(S)
G HOOF DISORDER
G LAMENESS
Source:
Country:
State:
United States
ILLINOIS
Zip:
61064
Episode Date:
05/30/2002
CVM _Report. rep
Source Report ld:
PAYUS02011
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Inhalation
#Died:
INHALED WHEN MIXING FEED
Species:
Species
ACCIDENTAL
Good
Not applicable
Not applicable
Unknown
Breed:
Age:
Weight:
Gender:
Page: 30
0
HUMAN
Not specified
Male
24 YR
UN
CM: FEBRILE, WEAK, UPSET STOMACH, "TINGLY" SENSATION. BECAME WEAKER AS DAY PROGRESSED. WENT TO
THE HOSPITAL THAT NIGHT, RTX UNK. BACK TO WORK THE NEXT DAY.
Causality
Assessment
2
-9
2
-9
Time
To Onset
4 HR
NA
4 HR
NA
Clinical Detail:
D NAUSEA
G FEVER, BODY
G HUMAN EXPOSURE
2 4 HR G WEAKNESS
2 4 HR N HYPOESTHESIA
Source:
Country:
United States
State:
OKLAHOMA
Zip:
SPECIFIC INFO LACKING
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
07/14/2002
Recommended dose
Oral (in dry feed)
18 GM/TON
None
73644
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, CARCASS LEANNESS
CVM _Report. rep
PAYUS02012
UNK
#Treated:
100
#Reacted: 10
#Died:
10
Species: PIG
Age: UN
Health Status: Good
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Weight:
Gender:
Page: 31
UN
Unknown
NUTRITIONIST REPORTED THAT HE HAD PARTICIPATED IN FEEDING EXPERIMENTS THAT REULTED IN A 10%
DEATH LOSS IN THE PIGS FED RACTOP AMINE. INFORMATION ABOUT THE NUMBER OF ANIMALS AND THE DATES
THEY WERE FED WAS NOT GIVEN.
Causality
Assessment
-7
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
United States
State:
OKLAHOMA
Zip:
73045
LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08116/2000
Unknown
Oral (in dry feed)
UNK
Unknown
INCREASE ADG, LEANNESS
Good
Owner
Medium
Unknown
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
PAYUS02013
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
PIG
Unknown (pig)
Unknown
UN
UN
A PIG BROKE W/ DIARRHEA. VET INQUIRED IF DIARRHEA A POSSIBLE SIDE EFFECT. 10/3/02-VET HAS NOT HAD
ADDITIONAL COMPLAINTS BUT NOT AS MANY PRODUCERS ARE USING RACTOPAMINE NOW. OBSERVED SOME
DIARRHEA, ASSOC W/ TOP DRESSING OR OVERDOSE.
Causality
Assessment
CVM _ Report.rep
Time
UN D DIARRHEA
Page: 32
Source:
Country:
United States
State:
INDIANA
Zip:
47725
CM NOT DESCRIBED
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/ 16/2000
Recommended dose
Oral (in dry feed)
18 GM/TON
Species subgroup
Good
Owner
Unknown
Source Report Id:
PAYUS02014
NDC:
Product Lot No:
UNK
#Treated:
10
#Reacted: 3
#Died:
0
Species: PIG
Age: UN
Weight:
290 LB
Gender: Male
ELU: INDICATED FOR USE IN PIGS WEIGHING 150 TO 240 LBS. FEED REP REPORTED COMPLAINT FROM PRODUCER.
CM: "STRESS" IN THE BACK LEGS. "STRESS" NOT DESCRIBED.
FlU: CUSTOMER HAD ADMINISTERED TO HAMPSHIRE BOARS. HE IS NO LONGER FEEDING PRODUCT TO BOARS.
FELT THAT THE PROBLEM WAS RELATED TO RACTOP AMINE, SUMMER HEAT AND THE STRESS GENE. BOARS
WOULD PICK UP ONE FOOT, PUT IT DOWN, THEN PICK UP THE OTHER FOOT AS THEY ATE. ALSO DESCRIBED AS
HYPERACTIVE, OR DANCING AND NERVOUS. OCCURRED IN 3 OUT OF 10 BOARS. PROBLEM STOPPED WHEN
PRODUCT DISCONTINUED. LATER FED 9GM/TON W/0 PROBLEMS. HAS ONLY SEEN PROBLEMS IN SHOW PIGS.
PRODUCERS HAVE COMPLAINED THAT PIGS ARE HARDER TO HANDLE. SOMETIMES HE DOES NOT SEE A
CARCASS EFFECT.
Causality
Assessment
0
2
3
Time
To Onset
NA
UN
UN
Clinical Detail:
N HYPERACTIVITY
N PARES IS, HIND LIMB(S)
Source:
Country:
State:
CVM _ Repmt.rep
United States
INDIANA
Zip:
XX :XXX
Poor
Package ID: A 4
Source Report Id:
NDC:
Product Lot No:
PAYUS02015
UNK
Report Quality:
INFO LACKING
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Prepared on 04/18/2 0 11
09/06/2000
Unknown
Oral (in dry feed)
UNK
Species subgroup
Good
Owner
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 33
2
2
2
PIG
Unknown (pig)
UN
270 LB
Unknown
ELU: LABEL INDICATES USE IN PIGS 150-240 LBS. STRESS SUSPECTED AS CAUSE OF DEATH. BOTH TESTED
NEGATIVE FOR "STRESS SYNDROME". FlU: NO FURTHER INFO.
Causality
Assessment
Time
UN G DEATH
Source:
Country:
United States
State:
TEXAS
Zip:
76351
Episode Date:
09118/2000
Dose Description: 18 GM/TON; 9/ 1/00 TO 9/18/00
Extra Labei:
Unknown
Reason For Use:
Health Status:
Good
Administered By:
Owner
CVM _ Repmt.rep
Source Report Id:
PAYUS02016
NDC:
Product Lot No:
UNK
#Treated:
4
#Reacted: 4
#Died:
0
Species: PIG
Age: UN
Weight: UN
Gender: Unknown
Concomitants:
Unknown
Page: 34
CM: PIGS SEEMED MORE "CRANKY", HAD PAINFUL FEET AND STIFFNESS IN REAR LEGS AFTER 2-3 WEEKS ON
RACTOPAMINE. FlU: 10/3/02-PIGS WI STIFF LEGS PROGRESSED TO HAVING "WORN OUT" AND BLEEDING FEET.
TREATED PIGS(UNK RTX) AND HAS NOT HAD MORE PROBLEMS. CURRENTLY USES A LOWER DOSE AND ADDS
GLUCOSAMINE, BIOTIN, ZINC AND SELENIUM.
Causality
Assessment
2
Drug Name:
Time
To Onset
2 WK
3 WK
2 WK
2 WK
RACTOP AMINE
Clinical Detail:
G BEHAVIOR DISORDER
G BLD, FEET/DIGIT(S)
G PAIN, FEET/DIGIT(S)
G STIFFNESS, HIND LIMB(S
Source:
Country:
United States
State:
INDIANA
Zip:
47977
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/1 0/2000
Unknown
Oral (in dry feed)
8115/00 TO 10115/00
Unknown
Good
Owner
Unknown
Source Report ld:
NDC:
Product Lot No:
PAYUS02017
UNK
#Treated:
150
#Reacted: 150
#Died:
0
Species: PIG
Age: UN
Weight: 200 LB
Gender: Unknown
COMPLAINT OF !EFFECT BY OWNER. FED RATION THAT CONTAINED UNSTATED AMOUNT OF RACTOPAMINE IN
BONE MEAL. OWNER FELT PIGS DID NOT RESPOND WELL COMPARED TO ANOTHER GROUP THAT WERE NOT FED
RACTOPAMINE. NON-SUPPLEMENTED PIGS WERE LEANER AT SLAUGHTER. OWNER DID NOT FEEL EFFICIENCY
WAS BETTER IN SUPPLEMENTED GROUP AND THIS GROUP WAS MARKED DOWN A POINT AT SLAUGHTER. NO
FEED SAMPLES PROVIDED.
Causality
Assessment
CVM _ Repmi. rep
Time
0 NA
E INEFFECT
Page: 35
Source:
Country:
United States
State:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
XX XXX
09/15/2000
Unknown
Oral (in dry feed)
5/15/00 TO 8/ 15/00(12 WEEKS)
Species subgroup
Good
Owner
Unknown
Source Report Id:
PAYUS02018
NDC:
Product Lot No:
UNK
#Treated:
32
#Reacted: 14
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Female
12 GILTS WERE FED RACTOPAMINE X 12 WEEKS. TAKEN OFF FOR 1 MONTH BEFORE BREEDING. THEY CAME INTO
HEAT AND WERE ARTIFICIALLY INSEMINATED TWICE. SEVERAL ARE NOW COMING BACK INTO HEAT. ELU:
INDICATED FOR FINISHERS NOT BREEDERS. FlU: GILTS REPEATEDLY RETURNED TO ESTRUS. UNABLE TO GET
ANY OF THE BRED. PRODUCER NO LONGER USES RACTOPAMINE IN BREEDING STOCK. 20 SHOW PIGS
SUPPLEMENTED. 1 BECAME RELUCTANT TO WALK, ANOTHER BECAME STIFF W/ A HOBBLING GAIT IN BOTH HIND
LEGS.
Causality Time
2 UN G LOCOMOTION DISORDER
2 UN G RELUCTANT TO MOVE
2 UN G STIFFNESS, HIND LIMB(S
4 MO X FERTILITY, LACK OF
4 MO X FERTILITY, REDUCED
CVM _ Rep01t.rep
N 140863 L 45 Package ID: A 8 Corrsp Date: 06/27/2002
Source:
Country:
State:
United States
CALIFORNIA
Zip:
95201
Episode Date:
10/30/2000
Dose Description: 4.5 TO 18 GM/TON X 5 WEEKS
Source Report ld:
PA YUS02019
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 36
12
4
0
Extra Label:
None Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Age: UN
Weight: UN
Gender: Unknown
CM: STIFFNESS AND LAMENESS WHEN TAKEN TO A SHOW. WORKED OUT OF THEIR STIFFNESS. OWNER
CONSIDERING USING AT LOWER RATE IN NEXT GROUP OF PIGS. FlU: 10/3/02-LOWERED RATE TO 9 GM/TON AND
HAD FEWER PROBLEMS.
Causality
Assessment
2
2
Time
To Onset
5 WK
5 WK
Clinical Detail:
G LAMENESS
Source:
Country:
State:
United States
INDIANA
Zip:
46120
Episode Date:
10/30/2000
CVM _Report. rep
Source Report ld:
PAYUS02020
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Extra Label: Species subgroup
Reason For Use:
ACCIDENTAL
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
Breed:
Age:
Weight:
Gender:
Page: 37
Unknown (pig)
Male
UN
UN
ELU: NOT INDICATED IN BREEDING ANIMALS. BOAR WAS UNINTENTIONALLY FED SAME RATION AS FINISHERS.
CM: "TIGHT MUSCLES AND GOOSE STEPPING". BOAR IS HEAVILY MUSCLED AND HAD JOINT PROBLEMS. FlU:
RECOVERED.
Causality
Assessment
Time
2 2 WK G LOCOMOTION DISORDER
2 2 WK G STIFFNESS
2 2 WK N HYPERTONIA
Source:
Country:
State:
United States
MINNESOTA
Zip:
56244
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/23/2000
Recommended dose
Oral (in dry feed)
9 GM/TON; FROM 10/20/00
Unknown
Good
Owner
Unknown
Package ID: A 1 0
Source Report Id:
NDC:
Product Lot No:
PAYUS02021
UNK
#Treated:
100
#Reacted: 50
#Died:
0
Species: PIG
Age: UN
Weight:
UN
UNK #EXPOSED/REACTED. CM: APPEARED "VERY HYPER". PLANS TO CHANGE TO LOWER CONCENTRATION. FlU:
REDUCED DOSE TO 4.5 GM/TON. PIGS ARE STILL MORE EXCITABLE THAN NORMAL BUT LESS THAN WI 9GMITON.
HAVE ALSO ALTERED HANDLING TECHNIQUES; HAVE SLOWED DOWN AND ARE MORE "MELLOW".
CVM _Report. rep
Page: 38
Causality
Assessment
3
Time
To Onset
3 DA
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
United States
State:
TEXAS
Zip:
75431
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01110/2001
Unknown
Oral (in dry feed)
UNK
Unknown
INCREASEADG; LEANNESS
Good
Owner
Unknown
Source Report ld:
PAYUS02022
NDC:
Product Lot No:
UN
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: UN
Weight: 230 LB
Gender: Unknown
UNREPORTED # OF SHOW PIGS FED UNREPORTED CONCENTRATION OF RACTOPAMINE. ONE PIG DEVELOPED A
"TYING UP" SYNDROME. RACTOPAMINE WAS REMOVED FROM THE FEED. THE PIG CONTINUED TO HAVE MUSCLE
TREMORS FOR APPROXIMATELY 3 DAYS. FlU: NO FURTHER INFO.
Causality
Assessment
2
2
Time
To Onset
UN
UN
Clinical Detail:
M MYOSITIS
N TREMBLING
Source:
Country:
United States
State:
TEXAS
POOR QUAL INFO
CVM _Report. rep
Zip:
76424
Source Report ld:
PAYUS02023
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01/25/2001
Unknown
Oral (in dry feed)
NOT REPORTED
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Good
Owner
Medium
No Value
Weight:
Gender:
Page: 39
240
6
6
PIG
Unknown (pig)
UN
UN
Unknown
SHOW PIGS. TYING UP SYNDROME, PORCINE STRESS SYNDROME. UNK #REACTED. VET DID NOT REPORT THAT
HE HAD CONFIRMED THAT THE PIGS WERE FED RACTOPAMINE OR AT WHAT DOSAGE, THEREFORE THERE IS NOT
ENOUGH INFORMATION TO ASSESS. F/U: 10/3/02-VET REPORTS THAT RACTOPAMINE IS BEING FED MORE
CAREFULLY AND FEWER PROBLEMS ARE SEEN. BELIEVES PRESCENCE OF PSS GENE A FACTOR. SUSPECTS DEATH
DUE TO OTHER COMPOUND.
Causality
Assessment
-8
-8
Time
To Onset
UN
UN
Clinical Detail:
G DEATH
M MYOSITIS
Source:
Country:
Report from sponsor or distibutor of dmg .
United States
State:
ILLINOIS
Zip:
LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
02/05/2001
Unknown
Oral (in dry feed)
NOT REPORTED
Unknown
62301
Package ID: A 13
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Unknown
CVM _ Repmt.rep
PAYUS02024
UNK
#Treated:
100
#Reacted: 20
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
Administered By:
Vet Opinion:
Concomitants:
Owner
No Value
Page: 40
UNK #TREATED/REACTED. FEED COMPANY REPORTED THAT SOME PIGS DIED WHILE ON FEED CONTAINING
RACTOPAMINE. FlU: 10/3/02-NO NEW INFO
Causality
Assessment
Time
UN G DEATH
Source:
Country:
United States
State:
MINNESOTA
Zip:
55962
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Evaluation
02/20/2001
Unknown
Unknown
NOT REPORTED
Unknown
Good
Owner
Unknown
Source Report Id:
PAYUS02026
NDC:
Product Lot No:
UNK
#Treated:
100
#Reacted: 10
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
UNK #TREATED/REACTED. CM: PIGS DEVELOPED A COUGH AND SIGNS OF RESPIRATORY DISEASE. OWNER
INQUIRED ABOUT W/DRAWL TIME. FlU: 10/3/02-NO NEW INFO
Causality
Assessment
-1
-1
Time
To Onset
UN
UN
Clinical Detail:
R COUGHING
R RESPIRATORY DISORDER
Source:
CVM _Report. rep
Country:
United States
State:
ILLINOIS
Zip:
62301
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
02/05/2001
Unknown
Oral (in dry feed)
UNREPORTED DOSE
Unknown
INCREASEADG, LEANNESS
Unknown
Owner
Unknown
Source Report Id:
PAYUS02025
NDC:
Product Lot No:
UN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 41
100
10
0
PIG
Unknown (pig)
UN
UN
Unknown
FEED MILL RECEIVED E-MAIL FROM A CLIENT WHO USED A FEED W/ RACTOPAMINE ADDED. CM: SOME PIGS
BECAME DOWNER PIGS WHILE EATING THE SUPPLEMENTED FEED. FlU: 10/3/02-NO NEW INFO.
Causality
Assessment
Time
UN G RECUMBENCY
Source:
Country:
State:
United States
ILLINOIS
Zip:
61491
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
06/15/2001
Unknown
Oral (in dry feed)
UNREPORTED
Unknown
Package ID: A 16
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, INCREASE LEANNESS
CVM _Report. rep
PAYUS02027
UNK
#Treated:
10
#Reacted: 10
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Health Status: Good
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Gender:
Page: 42
Unknown
CM: HYPERACTIVITY IN SHOW PIGS. HAS SEEN THIS BEHAVIOR IN THE PIGS' DAM WHO DID NOT RECEIVE
RACTOPAMINE. FlU: 10/3/02-NO NEW INFO.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
State:
United States
OKLAHOMA
Zip:
73628
Episode Date:
07/06/2001
Dose Description: 18OM/TON; 5 LB FEED /PIG
Extra Label: None
Package ID: A 1 7
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADO, CARCASS LEANNESS
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
PAYUS02028
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
2
PIG
Unknown (pig)
Unknown
UN
UN
SHOW PIGS. FEED WAS MIXED WI MILK REPLACER. ATTENDING VET CONSIDERED HEAT STRESS AS POSSIBLE
CAUSE OF DEATH. FlU: 10/3/02: BOTH PIGS WERE ON THE SAME FEED. THE DEATH WAS IN THE ONE MOST ACTIVE
AND MUSCULAR. OTHER PIG RECOVERED. VET SUSPECTED H ~ A T AS CAUSE OF DEATH.
Causality
Assessment
CYM _Repmt.rep
Time
UN G DEATH
Page: 43
Source:
Country:
United States
State:
WISCONSIN
Zip:
53925
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/16/2000
Unknown
Oral (in dry feed)
SUMMER2000
None
Good
Owner
Unknown
Source Report Id:
PAYUS02029
NDC:
Product Lot No:
UN
#Treated:
65
#Reacted: 6
#Died:
0
Species: PIG
Breed: Various (pig)
Age: 5 MO
Weight:
240 LB
DUROC AND YORKSHIRE SHOW PIGS. CM: STIFFNESS. FlU: 10/7/02- SHOULDER LAMENESS 6 DAYS TO 3 WEEKS
AFTER STARTING RACTOPAMINE IN AT LEAST 4 PIGS, 3 OF WHICH WERE LITTERMATES. PIGS SEEMED TO HAVE
MORE TROUBLE AFTER BEING STRESSED. 2 PIGS HAD FOOT PAD LESIONS. RTX: AMBESOL; 1 IMPROVED. OWNER
DID NOT ASSOCIATE LAMENESS WI FLOORING.
Causality
Assessment
0
2
Time
To Onset
UN
Clinical Detail:
G HOOF DISORDER
6 DA G LAMENESS
6 DA G STIFFNESS
Source:
Country:
State:
United States
INDIANA
Zip:
46962
MISSING INFO
Episode Date:
03/26/2000
CVM _ Repmt.rep
Source Report Id:
PAYUS02030
NDC:
Product Lot No:
UN
#Treated:
20
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
4.5 GM/TON; WINTER 2000
None
Good
Owner
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 44
10
0
PIG
Unknown (pig)
UN
UN
Unknown
UNK #TREATED/REACTED. OWNER FEELS THE EFFECTS OF RACTOPAMINE ARE "TAPERING OFF". SUSPECTS LOE.
WONDERED IF HOT WEATHER AND STORAGE CONDITIONS COULD AFFECT THE PRODUCT. FlU: 10/3/02-
PRODUCER IS CURRENTLY USING RACTOP AMINE. PIGS ARE "TOUCHIER" TO HANDLE.
Causality
Assessment
-1
Time
To Onset
NA
Clinical Detail:
E INEFFECT
UN N NERVOUSNESS
Source:
Country:
United States
State:
PENNSYLVANIA
Zip:
16314
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _ Report.rep
08/13/2001
Unknown
Oral (in dry feed)
UNK CONCENTRATION
Unknown
Good
Owner
Unknown
Package ID: A 20
Source Report ld:
NDC:
Product Lot No:
PAYUS02031
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
PIG
Unknown (pig)
Unknown
UN
UN
Page: 45
REPORTED BY . CUSTOMER'S PIG VOMITED AFTER EATING FEED W/ RACTOPAMINE. PIG WOULD EAT
SOME FEED THEN VOMIT, REPEATING THIS BEHAVIOR SEVERAL TIMES. FlU: 10/3/02- SHOW PIG HAD BEEN PUT ON
GREATLY REDUCED FEED (1 TO 2 LBS/WK) AND DECREASED WATER TO REDUCE WEIGHT PRIOR TO WEIGH IN AT
THE SHOW. ONCE WEIGHED IN THEY PROVIDED FOOD AND WATER EVERY HOUR UNTIL THE PIG STOPPED
EATING. REPRESENTATIVE BELIEVES RACTOPAMINE AGGRA YATES PRE- EXISTING SKELETAL PROBLEMS
(STRAIGHT LEGS AND JOINT SWELLING).
Causality
Assessment
Time
0 2 MN D VOMITING
Source:
Country:
United States
State:
COLORADO
Zip:
80734
INSUFFICIENT INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/04/2002
Unknown
Oral (in dry feed)
UNK
Unknown
INCREASE ADG; LEAN CARCASS
Good
Owner
Unknown
Source Report ld:
PAYUS02032
NDC:
Product Lot No:
UNK
#Treated:
200
#Reacted: 50
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Female
UNK #REACTED. GILTS AT DENVER LIVESTOCK SHOW WERE EXAMINED BY ULTRASOUND. UNIVERSITY
EXAMINERS WERE "ALARMED" BY THE GILTS' OVARIES. NO DESCRIPTION OF ABNORMALITY. NOT CONFIRMED
THAT THE GILTS HAD BEEN FED RACTOP AMINE. .
F /U: 9118/02 -ULTRASOUND PROBE WAS DESIGNED FOR BACK FAT EVALUATION. 2 OUT OF 10 RACTOP AMINE FED
GILTS WERE BRED ON 2 TO 3 CONSECUTIVE HEAT CYCLES AND DID NOT CONCEIVE. OTHERS PRODUCED
SMALLER THAN EXPECTED LITTERS.
Causality
Assessment
-8
CVM _Report. rep
Time
UN X FERTILITY, LACK OF
UN X FERTILITY, REDUCED
UN X PR-OVARY(S), LESION(S)
Page: 46
Source:
Country:
State:
Foreign
Zip:
Episode Date:
04/ 13/2002
PackageiD: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 10 PPM IN FEED X 28 DAYS; 3/ 12 TO 5/15/02
Extra Label:
None
Reason For Use:
INCREASE ADG, LEAN YIELD
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
PAYC002001
C058FC1
#Treated:
3200
#Reacted: 40
#Died:
40
Species: PIG
Breed: Other (pig)
Age: 160 DA
Weight:
115 KG
BREED: PIC. 60 % SENT TO PLANT 12-14 HRS AWAY, 40 % SENT TO A PLANT 2.5 HRS AWAY. CM: MORTALITY RATE
DOUBLED IN GROUP W/ LONGER SHIPPING TIME. PIGS SENT TO PLANT 2.5 HRS A WAY WERE OBSERVED TO BE
VERY EXCITED. UNK #REACTED. FlU: PRODUCER STOPPED PRODUCT THEN RESUMED USE. THEY DECREASED
THE# OF PIGS /TRUCK AND IMPROVED HANDLING TECHNIQUE. THEY THEN GRADUALLY INCREASED THE USE OF
PA YLEAN AND ARE SELECTING FOR GENETICS W/0 THE STRESS GENE.
Causality
Assessment
2
2
Time
To Onset
4 WK
4 WK
Clinical Detail:
G DEATH
N HYPERACTIVITY
Source:
Country:
State:
Foreign
Zip:
Episode Date:
05/0112002
CVM _Report. rep
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
PAYBL02001
UNK
#Treated:
#Reacted:
600
240
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
#Died:
4.5 GM/TON; X 28 DAYS
Species:
None Breed:
INCREASE ADG; LEAN YIELD
Age:
Weight:
Good
Gender:
Owner
Low
No Value
Page: 47
0
PIG
Unknown (pig)
180 DA
128 KG
Group (m & f)
BRAZIL. 2 GROUPS OF 300 PIGS WERE FED RACTOPAMINE. 1ST GROUP HAD A 60% LIVER CONDEMNATION WI
FIBROSIS AND WHITE POINTS ON THE SURF ACES OF THE LIVERS. THE SECOND GROUP HAD 20 % LIVER
CONDEMNATION. ON FlU IT WAS REPORTED THAT NO MORE LIVER LESIONS WERE REPORTED. FlU: 7/2/02:
VERMINOSIS DIAGNOSED.
Causality
Assessment
Time
-1 4 WK L PR-LIVER, LESION(S)
Source:
Country:
United States
State:
INDIANA
Zip:
47907
Episode Date:
06/27/2002
Dose Description: 9PPMX4 WKS
Extra Label:
None
Reason For Use:
INCREASE GAIN
Health Status:
Good
Administered By:
Owner
Vet Opinion: High
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS02033
UNK
#Treated:
36
#Reacted: 36
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight:
220 LB
Gender: Unknown
BREED: NEWSHAM. RESEARCH TRIAL. 36 FED RACTOP AMINE, 36 CONTROLS. BEHAVIOR AND PHYSIOLOGY OF
THE TWO GROUPS WAS COMPARED. PIGS FED RACTOPAMINE WERE INITIALLY MORE ACTIVE AND SPENT LESS
CVM _Report. rep
Page: 48
TIME LYING ON THEIR SIDES. BY THE END OF THE FIRST WEEK AND PERSISTING THROUGHOUT THE STUDY, PIGS
FED RACTOPAMINE TOOK LONGER TO BE REMOVED FROM THE PEN, LONGER TO HANDLE TO THE WEIGHING
SCALE AND NEEDED MORE INTERACTIONS FROM THE HANDLER TO ENTER THE SCALES. AT THE END OF THE 4TH
WEEK, RACTOPAMINE FED PIGS HAD HIGHER HEART RATES IN THE PRESCENCE OF AN UNFAMILIAR HUMAN AND
DURING TRANSPORT BUT NOT DURING LOADING AND UNLOADING. THEY ALSO HAD HIGHER CIRCULATING
EPINEPHRINE AND NOREPINEPHRINE CONCENTRATIONS THAN CONTROLS. THE CONCLUSION WAS THAT
RACTOP AMINE AFFECTS BEHAVIOR AND PHYSIOLOGY AND MAY MAKE THE PIGS MORE DIFFICULT TO HANDLE
AND MORE SUSCEPTIBLE TO HANDLING AND TRANSPORT STRESS.
FlU: NO FURTHER INFO. ABSTRACT PUBLISHED IN JOURNAL OF ANIMAL SCIENCE, SUPPLEMENT 2, 2002.
Causality
Assessment
3
Time
To Onset
4 WK
Clinical Detail:
c TACHYCARDIA
3 1 WK G BEHAVIOR DISORDER
3 1 WK N HYPERACTIVITY
3 1 WK N NERVOUSNESS
Source:
Country:
United States
State:
MINNESOTA
Zip:
XX :XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/15/2001
Recommended dose
Oral (in dry feed)
4.5 GM/TON X 2-3 WEEKS
None
INCREASE GAIN, LEAN CARCASS
Good
Owner
Not applicable
No Value
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
PAYUS02034
UNK
#Treated:
5000
#Reacted: 2000
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 245 LB
PIC GENETICS. UNK #REACTED. FED RACTOPAMINE TO THE "TAIL ENDERS" OF A GROUP OF FINISHERS. CM:
BECAME MORE DIFFICULT TO HANDLE, MORE EXCITED, SCARED AND STUBBORN. ALSO DIFFICULT TO LOAD
AND UNLOAD FROM THE TRUCK. FlU: 10/3/02- NO INFO
Causality
Assessment
CVM _Report. rep
Time
Page: 49
2 1 WK G BEHAVIOR DISORDER
2 1 WK N APPREHENSION
2 1 WK N NERVOUSNESS
Source:
Country:
State:
United States
IOWA
Zip:
52057
Episode Date:
06/21 /2002
Dose Description: 9 GM/TON 6111/02 TO PRESENT
Extra Label:
None
Package ID: A 3
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, IMPROVE FEED EFFICIENCY
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
PAYUS02035
UNK
#Treated:
12
#Reacted: 6
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
250 LB
DUROC X. SHOW BARROWS AND GILTS. 6 GILTS DEVELOPED HIVES. STAR TED ON BACK AND SPREAD TO BELLY
IN AT LEAST ONE GILT. RTX: CEFTIOFUR IN ONE W/0 RESPONSE. DDX: ERYSIPELAS, INSECT BITES. FlU: NO
FURTHER INFO.
Causality
Assessment
0
Time
To Onset
10 DA
Clinical Detail:
URTICARIA
Source:
Country:
State:
CVM _Report. rep
United States
MICHIGAN
Zip:
49403
Good
Source Report Id:
PAYUS02038
NDC:
Product Lot No:
UNK
Report Quality:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/25/2002
Not applicable
Oral (all other)
UNK AMT EATEN BY PUPPY
Species
ACCIDENTAL
Good
Not applicable
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 50
0
DOG
10 MO
25 LB
Female, neutered
CM: LETHARGIC, STIFF, ANOREXIC. DDX: FELL DOWN THE STAIRS ON 7/24/02. NO RTX; OUTCOME UNK. FlU:
RECOVERED W/0 RTX.
Causality
Assessment
Time
To Onset
12 HR
Clinical Detail:
G ANOREXIA
12 HR G DEPRESSION/LETHARGY
12 HR G STIFFNESS
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
CVM _Report. rep
Zip:
07/08/2002
Recommended dose
Oral (in dry feed)
4.5 GM/TON
None
52154
Good
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
PAYUS02036
UNK
#Treated:
1000
#Reacted: 39
#Died:
4
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 265 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Page: 51
BREED: AUSGENE. PRRS POSITIVE HERD. ELU: OVER 240 LB. APPROXIMATELY 1000 PIGS SHIPPED. 39 P I G S ( ~ 4 %)
WERE CLASSIFIED AS SUBJECT WHEN UNLOADED AT THE PLANT, 4 DIED SHORTLY AFTER ARRIVAL. PRODUCER
USUALLY HAS A 0.4 % SUBJECT RATE.
FlU: CHANGED HANDLING AND LOADING PROCEDURES. DEADS AND DOWNERS ARE AT PRE-RACTOPAMINE
LEVELS.
Causality
Assessment
Time
2 20 DA G DEATH
2 20 DA N HYPERTONIA
Source:
Country:
United States
State:
UNKNOWN
Zip:
XX :XXX
INFO LACKING
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/22/2002
Unknown
Oral (in dry feed)
UNK
Unknown
Unknown
Owner
Unknown
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
PAYUS02037
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
Unknown (pig)
Unknown
UN
UN
PIG DIED AT A SHOW. SUSPECTED THE PIG HAD BEEN GIVEN AN OVERDOSE OF RACTOP AMINE. OWNER INFO
NOT AVAILABLE.
Causality
Assessment
2
CVM _ Rep01t.rep
Time
To Onset
UN
Clinical Detail:
G DEATH
Page: 52
Source:
Country:
United States
State:
COLORADO
Zip:
80653
Episode Date:
07/28/2002
Dose Description: 18 GM/TON; 6/ 1102 TO 7/30/02
Extra Label: None
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: Yes
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
TYLOSIN PF, 100 GM/TON IN FEED. 6/1102 UNTIL PRESENT
PAYUS02039
UNK
#Treated:
2
#Reacted:
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
220 LB
Gender: Female
HAMPSHIRE X. SHOW GILT ON FULL FEED: 20% PROTEIN, 1.2% LYSINE. CM: LIMPING AND LIMB EDEMA.
ATTENDING SUSPECTED SPAINED LEG OR JOINT INFECTION-TREATED WI LINCOSIN INJECTION AND REDUCED
FEED. TYLOSIN LABELED AT 100 GM/TONFOR21 DAYS WHEN FED W/ RACTOPAMINE. FlU: 9/17/02- REMOVED
FEED 3-5 DAYS BEFORE SHOW, SHE CONTINUED TO LIMP. GILT WAS BUTCHERED. THE OTHE RPIG HAD NO
PROBLEM.
Causality
Assessment
-1
0
Time
To Onset
2 MO
2 MO
Clinical Detail:
G EDEMA, LIMB(S)
G LAMENESS
Source:
Country:
State:
United States
UNKNOWN
Zip:
XX XXX
LITTLE INFO PROVIDED
Episode Date:
04/05/2002
CVM _Report. rep
Source Report ld:
PAYUS02040
NDC:
Product Lot No:
UNK
#Treated:
10
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Oral (in dry feed)
UNK
Unknown
Unknown
Owner
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 53
10
10
PIG
Unknown (pig)
UN
UN
Unknown
UNK NUMBER OF ANIMALS INVOLVED. PIGS WERE TAKEN OFF RACTOPAMINE FOR A FEW DAYS THEN PUT BACK
ON AND ruST BEFORE SLAUGHTER THEY ALL DIED. DATES, LENGTH OF TREATMENT AND CONCENTRATION OF
RACTOPAMINE NOT PROVIDED.
Causality
Assessment
-7
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/1 1/2002
Recommended dose
Oral (in dry feed)
4.5 GM/TON X 2.5 WK, 6 GM/TON X 1 WK
None
Good
Owner
No Value
Source Report ld:
NDC:
Product Lot No:
9/3/02
UNK
#Treated:
384
#Reacted: 37
#Died:
6
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
240 LB
8/1 1/02-192 PIGS WERE SHIPPED 7 HRS TO SLAUGHTER. 25 PIGS WERE DOWN ON ARRIV AL-12 B/4 SCALES, 13 AFTER
CVM _Report. rep
Page: 54
SCALES. ONE PIG WAS DEAD. ON 8/13/02, 190 PIGS WERE SHIPPED, 6 WERE DOWN B/4 SCALES AND 5 WERE DEAD
ON ARRIVAL. TRAILER HAD SPECIAL COOLING FEATURES. NO PIGS DEAD PREVIOUSLY WHEN RACTOPAMINE
FED AT LOWER DOSE OF 4.5 GM/TON.
Causality
Assessment
2
2
Time
To Onset
4 WK
4 WK
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
PENNSYLVANIA
Zip:
17001
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
08/20/2002
Recommended dose
Oral (in dry feed)
4.5 GM/TON
None
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
9/3/02
UNK
#Treated:
25000
#Reacted: 875
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
VA
BREED: PIC. #REACTED APPROX 3-4 %. CM: PIGS ACTT EXCITABLE. BECAME LESS EXCITABLE OVER 2 WEEKS WI
PROPER HANDLING.
Causality
Assessment
Time
8 DA N HYPERACTIVITY
Source:
Country:
State:
CVM _Report. rep
United States
PENNSYLVANIA
Zip:
17003
Source Report ld:
9/3/02
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/20/2002
Recommended dose
Oral (in dry feed)
4.5 GM/TON
None
Good
Owner
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 55
6000
90
0
PIG
Other (pig)
UN
VA
Group (m & f)
BREED-PIC; 150-240 #. 1 TO 2% BECAME EXCITABLE 7 TO 10 DAYS AFTER STARTING THE RATION. PIGS WERE
MAINTAINED ON THE 4.5 GM/TON DOSE AND BECAME LESS EXCITABLE W/IN 1 TO 2 WEEKS. PIGS WENT TO
SLAUGHTER AS USUAL. NO DEATHS OR OTHER ADVERSE EFFECTS.
Causality
Assessment
Time
2 7 DA N HYPERACTIVITY
Source:
Country:
United States
State:
TEXAS
Zip:
77870
Episode Date:
0911112002
Dosage: Overdose
Dose Description: 1125 MG/ 2 PIGS; 9111102
Extra Label:
Overdose
Reason For Use:
ACCIDENTAL
Health Status:
Good
Administered By:
Not applicable
CVM _Rep01t.rep
Source Report Id:
PAYUS02045
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Breed: Hampshire (pig)
Age: 4 MO
Weight: 183 LB
Concomitants:
Unknown
Page: 56
SHOW PIG ATE 12.5 LB OF RACTOPAMINE SUPPLEMENT(90 MG/LB). CM: SLIGHTLY DEPRESSED. LAYED AROUND
BUT WAS JUMPY WHEN IT GOT UP TO GO TO THE FEEDER. SIGNS LASTED FOR 1-2 DAYS.
Causality
Assessment
-9
3
3
3
Time
To Onset
NA
2 HR
2 HR
2 HR
Clinical Detail:
N HYPERACTIVITY
N NERVOUSNESS
Source:
Country:
United States
State:
MISSOURI
Zip:
65211
Episode Date:
0911112002
Extra Label:
Species
Reason For Use:
RESEARCH TRIAL
Health Status:
Unknown
Administered By:
Veterinarian
Concomitants:
No Value
Source Report ld:
NDC:
Product Lot No:
PAYUS02046
UNK
#Treated:
4
#Reacted: 0
#Died:
0
Species: HORSE
Breed: Shetland
Age: UN
Weight:
UN
Gender: Unknown
WAS MADE A WARE OF A RESEARCH TRIAL AT UNIV OF MO INVOLVING THE USE OF RACTOPAMINE TO
OBESITY IN SHETLAND PONIES. NO ADE REPORTED.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
CVM _ Repmt.rep
Source:
Country:
United States
State:
NEBRASKA
Zip:
68352
Episode Date:
08/27/2002
Dose Description: 4.5 GM/TON X 3 WEEKS
Extra Label:
None
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Low
Yes
MONENSIN AT< 0.9 GM/TON
Source Report ld:
PAYUS02044
NDC:
Product Lot No:
829PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 57
65
25
18
PIG
Other (pig)
UN
UN
Group (m & f)
BREED: NATIONS. 17 FINISHING HOGS FOUND DEAD 8/27/02; 8 OTHER PIGS WERE DYSPNEIC, WEAK AND SLOW TO
MOVE. 1 WAS EUTHANIZED AND NECOPSIED, ONE OF THE PIGS FOUND DEAD WAS ALSO NECROPSIED: SMALL
AMOUNT OF BLEEDING-KIDNEY, HISTOPATH RESULTS DID NOT INDICATE CAUSE OF DEATH. NEW FEED
SHIPMENT 8/24/02. 4 SAMPLES TESTED FOR RACTOPAMINE: 2.6 TO 4.8 G/TON; AND MONENSIN: 0.9 GM/TON. DDX:
MONENSIN.
Causality
Assessment
0
Drug Name:
Time
To Onset
22 DA
22 DA
22 DA
22 DA
22 DA
22 DA
RACTOP AMINE
Clinical Detail:
G DEATH
G DEATH(EUTHANIZED)
G WEAKNESS
R DYSPNEA
u PR-KIDNEY(S), LESION(S
Source:
Country:
State:
CVM _Report. rep
United States
MINNESOTA
Zip:
56031
Source Report Id:
NDC:
Product Lot No:
PAYUS02055
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/15/2002
Not applicable
Multiple routes
SECONDARY EXPOSURE
Secondary exposure
SECONDARY EXPOSURE WHEN FEEDING PIGS
Unknown
Not applicable
Not applicable
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 58
0
HUMAN
Not specified
Male
31 YR
UN
CALLER WORKS ON PIG FARM. HAS USED RACTOP AMINE FOR 6 MONTHS. HAS BEGUN TO COUGH AND SPIT UP
MUCUS RECENTLY, HAS ATTRIBUTED THIS TO SEASONAL ALLERGIES. WAS ADVISED TO CONTACT MD AND TO
WEAR PROTECTIVE CLOTHING WHEN HANDLING RACTOPAMINE
Causality
Assessment
0
-9
-9
-9
-9
0
Drug Name:
Time
To Onset
6 MO
NA
NA
NA
NA
6 MO
RACTOP AMINE
Clinical Detail:
D DISCHARGE, MOUTH/LIP(S
G HUMAN EXPOSURE
G HUMAN EXPOSURE, TOPICA
R COUGHING
Source:
Country:
State:
United States
ILLINOIS
Zip:
61443
Episode Date:
09/11/2002
CVM _ Repmt.rep
Source Report ld:
NDC:
Product Lot No:
PAYUS02054
UN
#Treated:
#Reacted:
#Died:
770
10
10
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
9 GM/TON; 8/02
None
INCREASE ADG, CARCASS LEANNESS.
Good
Owner
No Value
Species:
Breed:
Age:
Weight:
Gender:
Page: 59
PIG
Other (pig)
5 MO
250 LB
Group (m & f)
9/11/02: 190 MARKET AGE HOGS WERE SHIPPED 5 HOURS TO PACKING PLANT. 5 WERE DOA. ON 9114/02, 280 HOGS
WERE SHIPPED 2 HOURS FROM THE FARM AND 5 WERE DOA. THERE WERE NO PROBLEMS LOADING HOGS AT THE
FARM. FARM HAS NOT HAD MANY SHIPPING RELATED DEATHS IN THE PAST. NOT ALL HOGS IN THE GROUP
WERE FED RACTOP AMINE. OWNER PLANS TO CONTINUE FEEDING RACTOP AMINE TO HOGS W/ DIFFERENT
GENETICS.
Causality
Assessment
2
Time
To Onset
1 MO
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
IOWA
Zip:
XX XXX
Episode Date:
08/29/2002
Dose Description: 4.5 GM/TON X 28 DAYS; 8/1-9/2/02
Extra Label:
None
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
PAYUS02049
UNK
#Treated:
1000
#Reacted: 11
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 5 MO
Weight:
265 LB
8/29/02: 180 HOGS SHIPPED TO PROCESSING PLANT; 5 ANIMALS WENT DOWN AFTER BEING UNLOADED FROM THE
TRUCK. 9/2/02: 180 HOGS SHIPPED; 6 WENT DOWN AFTER UNLOADING. OWNER HAD NO HOGS DOWN PRIOR TO
USING RACTOPAMINE.
CVM _Report. rep
Causality
Assessment
Time
To Onset
1 MO
1 MO
Clinical Detail:
G COLLAPSE
G WEAKNESS
Source:
Country:
State:
United States
MINNESOTA
Zip:
56065
Episode Date:
07115/2002
Dosage: Overdose
Source Report Id:
PAYUS02047
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 60
12
0
0
Extra Label:
Overdose Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
INCREASE ADG/ACCIDENTAL OD
Good
Owner
Not applicable
No Value
Age: UN
Weight:
UN
Gender: Unknown
NO SIGNS AT THIS TIMNE. OWNER CONCERNED THAT PIGS MIGHT HAVE DIFFICULTIES WHEN MOVED/ SHOWED
AT THE FAIR.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
-9 NA G TECH ERROR, MIXING
Source:
Country:
State:
United States
MINNESOTA
Zip:
56065
CVM _Report. rep
Package ID: A 5
Source Report Id:
NDC:
Product Lot No:
PAYUS02047
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/02/2002
Recommended dose
Oral (in dry feed)
9 GMITON X 2 TO 4 WKS
None
INCREASE ADG;CARCASS LEANNESS
Good
Owner
Missing infom1ation
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 61
1200
25
16
PIG
Other (pig)
31 WK
270 LB
Group (m & f)
BREED: NEWSHAM. MANY(UNK #)WERE HYPERACTIVE WHEN LOADED; 16 WERE DOA AND 9 WERE SLOW. FIRST
TIME THE OWNER HAD FED NEWSHAMS W/ RACTOPAMINE. PLANS TO CHANGE TO OTHER GENETIC LINE.
Causality
Assessment
Time
To Onset
2 WK
Clinical Detail:
G DEATH
2 WK G DEPRESSION/LETHARGY
2 WK N HYPERACTIVITY
Source:
Country:
State:
United States
MISSOURI
Zip:
XX XXX
Episode Date:
08/1 5/2002
Dose Description: 4.5 GM/TON; X 3 WEEKS
Reason For Use:
INCREASE ADG; LEANNESS
Health Status:
Good
CYM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS02050
UNK
#Treated:
3950
#Reacted: 1600
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: 6 MO
Weight: 270 LB
Gender: Female
Page: 62
Administered By:
Owner
Vet Opinion: Low
ELU: NOT FOR USE IN BREEDING SWINE. SOME GILTS WERE BRED 10-18 WEEKS AFTER THEY WERE OFF
RACTOPAMINE. ONLY 37% BECAME PREGNANT; 80% IS THE USUAL CONCEPTION RATE. FEED WAS NEGATIVE
FOR MYCOTOXINS.
Causality
Assessment
Time
0 14 WK X FERTILITY, LACK OF
Source:
Country:
United States
State:
TENNESSEE
Zip:
38231
Episode Date:
09/19/2002
Extra Label: None
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS02057
UNK
. #Treated:
180
#Reacted: 9
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 4 MO
Weight:
295 LB
PIC/DEKALB. 4 TO 5 HRS TRUCK RIDE TO PLSANT. 8-10 PIGS WERE UNWILLING TO MOVE TO THE KILL FLOOR.
FLOOR IS 3 STORIES ABOVE UNLOADING AREA. ANIMALS WERE PROCESSED AS USUAL.
Causality
Assessment
Time
2 3 WK G RELUCTANTTOMOVE
CVM _ Rep01t.rep
PAYUS02051
Country:
United States
State:
MISSING INFORMA' Zip:
INFORMATION LACKING
Episode Date:
08/01/2002
Dosage: Unknown
Dose Description: UN
Extra Label:
Unknown
xxxxx
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No Value
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
UNLOADED AT PACKER W/0 INCIDENT; UNK #DIED DURING THE SORTING PROCESS.
Causality
Assessment
2
Time
To Onset
UN
Clinical Detail:
G DEATH
Page: 63
170
10
0
PIG
Unknown (pig)
4 MO
285 LB
Unknown
Source:
Country:
United States
State:
MISSOURI
Zip:
XX XXX
INFO LACKING
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
CVM _Report. rep
08/20/2002
Reconm1ended dose
Oral (in dry feed)
4.5 OM/TON X 3 WKS
None
Fair
Source Report ld:
PAYUS02056
NDC:
Product Lot No:
UNK
#Treated:
13000
#Reacted: 100
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 220 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Medium
No Value
Gender:
UNK # OF DOWNER PIGS AT PRODUCER. UNK OUTCOME.
Causality
Assessment
2
Time
To Onset
7 DA
Clinical Detail:
G RECUMBENCY
Page: 64
Group (m & f)
Source:
Country:
United States
State:
TEXAS
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
0211 5/2002
Unknown
Oral (in dry feed)
UNK
None
79409
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No Value
Source Report Id:
PAYUS02053
NDC:
Product Lot No:
UNK
#Treated:
2437
#Reacted: 498
#Died:
78
Species: PIG
Age: 4 MO
Weight: 260 LB
SHOW PIGS SHIPPED FROM A FAIR TO A PROCESSING PLANT. 3.2% WERE DOA AND 17.23% (420) WERE DOWNERS.
UNK HOW MANY WERE TREATED WI RACTOP AMINE BUT VET REPORTED THAT MANY HAD BEEN FED TWICE THE
LABEL DOSE PRIOR TO THE SHOW. NOT ENOUGH INFO TO ASSESS. NOT SURE IF THOSE REACTING HAD RECEIVED
PAYLEAN.
Causality
Assessment
-8
CYM _Report. rep
Time
To Onset
UN
Clinical Detail:
G DEATH
Page: 65
-8 UN G RECUMBENCY
Source:
Country:
United States
State:
SOUTH DAKOTA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08115/2002
Recommended dose
Oral (in dry feed)
4.5 GM/TON X 20 DAYS
None
INCREASE ADG
Good
Owner
No Value
XX :XXX
Source Report Id:
PAYUS02052
NDC:
Product Lot No:
UNK
#Treated:
3300
#Reacted: 100
#Died:
19
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 230 LB
PIC GENETICS. PIGS WERE ON RACTOPAMINE FOR 10 DAYS, OFF FOR 4, THEN BACK ON FOR 10. FEED INTAKE
DECREASED WHEN RACTOPAMINE STOPPED. WHEN THEY RESTARTED RACTOPAMINE, SOME PIGS DIED(UNK#),
AND OTHERS HAD SIGNS OF GASTRIC ULCERS. CF: FEED FLOW ABILITY AND AVAILABILITY ISSUES(?).
Causality
Assessment
-7
Time
To Onset
18 DA
18 DA
Clinical Detail:
D ULCER(S), GI
G DEATH
Source:
Country:
United States
State:
TEXAS
MISSING INFO
CVM _Report. rep
Zip:
78155
Source Report Id:
PAYUS02060
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/1712001
Unknown
Oral (in dry feed)
UNK
Unknown
Unknown
Owner
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 66
0
PIG
Unknown (pig)
Unknown
UN
UN
FEED COMPANY CALLED WI INQUIRY ABOUT W IDRA W AL TIMES FOR FEEDING RACTOPAMINE AND TYLOSIN
PREMIXES. ASKED ABOUT PIGS DYING DURING TRANSPORT. FlU: 1014102- QUESTIONS MAY HAVE BEEN ASSOC
WI LIVESTOCK SHOW PIGS. NOT ENOUGH INFO TO ASSESS.
Causality
Assessment
Time
-8 UN G DEATH
Source:
Country:
United States
State:
MONTANA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
0411 512002
Recommended dose
Oral (in dry feed)
4.5 & 9 GMITON
None
59486
Reason For Use:
INC ADG, CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
Good
Owner
Unknown
Package ID: A 53 Corrsp Date: 1011 512002
Source Report ld:
PAYUS02061
NDC:
Product Lot No:
UNK
#Treated:
1000
#Reacted: 6
#Died:
6
Species: PIG
Breed: Other (pig)
Age: 5 MO
Weight:
240 LB
Page: 67
COTS WOLD IS GIVEN AS BREED( ? THIS IS A SHEEP BREED?). SUSPECTED LOE. WHEN HE INCREASED THERA TION
FROM 4 TO 9 GM/TON, THE CARCASS SCORE DECREASED SLIGHTLY (52.7 VS 53.2). FlU: 10/4/02- 6 PIGS DIED WHILE
LOADING. THEY HAD BEEN GETTING 9 GM/TON PRODUCER HAD D/C RACTOPAMINE. PLANS TO FEED AT 4.5
GM/TON.
Causality
Assessment
Time
0 UN E INEFFECT, LEAN CARCASS
UN G DEATH
Source:
Country:
State:
United States
MINNESOTA
Zip:
55924
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01 /22/2002
Recommended dose
Oral (in dry feed)
4.5 & 9 GM/TON
Unknown
Package ID: A 54
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED ADG, CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
PAYUS02062
UNK
#Treated:
20
#Reacted: 10
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
TAIL BITING IN A GROUP OF FINISHERS. FlU: RTX TREATED W IODINE AND SENT TO MARKET. FARM HAS PRRS.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G BITING/CHEWING
G TAIL DISORDER
Source:
Country:
CVM _Report. rep
United States
Source Report Id:
PAYUS02063
NDC:
State:
OHIO
NO INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/27/2002
Unknown
Unknown
NO INFO
Unknown
UNK
Unknown
Unknown
Unknown
Unknown
Zip:
45368
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 68
0
0
0
PIG
Unknown (pig)
UN
UN
Unknown
END USER CALLED FOR INFO RE: FEEDING RACTOPAMINE TO SHOW PIGS. CONCERNED ABOUT PIGS GETTING
"HYPER". NO SIGNS REPORTED.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
Source:
Country:
United States
State:
OKLAHOMA
Zip:
VET REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
03/05/2002
Unknown
Oral (in dry feed)
NO DESCRIPTION
Unknown
73942
Package ID: A 58
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
CVM _ Report.rep
PAYUS02066
UNK
#Treated:
2
#Reacted: 2
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
UN
Health Status: Good
Administered By:
Vet Opinion:
Concomitants:
Owner
Low
Unknown
Gender:
Page: 69
Group (m & f)
CM: "TYING UP" IN SHOW PIGS. ANECDOTAL INFO FROM OWNERS OF SHOW PIGS. VET EXAMINED ONE PIG; IT
HAD MUSCLE TREMORS AND DID NOT WANT TO MOVE. RTX: FLUNIXIN, STOPPED RACTOPAMINE. UNK
OUTCOME. SAW 2ND PIG THAT WAS LIMPING. RTX: FLUNIXIN, STOPPED RACTOPAMINE-IMPROVED. DDX:
TRAUMA. VET SUSPECTS PRODUCT WAS TOP DRESSED AND/OR OVERDOSED IN SOME ANIMALS BUT HAS NO
DIRECT INFORMATION.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G LAMENESS
G RECUMBENCY
0 UN N TREMBLING
Source:
Country:
State:
United States
OHIO
Zip:
45177
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
05110/2001
Not applicable
Multiple routes
DERMAL AND INHALATION
Secondary exposure
SECONDARY EXPOSURE
Unknown
Not applicable
Not applicable
Yes
IBUPROFEN UNK DATES
CVM _Rep ott. rep
Package ID: A 59
Source Report ld:
NDC:
Product Lot No:
PAYUS02067
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
50 YR
UN
Male
Page: 70
END USER CONTACTED RMPDC 5/31101. REPORTED HAVING RESPIRATORY PROBLEMS SINCE EXPOSURE. WAS
REFERRED TO MD. PROTECTIVE GEAR RECOMMENDED WHEN USING PRTODUCT. 6/6/01: USER AGAIN CONTACTED
RMPDC. REPORTED THAT 20 MIN AFTER EXPOSURE HE EXPERIENCED "HEART FLUTTERS" BUT THOUGHT THEY
MIGHT HAVE BEEN BACK SPASMS. ALSO HAD INTERMITTENT DIZZINESS X 3 WEEKS. HAD NOT SOUGHT
MEDICAL EVALUATION. WAS TAKING IBUPROFEN AND PAIN KILLERS FOR BACK PAIN. RMPDC ATTEMPTED FlU
ON 6/8/01, 6/9/01, AND 6111101 AND RECEIVED NO ANSWER.
Causality
Assessment
Time
To Onset
20 MN
Clinical Detail:
c TACHYCARDIA
-9 NA G HUMAN EXPOSURE
20 MN G SPASM
0 UN N DIZZINESS
Source:
Country:
United States
State:
OHIO
Zip:
XX XXX
Episode Date:
02/1112000
Route: Multiple routes
Dose Description: DERMAL, INHALATION
Extra Label:
Secondary exposure
Reason For Use:
SECONDARY
Health Status:
Good
Administered By:
Not applicable
Vet Opinion: Not applicable
CVM_Report.rep
PackageiD: A 60
Source Report ld:
NDC:
Product Lot No:
PAYUS02068
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
41 YR
UN
Male
Page: 71
A NURSE CALLED AAPCC(REPORTED THROUGH RMPDC) FOR INFO ABOUT EFFECTS OF RACTOPAMINE ON
HUMANS. PATIENT WAS EXPOSED TO AN UNK AMT OF RACTOPAMINE OVER A 2 MONTH PERIOD. CM:
PREMATURE HEART BEATS, TACHYCARDIA X 2 MONTHS. CALLER DECLINED TO GIVE MORE INFO.
Causality
Assessment
0
0
-9
Time
To Onset
UN
UN
NA
Clinical Detail:
c ECGABN
c TACHYCARDIA
G HUMAN EXPOSURE
Source:
Country:
United States
State:
ILLINOIS
Zip:
62301
Episode Date:
07/1 1/2001
Dosage: Unknown
Dose Description: NO INFO
Extra Label:
Unknown
Reason For Use:
UNK
Health Status:
Unknown
Administered By:
Owner
Package ID: A 62
Source Report ld:
NDC:
Product Lot No:
PAYUS02070
UNK
#Treated:
4
#Reacted: 4
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
REP HAS RECEIVED REPORTS OF SHOW PIGS' HOOVES SPLITTING OR COMING OFF. 9/309/02-F/U:
" = ' = ~ ~ ~ = ~
FEED CO REP REPORTS SHOW PEOPLE HAVE REALIZED CONSEQUENCES OF OVERFEEDING AND HAVE BECOME
MORE CAREFUL. THEY USE A MAXIMUM 9 G/TON CONCENTRATION. NO FURTHER HOOF PROBLEMS REPORTED.
Causality
Assessment
Time
UN G HOOF DISORDER
CVM_ Report. rep
Page: 72
Country:
United States NDC:
State:
OKLAHOMA
Zip:
73738
Product Lot No:
Episode Date:
01103/2001
Dosage: Unknown
Extra Label:
Unknown
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
High
Unknown
PAYUS02074
UNK
#Treated:
300
#Reacted: 60
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight: 240 LB
VET HAS SEEN LAMENESS IN SHOW PIGS. HE FEELS RACTOPAMINE MAY POTENTIATE PROBLEMS IN HEAVILY
MUSCLED PIGS THAT MAY BE TOO STRAIGHT. HE HAS SEEN PIGS BECOME LAME AFTER BEING FED UNK LEVELS
OF RACTOPAMINE FOR UNK DURATION. FEELS ABOUT 20% OF THE SHOW PIGS HE SEES EACH YEAR EXHIBIT
PROBLEMS W/ LAMENESS. HE HAS TAKEN MOST OF THESE PIGS OFF RACTOPAMINE. RTX: TYLOSIN,
LINCOMYCIN, FLORFENICOL, CEFTIOFUR SODIUM AND GLUCOSAMINE. VERY LITTLE IMPROVEMENT SEEN.
PRODUCERS HAVE LEARNED TO SELECT PIGS CAREFULLY AND SUPPLEMENT FOR A SHORTER DURATION.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G LAMENESS
Source:
Country:
State:
United States
TEXAS
Zip:
78653
Dosage: Unknown
CVM _Report. rep
Source Report Id:
PAYUS02076
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
UNK
Unknown
Unknown
Owner
Unknown
Species:
Breed:
Age:
Weight:
Gender:
Page: 73
PIG
Unknown (pig)
Unknown
UN
UN
A SHOW PIG FED RACTOPAMINE X 2 WEEKS DEVELOPED A HERNIA. FlU: 1017/02-PIG HAD GONE TO MARKET, HAD
NOT HAD A PROBLEM WI OTHER PIGS.
Causality
Assessment
Time
0 2 WK G RUPTURE
Source:
Country:
State:
United States
IOWA
Zip:
52776
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/26/2001
Recommended dose
Oral (in dry feed)
4.5 TO 18 G/TON
Species subgroup
INCR ADG, CARCASS LEANNESS.
Good
Owner
High
No Value
Source Report Id:
PAYUS02077
NDC:
Product Lot No:
UNK
#Treated:
350
#Reacted: 4
#Died:
0
Species: PIG
Age: UN
Weight:
UN
VET REPORTED THAT A CLIENT PUCHASED A BOAR WHICH HAD BEEN FED RACTOPAMINE. BOAR IS NOW LAME
AND HAS SWOLLEN HOCKS. RTX: LINCOMYCIN INJ, FLUNIXIN; SAW SOME IMPROVEMENT IN MOBILITY,
SWELLING UNCHANGED. THE BOAR WAS EVENTUALLY MARKETED. VET HAS 1% INCIDENCE OF
LAMENESS OTHER ANIMALS GET STIFF AT 18 G/TON DOSE FOR 4 WEEKS; AND HAS SEEN SOME PROBLEMS AT THE
9 GM/TON LEVEL. ALSO SEES HYPER EXCITABILITY AND AGGRESION IN IN EPISODE 2.
CVM _Report. rep
Causality
Assessment
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Time
To Onset
4 WK
4 WK
4 WK
10/10/2002
Clinical Detail:
G LAMENESS
G STIFFNESS
Recommended dose
Oral (in dry feed)
4.5 G/TON
Unknown
Good
Owner
High
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 74
350
262
0
PIG
Mixed (pig)
UN
UN
Group (m & f)
VET REPORT. CM: 75 % OF RACTOPAMINE FED SHOW ANIMALS ARE MORE EXCITABLE, HYPERACTIVE AND
AGGRESSIVE WHEN SNARED FOR BLOOD TESTING. 1 %LAMENESS INCIDENCE REPORTED IN EPISODE 1.
Causality
Assessment
Time
To Onset
Clinical Detail:
UN N AGGRESSION
UN N HYPERACTIVITY
Source:
Country:
State:
United States
TEXAS
Zip:
77905
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
CVM _ Repmt.rep
01/31/2001
Recommended dose
Oral (in dry feed)
9 GM/TON
Unknown
Package ID: A 71
Source Report ld:
NDC:
Product Lot No:
PAYUS02079
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Breed: Mixed (pig)
80
2
0
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Age:
Weight:
Gender:
Page: 75
UN
UN
Group (m & f)
SHOW PIGS. PRODUCER/4-H LEADER QUESTIONED IF RACTOPAMINE AFFECTS THE COLOR OF THE MEAT. F/U:
10/11/02: 5% INCIDENCE OF LAMENESS/STIFFNESS, MOBILITY PROBLEMS. SUSPECT ASSOCIATION WI STRAIGHT
LEGS AND/OR INADEQUATE SKELETAL STRUCTURE; OTHERS HAD JOINT SWELLING SUSPICIOUS OF
MYCOPLASMA INFECTION PRIOR TO RACTOPAMINE FEEDING. THOSE WERE TREATED WI LINCOMYCIN-
IMPROVED AFTER A FEW WEEKS. PRODUCER NOW RECOMMENDS FEEDING A STEP UP PROGRAM STARTING AT
4.5 GM/TON X 10 DAYS, THEN UP TO 9 GM/TON FOR MAINTENANCE AND FOR THE FEW THAT HAVE THE
STRUCTURE, INCREASING TO 18 GM/TON FOR THE LAST 2 WEEKS.
Causality
Assessment
Time
To Onset
UN
Clinical Detail:
G LAMENESS
UN G RELUCTANT TO MOVE
UN G STIFFNESS
0 UN M SWELLING, JOINT(S)
Source:
Country:
State:
United States
COLORADO
Zip:
80215
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01/18/2001
Unknown
Oral (in dry feed)
UNK
Species subgroup
PackageiD: A 74
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, INCREASE CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _ Report.rep
Unknown
Owner
High
Unknown
PAYUS02082
UNK
#Treated:
11
#Reacted: 11
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Page: 76
LIVESTOCK SHOW VET SUSPECTED SHOW PIGS WERE OVERDOSED. 5 PIGS LAST YEAR AND 5 OR 7 THIS YEAR. CM:
TREMBLING, UNABLE TO RISE, DIFFICULTY WALKING. URINE TESTING REVEALED RACTOP AMINE AT
TOLERANCE LEVEL 5-6 DAYS AFTER PRODUCT LAST FED. MANY WERE 260-270 LBS(OVER WEIGHT) .
Causality
Assessment
Drug Name:
Time
To Onset
UN
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G DIFFICULTY RISING
G RECUMBENCY
G RELUCTANT TO MOVE
N TREMBLING
Document ID: N 140863 Submission ID: L 60 Package ID: A 7 5
Source:
Country:
United States
State:
MINNESOTA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01/31/2001
Recommended dose
Oral (in dry feed)
9 GM/TON
Unknown
56385
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
Source Report Id:
NDC:
Product Lot No:
PAYUS02083
UNK
#Treated:
1000
#Reacted: 15
#Died:
15
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
UN
PIETRAN BOAR; SOWS NEGATIVE FOR PSS. CM: INCREASED IN SUDDEN DEATH LOSSES AFTER 3 WEEKS ON
RACTOPAMINE. CMP: MYCOPLASMA PROBLEM. NOT CURRENTLY FEEDING RACTOPAMINE.
Causality
Assessment
Time
To Onset
3 WK
CYM_Report.rep
Clinical Detail:
G DEATH
Document ID: N 140863 Submission ID: L 60 Package ID: A 76 Corrsp Date: 10/ 15/2002
Source:
Country:
State:
United States
ILLINOIS
Zip:
60541
Episode Date:
02114/2001
Dose Description: 14 GM/TOM
Source Report ld:
PAYUS02084
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 77
40
2
0
Extra Label:
Various Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
UNK
Unknown
Owner
Unknown
Age: UN
Weight:
UN
Gender: Female
GILT WAS PURCHASED FROM SHOW. SUSPECT SHE WAS FED RACTOPAMINE, NOT CONFIRMED. DID NOT RECEIVE
RACTOPAMINE FOR AT LEAST 45 DAYS PRIOR TO BREEDING. CM: SEEMED TO ABSORB THE PIGS JUST BEFORE
FARROWING. ELU: NOT FOR USE IN BREEDING ANIMALS. FlU: 10/10/02: PRODUCER HAS FED RACTOPAMINE TO
APPROX 40 PIGS OVER 2 YEARS. 2 BECAME LAME AT 14 GM/TON DOSE. CALLER WAS CONCERNED ABOUT
DEATHS AT STATE FAIR. NO INFO PROVIDED. UNK IF DEATHS WERE IN HIS ANIMALS. PRODUCER CURRENTLY
FEEDS RACTOPAMINE TO BARROWS ONLY.
Causality
Assessment
-8
Time
UN G LAMENESS
UN X ABORTION
Source:
Country:
State:
United States
INDIANA
Zip:
46188
Episode Date:
01 /26/2001
Dosage: Unknown
CVM _Report. rep
Package ID: A 77
Source Report ld:
NDC:
Product Lot No:
PAYUS02085
UNK
#Treated:
#Reacted:
4
4
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
UNK
Species subgroup
Unknown
Owner
Unknown
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 78
0
PIG
Unknown (pig)
UN
UN
Female
4 GILTS WERE ON RACTOPAMINE FOR UNK DURATION AND DOSE. NOT FED RACTOP AMINE FOR UNK PERIOD
PRIOR TO BREEDING. THEY HAD AN AVG OF 3-4 PIGS/LITTER AND ALL DIED. FlU: 10/10/02: PRODUCER COULD NOT
RECALL DETAILS OF THE SITUATION. HE COULD NOT GET THE GILT TO BREED ALTHOUGH THEY CAME IN HEAT
REGULARLY.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
X DEATH(NEWBORN)
X FERTILITY, REDUCED
Source:
Country:
United States
State:
MISSOURI
Zip:
63166
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CYM _Rep01t.rep
03/22/2001
Unknown
Oral (in dry feed)
UNK
Unknown
Unknown
Owner
Unknown
Source Report ld:
NDC:
Product Lot No:
PAYUS02086
UNK
#Treated:
10
#Reacted: 10
#Died:
10
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
Page: 79
VET CALLED W/ QUESTIONS RE: LABELLING. HAD HEARD OF DEATHS ASSOC WI A PRE-MIX
G/TON RACTOPAMINE. VET CONCERNED THAT HIGHER THAN LABEL DOSES MAY HAVE BEEN
FED. HAD NO INFO ON DEATHS. FlU 10/8/02: NO MORE INFO.
Causality
Assessment
Time
-8 UN G DEATH
Source:
Country:
United States
State:
INDIANA
Zip:
47591
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/1 3/2001
Unknown
Oral (in dry feed)
UNK
Unknown
INADVERTANT EXPOSURE
Good
Owner
Unknown
Source Report Id:
PAYUS02087
NDC:
Product Lot No:
UNK
#Treated:
4
#Reacted: 4
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
EXACT# UNK; "SEVERAL" REPORTED. SEVERAL 90 #PIGS PURCHASED TO SHOW AT THE FAIR. THEIR FEED
CONTAINED RACTOPAMINE AT AN UNK CONCENTRATION; THE OWNER DID NOT REALIZE THIS. THE PIGS GREW
TOO LARGE AND THE FEED WAS CHANGED TO ONE WI LOWER CARBOHYDRATES AND FAT. THE PIGS SEEMED
HUNGRY ALL THE TIME; THEY "DRIFTED BACK" (I ASSUME THIS MEANS LOST WEIGHT/CONDITION) FOR ONE
MONTH. THEY DID "TERRIBLE" AT THE FAIR.
Causality
Assessment
Time
-2 UN G LOSS OF CONDITION
-2 UN G POLYPHAGIA
Source:
Country:
CYM _ Rep01t.rep
United States
Package ID: A 80
Source Report ld:
NDC:
PAYUS02088
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
08/0112001
Not applicable
Oral (in dry feed)
4.5 TO 9 GM/TON
Species subgroup
50851
Fair
Owner
Yes
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
ELECTROLYTES
Page: 80
10
10
0
PIG
Unknown (pig)
UN
60 LB
Unknown
UNK #ANIMALS TREATED/REACTED. A PEN OF 60 #PIGS HAD DEVELOPED LOOSE STOOLS. ELU: UNDERWEIGHT.
FlU: 10/11/02: SWITCHED TO FEED CONTAINING CARBADOX; PIGS WERE MARKETED SUCCESSFULLY.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
D DIARRHEA
Source:
Country:
State:
United States
NEBRASKA
Zip:
69034
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
CVM _Report. rep
07119/2001
Recommended dose
Oral (in dry feed)
12 GM/TON
Unknown
Source Report ld:
PAYUS02090
NDC:
Product Lot No:
UNK
#Treated:
50
#Reacted: 20
#Died:
0
Species: PIG
Age: UN
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
Weight:
Gender:
Page: 81
UN
Unknown
NUMBER TREATED/REACTED NOT REPORTED. HAS HAD SOME LAME AND DOWNERS IN HIS GROUP. FlU: 10/10/02:
CURRENTLY FEEDING 9 GM/TON W/0 PROBLEMS. PRODUCER FEELS PEOPLE WERE FEEDING RACTOPAMINE TOO
EARLY AND TOO LONG.
Causality
Assessment
Time
UN G LAMENESS
UN G RECUMBENCY
UN G RELUCTANT TO MOVE
Source:
Country:
United States
State:
IOWA
LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
51334
08/08/2001
Recommended dose
Oral (in dry feed)
9 GM/TON X 30 DAYS
Unknown
Unknown
Owner
Unknown
Source Report ld:
NDC:
Product Lot No:
PAYUS02091
UNK
#Treated:
10
#Reacted: 10
#Died:
0
Species: PIG
Age: UN
Weight: UN
UNK #TREATED OR REACTED. DID WELL IN SHOWS BUT WERE REJECTED FOR SLAUGHTER JUDGING. OWNER
WONDERED IF RACTOPAMINE CAUSED THE MEAT TO BE PSE.
CVM_Repott.rep
Causality
Assessment
-7
Time
To Onset
30 DA
Clinical Detail:
G MEATABN
Source:
Country:
State:
United States
MISSISSIPPI
Zip:
39422
Episode Date:
Dosage:
Route:
Dose Description:
01/05/2001
Recommended dose
Oral (in dry feed)
18 GM/TON
Source Report ld:
PAYUS02093
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 82
2
2
0
Extra Label:
Unknown Breed: Mixed (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
Age:
Weight:
Gender: Unknown
UNK # TREATED. TWO PIGS HAD JOINT PROBLEMS. RTX: BO-SE. ATTEMPTS AT FlU UNSUCCESSFUL.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
M JOINT DISORDER
Source:
Country:
State:
United States
IOWA
Zip:
52247
LITTLE INFO
Episode Date:
01/29/2001
Dosage: Unknown
CVM _ Repmt. rep
PackageiD: A 84 Corrsp Date: 10/1 5/2002
Source Report ld:
PAYUS02094
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
UN
UN
10
10
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
UNK
Unknown
UNK
Unknown
Owner
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Unknown
Page: 83
0
PIG
Unknown (pig)
UN
UN
Unknown
UNK #TREATED/REACTED. PIGS BREAKING WITH BLOODY DIARREA. VET WANTS TO KNOW IF BMD(BACITRACIN
METHYL DISALICYLATE) CAN BE USED W/ RACTOPAMINE. 1017/02: FlU: VET DID NOT REMEMBER INCIDENT.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
D DIARRHEA, BLOODY
Source:
Country:
United States
State:
OHIO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
43164
06/0112001
Recommended dose
Oral (in dry feed)
9 GM/TON X 3 WEEKS
None
Good
Owner
Unknown
Source Report Id:
NDC:
Product Lot No:
PAYUS02098
UNK
#Treated:
10
#Reacted:
#Died:
0
Species: PIG
Age: UN
Weight: 180 LB
Gender: Unknown
UNK #TREATED. IN 2001, ONE PIG OUT OF A SMALL GROUP FED RACTOPAMINE HAD TENDER FEET DURING THE
LAST WEEK OF TREATMENT. THIS GROUP WAS FINE BONED. THIS YEAR(2002) HE RAISED 2 PENS FOR SHOW; ONE
GROUP FED RACTOPAMINE@ 9 GM/TON X 4 WEEKS, THE OTHER X 6 WEEKS. NO PROBLEMS W/ EITHER GROUP.
ONE PIG LOST SOME MUSCLE MASS, ALL DID WELL AT THE SHOW.
CVM_Repmt.rep
Causality
Assessment
-1
Time
To Onset
2 WK
2 WK
UN
Clinical Detail:
G LAMENESS
M ATROPHY, MUSCLE(S)
Page: 84
Source:
Country:
United States
State:
NEBRASKA
Zip:
68583
Episode Date:
04/20/2001
Dosage: Unknown
Extra Label:
Unknown
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Source Report Id:
PAYUS02099
NDC:
Product Lot No:
UNK
#Treated:
880
#Reacted: 7
#Died:
7
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
UN
EXTENSION VET REQUESTED INFORMATION ON HANDLING RACTOPAMINE FED PIGS. SAW 7 DEATHS OUT OF 880
PIGS EXHIBITED AT 2 SHOWS. DOES NOT KNOW FOR CERTAIN, BUT SUSPECTS THAT MOST WERE ON
RACTOP AMINE. VET SEES EXTREME MUSCLING IN 90% OF PIGS SHOWN NOW COMPARED TO 60 % OF PIGS
SHOWN PRIOR TO RACTOP AMINE APPROVAL. SLOW MOVEMENT AND HANDLING ISSUES IN 60% COMPARED TO
20-25% PRE-APPROVAL. INCREASE IN PIGS THAT TURN RED WHEN STRESSED FROM 15-20 % PRE-RACTOPAMINE
TO 25-30 % NOW. VET FEELS THAT SOME SHOW PIGS ARE BEING FED RACTOP AMINE AT 3-4 X THE
RECOMMENDED DOSE OR FOR THE ENTIRE GROW OUT PERIOD AND/OR IN PIGS AT 30-40LBS. CAUSALITY
SCORING REFLECTS THE FACT THAT RACTOP AMINE FEEDING WAS SUSPECTED BUT NOT CONFIRMED IN THESE
PIGS.
Causality Time
-8 NA G BEHAVIOR DISORDER
-8 NA G DEATH
-8 NA G RELUCTANT TO MOVE
CVM _ Repmt.rep
Page: 85
-8 NA I CONGESTION, SKIN
-8 NA N HYPERACTIVITY
-8 NA N NERVOUSNESS
Source:
Country:
State:
United States
ARIZONA
Zip:
85730
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
09/21 /2000
Recommended dose
Oral (in dry feed)
4.5 TO 18 GM/TON
Species subgroup
Package ID: A 92
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
PAYUS02104
UNK
#Treated:
8
#Reacted:
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
247 LB
Gender: Unknown
ELU: OVER 240 LB. FED RACTOPAMINE 2 TO 3 WEEKS BEFORE THE SHOW. ONE ANIMAL WAS STIFF ON THEDA Y
OF THE SHOW. DDX: CONCRETE FLOORING AT SHOW(DIRT AND STRAW AT HOME).
Causality
Assessment
Time
To Onset
3 WK
Clinical Detail:
G STIFFNESS
Source:
Country:
State:
United States
NEBRASKA
Zip:
68748
CYM_Repmt.rep
Source Report ld:
PAYUS02106
NDC:
Product Lot No:
UNK
INFO LACKING
Episode Date:
10116/2000
Dosage: Unknown
Route: Unknown
Extra Label:
Unknown
Reason For Use:
UNK
Health Status:
Unknown
Administered By:
Owner
Vet Opinion: Medium
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 86
0
PIG
Unknown (pig)
UN
UN
Unknown
USDA MEAT INSPECTION VET CALLED WITH QUESTIONS ABOUT PIGS THAT WERE VERY WEAK AND UN-WILLING
TO MOVE. FlU CALL ON 1017/02: VET NO LONGER THERE. NO PROBLEMS TO REPORT.
Causality
Assessment
Time
-8 UN G RELUCTANT TO MOVE
-8 UN G WEAKNESS
Source:
Country:
United States
State:
TEXAS
Zip:
78387
Episode Date:
10/26/2000
Dosage: Unknown
Route: Unknown
Extra Label:
Species subgroup
Reason For Use:
UNK
Health Status:
Unknown
Administered By:
Owner
CYM _Report.rep
Package ID: A 95
Source Report ld:
NDC:
Product Lot No:
PAYUS02107
UNK
#Treated:
2
#Reacted: 2
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Female
Concomitants:
Unknown
Page: 87
AG TEACHER HAD QUESTIONS RE: RACTOPAMINE USE IN BREEDING ANIMALS. UNK # TREATED/REACTED. SHE
HAS SEEN SOME LAMENESS PROBLEMS. NO DETAILS.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G LAMENESS
Source:
Country:
State:
United States
MICHIGAN
Zip:
49423
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11/27/2000
Recommended dose
Oral (in dry feed)
4.5 GM/TON
Species subgroup
Package ID: A 97
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Not applicable
Unknown
PAYUS02110
UNK
#Treated:
100
#Reacted: 0
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Female
PRODUCER FEEDS RACTOP AMINE TO GILTS INTENDED FOR BREEDING. HAS NOT HAD TROUBLE BREEDING THEM.
CALLED WITH QUESTIONS REGARDING DOWNERS AT THE SLAUGHTER PLANT.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
Source:
Country:
United States
State:
TEXAS
CVM _Report. rep
Zip:
75407
Source Report Id:
PA YUS02111
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/08/2000
Unknown
Oral (in dry feed)
UNK
Unknown
UNK
Unknown
Owner
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Unknown
Page: 88
10
5
0
PIG
Unknown (pig)
UN
VA
Group (m & f)
CALLER HAD BOUGHT UNK #OF 100 LB GILTS AT SHOW. THINKS THEY MAY HAVE BEEN FED RACTOPAMINE.
WANTS TO KNOW IF THERE IS A URINE TEST. CM: THE GILTS HAVE TAPERED OFF FROM THEW A Y THEY LOOKED
AT THE SHOW. FlU CALL: 10111/02: GILTS HAD RECOVERED THEIR WEIGHT AND WERE MARKETED. THIS YEAR,
THE PRODUCER HAD FED 3 PIGS AT 9-18 GM/TON IN PREPARATION FOR A SHOW. ONE DEVELOPED HOOF CRACKS
THE LAST WEEK OF FEEDING. IT WAS LIGHTER BONED AND DIDN'T PUT ON AS MUCH MUSCLE.
Causality
Assessment
Time
UN G HOOF DISORDER
-8 UN G LOSS OF CONDITION
-8 UN G WEIGHTLOSS
Source:
Country:
United States
State:
INDIANA
Zip:
MISSING INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
1211 1/2000
Recommended dose
Oral (in dry feed)
4.5 GM/TON
None
46932
Package ID: A 99
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, CARCASS LEANNESS, FEED
EFFICIENCY
CVM _Report. rep
PAYUS02112
UNK
#Treated:
200
#Reacted: 10
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight: 240 LB
Health Status: Good
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Gender:
Page: 89
Group (m & f)
UNK #REACTED. DOWNER RATE DOUBLED WHEN SENDING RACTOP AMINE FED PIGS TO MARKET. HAS STRESS
GENE IN HIS HERD. REPORTS THAT SLAUGHTER PLANT DID NOT WANT TO USE RACTOPAMINE. FlU CALL TO
PLANT 10/02: PLANTS DEAD AND DOWNER RATE IS APPRO X 0.5%; LOWER THAN PREVIOUSLY.
Causality
Assessment
Time
UN G RECUMBENCY
Source:
Country:
United States
State:
OKLAHOMA
Zip:
MISSING INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11126/2000
Unknown
Oral (in dry feed)
UNK
Unknown
74462
Package ID: A 100
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
PAYUS02113
UNK
#Treated:
14
#Reacted: 14
#Died:
14
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
CALLER REPORTS INCREASED DEATHS AT FAIR THIS YEAR COMPARED TO PREVIOUS YEAR. 14 DEAD IN 2000; 2
TO 3 IN 1999. WONDERS IF DEATHS DUE TO RACTOPAMINE USE. UNK NUMBER TREATED. NOT ENOUGH INFO TO
ASSESS.
Causality
Assessment
-8
CVM _Repmi.rep
Time
To Onset
UN
Clinical Detail:
G DEATH
Page: 90
Source:
Country:
State:
United States
ILLINOIS
Zip:
61570
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
03/01/2002
Recommended dose
Oral (in dry feed)
9 GM/TON
Unknown
Package ID: A 101
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Yes
FLUNIXIN MEGLUMINE, 5ML
PAYUS02114
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: UN
Weight:
UN
BARROW TESTED POSITIVE FOR FLUNIXIN MEGLUMINE AT 76 HRS POST ADMIN. WITHDRAW TIME USUALLY 72
HRS. FLUNIXIN IS NOT APPROVED FOR SWINE. OWNER SUSPECTED THAT RACTOPAMINE DELAYED METABOLISM
OF DRUG.
Causality
Assessment
Time
-8 NA G INTERACTION, DRUG(S)
Source:
Country:
State:
United States
INDIANA
Zip:
XX XXX
Episode Date:
08/03/2002
CVM _Report. rep
Package ID: A 103
Source Report ld:
NDC:
Product Lot No:
PAYUS02116
UNK
#Treated:
#Reacted:
#Died:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
LABEL
None
Unknown
Owner
Unknown
Species:
Breed:
Age:
Weight:
Gender:
Page: 91
PIG
Unknown (pig)
Unknown
UN
UN
WAS MADE AWARE OF A RUMOR THAT 15 RACTOPAMINE SUPPLEMENTED PIGS HAD DIED WHILE
AT A STATE FAIR THE LIVESTOCK EXTENSION SPECIALIST AND THE FAIR BARN MANAGER WERE
CONTACTED FOR INFORMATION. THEY HAD HEARD THAT 15 HAD DIED, DID NOT KNOW IF THEY HAD BEEN FED
RACTOP AMINE. FELT THAT HEAT, STRESS, WATER DEPRIVATION, THE STRESS GENE AND OTHER FACTORS AS
WELL AS RACTOP AMINE WERE INVOLVED. THEY WERE AWARE OF 1 DEATH IN A PIG KNOWN TO HAVE BEEN FED
RACTOPAMINE PER LABEL. THIS INCIDENT IS REPORTED IN 2 EPISODES.
Causality
Assessment
0
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Time
To Onset
UN
08/03/2002
Unknown
Clinical Detail:
G DEATH
Oral (in dry feed)
UNK
Unknown
Unknown
Owner
Unknown
#Treated:
14
#Reacted: 14
#Died:
14
Species: PIG
Age: UN
Weight:
UN
APPROXIMATELY 15 RACTOP AMINE SUPPLEMENTED PIGS WERE RUMORED TO HAVE DIED WHILE UNLOADING AT
THE STATE FAIR. THE SWINE BARN MANAGER AT THE FAIR INDICATED THAT HE HAD NO DOCUMENTATION
THAT THE WERE FED RACTOPAMINE. OTHER FACTORS SUCH AS HEAT, WATER DEPRIVATION, STRESS GENE
SUSPECTED. ONE GROUP HAD BEEN IN A TRAFFIC ACCIDENT PRIOR TO ARRIVAL, WERE VERY HOT UPON
RECEIPT AND DIED WHILE UNLOADING. ONE WAS SUPPOSEDLY FEEDING A HIGHER THAN LABEL DOSE.
REPORTED IN 2 EPISODES.
Causality
Assessment
-8
Time
To Onset
UN
CVM _ Repmt.rep
Clinical Detail:
G DEATH
Page: 92
Country:
United States
State:
IOWA
INFORMATION NOT SPECIFIC
Episode Date:
0912812002
Dosage: Unknown
Zip:
Route:
Dose Description:
Oral (in dry feed)
UNKX40DAYS
Extra Label:
Unknown
50543
Package ID: A 104
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE FEED EFFICIENCY, CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
High
Yes
TYLAN SOLUBLE, IN WATER
Corrsp Date:
1011512002
PAYUS02117
UNK
#Treated:
200
#Reacted: 100
#Died:
10
Species: PIG
Age: UN
Weight: UN
UNK # OF PIGS DEVELOPED ILEITIS AFTER TYLOSIN WAS STOPPED; 10 DIED. WAS NOT USING RACTOPAMINE WI
TYLOSIN AT THE TIME OF THE OUTBREAK. TREATED WI TYLOSIN TARTRATE IN THEW ATER. OWNER
BUTCHERED 2 PIGS; COMPLAINED THAT THE MEAT WAS TOUGH AND DRY.
Causality
Assessment
-1
0
Time
To Onset
UN
UN
Clinical Detail:
D ENTERITIS
G DEATH
0 NA G INTERACTION, DRUG(S)
-1 UN G MEATABN
Source:
Country:
State:
United States
NEBRASKA
Zip:
68873
Episode Date:
0611312001
CVM _Report. rep
Package ID: A 1 06
Source Report ld:
NDC:
Product Lot No:
Corrsp Date: 1011 512002
PAYUS02119
UNK
#Treated:
80
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Oral (in dry feed)
UNK
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Unknown
Gender:
Owner
Low
Unknown
PIG
Page: 93
4
4
Mixed (pig)
UN
UN
Unknown
DIARRHEA OF 2 WEEKS OR LONGER DURATION. FECAL EXAM WAS NEGATIVE. PIGS HAD PURPLE EARS.
NECROPSY REVEALED SALMONELLA CHOLERASUIS. TREATED WI CEFTIOFUR, MOST RECOVERED. NOT SURE IF
OWNER CONTINUED FEEDING RACTOPAMINE.
Causality
Assessment
-1
0
-1
Drug Name:
Time
To Onset
1 DA
2 WK
2 WK
2 WK
RACTOP AMINE
Clinical Detail:
D DIARRHEA
G CONGESTION, EAR(S)
G DEATH
s EAR DISORDER
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
CVM _ Rep01t.rep
Zip:
0611 5/2002
Recommended dose
Oral (in dry feed)
4.5 TO 18 GM/TON
Various
52214
Good
Source Report ld:
NDC:
Product Lot No:
PAYUS02129
UNK
#Treated:
30
#Reacted: 15
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
240 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Prepared on 04/18/ 2011
No Value
Page: 94
ELU: WEIGHT FROM 220 TO 260 LB. LABEL INDICATES FOE 150 TO 240 LB. CM: CRACKED HOOVES. RACTOPAMINE
WAS DISCONTINUED IN AFFECTED ANIMALS. THE REST CONTINUED ON RACTOP AMINE AND WERE MARKETED
NORMALLY.
Causality
Assessment
2
Time
To Onset
2 WK
Clinical Detail:
G HOOF DISORDER
Source:
Country:
State:
United States
WISCONSIN
Zip:
53588
Episode Date:
10/1 5/2002
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Dose Description: 6.5 GM/TON X 3 WEEKS, THEN 9 GM/TON X 2 WEEKS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species subgroup
EFFICIENCY
Fair
Owner
No Value
PA YUS02128
UNK
#Treated:
6500
#Reacted: 97
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 260 LB
BREED: PIC. HIGHER PERCENTAGE OF RACTOPAMINE FED PIGS WERE DOWNERS (UP TO 1.5%) DURING A
RESPIRATORY DISEASE OUTBREAK. COMPANY HAS REMOVED FEED CONTAINING RACTOPAMINE FROM SITE.
PLAN TO REINTRODUCE ONCE THE RESPIRATORY OUTBREAK IS UNDER CONTROL.
Causality
Assessment
-1
Time
UN G RECUMBENCY
UN R RESPIRATORYDISORDER
CVM _ Repmt.rep
Page: 95
Source Report ld:
Country:
United States NDC:
State:
ILLINOIS
Zip:
61882
Product Lot No:
Episode Date:
10/0112002
Dose Description: 9 GM/TON FOR AT LEAST 28 DAYS; 7 & 8/02
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species subgroup
EFFICIENCY
Good
Owner
Unknown
PAYUS02125
UNK
#Treated:
4
#Reacted: 4
#Died:
0
Species: PIG
Breed: Spotted (pig)
Age: UN
Weight: 265 LB
Gender: Female
ELU: NOT FOR BREEDING ANIMALS. OFF RACTOPAMINE AT LEAST 2.5 MONTHS. GILTS ARE NOT CYCLING.
Causality
Assessment
2
Time
To Onset
3 MO
Clinical Detail:
X ANESTRUS
2 3 MO X ESTRUS CYCLE ABNORMAL
2 3 MO X FERTILITY, LACK OF
Source:
Country:
State:
United States
MINNESOTA
Zip:
55912
Episode Date:
10116/2002
Dose Description: 6.75 GM/TON; 9118 TO 10/16/02
CVM _Report. rep
PackageiD: A 4
Source Report Id:
NDC:
Product Lot No:
PAYUS02130
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
1000
20
20
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species subgroup
INCREASE ADG, CARACSS LEANNESS, FEED
EFFICIENCY
Good
Owner
No Value
Breed:
Age:
Weight:
Gender:
Page: 96
Other (pig)
UN
265 LB
Group (m & f)
BREED: DEKALB. CM: 2% DEAD RATE ON ARRIVAL AT PROCESSING PLANT. EXPECTED RATE IS 0.2 %. THIS WAS
FIRST GROUP OF RACTOP AMINE FED PIGS FROM A NEW CONTRACT BARN. RTX: ADJUSTMENTS WERE MADE TO
LOADING PROCESS, FACILITIES AND STAFF AT CONTRACT BARN. NO PROBLEMS WITH PIGS NOT FED
RACTOP AMINE AFTER ADJUSTMENTS WERE MADE.
Causality
Assessment
Time
2 4 WK G DEATH
Source:
Country:
State:
United States
IOWA
Zip:
51246
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10115/2002
Reconm1ended dose
Oral (in dry feed)
4.5 GM/TON; X 28 DAYS
None
Good
Owner
Unknown
Source Report ld:
PAYUS02132
NDC:
Product Lot No:
UNK
#Treated:
1000
#Reacted: 10
#Died:
3
Species: PIG
Breed: Other (pig)
Age: 5 MO
Weight:
UN
BREED: PIC. SOME PIGS WERE COUGHING PRIOR TO STARTING PAYLEAN. TREATED 2 PIGS W/ LINCOMYCIN
INJECTABLE. FED PAYLEAN TO FINISH. 2 TO 3 PIGS DIED ON THE TRUCK TO THE PROCESSING PLANT. REPORT
STATES ABOUT 10 REACTED, 2 TO 3 DIED. NO SIGNS DESCRIBED OTHER THAN DEATH.
Causality
Assessment
CVM _Report. rep
Time
Page: 97
2 4 WK G DEATH
Source:
Country:
United States
State:
IOWA
Zip:
XX XXX
Episode Date:
11/04/2002
Dose Description: 4.5 GM/TON
Extra Label:
Unknown
Reason For Use:
INCREASE ADG
Health Status:
Good
Administered By:
Owner
Source Report ld:
PAYUS02131
NDC:
Product Lot No:
UNK
#Treated:
402000
#Reacted: 7092
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
TRUCKERS REPORT AN INCREASE# OF DOWNER PIGS AT DELIVERY AT THE PLANT FROM ONE FARM. USUALLY
ONLY ONE DOWNER/LOAD. THEY ARE NOW SEEING 2 TO 3 PER LOAD. REP FROM FARM REPORTS THEY HAVE
NOT SEEN AN INCREASE IN DOWNERS.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G COLLAPSE
G RECUMBENCY
Source:
Country:
State:
United States
IOWA
Zip:
31346
CVM _Report. rep
Source Report ld:
PAYUS02133
NDC:
Product Lot No:
UNK
Episode Date:
11112/2002
Reason For Use:
ACCIDENTAL
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 98
2
2
2
PIG
Unknown (pig)
UN
55 LB
Unknown
PRODUCER INADVERTENTLY FED FINISHER RATION TO 50-60 LB PIGS. GROWER RATION HAD BEEN ADDED TO
LEFTOVER FINISHER RATION WI RACTOPAMINE. 2 PIGS DIED-UNK CAUSE.
Causality
Assessment
Time
0 UN G DEATH
Source:
Country:
United States
State:
SOUTH DAKOTA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CYM _ Rep01t.rep
1110112002
Recommended dose
Oral (in dry feed)
9 GM/TON; X 21 DAYS
None
INCREASE ADG
Good
Owner
No Value
57330
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS02138
UNK
#Treated:
100
#Reacted: 100
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 230 LB
Gender: Unknown
Page: 99
UNK #TREATED/REACTED. BREED: PREMIERE. PRODUCER DID NOT SEE THE $2 TO $3 PER PIG RETURN THAT WAS
EXPECTED. NO LONGER FEEDING RACTOPAMINE.
Causality
Assessment
Time
Source:
Country:
United States
State:
ILLINOIS
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
1110112002
Reconm1ended dose
Oral (in dry feed)
None
INCREASE ADG
Good
Owner
No Value
XX XXX
PackageiD: A 2
Source Report ld:
NDC:
Product Lot No:
PAYUS02137
UN
#Treated:
1000
#Reacted: 1000
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
240 LB
PRODUCER DID NOT ACHIEVE THE EXPECTED 10% IMPROVEMENT IN ADG AND A $2 TO $3 /HEAD RETURN.
Causality
Assessment
Time
Source:
Country:
State:
United States
ILLINOIS
Zip:
xxxxx
CVM _ Repmt.rep
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
PAYUS02136
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
1110112002
Recommended dose
Oral (in dry feed)
4.5 GM X 2 WEEKS, 9 GM/TON X 3-4 WEEKS
Species subgroup
INCREASE ADG
Good
Owner
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 100
190
30
0
PIG
Other (pig)
UN
270 LB
Group (m & f)
BREED: PIC. ELU: LABELED FOR 150 TO 240 LB PIGS. 30 PIGS WERE DOWN ON ARRIVAL AT PLANT. ANIMALS
WERE ALLOWED TO REST OVERNIGHT AND PROCESSED AS USUAL THE NEXT DAY. PRODUCER BELIEVES PIGS
WERE FED RACTOP AMINE TOO LONG( 6-7WEEKS).
Causality
Assessment
Time
2 6 WK G RECUMBENCY
Source:
Country:
State:
United States
IOWA
Zip:
X XXX X
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
1110112002
Reconm1ended dose
Oral (in dry feed)
4.5 GM/TON X 21-28 DAYS
None
INCREASE ADG
Good
Owner
No Value
Source Report ld:
PAYUS02135
NDC:
Product Lot No:
UN
#Treated:
1000
#Reacted: 10
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 29 WK
Weight: 275 LB
Page: 101
BREED: PIC. DOWN AT UNLOADING AT THE PLANT. 180 PIGS IN A TRUCK LOAD; 2 OF 6 TRUCKS HAD DOWNERS.
Causality
Assessment
Time
2 4 WK G RECUMBENCY
Source:
Country:
United States
State:
IOWA
Zip:
XX :XXX
Episode Date: 1110112002
Dosage: - Recommended dose
Dose Description: 4.5 OM/TON X 28 DAYS
Extra Label: None
Reason For Use: INCREASE ADO
Health Status: Good
Source Report Id:
PA YUS02134
NDC:
Product Lot No:
UNK
#Treated:
2000
#Reacted: 8
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
270 LB
Gender: Unknown
BREED: PIC. 4-6 PIGS JUMPED FROM PENS; 2 PIGS DOWN ON TRUCK WHEN SHIPPED.
Causality
Assessment
2
2
2
Time
To Onset
4 WK
UN
UN
Clinical Detail:
G RECUMBENCY
N HYPERACTIVITY
N NERVOUSNESS
Source:
Country:
State:
United States
OKLAHOMA
Zip:
73063
CVM _ Repmt.rep
Source Report Id:
PAYUS02140
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
11/11/2002
Not applicable
Oral (in dry feed)
#Treated:
#Reacted:
#Died:
9/GM/TON X 3 WEEKS
Species:
Species subgroup
Breed:
ACCIDENTAL
Age:
Weight:
Good
Gender:
Owner
No Value
PIG
Page: 102
100
10
Mixed (pig)
UN
55 LB
Group (m & f)
ELU: UNDERWEIGHT. LABEL FOR 150 TO 270#. CM: SWOLLEN LEGS ABOVE THE HOOF. SOME HAD OPENED AND
BECOME NON-HEALING WOUNDS. ONE PIG DIED, POSSIBLY FROM A BROKEN LEG. UNCLEAR IF THIS PIG HAD
SWOLLEN LEGS.
Causality
Assessment
0
Time
To Onset
3 WK
3 WK
3 WK
Clinical Detail:
G DEATH
G SWELLING, LIMB(S)
LESION(S), SKIN
Source:
Country:
State:
United States
TEXAS
Zip:
76088
Episode Date:
04115/2002
Dose Description: 18 G/TON; X 4 WEEKS; 12/01
Reason For Use:
INCREASE ADG
Health Status:
Good
CVM _Report. rep
Source Report Id:
PAYUS02141
NDC:
Product Lot No:
UNK
#Treated:
8
#Reacted: 2
#Died:
0
Species: PIG
Breed: Mixed (pig)
.Age: UN
Weight:
300 LB
Gender: Female
Page: 103
Administered By:
Vet Opinion:
Concomitants:
Owner
No Value
ELU: NOT LABELED FOR BREEDING ANIMALS. GILTS WERE BRED 4/02 BY AI. 2 RETURNED TO HEAT AND WERE
RE-BRED 3 TIMES BY AI AND ONCE WI A LIVE BOAR. THEY DID NOT CONCEIVE AND WERE CULLED.
Causality
Assessment
2
Time
To Onset
5 MO
Clinical Detail:
X FERTILITY, LACK OF
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
51230
1111 112002
Recommended dose
Oral (in dry feed)
4.5 OlTON X 2 WKS, 9 OM/TON X 2 WKS
None
INCREASE ADO
Good
Owner
No Value
Source Report ld:
NDC:
Product Lot No:
PAYUS02142
UNK
#Treated:
570
#Reacted: 18
#Died:
18
Species: PIG
Age: UN
Weight:
280 LB
NEW GENETIC LINE RECENTLY INTRODUCED TO THIS FARM. CM: SEVERAL PIGS BEGAN TO TREMBLE WHEN
LOADED. 18 DEAD PIGS ON TRUCKS ON ARRIVAL AT THE PLANT. CF: TRUCKS OVERLOADED FOR PIGS OF THIS
WEIGHT.
Causality
Assessment
2
2
Time
To Onset
4 WK
4 WK
Clinical Detail:
G DEATH
N TREMBLING
CVM _Report. rep
Source:
Country:
United States
State:
UNKNOWN
Zip:
XX :XXX
LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/11/2000
Not applicable
Multiple routes
INHALED AND TOPICAL EXPOSURE
Species
EXPOSED AT WORK
Good
Not applicable
Not applicable
No Value
Source Report ld:
PAYUS02139
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 104
0
HUMAN
Not specified
Male
41 YR
UN
RMPDC. EXPOSED VIA INHALATION AND DERMAL ROUTE FOR 2 MONTHS AT WORKPLACE. CM: PREMATURE
HEART BEATS AND TACHYCARDIA FOR 2 MONTHS.
Causality
Assessment
0
0
-9
-9
-9
-9
Drug Name:
Time
To Onset
UN
UN
NA
NA
NA
NA
RACTOP AMINE
Clinical Detail:
c ARRHYTHMIA
c TACHYCARDIA
G HUMAN EXPOSURE
G HUMAN EXPOSURE, TOPICA
Document ID: N 140863 Submission ID: _ L 71 Package ID: A 1
Source:
Country:
State:
United States
MINNESOTA
Zip:
55060
Episode Date:
12/30/2002
CVM _ Repmt.rep
Source Report ld:
NDC:
Product Lot No:
PAYUS02144
UNK
#Treated:
200
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
4.5 TO 18 GM/TON X 3 WEEKS OR MORE
Other
Unknown
Owner
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 105
100
0
PIG
Mixed (pig)
UN
250 LB
Group (m & f)
SHOW PIGS. AFTER 3 WEEKS ON RACTOPAMINE THE PIGS DEVELOP A SLIGHT STIFFENING OF THE JOINTS AND
ARE LESS FLUID IN THEIR GAIT. ELU: NOT LABELED FOR >240 LBS.
Causality
Assessment
Time
2 3 WK G LOCOMOTION DISORDER
2 3 WK G STIFFNESS, LIMB(S)
Source:
Country:
State:
United States
IOWA
Zip:
50122
Episode Date:
09115/2002
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 GM/TON X 21 DAYS; SEPT AND OCT/02
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
None
INC REASE ADG, LEANNESS
Good
Owner
No Value
PAYUS03002
UN
#Treated:
2000
#Reacted: 17
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 250 LB
Page: 106
MBG GENETICS. CM: INCREASE IN# OF DOWNER PIGS AT PROCESSING PLANT. EXPECTS AVG OF 1/1000; HAS HAD
AVG 1/120 SHIPPED SINCE FEEDING RACTOPAMINE. DID NOT MAKE CHANGES IN HANDLING ROUTINE. WILL NOT
CONTINUE FEEDING TO FINISHING PIGS BUT WILL FEED TO SHOW PIGS.
Causality
Assessment
2
Time
To Onset
3 WK
Clinical Detail:
G RECUMBENCY
Source:
Country:
State:
Foreign
Zip:
ANIMAL NUMBERS NOT GIVEN
Episode Date:
07/15/2002
Package ID: A
Source Report Id:
NDC:
Product Lot No:
Dose Description: 10 PPM; X 4 WEEKS; JULY/AUG, 2002
Extra Label: None
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
PAYPL02001
UNK
#Treated:
100
#Reacted: 100
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 4.5 MO
Weight:
190 LB
PHILIPPINES. BREED: PIETRAN. UNK #TREATED/REACTED. CUSTOMER DID NOT SEE SIGNIFICANT
IMPROVEMENT IN ADG. 560 GRAMS GAIN OVER THE 28 DAY PERIOD. ANOTHER FARM HAD 890 GRAMS OF ADG.
CUSTOMER IS CONCERNED THAT FEED INTAKE IN PIETRAN PIGS IS LOWER AND WONDERS IF DOSE SHOULD BE
HIGHER. CF: FARM HAD RESPIRATORY PROBLEMS THAT COULD CONTRIBUTE TO REDUCED FEED INTAKE.
Causality
Assessment
Time
Source:
Country:
State:
CYM _ Report.rep
United States
IOWA
Zip:
52353
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS03003
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01/09/2003
#Treated:
Recommended dose
#Reacted:
4.5 GM/TON X 23 DAYS; 12/18/02-1 /9/03
Species:
None
Breed:
Age:
Weight:
Good
Gender:
Owner
Low
Unknown
Page: 107
510
12
0
PIG
Other (pig)
UN
275 LB
Group (m & f)
BREED: NEWSHAM. 8 PIGS DOWN IN THE TRUCKS AT ARRIVAL. THEY WERE PROCESSED NORMALLY. 3 TO 5 PIGS
WERE LEFT AT THE FARM BECAUSE THEY WERE STRESSED AND OPEN MOUTH BREATHING. FEED WAS TESTED
FOR RACTOPAMINE LEVELS: 2 SAMPLES WERE W/IN RANGE @ 4.5 AND 4.6 GM/TON; 1 WAS 5.5 GM/TON AND THE
FOURTH WAS 2.6 GM/TON. (STILL NOT AN OD).
Causality
Assessment
2
2
Time
To Onset
23 DA
23 DA
Clinical Detail:
G COLLAPSE
G RECUMBENCY
Source:
Country:
State:
United States
IOWA
Zip:
51577
Episode Date:
10/03/2002
Dose Description: 4.5 GM/TON; X 3 WEEKS; 10/1-21102
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
CVM _ Report.rep
PAYUS03001
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
3200
3200
Unknown (pig)
UN
265 LB
Group (m & f)
Administered By:
Vet Opinion:
Concomitants:
Owner
No
Page: 108
PIGS WERE HYPERACTIVE AND MORE DIFFICULT TO HANDLE. ONE TO 2 DIED WHEN BEING LOADED. MANURE
WAS "HARD PACKED" AND MORE DIFFICULT TO REMOVE FROM THE CONCRETE FLOORS AND SLATS OF THE
PENS.
Causality
Assessment
0
2
2
Time
To Onset
3 WK
3 WK
2 DA
Clinical Detail:
D STOOLABN
G DEATH
N HYPERACTIVITY
Source:
Country:
State:
United States
INDIANA
Zip:
47601
Episode Date:
03/15/2002
Dosage:
Recommended dose
Dose Description: 4.5 GM/TON; 2/02 TO 9/02
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Medium
No Value
PAYUS02058
UNK
#Treated:
12000
#Reacted: 80
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 5 MO
Weight:
250 LB
BREED: PIC; AGE: MAKET AGE. NO PROBLEM WITH PREVIOUS FINISHERS ON RACTOP AMINE. CM: 20 OUT OF
EACH LOAD OF 190 WERE DOWNERS ON ARRIVAL AT PACKER; 4 LOADS IN ALL. STOPPED USING PRODUCT DUE
TO THIS PROBLEM. PRODUCER'S VET REPORTED THERE WERE PIG CONFORMATION PROBLEMS ON THE FARM
AND THE PRODUCER PLANS TO USE A NEW BOAR LINE.
Causality
Assessment
CVM _Report. rep
Time
To Onset
4 WK
Clinical Detail:
G RECUMBENCY
Page: 109
Source:
Country:
State:
United States
VIRGINIA
Zip:
23430
Extra Label: None
PackageiD: A 2
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Not applicable
No Value
PAYUS02059
UNK
#Treated:
150
#Reacted:
#Died:
0
Species: PIG
Age: 5 MO
Weight:
225 LB
Gender: Unknown
CLIENT INQUIRY RE: RACTOPAMINE'S EFFECT ON FATTY ACID COMPOSITION AND IODINE LEVELS. ONE
RESEARCH STUDY MEASURED IODINE LEVELS(AN INDICATION OF FAT SOFTNESS). THERE WAS AN INCREASE IN
IODINE VALUES IN THOSE FED RACTOPAMINE AND NO CHANGE IN THE UNSUPPLEMENTED GROUPS. HIGH
IODINE INDICATES INCREASE IN DOUBLE BONDS WHICH GIVES AN INCREASE IN UNSATURATED FAT AND AS A
RESULT, SOFTER FAT.
NOT CLEAR IF THERE IF THIS IS A COMPLAINT RE: FAT COMPOSITION OR POSSIBLY EFFICACY.
Causality
Assessment
Time
-9 NA G REACTION, UNSPECIFIED
Source:
Country:
State:
United States
TENNESSEE
Zip:
38231
Episode Date:
10/02/2002
CVM _ Rep01t.rep
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
PAYUS02122
UNK
#Treated:
#Reacted:
#Died:
100
10
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
None
Good
Owner
No Value
Species:
Breed:
Age:
Weight:
Gender:
Page: 110
0
PIG
Unknown (pig)
6 MO
280 LB
Group (m & f)
UNK # TREATED/REACTED. AFTER 6 HR RIDE TO PLANT, THE HEAVIER PIGS WERE RELUCT ANT TO WALK UP THE
INCLINE (REPORTEDLY 3 STORIES) TO THE LEVEL OF THE PROCESSING FLOOR. NO DEATHS OR DOWNERS.
Causality
Assessment
Time
To Onset
21 DA
21 DA
Clinical Detail:
G RELUCT ANT TO CLIMB
G STIFFNESS
Source:
Country:
United States
State:
MONTANA
Zip:
REACTED/DIED #NOT PROVIDED
Episode Date:
08/01/2002
XX XXX
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
No Value
Source Report ld:
NDC:
Product Lot No:
PAYUS02124
UNK
#Treated:
300
#Reacted: 20
#Died:
10
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 240 LB
BREED: THUNDERBIRD. THE NUMBER OF ANIMALS THAT REACTED OR DIED WAS NOT REPORTED. CM: DEAD
AND DOWNER PIGS WERE ON THE TRUCK WHEN IT ARRIVED AT THE PACKER. OWNER PLANS TO INCREASE
CYM _Report. rep
Page: 111
SELENIUM IN THE DIET.
Causality
Assessment
Time
To Onset
4 WK
4 WK
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
NEBRASKA
Zip:
68728
Episode Date:
09/24/2002
Dose Description: 4.5 GM/TON; SINCE 9/24/02
Extra Label: None
Package ID: A 5
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
PAYUS02123
UNK
#Treated:
800
#Reacted: 400
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 21 WK
Weight: 200 LB
SPIKE IN WATER CONSUMPTION; UP TO 200-300 GALLONS/DAY. PERSISTED FOR 3 DAYS THEN RETURNED TO PRE-
RACTOPAMINE LEVELS. DAILY TEMPS WERE SEASONAL, 65-76 DEGREES. UNK NUMBER REACTED.
Causality
Assessment
Time
To Onset
12 HR
Clinical Detail:
G POLYDIPSIA
Source:
Country:
State:
United States
ARIZONA
Zip:
85721
CYM _Report. rep
Source Report ld:
PAYUS02126
NDC:
Product Lot No:
UNK
Episode Date:
D ~ s a g e :
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/01/2002
Recommended dose
Oral (in dry feed)
UNK AMT X 40 DAYS
Species subgroup
Unknown
Owner
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 112
3
3
0
PIG
Unknown (pig)
UN
145 LB
Unknown
A FEEDING STUDY COMPARED SHOW PIGS FED OXY-GEN TO PIGS FED RACTOPAMINE AND A NON-MEDICATED
CONTROL GROUP. RESULTS INDICATED OXY-GEN FED PIGS HAD GREATER FEED EFFICIENCY(l3% VS 9%) AND
BETTER DAILY WEIGHT GAIN (20.8% VS 16.6%) WHEN EACH WAS COMPARED TO THE CONTROL GROUP. OXY-GEN
AND CONTROL PIGS HAD NO JOINT STIFFNESS BUT EVERY SHOW PIG FED RACTOPAMINE EXHIBITED STIFFNESS.
ON SLAUGHTER THE RACTOP AMINE FED PIGS HAD SLIGHTLY LARGER LOIN EYES AND REDUCED BACK FAT BUT
THE TENDERNESS OF THE LOIN EYES WAS UNACCEPTABLE WHEN THE SHEAR TEST WAS APPLIED. BACON WAS
ALSO SUBSTANDARD. 145 PEOPLE TASTE TESTED THE COOKED PORK FROM ALL THREE GROUPS AND THE OXY-
GEN FED PORK WON OVERWHELMINGLY.
THE STUDY WAS NOT IDENTIFIED. ONLY 3 ANIMALS IN THE RACTOPAMINE GROUP; UNK #IN OTHER GROUPS.
Causality
Assessment
-7
Time
To Onset
UN
Clinical Detail:
G MEATABN
UN G STIFFNESS
Source:
Country:
State:
United States
IOWA
Zip:
xxxxx
NO ANIMAL NUMBERS
Episode Date:
09/15/2002
Dose Description: 4.5 GM/TON; X 3-4 WEEKS
Extra Label:
None
Package ID: A 7
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
CVM _Report. rep
PAYUS02127
UNK
#Treated:
100
#Reacted: 20
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Health Status: Good
Administered By:
Vet Opinion:
Concomitants:
Owner
No Value
Weight:
Gender:
Page: 113
240 LB
Group (m & f)
BREED: PIC. ANIMAL NUMBERS NOT PROVIDED. 20 % OF RACTOPAMINE FED PIGS EXHIBITED EXCITABILITY
WHEN LOADED FOR SHIPPING TO PROCESSOR. NUMBER OF PIGS UNK. NO PROBLEMS ON ARRIVAL AT PLANT.
Causality
Assessment
2
Time
To Onset
4 WK
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
State:
Foreign
Zip:
ELANCO CONSULTANT
Episode Date:
06/15/2002
Dose Description: 5 PPM; 6/2002 THROUGH 11/2002
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By: .
Vet Opinion:
Concomitants:
Good
Owner
High
Yes
OXYTET, 200 PPM PO, STARTED JAN/2000
PAYME03001
UNK
#Treated:
200
#Reacted: 20
#Died:
18
Species: PIG
Breed: Mixed (pig)
Age: 150 DA
Weight:
92.5 KG
2 PROMICIL(ALUMINUM SILICATE) PO, 5/KG/1000 KG, SINCE APRIL 2002
MEXICO. PROGRESSIVE INCREASE IN SUDDEN DEATH. AT NECROPSY, HEMORRHAGES FOUND ON INTERIOR
SURF ACE OF THE SMALL AND LARGE INTESTINE COMPATIBLE WI HEMORRHAGIC BOWEL SYNDROME. SUDDEN
DEATH STAR TED IMMEDIATELY AFTER RACTOP AMINE ADMINISTRATION BEGAN. FARM STOPPED FEEDING
RACTOPAMINE. RTX: ZINC BACITRACIN, 50 PPM IN THE FEED.
CVM _ Rep01t.rep
Page: 114
Causality
Assessment
0
Drug Name:
Time
To Onset
1 DA
1 DA
1 DA
1 DA
NA
RACTOP AMINE
Clinical Detail:
D PR-INTEST, LESION(S)
D PR-SM INTEST, LESION(S
D PR-SM INTEST, LESION(S)
G DEATH
G INTERACTION, DRUG(S)
Source:
Country:
Foreign
State:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
12/17/2002
Recommended dose
Oral (in dry feed)
5 PPM; X 13-35 DAYS
None
INCREASE ADG; CARCASS LEANNESS
Good
Owner
High
Yes
Source Report ld:
NDC:
Product Lot No:
ZINC BACITRACIN, PO 50 PPM FED CONTINUOUSLY.
PAYME03002
UNK
#Treated:
1150
#Reacted: 40
#Died:
33
Species: PIG
Breed: Other (pig)
Age: 24.5 WK
Weight:
111 KG
MEXICO. BREED: PIC CAM 22X422, 419 X 406. CM: REFUSED TO WALK WHEN TAKEN OUT OF THE PEN; WHEN
MOVED THROUGH THE CORRIDOR, ANIMALS STARTED TO TREMBLE, CRIED, FELL DOWN OR DIED. SOME PIGS
DIED DURING TRANSPORT TO SLAUGHTER. SOME WERE LEFT AT THE FARM AND RECOVERED. RACTOPAMINE
WAS DISCONTINUED. IT WAS ESTIMATED THAT MORE THAN 20% OF THE ANIMALS WERE CARRIERS OF THE
"HALOTHANE GENE". RTX: ONE DOSE OF AZAPERONE, 2 MG/KG IV. FlU: PRODUCER FED ANOTHER GROUP OF 500
PIGS AT 5 PPM. NONE SHOWED A REACTION AS BEFORE. PRODUCER WILL CONTINUE TO FEED RACTOPAMINE.
Causality
Assessment
2
CVM _ Repmt.rep
Time
To Onset
2 WK
Clinical Detail:
G COLLAPSE
Page: 115
2 2 WK G DEATH
2 2 WK G RELUCTANTTOMOVE
2 2 WK G VOCALIZATION
2 2 WK N TREMBLING
Source:
Country:
United States
State:
INDIANA
Zip:
NO ANIMAL NUMBERS, MULTIPLE LOADS
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01/01/2003
Unknown
Oral (in dry feed)
UNl/1/03 TO 1/28/03
Species subgroup
XX :XXX
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No Value
Source Report ld:
NDC:
Product Lot No:
P A YUS03004/3005
UNK
#Treated:
60000
#Reacted: 600
#Died:
2
Species: PIG
Age: UN
Weight: 275 LB
PROCESSOR HAD 2X INCR IN DOWN/ SLOW PIGS AT ALL PLANTS. NO ANIMAL #S. P A YLEAN EXPOSURE NOT
KNOWN FOR SURE. FlU: 1/28/03: SEEING 15-30 HEAD DOWN/DAY. USUALLY SEE 8-15/DAY. 4 FARMS NAMED: 2
WERE NOT FEEDING PA YLEAN, 1 SAID THEY DID NOT SEE INCREASE BUT HAD ANIMALS SLIPPING ON ICY
FLOORS. 4TH FARM IS FEEDING RACTOPAMINE-NO INCREASE IN DEAD/DOWN/ SLOW PIGS. FlU: 4/16/03: PROBLEMS
REPORTED INVOLVED 14 PRODUCERS FROM 4 PLANTS. 6 NOT PRESENTLY USING RACTOPAMINE & 3 UNSURE BUT
THOUGHT PA YLEAN WAS NOT BEING USED. OF THOSE FEEDING P A YLEAN: (1ST) PRODUCER HAD DOWNERS AND
SLOWS FROM MULTIPLE SITES. FEEDING 4.5 G/TON FOR 21-28 DAYS. DOCUMENTED 8 DOWN, 1 DEAD OUT OF 3
LOADS. PIGS SAT ON TRUCK FOR 4 HRS THAT DAY DUE TO A LINE CLOSURE. OTHERWISE HAD ABOUT 2% DOWNS
& DEADS. PLAN: CHANGE BOAR GENETICS. AVG _WT: 270# WI SOME 300# PIGS. (2ND) PRODUCER FED @ 4.5 GM/TON
X 3 WK THEN 9 GM/TON X 2 WKS. PIGS WERE VERY DIFFICULT TO MOVE. SUSPECT GENETICS. HAD PROBLEM
PRIOR TO FEEDING PA YLEAN. FOUND THAT 2 TRUCKERS WERE LOADING TOO DENSELY. WT: 265-270#. (3RD)
PRODUCER FED 4.5 GM/TON X 2 WEEKS THEN 9 GM/TON X 2-3 WEEKS. NO DOWNER PROBLEM. (4TH) PRODUCER-I
LOCATION WI 14 DOWNERS/2 LOADS. AVG WT 270#. APPROX 25% OF PIGS AT THAT LOCATION WERE FED 4.5
GM/TON X 3 WKS WHEN THEY WERE SHORT OF FINISHING SPACE. OCCASIONAL SPIKES IN DOWNER NUMBERS.
PREVIOUSLY FED AT MUCH HIGHER DOSAGE; RTX: REDUCED DOSE AND ADDRESSED PIG HANDLING. FEEL THAT
PROBLEM HAS RESOLVED. (5TH) PRODUCER-I LOAD THAT WAS DOPEY AND SLOW. FED@ 4.5 GM/TON X 3
CVM _Report. rep
Page: 116
WEEKS. (6TH) PRODUCER FED@ 9 GM/TON X 4 WK. HAVE HAD LOADS W/ NUMEROUS DOWNERS AND SLOWS AND
OTHER LOADS THAT WERE NL. ON 2/7/03 2 LOADS HAD 12 DOWNERS. ON 2110/03,2 LOADS HAD 14 SUBS/DOWNERS.
A VG WT=298#. 7(TH) PRODUCER: 9 SUBS, 1 DEAD IN 1ST PA YLEAN LOAD SENT. FED 9 GM/TON X 18 DAYS. WT=247-
266. 206 PIGS ON TRUCK THAT SHLD HOLD MAX OF 197. ADDITIONAL FARM FED 4.5 GM/TON X 21-28 DAYS. 0.5 TO
0.7% SLOWS. ELECTROLYTES IN H20 GIVEN PRIOR TO LOADING.
Causality
Assessment
2
2
2
2
2
2
Drug Name:
Time
To Onset
3 WK
3 WK
3 WK
3 WK
3 WK
3 WK
RACTOP AMINE
Clinical Detail:
G DEATH
G DIFFICULTY RISING
G RECUMBENCY
G RELUCTANT TO MOVE
G STIFFNESS
Source:
Country:
State:
United States
INDIANA
Zip:
46723
PRODUCER
Episode Date:
07115/2002
Dose Description: 4.5 GM/TON; FOR UP TO 28 DAYS
Extra Label:
Species subgroup
Source Report Id:
NDC:
Product Lot No:
ReasoQ For Use:
INCREASE ADG, INCREASED CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
PAYUS03006
UNK
#Treated:
1000
#Reacted: 10
#Died:
0
Species: PIG
Breed: Yorkshire (pig)
Age: VA
Weight: 265 LB
Gender: Female
ELU: NOT LABELED FOR BREEDING GILTS. CM: DIFFICULTY GETTING GILTS BRED. FIRST TIME TO SETTLE WAS
LONGER THAN EXPECTED. THE BRED GILTS HAD LOWER THAN EXPECTED AVERAGE NUMBER BORN ALIVE.
LITTER SIZE AVERAGED 7-7.5 LIVE PIGS. GILTS HAD BEEN FED RACTOPAMINE PRIOR TO PURCHASE.
Causality
Assessment
CVM _Report. rep
Time
Page: 117
UN X FERTILITY, REDUCED
Source:
Country:
United States
State:
NEBRASKA
Zip:
XX XXX
LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01/28/2003
Overdose
Oral (in dry feed)
18-36 GM/TON; INTERMITTENTLY
Species subgroup
Unknown
Owner
Unknown
Source Report ld:
NDC:
Product Lot No:
PAYUS03007
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: UN
Weight: 110 LB
ELU: UNDERWEIGHT, OVERDOSE. PIG AT IOWA PORK CONGRESS HAD BEEN LIMIT FED AND WATERED.
RECEIVED 1-2 LBS FEED/DAY. CM: PIG WENT DOWN ON ONE LEG. REPORTING PARTY FELT THE RACTOPAMINE
WAS RESPONSIBLE. NOT CLEAR IF REPORTING INDIVIDUAL WAS AN OFFICIAL AT THE CONGRESS OR A
PARTICIPANT OR SPECTATOR.
Causality
Assessment
Time
UN G LAMENESS
UN N PARESIS
Source:
Country:
State:
United States
MINNESOTA
Zip:
55912
CYM _Report. rep
Package ID: A 3 Corrsp Date: 0211 0/2003
Source Report ld:
PAYUS03008
NDC:
Product Lot No:
UNK
PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/26/2002
Recommended dose
Oral (in dry feed)
None
Good
Owner
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 118
2500
100
0
PIG
Other (pig)
UN
265 LB
Group (m & f)
BREED: PREMIERE. PRODUCER SHIPPING 1000 PIGS/WEEK HAS SEEN INCREASE IN RATE OF DOWNERS. THE
DOWNER PIG PROBLEM RESOLVED AFTER HE DECREASED AMOUNT IN FEED TO 4.5 GM/TON.
Causality
Assessment
3
Time
To Onset
4 WK
Clinical Detail:
G RECUMBENCY
Source:
Country:
State:
United States
MINNESOTA
Zip:
55952
Episode Date:
01/01/2003
Package ID: A 4
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 GM/TON X 3 WK; 9 GM/TON X 2 WKS. 1/1 /03 -1114/0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
None
Poor
Owner
No Value
PAYUS03009
UNK
#Treated:
500
#Reacted: 25
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 280 LB
Page: 119
BREED: PIC. LAND 0' LAKES REP REPORTED AN INCREASED NUMBER OF DOWNER PIGS (UP TO 5%) ON THEIR
SHIPMENTS TO THE PROCESSOR. H/0 : ACTINOBACILLUS PLEUROPNEUMONIAE EXPOSURE AT 150 LBS; PIGS HAVE
COMPROMISED LUNGS. FARM IS NOW FEEDING RACTOPAMINE AT 4.5 GM/TON; DOWNER RATE HAS DECLINED TO
0.5%.
Causality
Assessment
2
Time
To Onset
4 WK
Clinical Detail:
G RECUMBENCY
Source:
Country:
United States
State:
IOWA
Zip:
PRODUCER
Episode Date:
01/15/2003
Extra Label:
None
50595
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Poor
Owner
No Value
PAYUS03016
UNK
#Treated:
500
#Reacted: 5
#Died:
0
Species: PIG
Age: UN
Weight:
257 LB
PROCESSOR REPORTED INCREASE NUMBER OF SLOW AND DOWNER PIGS. ELANCO CONTACTED ONE PRODUCER
WHO REPORTED 5 DOWNERS IN GROUP OF 360 SHIPPED. TRUCK DRIVER SAW SLOW PIGS BUT NOT ANY
DOWNERS; PROCESSOR REPORTED THEMA S DOWNERS. PRODUCER CONCERNED WITH HANDLING PIGS
RECEIVED AT THE PLANT AND HAS A CONFLICT WITH THE PROCESSOR OVERPAYMENT REGARDING SLOW OR
DOWN PIGS. PRODUCER IS NOT FEEDING RACTOPAMINE AT THIS TIME BECAUSE OF THIS ISSUE.
Causality
Assessment
2
2
Time
To Onset
3 WK
3 WK
Clinical Detail:
G RECUMBENCY
G RELUCTANT TO MOVE
CVM _Report. rep
Page: 120
Source:
Country:
Report from 'sponsor or distibutor of drug
United States
State:
ILLINOIS
Zip:
PRODUCER
Episode Date:
0112112003
Dose Description: 4.5 GM/ TONX21 DAYS
XX :XXX
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
No Value
Source Report Id:
PAYUS03014
NDC:
Product Lot No:
UNK
#Treated:
1260
#Reacted: 50
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 5.5 MO
Weight:
305 LB
BREED: PIC. PRODUCER WITH SEVERAL SITES REPORTS DOWNER PIGS AT ONLY ONE SITE. PIGS ARE MOVED
TWICE AND ELECTRIC PRODS ARE USED AT THIS SITE. CM: 50 PIGS DOWN IN THE BARN AT LOADING TIME.
OWNER FELT STRESS FACTORS MAY BE CONTRIBUTING TO THE PROBLEM.
Causality
Assessment
2
Time
To Onset
21 DA
Clinical Detail:
G RECUMBENCY
Source:
Country:
State:
United States
NEBRASKA
Zip:
68739
PRODUCER
Episode Date:
11115/2002
Dose Description: 4.5 GM/TON; 3 TO 4 WEEKS
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
CVM _Report. rep
PAYUS03013
UNK
#Treated:
2160
#Reacted: 144
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Health Status: Good
Administered By:
Owner
Concomitants:
No Value
Weight:
Gender:
Page: 121
260 LB
Group (m & f)
PRODUCER HAS HAD DOWNER PROBLEMS FOR A YEAR BUT PROBLEM HAS WORSENED OVER LAST THREE
MONTHS. 4 LOADS/MONTH OF 180 HEAD EACH. AVG 6-8 BARROWS AND 4-5 GILTS ARE DOWN IN EACH LOAD.
HAS HAD AS MANY AS 26 DOWN IN A SINGLE LOAD OF 180. NUMBERS CALCULATED FOR PAST 3 MONTHS.
Causality
Assessment
2
Time
To Onset
3 WK
Clinical Detail:
G RECUMBENCY
Source:
Country:
United States
State:
PENNSYLVANIA
Zip:
PROCESSOR
Episode Date:
11/15/2002
Dose Description: 4.5 GM/TON; X 21 DAYS
Extra Label:
None
XX XXX
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG; INCREASE CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No Value
PAYUS03015
UNK
#Treated:
70000
#Reacted: 10
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
240 LB
BREED: BABCOCK. WHEN ANIMALS ARE STUNNED THE BACK MUSCLES CONTRACT CAUSING THE BACKS TO
BREAK AND BLOOD TO SPILL OUT. THIS PROBLEM ONLY OCCURS IN PIGS FED RACTOPAMINE.
Causality
Assessment
CVM _ Repmt.rep
Time
To Onset
3 WK
Clinical Detail:
G SPASM
Page: 122
Source:
Country:
State:
Foreign
Zip:
VET
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
12/06/2002
Recommended dose
Oral (in dry feed)
5PPM; 7/02
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
IMPROVE QUALITY AND PERFORMANCE
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Fair
Owner
High
Yes
PAYME03003
UNK
#Treated:
1000
#Reacted: 100
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: 130 DA
Weight:
85 KG
TRIMETHOPRIM @ 40 PPM , SULPHA @ 200 PPM SINCE JANUARY 2002
MEXICO. BREED: SEGHER/DUROC. FARM HAD BEEN USING RACTOPAMINE FOR 5 MONTHS WHEN A GROUP OF 100
DEVELOPED SKIN BLOTCHES, ARTHRITIS, HOBBLING GAIT AND STUNTED GROWTH. SUSPECT ERYSIPELAS; PIGS
ARE NOT VACCINATED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G LAMENESS
-1 UN G POOR PERFORMANCE
-1 UN CONGESTION, SKIN
-1 UN M ARTHRITIS
Source:
Country:
United States
State:
IOWA
VET
CVM _ Repmt.rep
Zip:
XX XXX
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
PAYUS03010
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01101 /2003
Unknown
Oral (in dry feed)
NOT REPORTED
None
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Good
Owner
Medium
No Value
Weight:
Gender:
Page: 123
540
9
9
PIG
Other (pig)
5.7 MO
250 LB
Group (m & f)
WHITEBREED. THREE TRUCKLOADS (180/LOAD) SHIPPED THE WEEK OF FEB 3,2003. 2 TO 3 PIGS DIED ON EACH
LOAD. PRODUCER HAD NOT HAD DEATHS BEFORE. THESE PIGS NOTED TO HAVE THE STRESS GENE.
Causality
Assessment
2
2
Time
To Onset
4 WK
4 WK
Clinical Detail:
G DEATH
G SHAKING
Source:
Country:
United States
State:
IOWA
Zip:
PRODUCER
Episode Date:
02/06/2003
Extra Label:
None
50025
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG; CARCASS LEANNESS
Health Status:
Unknown
Administered By:
Owner
CVM _Report. rep
PAYUS03011
UNK
#Treated:
3600
#Reacted: 1000
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 5.7 MO
Weight: 265 LB
Page: 124
BREED: PIC. NUMBER REA TED NOT REPORTED. CM: PASTY MANURE, DIFFICULT TO REMOVE. RESULTED IN
HARD PACK ON THE SLATS. PRODUCER CONTINUES TO FEED RACTOP AMINE. DDX: HIGH PROTEIN/HIGH FAT
DIET.
Causality
Assessment
0
Time
To Onset
3 WK
Clinical Detail:
D DIARRHEA, MILD
Source:
Country:
State:
United States
IOWA
Zip:
50076
Episode Date:
02/01/2003
Extra Label: Other
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
No Value
PAYUS03012
UNK
#Treated:
100
#Reacted: 10
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
277 LB
Gender: Unknown
UNK #TREATED/REACTED. BREED: PIC. INCREASE# OF DOWNERS AT ARRIVAL TO THE PROCESSOR. DUE TO THE
HIGH COST OF RACTOP AMINE AND NUMBERS OF DOWNERS, THE PRODUCER DISCONTINUED USING
RACTOPAMINE. ELU: NOT LABELED FOR USE OVER 240 LBS.
Causality
Assessment
2
Time
To Onset
21 DA
Clinical Detail:
G RECUMBENCY
Source:
Country:
State:
CVM _ Report.rep
United States
IOWA
Zip:
50472
Source Report ld:
PAYUS03017
NDC:
Product Lot No:
UNK
INFO LACKING, PRODUCER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
02/01/2003
Recommended dose
Oral (in dry feed)
4.5 GM/TON; 21-28 DAYS
Species subgroup
Good
Owner
No Value
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 125
200
150
0
PIG
Unknown (pig)
UN
265 LB
Group (m & f)
ELU: OVER 240 LBS. WERE W/IN LABEL FOR MOST OF FEEDING PERIOD. CM: OUT OF THE "RED BOX"-CARCASS
WEIGHT 174-222 LBS, BACKFAT 0.5-1 .1 INCHES. TYPICALLY 50% ARE OUT OF THE RED BOX, 75% OF THESE PIGS
WERE OUT. THIS WAS THE FIRST TIME THIS PRODUCER FED RACTOPAMINE. REVIEWER COMMENTS: ASSUME
PIGS WERE OVERWEIGHT BUT NO BACKF AT MEASUREMENTS WERE PROVIDED.
Causality
Assessment
Time
-7 NA E INEFFECT, PRODUCTION (MEAT)
-1 NA G MEATABN
Source:
Country:
State:
United States
ILLINOIS
Zip:
XX XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
0211 7/2003
Recommended dose
Oral (in dry feed)
4.5 GM/TON
Species subgroup
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE AGD, CARCASS LEANNESS
Health Status:
Good
CVM _Repmt.rep
PAYUS03018
UNK
#Treated:
345
#Reacted: 345
#Died:
14
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 260 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Medium
No Value
Page: 126
PIC GENETICS. ADMINISTRATION DATES AND DURATION NOT REPORTED. WEIGHT: 255-270 LBS. ELU: NOT
LABELED FOR PIGS OVER 240 LBS. 2/ 17/03: 190 PIGS SHIPPED; 12 WENT DOWN. PIGS LOADED OK BUT WOULD NOT
GET OFF THE TRUCK. PIGS HAD NOT BEEN RESTED BEFORE SLAUGHTER AND WERE PROCESSED THAT DAY. ON
2/25/03, 155 HEAD WERE SHIPPED; 14 WERE DEAD AT ARRIVAL, AN ADDITIONAL 7 WERE DOWN. IT WAS REPORTED
THAT THE PIGS WERE "TURNING BLUE" IN THE BARN AT LOADING. 3/6/03: SITE VISIT BY BLANCO
REPRESENTATIVES. HANDLING AND LOAD OUT PROCEDURES OBSERVED; RECOMMENDATIONS FOR
IMPROVEMENT WERE MADE. FlU: 3/19/03: CRUDE PROTEIN IN DIET WAS 20%. GILTS NOT ON RACTOPAMINE THAT
WERE RECENTLY MOVED WERE ACTING STRESSED AND SOME WERE CRIPPLED. GENETICS CONSIDERED A
POSSIBLE CAUSE. ADDITIONAL 2 DIED: UNK IF THEY WERE ON RACTOPAMINE.
Causality
Assessment
2
2
2
2
Time
To Onset
UN
UN
UN
UN
Clinical Detail:
G CYANOSIS
G DEATH
G DIFFICULTY RISING
G RECUMBENCY
Source:
Country:
United States
State:
OBSERVER AT SHOW
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM_Report.rep
01115/2003
Unknown
Oral (in dry feed)
UNK AMT; JANUARY,2003
Unknown
INCREASED ADG, SHOW PIGS
Good
Unknown
No Value
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
PAYUS03019
UNK
#Treated:
4
#Reacted: 4
#Died:
0
Species: PIG
Age: UN
Weight:
200 LB
Page: 127
4 BARROWS AT SHOW WERE OBSERVED TO BE STRESSED AND UNABLE TO RISE. REPORTER KNEW THEY HAD
BEEN FED RACTOPAMINE BUT DID NOT KNOW DOSE. HE FELT THEY WERE FED MORE THAN THEY SHOULD HAVE
BEEN. HE HAD HEARD A GUEST SPEAKER AT ANOTHER SHOW SAY THAT RACTOPAMINE SHOULD NOT BE FED TO
PIGS BECAUSE IT CAUSED THEM TO STRESS AND DIE. REVIEWER COMMENT: INFORMATION IS FROM AN
OBSERVER, NOT AN OWNER, AGENT OR VETERINARIAN, THEREFORE, THE SIGNS RECEIVED A LOWER CAUSALITY
ASSESSMENT.
Causality
Assessment
0
0
0
Time
To Onset
UN
UN
UN
Clinical Detail:
G DIFFICULTY RISING
G RECUMBENCY
G RELUCTANTTOMOVE
Source:
Country:
United States
State:
MINNESOTA
Zip:
OWNER REPORT
Episode Date:
10/1 5/2002
56164
Dose Description: 4.5 GM/TON; X 14 DAYS; 10/02
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Owner
Source Report ld:
NDC:
Product Lot No:
PAYUS03021
UNK
#Treated:
250
#Reacted: 10
#Died:
4
Species: PIG
Age: UN
Weight: 250 LB
CM: 4 DEAD AND 6 DOWNERS WHEN PIGS WERE SHIPPED. THIS HAD NOT OCCURRED PRIOR TO FEEDING
RACTOP AMINE. THE FARM DISCONTINUED FEEDING RACTOPAMINE.
Causality
Assessment
2
2
Time
To Onset
2 WK
2 WK
CVM _ Repott.rep
Clinical Detail:
G DEATH
G RECUMBENCY
Page: 128
Document ID: N 140863 Submission ID: L 90 Package ID: A 1 Corrsp Date: 0410712003
PAYUS03024
Country:
United States NDC:
State:
INDIANA
Zip:
46818
Product Lot No:
UNK
OWNER REPORT, NUMBER AFFECTED NOT GIVEN
Episode Date:
0310212003
#Treated:
250
#Reacted: 100
0
Dose Description: 4.5 GMITON; 2110-3131103 Species: PIG
Extra Label:
None Breed: Other (pig)
Reason For Use:
INCREASE LEANNESS, FEED EFFICIENCY
Age: 4 MO
Weight: 225 LB
Health Status:
Good
Gender: Unknown
Administered By:
Owner
BREED: HAMROCK GENETICS. HAS USED RACTOPAMINE FOR 6 MONTHS WI EXCELLENT RESULTS. THE LAST 2
GROUPS HAD POORER CARCASS RESULTS. CARCASSES HAVE "LOOKED GREASIER". THESE ARE WI THE LEANEST
GENETIC LINES. INQUIRED ABOUT POSSIBLE INTERACTION WI OTHER FEED INGREDIENTS. *NUMBER OF
ANIMALS AFFECTED NOT PROVIDED.
Causality
Assessment
Time
0 NA E INEFFECT, LEAN CARCASS
0 NA G INTERACTION, DRUG(S)
Source:
Country:
State:
United States
IOWA
Zip:
XX XXX
OWNER REPORT
Episode Date:
0312412003
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS03023
UN
#Treated:
#Reacted:
#Died:
177
45
45
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
6 GM/TON; 4-5 WEEKS
Species subgroup
INCREASE FEED EFFICIENCY, CARCASSLEANNESS
Good
Owner
Unknown
Unknown
Species:
Breed:
Age:
Weight:
Gender:
Page: 129
PIG
Unknown (pig)
UN
300 LB
Group (m & f)
ELU: OVER WEIGHT-LABEL INDICATES USE UP TO 240 #. ON ARRIVAL, DURING UNLOADING AND SHORTLY
AFTER, 45 PIGS DIED; OTHERS POSSIBLY AFFECTED. FIRST TIME SHIPPING TO THIS PLANT. PIG HANDLING WAS
ROUGH, AMBIENT 70.
Causality
Assessment
2
Time
To Onset
5 WK
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
46991
Episode Date:
03/03/2003
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 GM/ TON X 2.5 TO 3 WKS; 2110 TO 3/3/03
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
PAYUS03025
UNK
#Treated:
200
#Reacted: 4
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight: 260 LB
. ELU: LABELED FOR USE UP TO 240 LBS. AGE: MARKET. 7 LOADS SENT TO BUYING STATION;
EACH) WENT DOWN. THE PIGS WERE ALLOWED TO REST THEN REGROUPED WITH THE
OTHER PIGS FOR SHIPMENT TO THE PROCESSING PLANT. THEY WERE PROCESSED AS USUAL.
CYM _Report. rep
Causality
Assessment
2
Time
To Onset
3 WK
Clinical Detail:
G RECUMBENCY
Page: 130
Source:
Country:
United States
State:
MISSOURI
Zip:
PRODUCER/PLANT
Episode Date:
04110/2003
Dosage: Reco111111ended dose
XX XXX
Dose Description: 4.5 GM/TON; 18-23 DAYS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Other
Good
Owner
Not applicable
No
Source Report Id:
PAYUS03027
NDC:
Product Lot No:
UNK
#Treated:
150000
#Reacted: 6500
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 270 LB
6500 ANIMALS ARE EVALUATED DAILY FOR MEAT COLOR. MEAT COLOR IS REPORTED LIGHTER THAN USUAL AT
PACKING PLANT. MEAT COLOR IS AN IMPORTANT FACTOR IN THE JAPANESE MARKET. THIS PRODUCER DECIDED
TO DISCONTINUE RACTOPAMINE USE IN CERTAIN AREAS OF PRODUCTION. NOTED THAT SEASONAL CHANGES
CAN AFFECT MEAT COLOR AND HEAVIER PIGS DO NOT CHILL AS THOROUGHLY CAISING MEAT TO BE LIGHTER IN
COLOR. FlU: 6/3/03: APPROX 6500 ANIMALS ARE EVALUATED DAILY FOR COLOR. SUBJECTIVE SCORING IS DONE
BY A JAPANESE EVALUATOR. JAPANESE HAVE A CULTURAL PREFERENCE FOR DARKER MEAT COLOR. LESS
THAN 20% OF CUTS MEET THE PASS RATE. PRODUCER HAS A DAILY QUOTA FOR A CERTAIN NUMBER OR
PERCENT OF MEAT CUTS HITTING THIS PRECISE RANGE AND CHANGES ARE MADE IN FEEDING AND HANDLING
PROGRAMS AS THE PERCENT HITTING THIS PASS RATE CHANGES. PRODUCER MONITORS THE PERCENT MEETING
THIS PASS RATE AND EVALUATES WHICH FACTORS CAN BE MANIPULATED TO AFFECT IT. THEY SEE A
SEASONAL DECLINE FROM WINTER TO SUMMER; FROM APRIL 15TH TO JULY 15TH THEY HAVE SEEN A
REDUCTION IN PASS RATES OVER THE LAST FEW YEARS. THIS YEAR THEY DETERMINED THAT RACTOPAMINE
MAY BE CONTRIBUTING TO THIS SEASONAL VARIATION AND REMOVED IT FROM THERA TION IN SEVERAL
COMPONENTS OF THEIR PRODUCTION SYSTEM.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G MEAT, ABNCOLOR
CVM _Report. rep
Page: 131
N 140863 L 96
Source:
Country:
United States
State:
IOWA
Zip:
INFORMATION LACKING
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
0412912003
Unknown
Oral (in dry feed)
UNKAMTS
Unknown
52041
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
PAYUS03028
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: UN
Weight: UN
VET INSPECTOR WI FOOD SAFETY INSPECTION SERVICE OBSERVED PIGS AT PACKING PLANTS THAT BECOME
WINDED, HAVE OPEN MOUTH BREATHING AND "GO DOWN. ALSO OBSERVED CORONARY BANDS BECOMING
LOOSE AND FALLING OFF. VET HAS BEEN WI FSIS A FEW WEEKS. COULD NOT PROVIDE ANIMAL NUMBERS OR
EVEN BE SURE OF RACTOP AMINE USE IN AFFECTED ANIMALS. HE WAS CALLING TO GET INFORMATION ON THE
PRODUCT.
Causality
Assessment
-8
-8
-8
Time
To Onset
UN
UN
UN
Clinical Detail:
G RECUMBENCY
N TREMBLING
R DYSPNEA
Source:
Country:
State:
United States
IOWA
Zip:
52073
PRODUCER REPORT
Episode Date: 0510212003
CVM _ Report.rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Corrsp Date: 05/1 512003
PAYUS03029
UNK
#Treated:
#Reacted:
5000
55
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
4.5 GM/TON X 4 WEEKS
Species subgroup
Good
Owner
No
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 132
0
PIG
Other (pig)
5.5 MO
275 LB
Group (m & f)
BREED: PIC. ELU: LABELED FOR USE UP TO 240 LBS. OWNER NOTICED MORE SQUEALING, HARDER TO HANDLE
PIGS AND PIGS HUDDLING IN THE BACK OF THE PEN. F/U: 50 TO 60 REACTED.
Causality
Assessment
2
2
2
Time
To Onset
4 WK
4 WK
4 WK
Clinical Detail:
G VOCALIZATION
N APPREHENSION
N HYPERACTIVITY
Source:
Country:
State:
United States
IOWA
Zip:
xxxxx
OWNER
Episode Date:
05115/2002
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 G/TON X 2 WEEKS; 9 G/TON X 2 WEEKS; 5/2002 TO
5/2003
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _ Repmt.rep
Species subgroup
Good
Owner
No
PAYUS03030
UNK
#Treated:
30000
#Reacted: 416
#Died:
100
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
272 LB
Page: 133
BREED: PIC/SIEGER CROSS. OVER THE PAST YEAR THE PRODUCER HAS SEEN AN INCREASE IN THE NUMBER OF
DEAD AND DOWN PIGS AT THE PACKING PLANT. WAS LOSING 1 PER 1000 HEAD, NOW IS LOSING 2 TO 3 PER 180
HEAD AND A TOTAL OF 10 DOWN AND DEADS AT A TIME. REPORT DOES NOT STATE# DEAD. LAST YEAR THE
FARM STARTED USING A PIC 337 BOAR CROSSED W/ SIEGER. DURING A PERIOD WHEN PIC 327 WAS USED THE
NUMBER OF DEAD/DOWNS DECREASED. FARM CONTINUES TO FEED RACTOPAMINE ONLY TO FINISHING
GIL TS(ELU). HAS CHANGED PACKER IN THE LAST YEAR.
Causality
Assessment
Time
To Onset
4 WK
4 WK
4 WK
Clinical Detail:
G DEATH
G DIFFICULTY RISING
G RECUMBENCY
Source:
Country:
United States
State:
OHIO
Zip:
OWNER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
06/ 12/2003
Recommended dose
Oral (in dry feed)
4.5 MG/TON
None
X XXX X
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
Source Report Id:
NDC:
Product Lot No:
PAYUS03032
UNK
#Treated:
4
#Reacted: 4
#Died:
0
Species: PIG
Breed: Mixed (pig)
Age: 4 MO
Weight: 184 LB
Gender: Unknown
BREED: YORKSHIRE CROSS. FOUR SHOW PIGS ON RACTOPAMINE FOR 2 WEEKS. NOT SHOWING EXPECTED
IMPROVEMENT. UNSURE OF THE CONCENTRATION IN THE FEED BUT THINKS THEY ARE GETTING 4.5 G/TON.
FlU: 9/24/03: FOLLOW UP PHONE CALLS NOT ANSWERED.
Causality
Assessment
0
Time
To Onset
NA
CVM _Report. rep
Clinical Detail:
Page: 134
Source:
Country:
State:
Foreign
Zip:
MEXICO
Episode Date:
05/0112003
Dosage: Altered dose
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 2.5 PPM X 15 DAYS THEN 5 PPM X 15 DAYS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Altered dose
Good
Owner
Low
No
PAYME03004
UNK
#Treated:
70000
#Reacted: 7000
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 23 WK
Weight: 100 KG
Gender: Missing information
BREED PIC. UNK #REACTED(# NOT PROVIDED). ELU: STEP UP FEEDING PROGRAM RECOMMENDED BY CARGILL
NUTRITIONIST-2.5 PPM X 15 DAYS THEN INCREASED TO 5PPM X 15 DAYS. RETAIL MEAT INSPECTORS DETECTED
CHLORINE- LIKE ODOR IN MEAT AFTER SLAUGHTER. PRODUCER STOPPED USING RACTOPAMINE. FlU: EXPERT
HIRED TO INVESTIGATE ODOR. FOUND THE STRANGE ODOR OCCURRED IN CERTAIN MEAT LOTS, NOT
UNIFORMLY; AND WAS UNABLE TO ASCERTAIN A CAUSE FOR THE ODOR. FUTURE GROUPS WILL BE FED
RACTOPAMINE AND EVALUATED FOR ODOR CONCERNS.
Causality
Assessment
Time
To Onset
30 DA
30 DA
Clinical Detail:
G MEATABN
G ODOR
Source:
Country:
State:
United States
INDIANA
Zip:
XX XXX
ELANCOREP
Episode Date:
06115/2002
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS03033
UNK
#Treated:
#Reacted:
1000
175
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
#Died:
4.5 G/TON X 60 DAYS
Species:
Species subgroup
Breed:
Age:
Weight:
Unknown
Gender:
Owner
Unknown
No Value
Page: 135
0
PIG
Mixed (pig)
7 MO
300 LB
Group (m & f)
ELANCO REP REPORTED ADE. CUSTOMER WAS ATTEMPTING TO MARKET HEAVIER PIGS. 2 GROUPS OF 500 PIGS
WERE FED RACTOPAMINE AT 4.5 G/TON FOR 60 DAYS. THEY DEVELOPED CRACKED HOOVES AND BECAME
TENDER FOOTED DURING THE LAST 14 DAYS OF TREATMENT AND REACHED APPROXIMATELY 300 LBS. ELU: NOT
FOR PIGS OVER 240 LB.
Causality
Assessment
2
2
Time
To Onset
7 WK
7 WK
Clinical Detail:
G HOOF DISORDER
G LAMENESS
Source:
Country:
State:
United States
NEBRASKA
Zip:
68045
VET
Episode Date:
06/15/2002
Dose Description: 4.5 G/TON X 21-28 DAYS IN 2002
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
Unknown
Owner
High
Unknown
PAYUS03034
UNK
#Treated:
1000
#Reacted: 85
#Died:
20
Species: PIG
Age: 6 MO
Weight: 240 LB
Page: 136
H/0 21180 PIGS TYPICALLY DOWN WHEN SHIPPING. THIS INCIDENCE INCREASED TO 161180 OR 700% OVER
NORMAL. THE PIGS WERE NOTED TO BE TREMBLING AT THE TIME OF LOADING AND DIED ON THE TRUCK. DDX:
HEAT STROKE. NOTE: THE NUMBER OF TRUCKLOADS IS NOT DESCRIBED. ELANCO WAS CONTACTED ABOUT
THIS AND HAS STATED THEY WILL SEND IN A CORRECTED REPORT.
FlU: 7116/03: VET REPORTED THAT HE SAW INCREASE IN DOWNERS AND DEADS WITH A NUMBER OF PRODUCERS
IN 5 OR 6 LOADS OF 180 HEAD/LOAD. PROBLEM PEAKED IN HOTTER MONTHS AND SO THE MAJORITY OF
PRODUCERS DISCONTINUED RADCTOPAMINE USE DURING THOSE MONTHS OR WOULD ONLY USE IT IN PIGS LEFT
OVER AFTER AN INITIAL GROUP WENT TO SLAUGHTER. VET STATED THAT HE HAS NOT BEEN NOTIFIED OF
COMPLAINTS RECENTLY BUT THIS COULD BE DUE TO THE DECREASE IN USE OF RACTOPAMINE BECAUSE OF THE
HEAT. NUMBER OF DEATHS NOT REPORTED.
Causality
Assessment
2
2
2
Time
To Onset
UN
UN
UN
Clinical Detail:
G COLLAPSE
G DEATH
N TREMBLING
Source:
Country:
State:
United States
FLORIDA
Zip:
32327
ow
Episode Date:
02/23/2003
Dose Description: 9 G/TON X 10 DAYS; 2/ 12/03
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Vet Opinion: Low
PAYUS0320
UNK
#Treated:
2
#Reacted:
#Died:
0
Species: PIG
Age: UN
Weight: 233 LB
SHOW PIGS. ONE HAD HEMATURIA AT THE SHOW. RECOVERED W/0 RTX. SHOW VET SUSPECTED POSSIBLE
KIDNEY STONE.
Causality
Assessment
0
CVM _ Repmt.rep
Time
To Onset
10 DA
Clinical Detail:
U BLD, URINE
Page: 137
Document ID: N 140863 Submission ID: L Ill
Source:
Country:
United States
State:
IOWA
BLANCO SALES REP
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
50536
05/03/2003
Recommended dose
Oral (in dry feed)
4.5 AND 9 G/TON X 28 DAYS
Species subgroup
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
High
No
PAYUS03035
UNK
#Treated:
56000
#Reacted: 56000
#Died:
0
Species: PIG
Breed: Other (pig)
Age: VA
Weight: 230 LB
WEIGHT: 210-275 LBS; LABEL INDICATES USE IN PIGS 150 TO 240 LBS. BREED: GENETIPORC. FARM HAD FED AT 4.5
G/TON X 28 DAYS FOR 9 MONTHS. ON 511/03 THE FARM INCREASED THE DOSE TO 9 G/TON X 28 DAYS. WITH IN 2
DAYS THE PIGS HAD AN INCREASE IN ACTIVITY, ANXIETY AND WERE NOTICEABLY JUMPIER. THIS BEHAVIOR
WAS MORE NOTICEABLE DURING LOADING AN SORTING BUT WAS OBSERVED BY FARM EMPLOYEES DURING THE
DAILY ROUTINE. SOME ANXIETY HAD BEEN NOTICED AT THE LOWER DOSE BUT TO A LESSER EXTENT. FARM IS
ADDING ELECTROLYTES TO WATER 2 DAYS BEFORE LOADING. THIS HAS DECREASED BUT NOT ELIMINATED THE
SIGNS. FARM IS NOW FEEDING AT 4.5 G/TON TO REDUCE EXCITABILITY AND TO PREVENT ENDANGERING
WORKERS. FARM NO LONGER HAS COMPLAINTS W/ RACTOPAMINE.
Causality
Assessment
4
4
Time
To Onset
2 DA
2 DA
Clinical Detail:
N APPREHENSION
N HYPERACTIVITY
Source:
Country:
United States
State:
CALIFORNIA
ASPCANET
CVM _Report. rep
Zip:
93420
Source Report Id:
PAYUS03036
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/07/2003
Not applicable
Oral (in dry feed)
9 G/TON; 7/7/03
Species
ACCIDENTAL
Good
Not applicable
Low
Yes
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
POSSIBLE EXPOSURE TO MANEB, CURZATE, MONITOR
Page: 138
3
3
0
DOG
Retriever, labrador
3 YR
65 LB
Male
3 MALE DOGS PRESENTED TO VET CLINIC W/ PARALYSIS AND VOCALIZATION AFTER POSSIBLE ORAL AND
DERMAL EXPOSURE TO RACTOPAMINE, MONITOR(ORGANOPHOSPHATE),
MANEB(ETHYLENE(BIS)DITHICARBAMATE PESTICIDE) AND CURZATE (FUNGICIDE). DOGS WERE TREATED WI
BATHS, FLUIDS, ELECTROLYTES, ACT CHARCOAL AND ATROPINE. SIGNS LASTED 2 DAYS; FULL RECOVERY.
Causality
Assessment
-9
-1
-1
Time
To Onset
NA
UN
UN
Clinical Detail:
G VOCALIZATION
N PARALYSIS
Source:
Country:
State:
Episode Date:
Dosage:
Route:
United States
CALIFORNIA
Zip:
XX XXX
07/07/2003
Recommended dose
Dose Description:
Oral (in dry feed)
4.5 G/TON; 6/2003
Extra Label:
None
Reason For Use:
CVM _Report. rep
Source Report ld:
NDC:
Product Lot No:
PAYUS03037
UNK
#Treated:
3
#Reacted: 3
#Died:
3
Species: PIG
Age: UN
Weight:
175 LB
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
Unknown
Gender:
Page: 139
Unknown
FEED COMPANY RECEIVED COMPLAINT FROM CUSTOMER THAT SHOW PIGS FED "SHOW STOPPER FEED" HAD 3
PIGS DIE. THE BREED OF PIG CARRIES "THE HIGH STRESS GENE" .
Causality
Assessment
Time
2 1 MO G DEATH
Source:
Country:
United States
State:
OHIO
OWNER
Episode Date:
07118/2003
Zip:
Dose Description: 6115 AND 16, 2003
Extra Label:
Species
Reason For Use:
ACCIDENTAL
Health Status:
Good
Administered By:
Not applicable
Concomitants: No
45304
Source Report Id:
PAYUS03038
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: DOG
Breed: Great dane
Age: 1 YR
Weight: 100 LB
Gender: Female
DOG CONSUMED UNK QUANTITY OF HOG FEED. DEVELOPED SEVERE DIARRHEA WHICH HAD SUBSIDED BY THE
TIME OF THE CALL, 7118/03. NO RTX.
Causality
Assessment
2
-9
CVM _Report. rep
Time
To Onset
1 DA
NA
Clinical Detail:
D DIARRHEA, SEVERE
Page: 140
Source:
Country:
State:
United States
MONTANA
Zip:
59456
OWNER
Episode Date:
07119/2003
Dose Description: 9 GM/TON; 6/29 THRU 7119/03
Extra Label: None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCRESAED ADG, CARCASS LEANNESS, FEED
EFFICIENCY
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
PAYUS03039
UNK
#Treated:
205
#Reacted: 27
#Died:
27
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
234 LB
BREED: COTSWALD. PRODUCER HAD BEEN FEEDING AT 4.5 G/TON SINCE JANUARY, 2003. INCREASED TO 9
GM/TON JUNE 12, 2003 AND FED IT FOR 21 DAYS. WITH THE HIGHER DOSE HE INCREASED HIS DAYS TO MARKET
BY 10 DAYS(DOES HE MEAN DECREASED?) BUT LOST 0.5% LEANNESS. 200 TO 210 PIGS WERE SHIPPED JULY 19,
ARRIVED JULY 20, 2003 WITH 27 DEAD ON THE TRUCK. ANOTHER PRODUCER W/ THE SAME BREED BEING FED 4.5
GM/ TON HAD 50 PIGS ON THE SAME TRUCK WITH NONE ARRIVING DEAD. PRODUCER HAD NOT HAD THIS
PROBLEM AT THE LOWER DOSE. FlU: CONTINUES TO USE RACTOPAMINE AT 4.5 GM/TON W/0 PROBLEMS. FED
ONLY 2 LOADS AT 9 GM/TON; ONE LOAD HAD PROBLEMS, OTHER DID NOT.
Causality
Assessment
2
Time
To Onset
21 DA
Clinical Detail:
G DEATH
Source:
Country:
State:
Episode Date:
Dosage:
CVM _Report. rep
United States
ILLINOIS
Zip:
61421
Good
07/26/2003
Not applicable
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
PAYUS03040
UNK
#Treated:
#Reacted:
Page: 141
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
UNKNOWN
Species
EXPOSED WHILE FEEDING PIGS
Good
Not applicable
Not applicable
No
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
29 YR
UN
Male
FED RACTOPAMINE FOR THE FIRST TIME THAT MORNING BETWEEN 7 TO 11 AM. SHORTLY AFTER, HE WAS
ADMITTED TO THE ER WITH A HIGH HEART RATE. SPENT THE WHOLE DAY ON A CARDIAC MONITOR. AT TIME OF
THE CALL TO RMPDC, THE MAN WAS HOME WITH A SLIGHTLY ELEVATED HR. MIXING THE RACTOPAMINE WAS
THE ONLY DIFFERENT THING HE HAD DONE THAT DAY. HE HAD USED PROTECTIVE GEAR BUT UNSURE IF HE
SHOWERED AFTER EXPOSURE. FlU ON 7/29/03: HR NORMAL BY 4 PM, 7/27. EXPERIENCED MINOR BODY ACHES BUT
WAS FEELING BETTER.
Causality
Assessment
2
Time
To Onset
1 HR
Clinical Detail:
C TACHYCARDIA
2 1 HR G PAIN
Source:
Country:
State:
Foreign
Zip:
OWNER
Episode Date:
07/24/2003
Dose Description: 5 PPM; 617/03 TO 7/4/03
Extra Label: None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE FEED EFFICIENCY AND RATE OF GAIN
Health Status:
Good
CVM _Report. rep
PAYME03005
UNK
#Treated:
2000
#Reacted: 2000
#Died:
0
Species: PIG
Age: 155 DA
Weight:
80 KG
Page: 142
Administered By:
Owner
Vet Opinion: Medium
Concomitants: No
MEXICO. NO RESULTS AFTER 28 DAYS OF TREATMENT. PREVIOUSLY ADMINISTERED PA YLEAN FOR 180 DAYS AT
98 KGS AND 90 KGS WITH SATISFACTORY RESULTS. OWNER CONTINUES TO USE PRODUCT AND BELIEVES POOR
MIXING MAY HAVE CONTRIBUTED TO THE LACK OF EFFICACY. UNKNOWN IF CRUDE PROTEIN IN THE RATION
WAS ADEQUATE.
Causality
Assessment
Time
Source:
Country:
State:
Foreign
Zip:
ow
Episode Date:
07/24/2003
Dose Description: 5 PPM; 617/03 TO 7/4/03
Extra Label:
None
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
IMPROVED FEED EFFICIENCY AND RATE OF WEIGHT
GAIN
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
Concomitants: No
PAYME03006
UNK
#Treated:
1500
#Reacted: 1500
#Died:
0
Species: PIG
Age: 140 DA
Weight:
80 KG
Gender: Group (rn & f)
MEXICO. NO RESULTS AFTER 28 DAYS OF ADMINISTRATION. HAD TREATED PRVIOUSLY FOR 170 DAYS AT 105
AND 98 KGS WEIGHT W/ SATISFACTORY RESULTS. OWNER CONTINUES TO USE RACTOPAMINE AND BELIEVES
POOR MIXING MAY HAVE CONTRIBUTED TO LOE.
Causality
Assessment
CVM _ Repmt.rep
Time
Page: 143
Source:
Country:
United States
State:
ILLINOIS
Zip:
X XXX X
VET
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
08/20/2003
Recommended dose
Oral (in dry feed)
4.5 GM/TON; 7/23/03 TO 8/20/03
Species subgroup
Package ID: A 4
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
PAYUS03042
UNK
#Treated:
2000
#Reacted: 500
#Died:
500
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 270 LB
PIC GENETICS. ELU: AT END OF TREATMENT PERIOD, AVERAGE WEIGHT WAS OVER LABEL MAXIMUM WEIGHT
OF 240 LBS. PLANT WAS SHUT DOWN WITH SEVERAL TRUCKS STILL IN LINE. OUTSIDE TEMP WAS 100 DEGEES F.
MANY PIGS HELD FOR 4 HOURS OR MORE. APPROXIMATELY 500 PIGS DIED ON THE TRUCK. A TOTAL OF 2000 PIGS
DIED THAT DAY FROM VARIOUS TRUCKS/PRODUCERS.
Causality
Assessment
Time
0 4 WK G DEATH
Source:
Country:
United States
State:
OHIO
ASPCA POISON CONTROL
Episode Date:
Dosage:
Route:
Dose Description:
CYM_Repmt.rep
08/08/2003
Not applicable
Oral (all other)
UNK; 8/8/03
Zip:
45439
Source Report ld:
PAYUS03041
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: DOG
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species
ACCIDENTAL
Good
Not applicable
Unknown
Unknown
Breed:
Age:
Weight:
Gender:
Page: 144
Retriever, labrador
6 YR
99 LB
Male, neutered
DOG ATE UNK AMOUNT OF SWINE FEED CONTAINING RACTOPAMINE. HR=190, TEMP=104, INJECTED MM. HEART
RATE AND TEMP WERE MONITORED BY VET. RTX: PROPANOLOL, FLUIDS, SYMPTOMATIC CARE. FOLLOW UP
PHONE CALL 8111-HRDECREASED AFTERPROPANOLOL.
Causality
Assessment
2
-9
2
Time
To Onset
6 HR
NA
6 HR
Clinical Detail:
C TACHYCARDIA
G FEVER, BODY
2 6 HR G MUCOUS MEMBR, ABN COLO
Source:
Country:
United States
State:
IOWA
VET AT STATE FAIR
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
50554
08/05/2003
Unknown
Oral (in dry feed)
UNK AMT; mL, AUGUST 2003
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
Good
Owner
High
Unknown
PAYUS03044
UNK
#Treated:
2
#Reacted: 2
#Died:
2
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
VA
Page: 145
lOW A STATE FAIR; AUGUST 5-11 , 2003. 15 TO 20 PIGS OUT OF APPROXIMATELY 1500 APPEARED HOT, THEIR
MUSCLES "TIED UP" AND THEY LOOKED LIKE THEY WERE CONVULSING. 3 PIGS DIED. THE REST WERE RESTED
AND MOST RECOVERED. A FEW WERE NOT SHOWN BUT WERE SENT TO SLAUGHHTER AS "SUBJECT". VET KNEW
THAT 2 OF THE 3 DEAD PIGS WERE ON RACTOPAMINE BUT WAS UNSURE OF THE REST. ON FOLLOW UP VET
STATED HE HAD SIMILAR PROBLEMS AT LAST YEARS STATE FAIR. THE MAJORITY OF CASES OCCURRED WHEN IT
WAS HOT AND AS THE PIGS WERE UNLOADED, ESPECIALLY AFTER TRA YELLING LONGER DISTANCES OR SITTING
IN LINE IN THE TRAILERS. VET WAS CALLING FOR TREATMENT RECOMMENDATIONS. ALSO REPORTED 2 LAMBS
HAD TESTED POSITIVE AT THE STATE FAIR LAMB SHOW.
REVIEWER NOTE-ONLY 2 PIGS REPORTED BECAUSE OTHERS NOT KNOWN FOR CERTAIN TO HAVE BEEN FED
RACTOP AMINE.
Causality
Assessment
Drug Name:
Time
To Onset
UN
UN
UN
UN
UN
RACTOPAMINE
Clinical Detail:
G DEATH
G FEVER, BODY
G SPASM
N CONVULSION(S)
N HYPERTONIA
Source:
Country:
United States
State:
MICHIGAN
Zip:
VET
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
07/15/2001
Unknown
Oral (in dry feed)
UNK
Unknown
48875
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED WEIGHT GAIN, CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
No Value
PAYUS03043
UNK
#Treated:
3
#Reacted: 2
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Female
VET REQUESTED INFO RE: FEEDING EFFECT OF RACTOP AMINE ON ESTRUS CYCLES OF HEIFERS. TWO TO THREE
YEARS AGO, A PRODUCER HAD HAD PURCHASED 2 OR 3 GILTS FROM A 4-H MARKET HOG SALE. PRODUCER
ATTEMPTED TO BREED THEM. HE HAD DIFFICULTY GETTING THE GILTS TO CYCLE AND SPECULATED THAT
THEY MAY HAVE BEEN FED RACTOP AMINE.
CVM _Report. rep
RACTOP AMINE EXPOSURE NOT KNOWN FOR SURE.
Causality
Assessment
-8
-8
-8
Time
To Onset
UN
UN
UN
Clinical Detail:
X ANESTRUS
X ESTRUS CYCLE ABNORMAL
X FERTILITY, REDUCED
Page: 146
Source:
Country:
United States
State:
INDIANA
Zip:
RESEARCH STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
04/05/1991
Recommended dose
Oral (in dry feed)
20 PPM; 4/4-711991
None
46158
Reason For Use:
INCREASED ADG, CARCASS LEANESS
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Source Report ld:
AF6679105
NDC:
Product Lot No:
UN
#Treated:
10
#Reacted: 5
#Died:
5
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight:
65 KG
Gender: Male
A 20 PIG RESEARCH STUDY# AF6679105 WAS TERMINATED PRIOR TO COMPLETION DUE TO ILLNESS IN SEVERAL
OF THE PIGS. TEMP 103-104. ONE WAS FOUND DEAD. NECROPSY: MILKY, WHITE SUBSTANCE IN BLADDER;
URETHRA BLOCKED W/ BLOOD. HEART SAC CONTAINED APPROC 200 ML CLEAR YELLOW FLUID INDICATING
PERICARDITIS, AND PALE MUSCLE. LUNG WAS EMPHYSEMATOUS AND ANIMAL'S NOSE SHOWED EXTERIOR
EVIDENCE OF RHINITIS. STUDY WAS TERMINATED ON 4/ 18/91 DUE TO ELEVATED TEMPS AND FEED
CONSUMPTION PROBLEMS. RTX: 6 CC OXYTET AND 10 CC ISOFLUPREDONE.
Causality
Assessment
0
0
CVM _Report. rep
Time
To Onset
3 DA
1 DA
3 DA
3 DA
Clinical Detail:
c PR-PERICARDIAL EFFUSIO
G ANOREXIA
G BLD
G DEATH
Page: 147
1 DA G FEVER, BODY
3 DA G PALLOR
3 DA M PR-MUSCLE(S), LESION(S)
0 3 DA
0 3 DA
U PR-BLADDER, LESION(S)
U PR-URETHRA, LESION(S)
Document ID: N 140863 Submission ID: L 131 Package ID: A. 2
Source:
Country:
State:
Foreign
Zip:
BRAZIL
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/05/2003
Recommended dose
Oral (in dry feed)
5PPM, 28 DAYS
None
INC ADG, CARCASS LEANESS
Good
Owner
Medium
No Value
Source Report ld:
NDC:
Product Lot No:
PAYBR03001
UNK
#Treated:
515
#Reacted: 5
#Died:
5
Species: PIG
Breed: Other (pig)
Age: 158 DA
Weight:
104 KG
BRAZIL. BREED: PIC. DIED DURING TRANSPORT TO SLAUGHTER. PROBLEMS IN STRUCTURE AND ADEQUATE
AREA FOR HANDLING ANIMALS DURING TRANSPORT.
Causality
Assessment
2
Time
To Onset
4 WK.
Clinical Detail:
G DEATH
Document ID: N 140863 SubmissioniD: L 131
Source:
Country:
CVM _ Report.rep
United States
Source Report ld:
T4V060311-002
NDC:
Page: 148
State:
INDIANA
Zip:
46140
Product Lot No:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/09/2003
Recommended dose
Oral (in dry feed)
5 PPM; 8/26/03 TO 9/9/03
None
INCREASE ADG, FEED EFFICIENCY, CARCASS
LEANNESS
Good
Owner
Unknown
Unknown
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
92.2 KG
Female
BREED: GENETIPORC V300 PROGENY. FOUND DEAD; RECORDED AS GI SYSTEM AFFECTED, SUBSYSTEM OTHER-
HEMORRHAGE. NECROPSY RESULTS NOT AVAILABLE.
Causality
Assessment
Drug Name:
Time
To Onset
2 WK
2 WK
2 WK
RACTOP AMINE
Clinical Detail:
D BLD, GI
G BLD
G DEATH
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
09/08/2003
Dose Description: 5PPM; 8118 THRU 9110/03
CYM _ Report.rep
46140
Source Report ld:
T4V370312-003
NDC:
Product Lot No:
634PP2
#Treated:
220
#Reacted:
#Died:
Species: PIG
Page: 149
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASE ADG, CARCASS LEANNESS, IMPROVED FEED
EFFICIENCY
Good
Owner
Unknown
No Value
Breed:
Age:
Weight:
Gender:
Other (pig)
23 DA
95.1 KG
Male, neutered
ONE PIG HAD LABORED BREATHING AND WAS REMOVED FROM THE STUDY. NECROPSY RESULTS NOT
AVAILABLE.
Causality
Assessment
Time
To Onset
23 DA
Clinical Detail:
R DYSPNEA
Source:
Country:
United States
State:
INDIANA
Zip:
P A YLEAN CLIN STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
09/10/2003
Recommended dose
Oral (in dry feed)
10 PPM; 9/2-22/03
None
46140
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INC RATE OF GAIN, IMPROVED FEED EFFICIENCY,
CARCASS LEANNESS.
Health Status:
Good
Administered By:
Owner
T4V370312-006
UN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
107.3 KG
Female
BREED: MONSANTO CHOICE GENETICS EB PROGENY. PIG #44 FROM PEN 3 WAS REMOVED FROM THE STUDY DUE
TO LAMENESS AFTER RECEIVING RACTOPAMINE FOR 20 DAYS.
Causality
Assessment
-1
CVM _ Rep01t.rep
Time
. To Onset Clinical Detail:
UN G DEATH(SLAUGHTERED)
Page: 150
2 20 DA G LAMENESS
Source:
Country:
United States
State:
INDIANA
Zip:
46140
Episode Date:
09/12/2003
Dose Description: 10 PPM; 8/18-9/17/03
Extra Label: None
Reason For Use:
Health Status:
Good
Administered By:
Owner
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
T4V370312-004
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
87.2 KG
Female
AFTER 30 DAYS ON RACTOP AMINE, PIG #85 FROM PEN 16 WAS REMOVED FROM THE STUDY DUE TO ANOREXIA
AND AN EYE ABSCESS.
Causality
Assessment
-1
-1
Time
To Onset
30 DA
30 DA
30 DA
Clinical Detail:
G ANOREXIA
S INFECTION, EYE(S)
Source:
Country:
State:
United States
IOWA
Zip:
50171
CVM _Report. rep
Source Report ld:
NDC:
Product Lot No:
PAYUS03046
UNK
INFO CAME FROM NEWSPAPER ARTICLE
Episode Date:
08113/2003
#Treated:
#Reacted:
Dose Description: UNKAMT Species:
Extra Label:
Species Breed:
Reason For Use:
UNK
Age:
Weight:
Health Status:
Unknown
Gender:
Administered By:
Owner
Page: 151
2
2
0
VARIOUS
Various
UN
UN
Male, neutered
2 FAMILIES WERE BANNED FROM THE lOW A STATE FAIR FOR ILLEGAL USE OF RACTOP AMINE IN A LAMB AND A
STEER EXHIBITED. OWNER OF THE STEER REPORTED THAT HE HAD GROUND FEED FOR PIGS CONTAINING
RACTOPAMINE AT 9 GM/TON. ON AUGUST 10, 2003, HE USED BUCKETS THAT HAD PREVIOUSLY CONTAINED PIG
FEED TO FEED THE STEER. FlU: LAMB TESTED POSITIVE FROM RANDOM URINE TESTING AFTER THE SHOW.
OWNER OF THE LAMB INDICATED HE HAD NOT FED RACTOPAMINE BUT HAD USED OTHER FEEDS W/ UNK
INGREDIENTS: SUBMITTED 5 FEED SAMPLES FOR TESTING. NONE WERE POSITIVE. UNK IF ANY HAD BEEN FED TO
THE LAMB.
Causality
Assessment
Time
2 3 DA G RESIDUE, MEAT
2 UN G RESIDUE, URINE
Source:
Country:
United States
State:
IOWA
MISSING INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
CVM _Report. rep
Zip:
09/23/2003
Not applicable
Oral (in dry feed)
UNKAMT
Species subgroup
xxxxx
Package ID: A 5
Source Report ld:
NDC:
Product Lot No:
PAYUS03045
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
PIG
10
10
0
Unknown (pig)
Reason For Use:
ACCIDENTAL
Health Status:
Unknown
Administered By:
Not applicable
Vet Opinion: Low
Weight:
Gender:
Page: 152
UN
65 LB
Unknown
PRODUCER REPORTED THAT AUGER USED TO MIX FEED CONTAINING RACTOPAMINE WAS NOT CLEANED BEFORE
BEING USED TO MIX FEED FOR 60-70 LB PIGS. THE SMALLER PIGS WERE SQUEALING WHILE MOVING AND
ACTING LIKE THEIR FEET WERE SORE. UNK # EXPOSED OR REACTED.
Causality
Assessment
-9
-8
-9
-8
Time
To Onset
NA
UN
NA
UN
Clinical Detail:
G TECH ERROR, MIXING
G VOCALIZATION
Source:
Country:
United States
Source Report ld:
NDC:
State:
MINNESOTA
Zip:
56169
Product Lot No:
PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/11/2003
Recommended dose
Oral (in dry feed)
4.5 G/TON X 10 DAYS THEN 9 G/TON X 10 DAYS; SINCE
8/20/03
None
INCREASE ADG, IMPROVED FEED EFFICIENCY,
CARCASS LEANNESS
Good
Owner
No Value
PAYUS03047
UNK
#Treated:
1500
#Reacted: 17
#Died:
17
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
255 LB
BREED: NGT. PIGS DIED AT LOADING, DURING TRANSPORT OR AT ARRIVAL AT THE PLANT. HANDLERS WERE
COMPETENT AND CAREFUL. PIGS WOULD SHAKE AND GO DOWN BEFORE THEY DIED. PRODUCER UNSURE IF HE
CVM _Report. rep
Page: 153
WILL CONTINUE TO USE RACTOPAMINE.
Causality
Assessment
2
2
2
2
Drug Name:
Time
To Onset
20 DA
20 DA
20 DA
20 DA
RACTOP AMINE
Clinical Detail:
G COLLAPSE
G DEATH
G RECUMBENCY
G SHAKING
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
09/29/2003
Recommended dose
Oral (in dry feed)
10 PPM; 8118-9/29/03
None
46140
PackageiD: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INC ADO, IMPROVE FEED EFFICIENCY, CARCASS
LEANNESS
Health Status:
Good
Administered By:
Owner
Concomitants: No
T4V370312-012
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
100.1 KG
Female
BREED: MONSANTO CHOICE GENETICS EB PROGRNY. PIG IN P A YLEAN CLIN STUDY WAS REMOVED DUE TO
LAMENESS. NECROPSY RESULTS NOT AVAILABLE.
Causality
Assessment
Time
To Onset
6 WK
Clinical Detail:
G LAMENESS
Source:
Country:
CVM _Report. rep
United States
Source Report ld:
T4V370312-008
NDC:
State:
INDIANA
Zip:
46140
Product Lot No:
634PP2
OWNER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/24/2003
Recommended dose
Oral (in dry feed)
5 PPM; 9/2 TO 9/24/03
None
INC ADG, IMPROVE FEED EFFICIENCY, CARCASS
LEANNESS
Good
Owner
Unknown
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 154
220
PIG
Other (pig)
23 WK
97.7 KG
Female
PIG FROM P A YLEAN CLINICAL STUDY WAS FOUND DEAD; NECROPSY RESULTS NOT AVAILABLE.
Causality
Assessment
Time
To Onset
22 DA
Clinical Detail:
G DEATH
Source:
Country:
United States
State:
IOWA
PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
XX XXX
10/08/2003
Recommended dose
Oral (in dry feed)
9/G/TON FOR 14-19 DAYS
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
CVM _ Repmt.rep
PAYUS03049
UNK
#Treated:
541
#Reacted: 28
#Died:
15
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 262 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Gender:
Page: 155
Group (m & f)
BABCOCK GENETICS. HIU: SWINE INFLUENZA VIRUS HAD DECREASED EFFICIENCY IN THE GROUP. PRODUCER
HAD 3 SHIPMENTS WITH SOME DEADS AND SLOWS ON ARRIVAL AT PLANT. PRODUCER PLANS TO CONTINUE
RACTOPAMINE AT LOWER DOSE IN ONE GROUP AND TO USE A STEP UP PROGRAM IN A SECOND GROUP.
Causality
Assessment
2
2
Time
To Onset
14 DA
14 DA
Clinical Detail:
G DEATH
G RELUCTANT TO MOVE
Source:
Country:
State:
United States
INDIANA
Zip:
XX :XXX
PRODUCER
Episode Date:
10/08/2003
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 G/TO X 2 WKS THEN 9 G/TON X 3 WKS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
No
PAYUS03050
UNK
#Treated:
190
#Reacted: 5
#Died:
5
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 237 LB
PREMIERE GENETICS. PRODUCER NORMALLY HAD 1 OR 2 DEADS PER LOAD WHEN FEEDING RACTOPAMINE AT
4.5 G/TON FOR 28 DAYS. HE RECENTLY CHANGED TO A PROGRAM OF FEEDING 4.5 G FOR 2 WEEKS THEN
INCREASING TO 9 G/TON FOR 3 WEEKS. HE HAD 5 DEAD ON A TRUCK ARRIVING AT THE PLANT ON 10/ 8/03. THE
TRIP WAS 4.5 HRS AND THE PRODUCER HAS HAD HAULING TROUBLE WITH THIS PARTICULAR TRUCKER IN THE
PAST.
CYM _Report. rep
Page: 156
Causality
Assessment
Time
2 5 WK G DEATH
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
10/16/2003
Dose Description: 10 PPM; 10113-20/03
Extra Label:
None
46140
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INC RATE OF GAIN, FEED EFFICIENCY, CARCASS
LEANNESS
Health Status:
Good
Administered By:
Owner
Concomitants: No
T431 0309-001
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
90.9 KG
Male, neutered
DANBRED PROGENY. PIG NUMBER 714 FROM PEN 32 WAS REMOVED FROM THE STUDY DUE TO LAMENESS.
EUTHANIZED AND NECROPSIED-RESULTS NOT AVAILABLE AT TIME OF REPORT.
Causality
Assessment
Time
-1 7 DA G DEATH(EUTHANIZED)
2 3 DA G LAMENESS
Source:
Country:
United States
State:
INDIANA
CLINICAL STUDY
CVM _Report. rep
Zip:
46140
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
T4V310309-002
634PP2
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/15/2003
Recommended dose
Oral (in dry feed)
10 PPM; 10/15-21/03
None
INCREASE RATE OF GAIN, CARCASS LEANNESS, FEED
EFFICIENCY.
Good
Owner
Unknown
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 157
220
PIG
Other (pig)
23 WK
78.3 KG
Male, neutered
BREED: DANBRED PROGENY. REMOVED FROM STUDY DUE TO LABORED BREATHING. EUTHANIZED AND A
NECROPSIED-RESULTS NOT AVAILABLE AT TIME OF REPORT.
Causality
Assessment
-1
0
Time
To Onset
6 DA
6 DA
Clinical Detail:
G DEATH(EUTHANIZED)
R DYSPNEA
United States
Source Report Id: . T4V370313-002
Country:
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
10/ 10/2003
Recommended dose
Oral (in dry feed)
5PPM; 10/5-10/03
None
NDC:
46140
Product Lot No:
Reason For Use:
INCEASED ADG, CARCASS LEANNESS, FEED
EFFICIENCY
Health Status:
Good
Concomitants: No
CVM _Report. rep
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
86.9 KG
Male, neutered
Page: 158
BREED: NEWSHAM PROGENY. REMOVED FROM THE STUDY DUE TO EAR INFLAMMATION. EUTHANIZED AND
NECROPSIED.
Causality
Assessment
Time
-1 5 DA S OTITIS
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
10/20/2003
Dose Description: 10 PPM; 10/5-20/03
Extra Label:
None
46140
Package ID: A 5
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, CARCASS LEANNESS, INCREASE FEED
EFFICIENCY
Health Status:
Good
Administered By:
Owner
Concomitants: No
T4V370313-003
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
101.4 KG
Female
REMOVED FROM THE STUDY DUE TO LAMENESS. EUTHANIZED AND NECROPSIED-RESULTS NOT AVAILABLE AT
TIME OF REPORT.
Causality
Assessment
Time
- 1 15 DA G DEATH(EUTHANIZED)
15 DA G LAMENESS
Source:
Country:
CYM _ Repmt .rep
Foreign
Package ID: A 1
Source Report ld:
NDC:
PAYC003001
State:
Zip: Product Lot No:
UNK
DOSAGE NOT EXPLAINED
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/05/2003
Unknown
Oral (in dry feed)
250 G/TON-MA Y BE ERROR; FOR 4 WEEKS IN 9/2003
Unknown
INC WEIGHT GAIN AND IMPROVED FEED EFFICIENCY
Fair
Veterinarian
Medium
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 159
1500
4
4
PIG
Other (pig)
155 DA
98 KG
Group (m & f)
REPORT FROM COLUMBIA. BREED: PIC. DOSE REPORTED AS 250 G/TON WITH NO MENTION OF THIS AS AN
OVERDOSE. POSSIBLY ERRONEOUSLY REPORTED. 4 PIGS DIED DURING 3 HOUR TRANSPORT TO SLAUGHTER.
Causality
Assessment
Time
To Onset
4 WK
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
TEXAS
Zip:
79602
Episode Date:
10/19/2003
Dose Description: PRIOR TO 9/30/03; UNK AMT
Reason For Use:
ACCIDENTAL
CVM _ Repmt.rep
Package ID: A 3
Source Report Id:
NDC:
Product Lot No:
PAYUS03051
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
PIG
Unknown (pig)
UN
UN
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Not applicable
Gender:
Unknown
Page: 160
Female
CALLER PURCHASED A 50 LB GILT AROUND 10/ 1103 THAT HAD BEEN ACCIDENTALLY EXPOSED TO RACTOPAMINE.
CALLER THOUGHT PIG HAD CONSUMED A 25 LB BUCKET OF PRODUCT CONTAINING RACTOPAMINE AT 18 G/LB.
HAS RECEIVED NO RACTOPAMINE FOR AT LEAST 3 WEEKS BUT HAS CONTINUED TO GET LARGER AND LARGER
AND HER HIND QUARTERS ARE 2/3 LARGER THAN THE OTHERS. SHE WAS UNABLE TO WALK ON 10/19/03 AND
DIED. THE OWNER REPORTS THAT THE GILT MAY HAVE THE STRESS GENE; SHE WAS ON 20% PROTEIN RATION.
Causality
Assessment
Time
0 3 WK G DEATH
3 WK G STIFFNESS, LIMB(S)
Source:
Country:
State:
United States
TEXAS
Zip:
79602
Episode Date:
09/15/2003
Dosage: Overdose
Dose Description: 90 G/TON; FOR 2-3 WEEKS
Extra Label:
Overdose
PackageiD: A 4
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INC WEIGHT GAIN, FEED EFFICIENCY, CARCASS
LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
PAYUS03052
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
Mixed (pig)
5 MO
200 LB
Female
SHOW PIG HAD BEEN FED 5 LBS OF RACTOP AMINE AT 18 G/LB INSTEAD OF 1 LB WITH 5 LBS OF A CORN-PROTEIN
MIX. GILT COULD NOT WALK OFF THE TRAILER AFTER THE SHOW. WAS FED STRAIGHT CORN FOR A FEW WEEKS;
CVM _ Report.rep
LOOSENED UP SOME BUT WAS NOT FIT FOR BREEDING AND WENT TO SLAUGHTER.
Causality
Assessment
2
2
2
Time
To Onset
5 WK
5 WK
5 WK
Clinical Detail:
G LAMENESS
G STIFFNESS
Page: 161
Source:
Country:
United States
State:
NEBRASKA
RMPDC
Episode Date:
10/22/2003
Route: Unknown
Zip:
68979
Dose Description: SECONDARY EXPOSURE
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Secondary exposure
ACCIDENTAL EXPOSURE
Unknown
Not applicable
Not applicable
Unknown
Source Report Id:
PAYUS03053
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HUMAN
Not specified
16 YR
UN
Male
AGE: 13 TO 19 YEARS. FAMILY HAS USED RACTOPAMINE FOR ABOUT 3 MONTHS. SON HAS PLATELET PROBLEMS
AND LOW HEMOGLOBIN. 11/3/03: DIAGNOSED WITH A VIRAL INFECTION THAT WAS DESTROYING THE BONE
MARROW. NOT BELIEVED TO BE CAUSED BY RACTOPAMINE.
Causality Time
-9 NA G HUMAN EXPOSURE, JUVENILE
CVM _Report. rep
Page: 162
0 3 MO H ANEMIA
0 3 MO H PLATELETS ABN
Source:
Country:
State:
United States
IOWA
Zip:
50010
Episode Date:
10/02/2003
Dose Description: 4.5 G/TON X 30 DAYS; 9/24-10/24/03
Extra Label: None
Package ID: A 6
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE FEED EFFICIENCY, WEIGHT GAIN, CARCASS
LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
PAYUS03054
UNK
#Treated:
50000
#Reacted: 50000
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
UN
BREED: PIC. CM: INCREASED EX CIT ABILITY NOTICED WHEN PIGS WERE MARKED IN THEIR PENS.
Causality
Assessment
2
Time
To Onset
9 DA
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
State:
United States
MICHIGAN
Zip:
xxxxx
OWNER REPORTED TO FEED STORE
Episode Date:
08115/2003
CVM _Report. rep
Source Report ld:
PAYUS03055
NDC:
Product Lot No:
UNK
#Treated:
4
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
H ~ a l t h Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
18 G/TON; UNK DURATION OF TREATMENT
Species subgroup
INCREASED RATE OF WEIGHT GAIN, FEED EFFICIENCY,
CARCASS LEANNESS
Good
Owner
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 163
2
PIG
Unknown (pig)
UN
265 LB
Male, neutered
BARROW IN A COUNTY FAIR SHOWMANSHIP CLASS STAR TED TO SHAKE AND TREMBLE, WENT DOWN AND DIED.
THE JUDGE SUGGESTED THAT THE BOY WHO OWNED THE PIG GET HIS SECOND PIG TO COMPLETE THE CLASS
BUT THIS ONE WAS ALSO SHAKING AND TREMBLING. SECOND PIG WAS TAKEN TO SLAUGHTER. TWO OF THEIR
OTHER PIGS ALSO ON RACTOPAMINE HAD NO SIGNS. IT WAS REPORTED THAT THE 2 AFFECTED CARRIED THE
"STRESS GENE".
Causality
Assessment
2
2
Time
To Onset
UN
UN
Clinical Detail:
G COLLAPSE
G DEATH
2 UN G DEATH(SLAUGHTERED)
2 UN G SHAKING
2 UN N TREMBLING
Source:
Country:
State:
United States
MONTANA
Zip:
59053
OWNER
Episode Date:
08115/2003
Dose Description: AUGUST -OCTOBER, 2003
Extra Label:
None
CVM _Report. rep
PackageiD: A 1
Source Report Id:
NDC:
Product Lot No:
PAYUS03056
UNK
#Treated:
1000
#Reacted: 11
#Died:
11
Species: PIG
Age:
. UN
Page: 164
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
INCREASED RATE OF GAIN, FEED EFFICIENCY,
CARCASS LEANNESS
Good
Owner
Unknown
Weight:
Gender:
230 LB
Group (m & f)
PRODUCER REPORTED THAT HE PLANS TO STOP USING RACTOPAMINE BECAUSE HE HAS HAD 10 TO 12 DEADS ON
TRUCKS. PREVIOUSLY HAD 1-2 DEADS PER WEEK ON AVERAGE.
Causality
Assessment
Time
2 4 WK G DEATH
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11/01/2003
Recommended dose
Oral (in dry feed)
10 PPM; 10/29-1111/03
None
46140
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INC RATE OF GAIN, IMPROVED FEED EFFICIENCY,
CARCASS LEANNESS.
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
No
T4V17031 0-002
628PP3
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
240
PIG
Other (pig)
23 WK
104 KG
Male, neutered
BREED: PIC 337 PROGENY. CLINICAL STUDY. REMOVED FROM STUDY DUE TO ANOREXIA. EUTHANIZED AND
NECROPSY PERFORMED; RESULTS NOT AVAILABLE AT TIME OF REPORT.
Causality
Assessment
-9
CVM _ Repmt.rep
Time
3 DA G ANOREXIA
3 DA G DEATH(EUTHANIZED)
Page: 165
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
11/04/2003
Recommended dose
Oral (in dry feed)
10 PPM; 10113-1114/03
None
46140
Package ID: A 3
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF GAIN, FEED EFFICIENCY,
CARCASS LEANNESS.
Health Status:
Good
Administered By:
Owner
Concomitants: No
T4V310309-003
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
84.1 KG
Female
CLINICAL STUDY. BREED: DANBRED PROGENY. PIG #512 WAS REMOVED FROM STUDY DUE TO LAMENESS. PIG
WAS EUTHANIZED AND NECROPSIED. NO RESULTS AVAILABLE AT TIME OF REPORT.
Causality .
Assessment
Time
2 21 DA G LAMENESS
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
CVM _Report. rep
10/28/2003
Recommended dose
Oral (in dry feed)
10 PPM; 10116-30/03
46140
Package ID: A 4
Source Report ld:
NDC:
Product Lot No:
T4V370313-007
634PP2
#Treated:
220
#Reacted:
#Died:
Species: PIG
Page: 166
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species subgroup
INCREASE RATE OF GAIN, FEED EFFICIENCY, CARCASS
LEANNESS
Good
Owner
Unknown
No
Breed:
Age:
Weight:
Gender:
Other (pig)
23 WK
118.6 KG
Female
CLINICAL STUDY. PIG# 1239. ELU: INDICATED FOR PIGS UP TO 109 KG. BREED: NEWSHAM PROGENY. PIG WAS
REMOVED FROM STUDY DUE TO LAMENESS. IT WAS EUTHANIZED AND NECROPSIED. RESULTS NOT YET
AVAILABLE.
Causality
Assessment
Time
2 14 DA G LAMENESS
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
10/30/2003
Extra Label:
Species subgroup
46140
Package ID: A 5
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASE RATE OF GAIN, FEED EFFICIENCY, CARCASS
LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
T4V370313-008
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
122 KG
Female
CLINICAL STUDY. ELU: LABELED FOR USE UP TO 109 KG. BREED: NEWSHAM PROGENY. PIG# 1261. REMOVED
FROM STUDY DUE TO HERNIA. EUTHANIZED AND NECROPSIED; RESULTS NOT YET AVAILABLE.
Causality
Assessment
CVM_Report.rep
Time
Page: 167
0 25 DA G PROLAPSE
Source:
Country:
United States
State:
IOWA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/08/2003
Recommended dose
Oral (all other)
9 G I TON FOR 14 DAYS
None
GROWTH PROMOTE
Good
Owner
Unknown
XX :XXX
Source Report ld:
PAYUS03049
NDC:
Product Lot No:
UNK
#Treated:
541
#Reacted: 28
#Died:
15
Species: PIG
Breed: Other (pig)
Age: 1 YR
Weight: 258 LB
PTX: OW HAD USED PA YLEAN 4.5 G/TON IN PAST WITH NO PROBLEM. CM: 10/8 FIRST LOAD OF PIGS - 186 TREATED
14 DAYS- SHIPPED AND 12 WERE DEAD I 8 SLOW UPON ARRIVAL. 10/10 SECOND LOAD 173 TREATED 16 DAYS-
SHIPPED AND 1 WAS DEAD I 1 SLOW UPON ARRIVAL. 10113 THIRD LOAD 182 TREATED 19 DAYS - SHIPPED AND 2
WERE DEAD I 4 SLOW UPON ARRIVAL. DDX: PIGS HAD FLU PRIOR TO MARKET, WERE 9-10# OVERWT UPON SHIP-
LESS ROOM FOR PIGS DURING SHIPMENT. HOT SHOT USE DURING LOADING SUSPECTED.
Causality
Assessment
0
Time
To Onset
14 DA
Clinical Detail:
G DEATH
Source:
Country:
State:
CVM _Report. rep
United States
INDIANA
Zip:
46140
Average
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
T4V370313-009
634PP2
Page: 168
Report Quality:
CLINICAL STUDY
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10/23/2003
Recommended dose
Oral (in dry feed)
5 PPM; 10/5-23/03
None
INCREASE ADG, CARCASS LEANNESS, IMPROVE FEED
EFFICIENCY
Good
Owner
Unknown
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
107.9 KG
Male, neutered
BREED: NEWSHAM PROGENY. CLINICAL STUDY. ONE PIG HAD ACUTE HEMORRHAGIC PNEUMONIA AT
SLAUGHTER AND WAS CONDEMNED.
Causality
Assessment
-2
Time
To Onset
18 DA
Clinical Detail:
R PNEUMONIA
Source:
Country:
United States
State:
INDIANA
Zip:
CLINICAL STUDY
Episode Date:
11113/2003
Extra Label:
None
46140
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED ADG, CARCASS LEANNESS, IMPROVED
FEED EFFICIENCY
Health Status:
Good
Administered By:
Owner
CVM _Report. rep
T4V370313-010
634PP2
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
220
PIG
Other (pig)
23 WK
121.6 KG
Male, neutered
Concomitants: No
PIG WAS CONDEMNED AT SLAUGHTER DUE TO INCOMPLETE/IMPROPER CASTRATION.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
Page: 169
Source:
Country:
State:
United States
IOWA
Zip:
51401
PROCESSING PLANT
Episode Date:
11/29/2003
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 G/TON X 3 WEEKS, THEN 9 G/TON X 3 WEEKS
Extra Label:
None
Reason For Use:
INCREASE ADG, FEED EFFICIENCY
Health Status:
Good
Administered By:
Owner
Vet Opinion: Medium
Concomitants: No
PAYUS03058
UNK
#Treated:
2000
#Reacted: 24
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 5 MO
Weight: 265 LB
BREED: PIC. 24 PIGS WERE DOWN ON ARRIVAL AT THE PLANT. THE PIGS LOADED WELL AND HAD A SHORT TRIP
TO THE PLANT BUT MAY HAVE WAITED ON THE TRUCKS FOR AN EXTENDED PERIOD BEFORE BEING UNLOADED.
ROUGH HANDLING AT THE YARD MAY HAVE CONTRIBUTED. 13 PIGS FROM ONE LOAD AND 11 FROM ANOTHER
WERE CLASSIFIED AS DOWN BUT WERE MOVED AND PROCESSED AT THE PLANT.
Causality
Assessment
Time
To Onset
32 DA
Clinical Detail:
G RECUMBENCY
Source:
Country:
State:
CVM _ Rep01t.rep
United States
MINNESOTA
Zip:
XX XXX
Source Report ld:
PAYUS03057
NDC:
Product Lot No:
UNK
PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
11116/2003
Recommended dose
Oral (in dry feed)
4.5 G/TON X 21 DAYS
None
Good
Owner
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 170
170
13
13
PIG
Other (pig)
5 MO
UN
Unknown
BREED: TRIUMPH GENETICS. 13 DEAD PIGS IN A SEMI-LOAD OF 170 SENT TO SLAUGHTER. PRODUCER HAS HAD
SOME DOWNS AND DEADS SINCE USING RACTOPAMINE BUT HAS FELT THE BENEFITS OUTWEIGHED THE
PROBLEMS. PRODUCER CONTINUES TO USE RACTOPAMINE.
Causality
Assessment
2
Time
To Onset
21 DA
Clinical Detail:
G DEATH
UN G RECUMBENCY
Source:
Country:
State:
United States
WISCONSIN
Zip:
53588
Episode Date:
12/0112003
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 G/TON X 2 WEEKS, THEN 9 G/TON X 2 WKS; UNK
DATES
Extra Label:
Reason For Use:
Health Status:
CVM _Report. rep
None
IMPROVED GROWTH PERFORMANCE AND CARCASS
LEANNESS
Unknown
PAYUS03059
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
PIG
Unknown (pig)
Unknown
UN
UN
Page: 171
Administered By:
Vet Opinion:
Concomitants:
Owner
High
Unknown
STILL SEEING SLOW AND NON-AMBULATORY, NON-INJURED PIGS AFTER USING RACTOPAMINE FOR MANY
YEARS. NO DATES OR NUMBERS.
Causality
Assessment
-8
-8
Time
To Onset
UN
UN
Clinical Detail:
G RECUMBENCY
G RELUCTANTTOMOVE
Source:
Country:
United States
State:
KANSAS
Zip:
PRODUCER
Episode Date:
11115/2003
Extra Label:
None
xxxxx
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Source Report ld:
NDC:
Product Lot No:
P A YUS03060
UNK
#Treated:
360
#Reacted: 14
#Died:
14
Species: PIG
Breed: Other (pig)
Age: 5 MO
Weight: 245 LB
Gender: Unknown
MONSANTO GENETICS. SEVEN DEAD PIGS ON ARRIVAL AT SLAUGHTER PLANT IN EACH OF TWO LOADS.
Causality
Assessment
Time
To Onset
4 WK
Clinical Detail:
G DEATH
CVM _ Rep01t.rep
Source Report ld:
PAYUS03061
Country:
United States NDC:
State:
INDIANA
Zip:
X :XXX X
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/04/2003
Unknown
Oral (in dry feed)
UNK DOSE; GREATER THAN 28 DAYS
Unknown
Unknown
Owner
Unknown
Unknown
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 172
0
PIG
Unknown (pig)
5 MO
280 LB
Unknown
PIGS PROCESSED AT THE PLANT HAD NO PROBLEMS UNTIL THEY REACHED 280 LBS OR WERE PART OF A LOAD
THAT WERE LAST OUT OF THE BARN AND. LIKELY ON RACTOPAMINE GREATER THAN 280 DAYS. REPORTED
INCREASED INCIDENTS WHILE HANDLING. NO NUMBERS, SPECIFIC SIGNS, DATES OR DOSES.
Causality
Assessment
-8
Time
To Onset
UN
Clinical Detail:
G REACTION, UNSPECIFIED
Source:
Country:
United States
State:
INDIANA
Zip:
/PACKING PLANT
Episode Date:
12/05/2003
Dosage: Unknown
Route:
Dose Description:
Oral (in dry feed)
UNKNOWN
xxxxx
Reason For Use:
IMPROVE GROWTH PERFORMANCE
CVM _Report. rep
Source Report ld:
NDC:
Product Lot No:
PAYUS03062
UNK
#Treated:
180
#Reacted: 18
#Died:
5
Species: PIG
Age: 5 MO
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
Weight:
Gender:
Page: 173
UN
Unknown
0 REPRESENTATIVE OBSERVED A LOAD OF "PA YLEAN PIGS" UPON ARRIVAL AT A PACKING PLANT IN
~ I N D ~ I ~ A ~ N A . APPROXIMATELY 5 WERE DEAD AND 12-13 WERE MOVING SLOW OR WENT DOWN.
Causality
Assessment
Time
UN G COLLAPSE
UN G DEATH
UN G RECUMBENCY
Source:
Country:
United States
State:
UNKNOWN
Zip:
INSUFFICIENT INFORMATION
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
12118/2003
Unknown
Oral (in dry feed)
UNK
Species subgroup
X XXX X
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASED GROWTH PERFORMANCE
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
PAYUS03064
UNK
#Treated:
3
#Reacted: 3
#Died:
0
Species: PIG
Age: 5 MO
Weight: 310 LB
Gender: Unknown
ELU: OVERWEIGHT. PACKER REPORTED THAT, "EVERYTIME WE GET HEAVYWEIGHT PIGS, WE KNOW THEY HAVE
HAD RACTOPAMINE BECAUSE THEY GO DOWN." HAD 3 DOWNERS ON ONE SHIPMENT.
Causality
Assessment
CVM _Report. rep
Time
Page: 174
-8 UN G RECUMBENCY
Source:
Country:
State:
United States
IOWA
Zip:
PACKING PLANT
Episode Date:
12/08/2003
Dosage: Unknown
Extra Label:
None
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE GROWTH PERFORMANCE
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
PAYUS03063
UNK
#Treated:
455
#Reacted: 27
#Died:
2
Species: PIG
Age: 5 MO
Weight: 235 LB
Gender: Unknown
AVERAGE OF 10 DOWN, NON-INJURED PIGS COMING OFF THE TRUCK; 10-15 WENT DOWN AFTER WEIGHING AND
1-2 DEAD ANIMALS PER LOAD. CUSTOMER HAS USED RACTOPAMINE FOR A FEW YEARS (DOSE UNK) BUT THIS IS
THE FIRST TIME THERE HAS BEEN A PROBLEM.
Causality
Assessment
Time
UN G DEATH
UN G RECUMBENCY
Source:
Country:
United States
State:
KANSAS
PRODUCER REPORT
CYM _Report. rep
Zip:
66427
Source Report ld:
PAYUS03065
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/30/2003
#Treated:
Recommended dose
#Reacted:
4.5 X 3 WKS, 9.0 G/TON X 2 WKS; 12/2-30/03
Species:
None Breed:
Age:
Weight:
Good
Gender:
Owner
Low
No
Page: 175
210
210
0
PIG
Unknown (pig)
UN
UN
Unknown
MARKET AGE AND WEIGHT. FEED CONSUMPTION DECREASED APPROX 50% WHEN RACTOPAMINE INCREASED TO
9 G/TON.
Causality
Assessment
Time
3 12 HR G ANOREXIA
Source:
Country:
United States
State:
TEXAS
VET
Episode Date:
12/28/2003
Zip:
Dose Description: 180 G/TON; 12/28/03
Extra Label: Species
Reason For Use:
ACCIDENTAL
Health Status:
Good
Vet Opinion: Not applicable
Concomitants: No
CVM _Report. rep
79088
Source Report ld:
PAYUS03066
NDC:
Product Lot No:
UNK
#Treated:
2
#Reacted: 0
#Died:
0
Species: HORSE
Breed: Quarter horse
Age: 11.5 YR
Weight:
UN
Page: 176
HORSES BROKE INTO A BUCKET CONTAINING 5 LBS RACTOAMINE W/ A PROTEIN CARRIER ESTIMATED TO BE THE
EQUIVALENT OF 180 G RACTOP AMINE/TON. VET ADMIN ACE PROMAZINE AND FLUNIXIN, ADMIN 1 GAL MIN OIL
ORALLY. 15-20 YR OLD GELDING AND A 8-10 YR OLD MARE. NO SIGNS REPORTED.
Causality
Assessment
Time
-9 NA G NO SIGNS
Source:
Country:
Foreign
State:
MISSING INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
01120/2004
Unknown
Oral (in dry feed)
UNK
Unknown
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
EFFICIENCY
Health Status:
Unknown
Administered By:
Owner
PAYMX04001
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age:
Weight:
Gender: Unknown
UN
UN
OWNER REPORTED THAT PIGE WERE FATTER THAN NORMAL. HAS DISCONTINUED USE OF THE PRODUCT.
REPORT FROM MEXICO. NO ANIMAL NUMBERS PROVIDED.
Causality
Assessment
Time
-8 NA E INEFFECT, PRODUCTION (MEAT)
Source:
Country:
State:
CVM _ Repmt.rep
United States
TEXAS
Zip:
77339
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
PAYUS04001
UNK
OWNER REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01115/2004
Overdose
Oral (in dry feed)
2.5 GM/DA Y X 14 DAYS
Overdose
Good
Owner
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 177
0
PIG
Unknown (pig)
Male
UN
220 LB
FFA SHOW PIG. DOSE IS 31-42 X THE RECOMMENDED DOSE. RTX: PEDIALYTE, PEPTO BISMOL, BABY FOOD, BABY
FORMULA; RECOVERED.
Causality
Assessment
3
3
3
Time
To Onset
12 DA
12 DA
12 DA
Clinical Detail:
D VOMITING
G ANOREXIA
G POLYDIPSIA
Source:
Country:
United States
State:
ILLINOIS
Zip:
62401
VET REPORT NO ANIMAL NUMBERS
Episode Date:
06/15/2003
Dose Description: 9 GITON FOR W KS
Reason For Use:
Health Status:
Good
CVM _ Repmt.rep
Source Report Id:
PAYUS04002
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: 7 MO
Weight: 250 LB
Gender: Female
Administered By:
Vet Opinion:
Concomitants:
Owner
Low
No
Page: 178
NO ANIMAL NUMBERS. REPLACEMENT GILTS NOT COMING IN HEAT AS EXPECTED; HAS NOTICED PROBLEMS FOR
THE PAST 6-9 MONTHS. THE GILTS HAD BEEN FED RACTOPAMINE FOR 3 WEEKS DURING THE FINISHING PARSE.
VET FELT THE PROBLEM WAS DUE TO POOR HEAT DETECTION. FlU SUBM 190,8116/04: VET REPORTED THAT THE
CYCLING PROBLEM IS SPORADIC, ONE GROUP WILL BE FINE THE NEXT WILL HAVE 25% FALL OUT FOR POOR
CYCLING. ALL GROUPS CONTINUE TO BE FED RACTOPAMINE. ELU: NOT FOR USE IN BREEDING SWINE.
Causality
Assessment
Time
0 UN X FERTILITY, REDUCED
Source:
Country:
United States
State:
MINNESOTA
Zip:
55973
MISSING INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01/28/2004
Unknown
Oral (in dry feed)
UNK
Unknown
Unknown
Owner
Unknown
Package ID: A 4
Source Report ld:
NDC:
Product Lot No:
PAYUS04003
UN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
Unknown (pig)
Unknown
UN
UN
HOG BUYER REPORTED A COMMENT MADE BY PRODUCER. HAVING DEADS AND DOWNERS AT SLAUGHTER.
PRODUCER PLANS TO D/C RACTOPAMINE. COMMENT: 3RD PERSON REPORT, NO ANIMAL NUMBERS REPORTED.
Causality
Assessment
-8
-8
Time
To Onset
UN
UN
CVM _ Rep01t.rep
Clinical Detail:
G DEATH
G RECUMBENCY
Page: 179
Country:
United States
State:
IOWA
OWNER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
52144
01/31/2004
Recommended dose
Oral (in dry feed)
4.5 GM/TON; 1126/04 TO PRESENT
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Concomitants: No
PAYUS04004
UNK
#Treated:
270
#Reacted: 27
#Died:
0
Species: PIG
Age:
UN '
Weight: 258 LB
STARTED FINISHING HOGS ON 4.5 G/TON RATION. 7 DAYS LATER HE SOLD 70 OF THE TOP END PIGS THAT
WEIGHED 258 LBS. SEVEN WERE CLASSIFIED AS SLOWS AT THE SLAUGHTER PLANT. ON 2/4/04 APPROXIMATELY
20 OF THOSE REMAINING SHOWED SIGNS OF STIFFNESS, LEG PROBLEMS AND WERE RELUCTANT TO MOVE.
THESE PIGS WERE DUE TO SELL 2110/04 . OWNER CONCERNED HE WILL BE PENALIZED FOR HAVING SLOWS AT
SLAUGHTER. FlU: 2/5/04: WEATHER WAS EXTREME WHEN HE SHIPPED THE FIRST LOAD(FEBRUARY IN IOWA).
PIGS SEEM TO BE MOVING BETTER SINCE THEN. PIGS WERE VACCINATED AGAINST ERYSIPELAS-OWNER DID
NOT THINK ERYSIPELAS COULD HAVE CONTRIBUTED.
Causality
Assessment
Time
2 5 DA G RELUCTANT TO MOVE
2 5 DA G STIFFNESS
Source:
Country:
State:
United States
FLORIDA
Zip:
33566
OWNER
Episode Date:
02/0112004
CYM _ Report.rep
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
PAYUS04005
UNK
#Treated:
2
#Reacted:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
#Died:
4.5 G/T X 15 DAYS, 9 G/T X 10 DAYS, 18 G/T X 5 DAYS Species:
None Breed:
Age:
Weight:
Good
Gender:
Owner
Unknown
Yes
LINCOMYCIN
2 ASPIRIN
Page: 180
0
PIG
Mixed (pig)
UN
258 LB
Male, neutered
2 BARROWS INTENDED FOR SHOW WERE TAKEN FOR GROOMING. DURING CLIPPING ONE BARROW BEGAN
SHAKING, SQUEALING, OPEN MOUTH BREATHING AND THEN WENT DOWN IN THE REAR. THIS WAS THE FIRST
DAY IT WAS FED RACTOPAMINE AT 18 G/TON. THE FEED WAS DISCONTINUED AND THE BARROW ALLOWED TO
REST. BY 2/5/04 THE BARROW WAS STILL UNABLE TO WALK MORE THAN A FEW FEET AND WAS KNUCKLING
OVER ON THE FORELIMBS. FlU: 8118/04-NO FURTHER INFO.
Causality
Assessment
3
3
3
3
3
Drug Name:
Time
To Onset
24 DA
24 DA
24 DA
24 DA
24 DA
RACTOP AMINE
Clinical Detail:
G SHAKING
G VOCALIZATION
N PARE SIS, FORELIMB(S)
N PARESIS, HIND LIMB(S)
R DYSPNEA
Source:
Country:
State:
United States
TEXAS
Zip:
76033
OWNER
Episode Date:
02116/2004
Dosage: Overdose
Source Report ld:
PAYUS04006
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
Dose Description: 9 GM/TON X 15 DAYS THEN ACCIDENTAL EXPOSURE TO Species:
10-15 LBS OF PREMIX. 2/ 1-16/04
CVM _ Rep01t.rep
PIG
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Overdose
INCREASE GROWTH PERFORMANCE
Good
Owner
Yes
Breed:
Age:
Weight:
Gender:
LINCOMYCIN
Page: 181
Mixed (pig)
UN
250 LB
Female
ACCIDENT ALL EXPOSED TO ONE-HALF OF A 25 LB BUCKET OF RACTOPAMINE PREMIX ON 2116/04. VOMITED THE
EVENING OF 2/16; BECAME "STRESSY AND LOCKED UP" WHEN TAKEN OUT FOR EXERCISE ON 2118/04. SHE
WALKED 100 YARDS AND WENT DOWN; OWNERS GOT HER UP AND TO HER PEN. LEFT HIND WAS WEAK AND HER
SKIN WAS RED. IMPROVED ON 2/1 9; STILL A BIT STIFF AND RED.
Causality
Assessment
5
Time
To Onset
6 HR
Clinical Detail:
D VOMITING
3 2 DA G COLLAPSE
3 2 DA G STIFFNESS
3 2 DA CONGESTION, SKIN
Source:
Country:
State:
United States
TEXAS
Zip:
XX XXX
NO ANIMAL NUMBERS
Episode Date:
06/15/2001
Dosage: Unknown
Dose Description: UNK AMT; 2000 THRU 2002
Extra Label:
Unknown
Package ID: A 3
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCREASE ADG, WEIGHT GAIN, CARCASS LEANNESS
Health Status:
Unknown
CVM _ Repmt.rep
PAYUS04007
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: 5.5 MO
Weight: 250 LB
Page: 182
Administered By:
Vet Opinion:
Concomitants:
Owner
High
Unknown
MEAT COMPANY REPORTED THAT MEAT AND SAUSAGE WAS TOUGH FROM SHOW PIGS TREATED WI
RACTOP AMINE. PROBLEM OCCURRED BETWEEN 2000 TO 2002 AFTER WHICH THE MEAT COMPANY STOPPED
ACCEPTING SHOW PIGS TREATED WI RACTOPAMINE.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G MEATABN
Source:
Country:
State:
United States
SOUTH DAKOTA
Zip:
xxxxx
OWNER
Episode Date:
12/15/2003
Package ID: A 4
Source Report Id:
NDC:
Product Lot No:
Dose Description: 9 OM/TON X 2 WEEKS; 4.5 OM/TON X 3 WEEKS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
Unknown
PAYUS04008
UNK
#Treated:
6
#Reacted: 6
#Died:
0
Species: PIG
Age: UN
Weight:
UN
OVER THE PAST 4 MONTHS THE OWNER HAS HAD 6 PIGS THAT WERE SLOW WHILE BEING LOADED AND MAY GO
TO SLAUGHTER AS "SUBJECT". HE HAD ALSO ALTERED VITAMINS, SELENIUM, CRUDE PROTEIN AND LYSINE IN
HIS FEED.
Causality
Assessment
2
Time
To Onset
5 WK
Clinical Detail:
G STIFFNESS
Source:
CVM _Report. rep
Country:
State:
United States
MINNESOTA
Zip:
xxxxx
OWNER, SCANT INFO
Episode Date: 12116/2003
Source Report Id:
NDC:
Product Lot No:
Dose Description: 9GM/TON X 1-2 WEEKS; 4.5 OM/TON X 2-3 WEEKS
Reason For Use:
Health Status:
Unknown
PAYUS04009
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 183
2166
44
44
PIG
Other (pig)
UN
UN
Unknown
DALLON GENETICS. AT THE TIME OF LOADING, 20-30 PIGS BECAME SHAKY, WENT DOWN AND DIED PRIOR TO
LOADING. FlU: 3/11/04: PRIOR TO RACTOPAMINE THE PIGS WERE GIVEN TIAMULIN AND CHLORTETRACYCLINE.
RACTOPAMINE STARTED 12/9; BETWEEN 12116 AND 3/ 1/04 15 LOADS(2166 PIGS) WERE SHIPPED TO PACKER. 41 DIED
PRIOR TO LOADING, 3 DIED ON THE TRUCKS. THEY WERE DIFFICULT TO LOAD. OWNER BELIEVES GENETICS ARE
CONTRIBUTING; PLANS TO CONTINUE RACTOPAMINE USE.
Causality
Assessment
2
2
2
2
Drug Name:
Time
To Onset
5 WK
5 WK
5 WK
5 WK
RACTOP AMINE
Clinical Detail:
G COLLAPSE
G DEATH
G RECUMBENCY
G SHAKING
Source:
Country:
State:
United States
MINNESOTA
Zip:
56117
PACKER
Episode Date:
02/23/2004
CVM _ Repmt.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
PAYUS04011
UNK
#Treated:
#Reacted:
160
23
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
4.5 G/TON X 2 WEEKS; 2 / 9 / 0 4 ~
None
Good
Owner
No
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 184
23
PIG
Unknown (pig)
UN
265 LB
Group (m & f)
SLAUGHTER HOUSE REPORTED THAT 2 TRUCKLOADS OF 80 PIGS EACH ARRIVED WITH 23 DEADS OR DOWN PIGS.
OWNER HAD STARTED USING RACTOPAMINE IN THE BEGINNING OF JANUARY 2004.
Causality
Assessment
2
2
Time
To Onset
2 WK
2 WK
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
SOUTH DAKOTA
Zip:
57440
OWNER
Episode Date:
07/15/2003
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 G/TON X 14 DAYS; SUMMER 2003
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
No
PAYUS04013
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
2000
12
Other (pig)
UN
264 LB
Group (m & f)
BREED: BABCOCK. PIGS WERE EX CIT ABLE AND DIFICUL T TO HANDLE. THEY WERE AGGRESSIVE TOWARDS
GATES AND HANDLERS WHILE LOADING. 12 "CRIPPLES" AND 1 DEAD DURING SHIPMENT.
CVM _Report. rep
Page: 185
Causality
Assessment
2
2
2
2
Drug Name:
Time
To Onset
14 DA
14 DA
14 DA
1 DA
RACTOP AMINE
Clinical Detail:
G DEATH
G RECUMBENCY
N AGGRESSION
N HYPERACTIVITY
Source:
Country:
State:
United States
SOUTH DAKOTA
Zip:
57005
FEED CONSULTANT
Episode Date:
01/15/2004
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 G/TON X 3 WKS THEN 9 G/TON X 2 WKS; 12/ 1/03 TO
2/29/04
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASED ADG, FEED EFFICIENCY, CARCASS
LEANNESS
Good
Owner
No
PAYUS04012
UNK
#Treated:
3000
#Reacted: 90
#Died:
28
Species: PIG
Breed: Mixed (pig)
Age: UN
Weight: 240 LB
FEED CONSULTANT FROM A 8000 SOW FARM REPORTED A HIGHER INCIDENCE OF NON-AMBULATORY NON-
INJURED AND DEAD PIGS DURING SHIPPMENT TO THE PACKERS. INCREASED INCIDENCE FROM DECEMBER TO
JANUARY AND EVEN HIGHER IN FEBRUARY. THE PROBLEM IMPROVED AS THE WEATHER IMPROVED.
Causality
Assessment
2
2
Time
To Onset
5 WK
5 WK
Clinical Detail:
G DEATH
G RECUMBENCY
CVM _Report. rep
Source Report ld:
PAYUS04014
Country:
United States NDC:
State:
TEXAS
Zip:
79015
OWNER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/07/2004
Recommended dose
Oral (in dry feed)
9 G/TON X 30 DAYS; 2/6 THRU 317/04
None
Good
Owner
No
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
Duroc
Page: 186
8
UN
240 LB
Male, neutered
A PIG WENT DOWN AFTER BEING MOVED INTO A CHUTE TO BE CLIPPED. HE WAS MOVED TO A PEN AND DIED 3
HRS LATER. ALL OTHERS WERE MOVED TO THE CHUTE AND CLIPPED WITH NO PROBLEMS.
Causality
Assessment
2
2
2
Time
To Onset
30 DA
30 DA
30 DA
Clinical Detail:
G COLLAPSE
G DEATH
G RECUMBENCY
Source:
Country:
United States
State:
IOWA
VET
Episode Date:
Dosage:
Route:
Dose Description:
CYM _Report. rep
Zip:
51038
03/11/2004
Unknown
Oral (in dry feed)
UN
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US20040007 6
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
100
3
3
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
FEED EFFICIENCY AND IMPROVED CARCASS
LEANNESS
Missing information
Owner
High
No Value
Breed:
Age:
Weight:
Gender:
Page: 187
Other (pig)
6 MO
250 LB
Group (m & f)
VET ASKED ABOUT W /DRAWING RACTOP AMINE A FEW DAYS BEFORE SHIPPING. HE HAS A CLIENT THAT HAS
EXPERIENCED A 2-3% DEATH LOSS FROM LOADING TO SLAUGHTER IN GROUPS ON RACTOPAMINE.
Causality
Assessment
Time
2 UN G DEATH
Source:
Country:
United States
State:
INDIANA
ELAN CO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
02/20/2004
Not applicable
Product defect
Not applicable
Not applicable
Not applicable
Not applicable
No
Zip:
46140
Source Report ld:
PAYGB04001
NDC:
Product Lot No:
640PP3
#Treated:
0
#Reacted: 0
#Died:
0
Age: NA
Weight:
NA
ON 2/20/04, , THE MANUFACTURING SITE FOR PA YLEAN 9, REPORTED AN OUT OF SPEC RESULT.
ASSAY AT 9 MONTH TIMEPOINT HAD RISEN TO 21.5G/KG. REGULATORY LIMITS ARE 17-21 G/KG. FlU: 6116/04:5
RESAMPLES TESTED WERE W/IN REULATORY LIMITS. IT WAS CONCLUDED THAT THE OUT OF SPEC STABILITY
RESULT WAS DUE TO ANALYTICAL VARIABILITY.
Causality
Assessment
CVM _Report. rep
Time
Page: 188
0 NA P PD-POTENCY, HI
Source:
Country:
United States
State:
NORTHDAKOTA Zip:
CLINTRIAL
Episode Date:
03111 /2004
58105
Dose Description: 9 GM/TON; 2/26/04 TO 3/11104
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Fair
Owner
Missing information
Yes
CEFTIOFUR 7 ML
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200400079
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
Unknown (pig)
Male
UN
151 LB
REMOVED FROM STUDY AND NECROPSIED. OBSERVED TO BE GAUNT AND PALE. SUSPECTED GASTRIC ULCER. 2
OTHERS NOT ON RACTOPAMINE WERE ALSO REMOVED AND NECROPSIED. RTX: CEFTIOFUR 7 ML; 3 TIMES.
Causality
Assessment
Time
-1 14 DA G LOSS OF CONDITION
0 14 DA G PALLOR
Source:
Country:
State:
United States
NORTH DAKOTA Zip: 58105
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200400483
UNK
TRIAL T4V380331
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0310712004
#Treated:
Recommended dose
#Reacted:
9 GITON; 313-411104 Species:
None Breed:
FEEDING TRIAL
Age:
Weight:
Fair
Gender:
Owner
Unknown
Page: 189
187
PIG
Other (pig)
UN
170 LB
Male, neutered
RACTOPAMINE/BARLEY FEEDING TRIAL. PIG BECAME GAUNT AND STIFF IN A REAR LEG. RTX: LINCOMYCIN-
IMPROVED BY THE NEXT DAY. ON 3114 HE PRESENTED WI LAMENESS IN THE SHOULDER AND WAS AGAIN
TREATED WI LINCOMYCIN FOR 3 DAYS. NEVER COMPLETELY RECOVERED AND WAS EUTHANIZED ON 412104.
Causality
Assessment
0
0
0
Time
To Onset
4 DA
4 DA
4 DA
Clinical Detail:
G LAMENESS
M PAIN, JOINT(S)
Source:
Country:
State:
United States
WISCONSIN
Zip:
53105
Episode Date:
08/1512003
Dosage: Unknown
Dose Description: UNK DOSE; UNK DATES OF ADMIN
Extra Label:
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INC ADG, LEAN CARCASS, FEED EFFICIENCY
Health Status:
Missing information
CVM _Report. rep
US200400779
UNK
#Treated:
30
#Reacted: 18
#Died:
18
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
Administered By:
Vet Opinion:
Concomitants:
Owner
No Value
Page: 190
MARKET AGE. A LOCAL COUNTY FAIR BOARD DECIDED TO BAN FEEDING RACTOPAMINE TO SHOW ANIMALS
DUE TO POOR MEAT QUALITY FROM SHOW PIGS SLAUGHTERED IN AUGUST 2003 . MEAT WAS SOFT AND WATERY
AT THE TIME OF PROCESSING. NO REPORTS OF DOWNERS. THE PLANT DID NOT DETERMINE IF THE PIGS HAD
BEEN FED RACTOPAMINE.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G MEATABN
Source:
Country:
United States
State:
SOUTH DAKOTA
Zip:
X XXX X
PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/01/2003
Recommended dose
Oral (in dry feed)
4.5, 9 G/TON; 2003-4/2004
None
CARCASS LEANNESS
Good
Owner
No Value
Source Report ld:
US200401020
NDC:
Product Lot No:
UNK
#Treated:
240
#Reacted: 240
#Died:
240
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
250 LB
RATE OF DOWNER AND DEADS OVER THE PAST 6 MONTHS IS HIGHER THAN LAST YEAR. FEEDING DISTILLERS
GRAINS OR DDGS HAS BEEN THE ONLY FACTOR THAT HAS CHANGED THIS YEAR. PRODUCER PLANS TO STOP
FEEDING THESE. *REPORT STATES 240 TREATED, REACTED, DIED. DOES NOT GIVE THE NUMBER OF ANIMALS
DOWN OR DEAD PRIOR TO SLAUGHTER.
Causality
Assessment
CVM _ Repmt.rep
Time
UN G DEATH
UN G RECUMBENCY
Page: 191
Source:
Country:
United States
State:
CALIFORNIA
Zip:
93274
Report Quality:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/02/2004
Unknown
Oral (in dry feed)
5PPM; 411 /04 THRU 5/2/04
None
CLINICAL TRIAL
Fair
Veterinarian
Low
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US20040 1463
655PP3
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
393
PIG
Other (pig)
23 WK
75 KG
Unknown
BREED: PIC. PIG NUMBER 423 WAS REMOVED FROM THE STUDY AFTER BEING OBSERVED LAME AND THEN WAS
FOUND DEAD IN THE PEN. FlU: LOT# ADDED.
Causality
Assessment
Time
To Onset
31 DA
1 DA
Clinical Detail:
G DEATH
G LAMENESS
Source:
Country:
United States
State:
CALIFORNIA
Zip:
STUDY T4V060408
Episode Date:
Dosage:
Route:
Dose Description:
CVM _Report. rep
05/26/2004
Recommended dose
Oral (in dry feed)
5PPM X 28 DAYS
93274
Source Report ld:
US200402298
NDC:
Product Lot No:
UNK
#Treated:
393
#Reacted:
#Died:
Species: PIG
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Breed:
SAFETY STUDY T4V060408
Age:
Good
Veterinarian
Low
Unknown
Weight:
Gender:
Page: 192
Other (pig)
23 WK
75 KG
Missing information
BREED: PIC. REMOVED FROM THE STUDY AFTER BEING TRANSPORTED DURING THE MARKETING STIMULATION
PHASE. CM: NON-AMBULATORY WI LABORED BREATHING AND DIARRHEA.
Causality
Assessment
2
2
2
Drug Name:
Time
To Onset
28 DA
28 DA
28 DA
28 DA
RACTOPAMINE
Clinical Detail:
D DIARRHEA
G DEATH
G RECUMBENCY
R DYSPNEA
Source:
Country:
United States
State:
CALIFORNIA
Zip:
93274
Episode Date:
05/27/2004
Dose Description: 10 PPM; FOR 28 DAYS
Extra Label:
None
Reason For Use:
STUDY T4V060408
Health Status:
Good
Administered By:
Veterinarian
Vet Opinion: Low
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200402079
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
393
PIG
Other (pig)
23 WK
75 KG
Unknown
BREED: PIC. ONE PIG WAS REMOVED FROM THE STUDY AFTER BEING TRANSPORTED DURING THE MARKET
STIMULATION PHASE AS IT WAS NON-AMBULATORY.
CVM _ Repmt.rep
Causality
Assessment
2
Time
To Onset
4 WK
Clinical Detail:
G RECUMBENCY
Source:
Country:
State:
United States
INDIANA
Zip:
46140
FEED SALES REPRESENT AIVE
Episode Date:
0611112004
Dosage: . Unknown
Dose Description: UNK DOSE; UNK DURATION
Source Report Id:
US200402763
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 193
180
5
5
Extra Label:
Unknown Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infom1ation
Owner
Missing information
No Value
Age: UN
Weight:
UN
Gender: Unknown
FEED SALES REP HAD PRODUCER REPORT TO HIM THAT 5 PIGS DIED ON THE TRANSPORT TRUCK. FlU: 180 PIGS ON
THE TRUCK.
Causality
Assessment
Time
UN G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
80523
VET
Episode Date:
12115/2001
CVM _Report.rep
Source Report Id:
US200402619
NDC:
Product Lot No:
UNK
#Treated:
200
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Oral (in dry feed)
DEC, 2001
Unknown
Good
Owner
Missing infom1ation
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 194
200
0
PIG
Unknown (pig)
UN
272 LB
Group (m & f)
A VET MAKING AN ANIMAL WELFARE AUDIT OBSERVED APPROX 200 PIGS AS THEY WERE UNLOADED FROM A
"POTBELLY" TRAILER. ALL PIGS WERE RELUCT ANT TO LEAVE THE TRUCK AND REQUIRED AN EXCESSIVE
AMOUNT OF PRODDING AND HOT SHOT USE. VET STATED THAT "THE PIGS JUST WOULDN'T GO AND THEY HAD
NO ENERGY". EXACT DOSE UNK, REPORTED TO BE A HIGH, BUT APPROVED DOSE. ANIMALS WEIGHED 270-275
LBS AND WERE IN GOOD CONDITION. ALL WERE PROCESSED NORMALLY AFTER UNLOADING.
Causality
Assessment
Time
UN G RELUCT ANT TO MOVE
Source:
Country:
United States
State:
OHIO
LITTLE USEFUL INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
Zip:
06115/2001
Unknown
Oral (all other)
UNK
Unknown
UN
Missing infom1ation
Owner
Missing information
Unknown
43450
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200403651
UNK
#Treated:
200
#Reacted: 200
#Died:
200
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
Page: 195
MAN WHO WORKED AT SLAUGHTER HOUSE REPORTED THAT OVER THE PAST 2-3 YEARS THE SHOW PIGS FED
RACTOP AMINE AND SLAUGHTERED AFTER THE STATE FAIR HAD LOWER INTRAMUSCULAR FAT SCORES. NOT A
CONTROLLED STUDY. PIGS WERE FROM DIFFERENT SOURCES, RECEIVED DIFFERENT DOSAGES.
Causality
Assessment
Time
-8 NA G MEATABN
Source:
Country:
United States
State:
IOWA
Zip:
50025
REPORTED BY THE GROWER/MANAGER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/29/2004
Recommended dose
Oral (in dry feed)
4.5 G/TON; 6115 TO 6/29/04
None
Good
Owner
Low
Unknown
Source Report ld:
US200404096
NDC:
Product Lot No:
UNK
#Treated:
360
#Reacted: 21
#Died:
4
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 270 LB
BREED: PIC. ON 6/29/04 A LOAD OF 180 PIGS WAS SHIPPED TO THE SLAUGHTER PLANT. 2 DEAD ON THE TRUCK, 2
DEAD ON THE ALLEYWAY AND 16 WERE DOWNERS. THE NEXT DAY 179 PIGS WERE SHIPPED. ONLY 1 DOWNER
ON THAT LOAD. THE VET FEELS THE PROBLEMS IN THE FIRST LOAD WERE DUE TO HANDLING.
Causality
Assessment
2
2
Time
To Onset
14 DA
14 DA
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
CVM _ Repmt.rep
United States
Source Report ld:
US200404187
NDC:
State:
OHIO
Zip:
XX :XXX
Product Lot No:
UNK
REPORTED BY PRODUCER
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
06/28/2004
Unknown
Oral (in dry feed)
UND DOSE FOR 48 HRS
Unknown
Good
Owner
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 196
900
15
0
PIG
Other (pig)
UN
UN
Unknown
PRODUCER REPORTED THAT IN 5 LOADS OF PIGS HE HAD 1 TO 3 FRACTURED LEGS PER LOAD OF 180 PIGS. THE
PIGS HAD BEEN ON RACTOPAMINE FOR 24T048 HRS AT AN UNK DOSE. NO EXPLANATION PROVIDED FOR THE
SHORT DURATION OF RACTOPAMINE ADMINISTRATION.
Causality
Assessment
0
Time
To Onset
48 HR
Clinical Detail:
G INJURY
0 48 HR M PR-BONE(S), LESION(S)
Source:
Country:
United States
State:
IOWA
OWNEREPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
CVM _ Repmi.rep
Zip:
50240 .
07119/2004
Unknown
Oral (in dry feed)
UNK AMT AS TOP DRESSING
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200404298
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
PIG
3
3
0
Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Age:
Weight:
Gender:
Page: 197
UN
UN
Missing infom1ation
4-H PIGS WERE FED RACTOPAMINE AS A TOP DRESSING WI INTENDED DOSE OF 9 G/TON. THEY WERE FED AN UNK
AMT OF THE TOP DRESS ON UNK DATES AND WERE EXPERIENCING STIFFNESS. CALLER WAS RELUCT ANT TO
PROVIDE ADDITIONAL INFORMATION.
Causality
Assessment
Time
2 UN G STIFFNESS
Source:
Country:
United States
State:
MINNESOTA
Zip:
OWNER REPORT
Episode Date:
07/20/2004
XX XXX
Dose Description: 9 G/TON AND 4.5 G/TON; 7115/04-
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Fair
Owner
Unknown
Source Report ld:
US200404584
NDC:
Product Lot No:
UNK
#Treated: .
70
#Reacted: 16
#Died:
0
Species: PIG
Age: UN
Weight:
162.5 LB
40 BARROWS AT 9 G/TON; 30 GILTS AT 4.5 GM/TON. 15 BARROWS HAD RED SPOTS ON THEIR BACKS DUE TO FLY
BITES. ONE GILT HAD MILD SPOTS. OWNER QUESTIONED IF HIGHER LEVEL OF RACTOPAMINE IS ATTRACTING
FLIES TO THE BARROWS. BARROWS WERE ALSO SUNBURNED. RTX: FLY REPELLANT. H/0: PRRS PROBLEMS ON
THE FARM. 8111104 FlU: LESIONS WERE HEALING, BELIEVES IT IS FLY STRIKE AND SUNBURN.
Causality
Assessment
CVM _Report. rep
Time
-1 5 DA
-1 5 DA
INFECTION, SKIN
SORE(S)
Page: 198
Source:
Country:
United States
State:
CALIFORNIA
Zip:
93274
STUDY T4V060408
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/30/2004
Recommended dose
Oral (in dry feed)
0, 5, 10 PPM
None
Good
Veterinarian
Missing information
Unknown
Source Report ld:
US200404767
NDC:
Product Lot No:
655PP3
#Treated:
192
#Reacted: 48
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 23 WK
Weight:
131 KG
NON CLINICAL STUDY: EFFECTS OF PA YLEAN AND MARKETING CONDITIONS ON NON-AMBULATORY INCIDENCE
IN HEAVYWEIGHT FINISHING SWINE. 288 PIGS ON STUDY, FED 0, 5 OR 10 PPM RACTOPAMINE. MARKETED UNDER
EITHER PROGRESSIVE OR NON-PROGRESSIVE MARKETING CONDITIONS. TOTAL OF 72 (24 FROM EACH DOSE
GROUP) WERE SELECTED FOR NECROPSY. PATHOLOGIST REPORT: PAYLEAN ADMINISTERED TO THE PROGENY OF
PIC 337 SIRES AT 5 AND 10 PPM, IN COMBINATION W/ PROGRESSIVE MARKETING CONDITIONS, HAD NO EFFECT ON
THE INCIDENCE OF MUSCLE ALTERATIONS RELATIVE TO 0 PPM CONTROLS. IN CONTRAST, WHEN PA YLEAN WAS
ADMINISTERED TO THE PROGENY OF PIC 337 SIRES AT LEVELS OF 5 AND 10 PPM IN THE FEED IN COMBINATION W/
NON-PROGRESSIVE MARKETING CONDITIONS RESULTED IN INCREASED INCIDENCE OF LOW GRADE
DEGENERATIVE MUSCLE ALTERATIONS RELATIVE TO CONTROLS. A VARIABLE INCIDENCE OF LOW GRADE
SPONTANEOUS DEGENERATIVE MUSCLE ALTERATIONS WERE NOTED IN BOTH RACTOP AMINE TREATED AND
CONTROL PIGS, IN BOTH PROGRESSIVE AND NON-PROGRESSIVE MARKETING CONDITIONS. BOTH PSOAS MINOR
AND BICEPS FEMORIS MUSCLES WERE AFFECTED IN FEMALES, ONLY BICEPS FEMORIS AFFECTED IN MALES. IN
ANIMALS W LESIONS LESS THAN 1% OF THE MYOFIBERS DEMONSTRATED THE DEGENERATIVE MUSCLE
ALTERATIONS. ALL ANIMALS COMPLETED THE TREATMENT AND MARKETING PHASE INDICATING THE
SUBCLINICAL NATURE OF THE FINDING. 3 ANIMALS PREVIOUSLY REPORTED AS ADE FOR NOT COMP-LETEING
THE MARKETING PHASE(O PPM -DEAD; NANI-10 PPM, NANI-5 PPM). THESE ANIMALS HAD SIMILAR MUSCLE
LESIONS; DID NOT APPEAR TO CORRELATE W/ CLIN SIGNS. NON-PROGRESSIVE MARKETING CONDITION-PIGS
WERE HANDLED MORE AGGRESSIVELY. THAN IN THE PROGRESSIVE MARKETING CONDITIONS WHICH WERE
SIMILAR TO INDUSTRY RECOMMENDED PRACTICES FOR HANDLING, MOVING, LOADING AND TRANSPORTING
MARKET HOGS.
CVM _Report. rep
Causality
Assessment
4
Time
To Onset
UN
Clinical Detail:
M PR-MUSCLE(S), LESION(S)
Document ID: N 140863 Submission ID: L 192 Package ID: A 1 Corrsp Date: 09/01 /2004
Source:
Country:
United States
State:
IOWA
Zip:
OWNER REPORT
Episode Date:
08117/2004
Dose Description: 4.5 G/TON; 7/20-8/17/04
XX XXX
Source Report ld:
US200405123
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 199
2400
72
72
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
INCREASE IN DEADS AND DOWNERS; 3% VERSUS TYPICAL 0.5 %.
Causality
Assessment
2
2
Time
To Onset
28 DA
28 DA
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
OWNER REPORT
Episode Date:
08/20/2004
CVM _Report. rep
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Age: UN
Weight: UN
Gender: Unknown
US200405086
UNK
#Treated:
1000
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
9 G/TON
None
Missing information
Owner
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 200
12
12
PIG
Unknown (pig)
UN
UN
Unknown
FARM FED A FEW SMALL GROUPS OF PIGS 9 G/TON WHILE OTHERS RECEIVED 4.5 G/TON. THOSE FED 9 G/TON
EXHIBITED AGGRESSIVE BEHAVIOR TOWARD THE LOADING CREWS. THEY WERE PILING UP, FIGHTING AND
BITING AT PEOPLE. ALSO REPORTED MORE CRIPPLED PIGS; THE PIGS WERE VOCALIZING MORE AND APPEARED
TO BE MORE STRESSED. THE 4.5 G/TON PIGS WERE NOT AS SEVERELY AFFECTED BUT WERE LESS AFRAID OF
HUMANS THAN THOSE NOT FED RACTOP AMINE. THE FARM HAD BEEN SHIPPING LARGER LOADS (200 VS 180) AND
NOTED MORE DEADS PIGS ON THE TRUCK (0.125%) THAN USUAL (0.04%) FOR THIS FARM OVER THE PAST 8-10
MONTHS.
Causality Time
3 UN G BITING/CHEWING
3 UN G DEATH
3 UN G RECUMBENCY
3 UN G VOCALIZATION
3 UN N AGGRESSION
3 UN N APPREHENSION
3 UN N NERVOUSNESS
Drug Name:
RACTOPAMINE
Country:
United States
State:
OHIO
Zip:
44412
Episode Date:
08118/2004
Route:
CVM _Report. rep
Source Report Id: US200405054
NDC:
Product Lot No: UNK
#Treated:
#Reacted:
#Died:
0
0
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Not applicable
Not applicable
NA
Not applicable
Not applicable
Not applicable
No Value
Species:
Breed:
Age:
Weight:
Gender:
Page: 201
0
PIG
Unknown (pig)
NA
NA
Not applicable
CALLER INQUIRED ABOUT POSSIBLE USE OF RACTOPAMINE BY INJECTION. REPORTED THAT HE SAW SOME
INFORMATION ON A WEBSITE AND THINKS SOME 4-H PIGS HAVE BEEN INJECTED. WAS TOLD IT MADE THE MEAT
RUBBERY. NO ACTUAL ANIMALS WERE KNOWN TO BE INJECTED WITH RACTOPAMINE.
Causality
Assessment
Time
-9 NA G NO SIGNS
Source:
Country:
United States
State:
IOWA
Zip:
ELANCO AND PRODUCER
Episode Date: 07/01 /2004
Extra Label: None
XX XXX
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Source Report ld:
US200405122
NDC:
Product Lot No:
UNK
#Treated:
5600
#Reacted: 5600
#Died:
2520
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
260 LB
Gender: Unknown
DEAD AND DOWNS INCREASED FROM 1.8% TO 3-5 %FROM 8/11/04 TO 8/24/04 (SHIPPING/SLAUGHTER TIME). THIS
INCREASE WAS SEEN IN PIGS FED FOR 28-30 DAYS AT 4.5 G/TON. THIS FARM MARKETS APPRO X 20,000 PIGS PER
WEEK. TOTAL LOSS FROM DEADS AND DOWNERS WAS 1.8% FROM JULY 1, 2004 TO 8/10/04 ON PIGS FED 14-21
CVM _Report. rep
Page: 202
DAYS AT 4.5 G/TON. THE 1.8 % LOSS WAS WHAT WAS NORMALLY EXPECTED FOR THIS SITE. THE HIGHER
INCIDENCE WAS ONLY FOR THIS GROUP AND ONLY FOR THE PIGS FED FOR THE LONGER DURATION. FlU: 911 /04-
DEATH LOSS FOR 711 /04 TO 8/10/04 WAS 1.5%, DOWN AND SUSPECT 3% (6 WKS AT 20K PIGS/WK = 1800 DEADS, 3600
SUSPECT/DOWN/DEAD). FROM 8110 TO 8/24 DEATH LOSS WAS 1.8%, TOTAL DEADS, DOWNS AND SUSPECTS WAS 5%
(2 WKS@ 20 K/WK = 720 DEAD, 2000 DOWN/SUSPECT/DEAD). DURING THE WEEK OF 911 THE FARM MARKETED A
BARN OF 10,000 PIGS THAT HAD NOT BEEN FED RACTOP AMINE. DOWNS, DEADS AND SUSPECT PIGS STILL
INCREASED OVER WHAT IS NORMALLY SEEN AT THE UNIT-ACTUAL NUMBERS/PERCENTAGES NOT PROVIDED.
Causality
Assessment
Time
2 28 DA G DEATH
Source:
Country:
United States
State:
MISSOURI
Zip:
65201
Episode Date: 08116/2004
Dose Description: 4.5 G/TON; 7119-8116/04
Extra Label: None
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Medium
Unknown
Source Report ld:
US200405164
NDC:
Product Lot No:
UNK
#Treated:
480
#Reacted: 60
#Died:
60
Species: PIG
Age: UN
Weight:
260 LB
INCREASE IN DOWN AND DEADS (12.5% DEATH RATE) AT THE PACKER. NUTRITIONIST WAS CONSIDERING
PROBLEMS W/ CA AND PIN THE RATION. 9/7/04-FEED SUBMITTED FOR ANALYSIS. CA AND P INCREASED IN THE
RATION. HAVING MANY PROBLEMS WI BROKEN BONES; NUTRITIONIST CONCERNED WI CAIP.
Causality
Assessment
2
2
Time
To Onset
27 DA
27 DA
CVM _Report.rep
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
IOWA
Zip:
51360
NUTRITIONIST FROM FEED CO
Episode Date:
08/23/2004
Dose Description: 4.5 G/TON X 7 DAYS THEN 9 G/TON
Source Report ld:
US200405172
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 203
119
27
15
Extra Label: Unknown Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing information
Owner
Missing information
Unknown
Age: UN
Weight:
UN
Gender: Unknown
PIGS WERE SHIPPED FROM MINNESTOA TO IOWA. THIS UNIT HAD NOT BEEN HAVING TRANSIT MORTALITY
PROBLEMS UNTIL RECENTLY. PIGS HAD BEEN ON THE STEP UP PROGRAM WHERE THEY RECEIVED
RACTOPAMINE @ 4.5 G/TON X 7 DAYS THEN MOVED UP TO 9 G/TON. FlU: 9/28/04: AFTER MARKETING THE WHOLE
BARN THE TOTAL NUMBER OF PIGS INVOLVED WAS 1199, W/ 15 DEAD AND 12 SUSPECT. IN THE 2 WEEKS PRIOR TO
THE START OF RACTOPAMINE THIS SITE MARKETED 384 HEAD WITH NO DEAD OR SUSPECT ANIMALS.
Causality
Assessment
3
3
Time
To Onset
UN
UN
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
INDIANA
Zip:
46140
FARM
Episode Date:
08/26/2004
CVM _ Repmt.rep
Package ID: A 4
Source Report ld:
NDC:
Product Lot No:
US200405174
UNK
#Treated:
#Reacted:
#Died:
500
500
0
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
UNK
Unknown
Unknown
Owner
Unknown
Species:
Breed:
Age:
Weight:
Gender:
Page: 204
PIG
Unknown (pig)
Unknown
UN
UN
PIGS IN A RESEARCH BARN SQUEAL WHEN THEY TAKE STEPS, AS IF IN PAIN. MOST NOTICABLE WHEN LOADING
FOR SHIPPING. PIGS WOULD VOCALIZE AND REFUSE TO LEAVE THE PEN DESPITE PROPER HANDLING
PROCEDURES. THE ANIMALS WERE DESCRIBED AS SEEMING PAINFUL, AS IF CRAMPING. THIS IS AN ONGOING
ISSUE AT THIS SITE W/ RACTOPAMINE FED PIGS. HANDLING HAS NOT CHANGED AND NO NEW PROCEDURES HAD
BEEN INTRODUCED.
Causality
Assessment
Time
UN G PAIN
UN G SPASM
2 UN G VOCALIZATION
Source:
Country:
United States
State:
IOWA
NOT ENOUGH INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
CVM _Report. rep
Zip:
09/07/2004
Unknown
Oral (in dry feed)
UNK
Unknown
UNK
Missing information
Unknown
Not applicable
50525
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200405300
UNK
#Treated:
3
#Reacted: 3
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
Page: 205
Concomitants:
No Value
A BUYER OF SHOW PIGS STATED THAT 3 PIGS HAD ADDITIVES OR RESIDUES IN THEIR BLOOD. THIS INFO CAME
FROM THE MEAT PACKER WHO TOLD THIS TO THE BUYER. IT WAS NOT KNOWN IF THE PIGS HAD BEEN FED
RACTOP AMINE BUT IT WAS SUSPECTED THAT AT LEAST ONE HAD BEEN FED RACTOP AMINE AND FLUNIXIN
MEGLUMINE. NO OTHER DETAILS WERE AVAILABLE.
Causality
Assessment
-8
Time
To Onset
UN
Clinical Detail:
G RESIDUE, MEAT
Source:
Country:
State:
United States
MINNESOTA
Zip:
56031
NO ANIMAL NUMBERS
Episode Date:
09/08/2004
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 OM/TON X 2 WK THEN 6 OlTON X 3 WKS.
Extra Label: None
Reason For Use:
INCREASE CARCASS LEANESS
Health Status:
Missing information
Administered By:
Owner
Vet Opinion: High
US200405315
UNK
#Treated:
37290
#Reacted: 173
#Died:
80
Species: PIG
Age: UN
Weight:
UN
Gender: Unknown
INCREASE IN MORTALITY FROM 0.25% TO GREATER THAN 1% IN PIGS FED RACTOPAMINE AT 4.5 OlTON FOR 2
WEEKS THEN 6 OlTON FOR 3 WEEKS. FARM IS DISCONTINUING RACTOPAMINE. FlU: SUBM 196,9/24/04: OVER A 4
MONTH PERIOD, MORE THAN 37,000 PIGS RECEIVED RACTOPAMINE AND 173 HAD REACTED OR DIED. CF:
POSSIBLE ANIMAL HANDLING PROBLEM.
Causality
Assessment
2
2
Time
To Onset
5 WK
5 WK
Clinical Detail:
G DEATH
G RECUMBENCY
CVM _Report.rep
Source:
Country:
United States
State:
MICHIGAN
OWNER REPORT
Episode Date:
09/12/2004
Zip:
49780
Dose Description: 1/3 OF A 50LB BAG @12 G/TON (lOOMG)
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species
ACCIDENTAL
Good
Not applicable
Low
Unknown
Source Report ld:
NDC:
Product Lot No:
US200405361
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 206
DOG
Great pyrenees
Male
10 MO
UN
DOG DIED AFTER EXHIBITING SIGNS OF LETHARGY AND CYAN OTIC GUMS. NECROPSY: PALE THROUGHOUT AND
"BLUISH" KIDNEYS. NO STOMACH TORSION OR LIVER PROBLEMS. FARM ALSO HAS RAT POISON. VET SENT HOME
VIT K INJECTIONS IN CASE OTHER DOGS EXHIBIT SIGNS.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
1 DA G CYANOSIS, MUCOUS MEMBR
1 DA G DEATH
1 DA G DEPRESSION/LETHARGY
1 DA u PR-KIDNEY(S), LESION(S
Source:
Country:
State:
United States
TEXAS
Zip:
75444
INFO LACKING
Episode Date:
09/07/2004
CVM _ Rep01t.rep
Source Report ld:
NDC:
Product Lot No:
US200405309
UNK
#Treated:
#Reacted:
3
3
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (all other)
UNK
Species
INCREASED MUSCLE IN SHOW LAMBS
Missing information
Owner
No Value
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 207
0
SHEEP
Unknown (sheep)
Unknown
UN
UN
WOMAN REPORTED THAT AN ANIMAL SUPPLY CO REP INFORMED HER THAT A GROUP(# NOT PROVIDED) OF
SMALL FRAMED LAMBS FED RACTOPAMINE FOR SHOW PURPOSES BECAME HEAVILY MUSCLED AND DEVELOPED
JOINT PROBLEMS. NOT APPROVED FOR USE IN LAMBS. SECOND HAND REPORT-NO CONFIRMATION OF ACTUAL
ADMINISTRATION OR ADE.
Causality
Assessment
-8
Time
To Onset
UN
Clinical Detail:
M JOINT DISORDER
Source:
Country:
State:
United States
UTAH
Zip:
84751
ON-FARM DEMONSTRATION
Episode Date:
08116/2004
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 G/TON X 3 WEEKS, THEN 9 G/TON X 2 WEEKS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASE ADG, ON FARM DEMONSTRATION
Good
Owner
High
Unknown
US20040541 0
UNK
#Treated:
24000
#Reacted: 526
#Died:
327
Species: PIG
Age: UN
Weight: 265 LB
PIGS WERE SHIPPED 8116/04. 293 (1.22%) WERE DEAD ON THE TRUCKS, 34 (.14%) DIED AT THE PLANT IN PENS AND
199 (.83%) WERE CLASSIFIED AS CRIPPLES OR SUBJECTS. THE DEMONSTRATION WAS TO DETERMINE IF A STEP-
CVM _Report. rep
Page: 208
UP PROGRAM WOULD HELP THE PIGS MAINTAIN WEIGHT DURING THE SUMMER HEAT. TOTAL EXPECTED
MORTALITY AND SUBJECTS WAS 1.56% AND IN THIS DEMONSTRATION THE RATE WAS 2.19%. THE FARM WILL
CONTINUE TO FEED AT 4.5 G/TON.
Causality
Assessment
Time
5 WK G DEATH
5 WK G RECUMBENCY
Source:
Country:
United States
State:
MARYLAND
Zip:
VET REPORT
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/15/2004
Not applicable
Oral (in dry feed)
8/15-9/17/04
Species subgroup
UNK
Good
Owner
Medium
No Value
21550
Source Report Id:
US200405427
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: 2 YR
Weight: 350 LB
Gender: Female
SOW WAS BRED 6/23/04 AND BELIEVED TO BE PREGNANT BUT STAR TED SHOWING SIGNS OF HEAT ON 9/15/04. DDX:
BOAR FERTILITY PROBLEM HAS BEEN IDENTIFIED. ELU: OVERWEIGHT, BREEDING STOCK.
Causality
Assessment
Time
0 1 MO X FERTILITY, LACK OF
Source:
Country:
State:
CVM _Rep01t.rep
United States
NEBRASKA
Zip:
xxxxx
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US2004054 77
UNK
INFO LACKING
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
09/08/2004
Recommended dose
Oral (in dry feed)
4.5 OlTON
None
IMPROVED RATE OF GAIN
Missing infonnation
Owner
Missing information
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 209
1000
8
8
PIG
Unknown (pig)
UN
270 LB
Unknown
SHIPPED 170 PIGS ON 9/9/04. 8 WERE DEAD ON ARRIVAL AT THE PACKING PLANT. NO INFO ON THE REMAINING
830 WHEN THEY WERE SHIPPED.
Causality
Assessment
Time
2 UN G DEATH
Source:
Country:
United States
State:
MINNESOTA
Zip:
OWNER REPORT
Episode Date:
08/13/2004
Extra Label:
None
56074
Reason For Use:
Health Status:
Missing information
Administered By:
Owner
CVM _Report. rep
Source Report Id:
US200405613
NDC:
Product Lot No:
UNK
#Treated:
189
#Reacted: 19
#Died:
12
Species: PIG
Age: UN
Weight: 279 LB
Page: 210
Concomitants:
Unknown
ONLY FED FOR 5 DAYS. 12 DEAD ON ARRIVAL AT SLAUGHTER PLANT AND 7 MORE WERE STRESSED. USUALLY
EXPECTS TO SEE NO STRESSED PIGS AND ONLY 5 DEAD PER 2000 SHIPPED. THE PACKER AND THE OWNER FELT
THE INEXPERIENCE OF THE TRUCK DRIVER MAY HAVE CONTRIBUTED. IT WAS SPECULATED THAT A FLOOR MAY
HAVE COLLAPSED DURING TRANSPORT AND MAY HAVE CONTRIBUTED TO THE DEATHS.
Causality
Assessment
Time
5 DA G DEATH
Source:
Country:
United States
State:
IOWA
Zip:
50010
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
10115/2004
Recommended dose
Oral (in dry feed)
911 0/04 TO 10/1 5/04
None
Missing information
Owner
Unknown
Source Report ld:
US200405841
NDC:
Product Lot No:
UNK
#Treated:
180
#Reacted: 19
#Died:
19
Species: PIG
Age: UN
Weight: 280 LB
180 PIGS SHIPPED TO PROCESSOR. 19 WERE DOA. THIS GROUP HAD BEEN FED 4.5 G/TON RACTOPAMINE FOR 2
WEEKS THEN 9 G/TON FOR 3 WEEKS. THEY WERE THE LAST LOAD FROM A GROUP OF 1000 FINISHERS THAT WERE
FED A RACTOP AMINE RATION. THIS WAS THE ONLY GROUP SHIPPED THAT HAD BEEN ON RACTOP AMINE FOR
THIS PERIOD OF TIME. THIS WAS THE FIRST TIME THE PRODUCER SAW PROBLEMS W/ RACTOPAMINE FED PIGS.
FlU: HAVE CONTINUED TO FEED RACTOPAMINE AT 4.5 G/TON FOR 21 DAYS. NO RECURRENCE OF ADE.
Causality
Assessment
2
Time
To Onset
5 WK
Clinical Detail:
G DEATH
Source:
CVM _Report. rep
Country:
United States
State:
NORTH CAROLINA Zip:
REPORT FROM PRODUCER
Episode Date:
09/0112004
XX :XXX
Dose Description: 4.5 G/TON; 8/11 TO 9/ 1104
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
INCREASE CARCASS LEANESS
Good
Owner
Unknown
Source Report Id:
US200405814
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 211
30000
180
180
PIG
Unknown (pig)
UN
255 LB
Group (m & f)
FARM OBSERVED BROKEN BONES IN ANIMALS RECEIVING DIETS WAND W/OUT RACTOPAMINE. FRACTURES
SEEN IN FINISHING BARNS AND DURING SHIPPING. NUTRITIONIST STATED THAT THERE WERE PROBLEMS W THE
CA/PHOS RTIO IN THE RATIONS.
Causality
Assessment
Time
-1 20 DA M PR-BONE(S), LESION(S)
Source:
Country:
State:
United States
NO ANIMAL NUMBERS
Episode Date:
09/03/2004
Dose Description: 4.5 G/TON; 8/20/04 TO 10/5/04
Extra Label:
None
Reason For Use:
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200405908
UNK
#Treated:
100
#Reacted: 20
#Died:
0
Species: PIG
Age: UN
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing infonnation
Owner
Unknown
Weight:
Gender:
Page: 212
UN
Missing information
PRODUCER REPORTED THAT PIGS WERE HYPERACTIVE AND EASILY STRESSED IN THE BARNS. RATE OF BONE
FRACTURES WAS HIGHER DURING SHIPMENT. RACTOP AMINE WAS DISCONTINUED. PRODUCER IS RELUCTANT TO
PROVIDE INFORMATION, NO ANIMAL NUMBERS PROVIDED-ESTIMATES USED.
Causality
Assessment
Time
To Onset
14 DA
14 DA
Clinical Detail:
G INJURY
N HYPERACTIVITY
Source:
Country:
State:
United States
IOWA
Zip:
50126
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/01 /2004
Not applicable
Oral (in dry feed)
4.5 GM/TON; 11/26/04
Species
ACCIDENTAL EXPOSURE
Good
Owner
Not applicable
No Value
ACCIDENTALLY FED CATTLE W/ SWINE RATION. NO SIGNS.
Causality
Assessment
-9
CVM _ Report.rep
Time
To Onset
NA
Clinical Detail:
Source Report ld:
NDC:
Product Lot No:
US200406372
UNK
#Treated:
45
#Reacted: 0
#Died:
0
Species: CATTLE
Age: 6 MO
Weight:
750 LB
-9 NA
G NO SIGNS
Document ID: N 140863 Submission ID: L 206 Package ID: A 1 Corrsp Date: 01 /06/2005
Source:
Country:
United States
State:
IOWA
Zip:
NO ANIMAL NUMBERS
Episode Date:
Dosage:
Route:
Dose Description:
12/14/2004
Unknown
Oral (in dry feed)
UNK DATE, DOSE
51048
Source Report ld:
US200406526
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 213
0
0
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Missing information
Owner
No
Age: UN
Weight:
UN
Gender: Unknown
A PRODUCER LEARNED THROUGH GENERAL CONVERSATION AND A TELECONFERENCE ABOUT RACTOPAMINE
THAT PIGS CONSUMING RACTOP AMINE ARE HYPERACTIVE AND HAVE A HIGHER DEATH LOSS DURING SHIPPING.
DOES NOT APPEAR TO BE A REPORT OF AN ADE REGARDING THE CALLER'S ANIMALS.
Causality
Assessment
-9
Time
To Onset
NA
Clinical Detail:
G NO SIGNS
Source:
Country:
State:
United States
IOWA
Zip:
52046
ASPCA
Episode Date:
01124/2005
CVM _ Rep01t.rep
Source Report ld:
US200500252
NDC:
Product Lot No:
UNK
#Treated:
30
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Oral (in dry feed)
#Reacted:
#Died:
UNK DOSE; 1124/05
Species:
Unknown Breed:
ACCIDENTAL
Age:
Weight:
Missing information
Gender:
Owner
High
Unknown
Page: 214
30
12
PIG
Other (pig)
UN
80 LB
Unknown
ACCIDENTAL EXPOSURE. OWNERS HAD SWEPT UP CORN SCREENINGS AND FED THEM TO GROWING PIGS.
LATER, AFTER PIGS HAD DIED, THEY REALIZED THAT A BAG OF RACTOPAMINE HAD BEEN SPILLED IN THE AREA
THEY SWEPT. WHEN THE VET ARRIVED, 10 WERE DEAD AND 2 WERE DOWN AND SHOWING CARDIOVASCULAR
SIGNS. VET COULD SEE THE HEART BEATING IN THE PIGS LAYING IN LATERAL RECUMBENCY. NECROPSY-NO
GROSS LESIONS. REMAINDER OF PIGS RECOVERED.
Causality
Assessment
2
Time
To Onset
24 HR
Clinical Detail:
c HEART DISORDER
2 24 HR G DEATH
2 24 HR G RECUMBENCY
2 24 HR N HYPERACTIVITY
Source:
Country:
State:
United States
ILLINOIS
Zip:
61801
POST APPROVAL STUDY REPORT
Episode Date:
07/20/2005
Dose Description: lOPPM JUL 2005-AUG 2005
Extra Label:
Indication
CVM _Report. rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Corrsp Date: 01 /05/2006
US200502036
NOT GIVEN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
PIG
3
3
Unknown (pig)
UN
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
POST APPROVAL RESEARCH STUDY T4Vl70504
Good
Veterinarian
Missing information
Unknown
Weight:
Gender:
Page: 215
UN
Group (m & f)
HX OF 2 GILTS INJURED DURING "SORTING" ON 7/ 13/05. 1ST PIG HAD SKIN LACERATIONS- RTX TOPICAL
DISINFECTANT. 2ND PIG WAS ATAXIC (HIND QUARTERS)- RTX 2ML PENICILLIN WLY 13-15. THESE PIGS WERE
REMOVED FROM STUDY (DISCREPANCY AS TO WHETHER OR NOT THESE ANIMALS WERE TREATED EXISTS.
FOLLOW UP INDICATES THEY MAY HAVE BEEN REMOVED PRIOR TO STUDY; ELSEWHERE IT SAYS THEY WERE
"TREATED") ON 8/17/05, A THIRD PIG WAS FOUND DEAD IN PEN. PR- CAUSE OF DEATH = BOWEL STRANGULATION
2NDARY TO UMBILICAL HERNIA. DDX: PRE-EXISTING CONDITIONS (INWRIES/UMBILICAL HERNIA)
Causality
Assessment
Time
-1 21 DA G DEATH
-1 UN G LAMENESS
Source:
Country:
United States
State:
PENNSYLVANIA
Zip:
17110
Report Quality: Missing Information
UNK #S TREATED/REACTED/DOSAGE/DATES
Episode Date:
09/20/2005
Dosage: Unknown
Dose Description: UNKNOWN DATES OF ADMIN
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Missing information
Unknown
Missing infom1ation
No Value
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
Corrsp Date: 01 /05/2006
US200503299
NOT GIVEN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
PIG
Unknown (pig)
Unknown
UN
UN
9116/05: USDA INSPECTOR CONDEMNED UNSPECIFIED# PIGS FOR SKELETAL MM THAT WAS EDEMATOUS AND
CONTAINED HEMORRHAGIC LESIONS. SUSPECTED RACTOPAMINE OVERDOSE. PR ON CARCASSES SHOWED
EDEMA AND GROSS HEMORRHAGE OF SKELETAL MM; OTHERWISE UNREMARKABLE. POSSIBLE TISSUE TESTING
CVM _Rep01t.rep
FOR RACTOPAMINE IS PENDING. EXPOSURE SPECULATED, BUT NOT CONFIRMED.
Causality
Assessment
-8
Time
To Onset
UN
Clinical Detail:
M PR-MUSCLE(S), LESION(S)
Page: 216
Source:
Country:
State:
United States
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01/0112000
Recommended dose
Oral (all other)
ORAL- 2000
None
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
EFFICIENCY, AND INCREASED CARRCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Unknown
US200602028
UNKNOWN
#Treated:
#Reacted:
#Died:
0
Species: PIG
Age: 6 MO
Weight:
260 LB
ON AUG 25, 2006, MR. DARRELL THEIS, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN PIGS. IN 2000, BRYAN
FOODS BEGAN PROCESSING PIGS THAT HAD BEEN FED RATIONS CONTAINING RACTOP AMINE RANGING FROM 4.5
G/TON TO 18 G/TON/ SINCE 2000, MR. BRAIN FRANK AND MR. KEITH RICHARDSON, OF BRYAN FOODS, FELT THAT
THE INCIDENCE OF DOWNER PIGS HAS INCREASED TO APPROXIMATELY 1% OF THE 5300 PIGS PROCESSED DAILY
AT THE FACILITY.
ELANCO CALCULATED THAT BASED UPON THE INFORMATION PROVIDED, APPROXIMATELY 3, 000,000 PIGS WERE
EXPOSED IN THE YEARS 2000 TO 2006, AND APPROXIMATELY 30, 000 WOULD HAVE BEEN CLASSIFIED AS
DOWNERS.
BRYAN FOODS HAS DISCONTINUED THE USE OF RACTOP AMINE IN THE RATIONS BUT DID REINSTATE THE
PRODUCT ON AN UNKNOWN DATE. NO FURTHER INFORMATION WAS PROVIDED.
Causality
Assessment
0
Time
To Onset
UN
CVM _Repmt. rep
Clinical Detail:
G COLLAPSE
Page: 217
Source:
Country:
Foreign
State: Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/15/2006
Recommended dose
Oral (all other)
5 AND 1 OPPM; ORAL- 7/26/06-8/23/06
None
IMPROVED PERFORMANCE
Good
Owner
Unknown
Unknown
Package ID: A 2
Source Report Id:
NDC:
Product Lot No:
CA200600063
436PP6
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
270
2
Other (pig)
Male
24 WK
120 KG
400 PIGS WERE IN A PA YLEAN TRIAL AND RECEIVING 0, 5 OR 10 PPM PA YLEAN. ON DAY 20 OF THE TRIAL, ONE PIG
IN THE 5 PPM TREATMENT GROUP BECAME NON AMBULATORY AFTER WEIGHING: WITH SIGNS OF MUSCLE
TREMORS, AN OPEN MOUTH BREATHING. IT DIED WITHIN A FEW HOURS. ONE OTHER PIG IN THE 10 PPM GROUP
HAD SIMILAR SIGNS, BUT RECOVERED. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
0
0
0
Drug Name:
Time
To Onset
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G DEATH
G RECUMBENCY
N TREMBLING
R POLYPNEA
Source:
Country:
State:
United States
TEXAS
Zip:
77515
Episode Date:
06/01/2005
CYM _Report. rep
Source Report Id:
US200602046
NDC:
Product Lot No:
REQUESTED, NOTPROV
#Treated:
10
Page: 218
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Oral (in dry feed)
UNK DOSE; 2005*
Unknown
INCREASED CARCASS LEANNESS, IMPROVED FEED
EFFICIENCY
Good
Owner
Missing information
Unknown
#Reacted: 10
#Died:
0
Species: PIG
Age: UN
Weight: 250 LB
Gender: Female
ON AUGUST 28 2006 ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN PIGS. MR. BRIAN SCARBOROUGH FED AN
UNKNOWN NUMBER OF SHOW PIGS RATION THAT CONTAINED RACTOP AMINE AT AN UNKNOWN LEVEL. MR
SCARBOROUGH STATED THAT THE RACTOP AMINE FED PIGS APPEARED TO BE MORE TIGHT IN THEIR BODY
STRUCTURE, STRAIGHTER IN THE HOCKS AND LESS FLEXIBLE. NO DOWNER PIGS OR DEATHS OCCURRED. MR.
SCARBOROUGH CONTINUED TO FEED RACTOP AMINE TO PIGS HE FELT NEEDED TO BECOME MORE LEAN PRIOR
TO SHOW. THE ANIMALS WERE SLAUGHTERED THEREFORE NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G POSTURE ABN
G STIFFNESS
Source:
Country:
State:
Foreign
Zip:
Episode Date:
07116/2007
Dose Description: 5 PPM ORAL UNKNOWN DATE
Extra Label: None
Reason For Use:
WEIGHT PERFORMANCE
Health Status:
Unknown
CVM _ Repmt.rep
Source Report ld:
CA200700054
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
1100
#Reacted: 17
#Died:
17
Species: PIG
Age: UN
Weight: UN
Gender: Unknown
Administered By:
Vet Opinion:
Concomitants:
COUNTRY: CANADA
Owner
Missing information
Unknown
Page: 219
ELAN CO ANIMAL HEALTH RECEIVED A CASE FROM CANADA REGARDING RACTOP AMINE IN PIGS. SOME
CUSTOMERS FROM A DISTRIBUTOR COMPLAINED THEY OBSERVED SOME INCREASED DEATH OF PIGS IN
TRANSPORT FROM 0.5% TO 1.5% SINCE INCLUSION OF PA YLEAN.
NO FURTHER INFORMATION WAS PROVIDED. THIS CASE WAS RECEIVED BY THE US GREENFIELD
PHARMACOVIGILANCE UNIT ON JULY 16,2007.
REV NOTE: PER LABEL, APPROPRIATE CONCENTRATION OF RACTOPAMINE IN TYPE C MEDICATED FEED 4.5 TO 9.0
G/TON* (5 TO 10 PPM)
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
Foreign
Zip:
Episode Date:
07116/2007
Dosage: Unknown
Dose Description: UNKNOWN DATE AND DOSE
Extra Label:
Unknown
Reason For Use:
WEIGHT PERFORMANCE
Health Status:
Good
Administered By:
Owner
COUNTRY: CANADA
CVM _Report. rep
Source Report ld:
CA200700055
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
4400
#Reacted: 4
#Died:
0
Species: PIG
Age: 25 WK
Weight: 110 KG
Page: 220
ELAN CO ANIMAL HEALTH RECEIVED A CASE FROM CANADA COMPLAINING ABOUT BROKEN LIMBS IN PIGS THAT
WERE ON RACTOPAMINE. A NUTRITIONIST REPORTED THAT SOME PIGS HAD BROKEN LIMBS WHEN THEY WHERE
EITHER IN THE BARN OR LOADED. IT WAS ABOUT ONE PIG PER 1100 PIGS SOLD EACH WEEK.
PHARMACOVIGILANCE UNIT ON JULY 16, 2007.
**REVIEWER NOTE: BROKEN LIMBS CODED AS "LEG DISORDER"
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G LEG DISORDER
Source:
Country:
State:
Foreign
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
07116/2007
Unknown
Oral (in dry feed)
JUN-20-2007* - JUL-11-2007*
Unknown
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
GROWTH/FEED CONVERSION ENHANCEMENT
Health Status:
Poor
Administered By:
Owner
COUNTRY: CANADA
CA200700059
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
720
PIG
Unknown (pig)
157 DA
120 KG
Male, neutered
ELANCO ANIMAL HEALTH RECEIVED A CASE FROM CANADA REGARDING RACTOPAMINE IN PIGS. TWO ELANCO
EMPLOYEES WITH ONE PRODUCTION MANAGER WERE TOURING THE BARN. THEY CAME ACROSS A PIG IN
SHIPPING PEN THAT EXHIBITED FATIGUED STRESS SYMPTOMS, LOCKED REAR LEGS, SQUEEZING, LABORED
BREATHING, AND PANICKED TEMPERAMENT. ELANCO EMPLOYEES REMOVED THIS SUBJECT FROM PEN TO THE
HALLWAY WHERE IT COULD BE LEFT ALONE TO REST AND RECOVER.
NEXT DAY, BOB CALLED TO INFORM THAT THE PIG WAS EUTHANIZED AS IT COULDN'T GET UP OR BE SHIPPED.
BOB THOUGHT THE PIG MIGHT HAVE A HEART ATTACK OR STROKE.
PHARMOCOVIGLANCE UNIT ON JULY 19, 2007
CVM _ Repmt.rep
Page: 221
**REVIEWER NOTE: F ATIQUED STRESS SYMPTOMS CODED AS "WEAKNESS". LOCKED REAR LEGS CODED AS
"GAIT DISORDER".
SUSPECT THAT THE CLINICAL SIGN DESCRIBED AS "SQUEEZING" MAY HAVE BEEN A TYPING ERROR AND SHOULD
SAY "SQUEALING". CODED AS "VOCALIZATION".
Causality
Assessment
0
0
0
0
0
0
0
Drug Name:
Time
To Onset
UN
UN
UN
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G BEHAVIOR DISORDER
G DEATH(EUTHANIZED)
G RECUMBENCY
G VOCALIZATION
G WEAKNESS
R DYSPNEA
Source:
Country:
State:
United States
CALIFORNIA
Zip:
93274
Episode Date:
06/25/2007
Source Report ld:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13 PPM; ORAL- JUNE 25, 2007* -JULY 9, 2007
Extra Label:
Species
Reason For Use:
Health Status:
Good
Administered By:
Owner
US200702425
555PP6
#Treated:
450
#Reacted: 40
#Died:
40
Species: TURKEY
Age: 20 WK
Weight:
UN
Gender: Male
ON 07/13/07, MS. KATHY VANNATTA, ELANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN TURKEYS IN A
CLINICAL STUDY. DURING STUDY T4V060621, 40 BIRDS DIED. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE
THE CLINICAL EFFECTS OF 2% RACTOPAMINE HYDROCHLORIDE TYPE A MEDICATED ARTILE (E.G.
INVESTIGATIONAL NEW ANIMAL DRUG) ON GROWTH PERFORMANCE IN TOM FINISHING TURKEYS. IT WAS
REPORTED THAT 40 BIRDS DIED (BELIEVED TO BE DUE TO EXTREME TEMPERATURES DURING THE STUDY). OF
CVM _ Repo1i.rep
Page: 222
THE 40 TURKEYS THAT DIED, 7 WERE IN THE CONTROL GROUP (0 PPM RACTOPAMINE), 15 IN THE 13 PPM GROUP,
12 IN THE 9 PPM GROUP AND 6 IN THE 5 PPM GROUP. A COMPLETE SUMMARY OF ADVERSE EVENTS, SERIOUS AND
NON-SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT.
MEDICAL HISTORY: NOT PROVIDED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
CALIFORNIA
Zip:
93274
Episode Date:
03/27/2007
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13 PPM; PO- MARCH 27, 2007* - APRIL 10, 2007
Extra Label: Species
Reason For Use:
Health Status:
Good
Administered By:
Owner
US20070251 0
55PP6
#Treated:
450
#Reacted: 2
#Died:
2
Species: TURKEY
Age: 15 WK
Weight:
UN
Gender: Female
ON 0711 6/07, MS. KATHY VANNATTA, BLANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
CLINICAL STUDY. DURING STUDY T4V60701 , 2 BIRDS DIED. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE
REPORTED THAT 2 BIRDS DIED ONE FROM THE 5 PPM TREATMENT GROUP AND ONE FROM THE 9 PPM TREATMENT
GROUP. A COMPLETE SUMMARY OF ADVERSE EVENTS, SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE
FINAL STUDY REPORT.
Causality
Assessment
0
Time
To Onset
UN
CVM _Report. rep
Clinical Detail:
G DEATH
Page: 223
US200702511
Country:
United States NDC:
State:
COLORADO
Zip:
80549
Product Lot No:
555PP6
Episode Date:
04/16/2007
#Treated:
450
#Reacted: 2
2
Dose Description: 0, 5, 9, 13 PPM; ORAL- APRIL 16, 2007*- APRIL 30, 2007*
Species: TURKEY
Extra Label:
Species Breed: Not specified
Reason For Use:
Age: 15 WK
Weight: UN
Health Status:
Gender: Female
Good
Administered By:
Owner
ON 07116/07, MS. KATHY VANNATTA, BLANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
REPORTED THAT 2 BIRDS DIED ONE FROM THE 5 PPM TREATMENT GROUP AND ONE FROM THE 13 PPM
TREATMENT GROUP. A COMPLETE SUMMARY OF ADVERSE EVENTS, SERIOUS AND NON-SERIOUS WILL BE
SUBMITTED IN THE FINAL STUDY REPORT.
MEDICAL HISTORY: NOT PROVIDED.
Causality
Assessment
0
Time
To Onset
5 SE
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
COLORADO
Zip:
80549
Episode Date:
03/05/2007
CVM _ Report.rep
Source Report Id:
US200702512
NDC:
Product Lot No:
555PP6
#Treated:
450
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (all other)
0, 5, 9, 13 PPM; ORAL- MARCH 5, 2007*- MARCH 19, 2007
None
Good
Owner
Unknown
Unknown
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 224
16
16
TURKEY
Not specified
Male
20 WK
UN
ON 07/1 6/07, MS. KATHY VANNATTA, ELAN CO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
REPORTED THAT 16 BIRDS DIED; 4 FROM THE CONTROL GROUP, ONE FROM THE 13 PPM GROUP, 9 FROM THE 9 PPM
TREATMENT GROUP, AND 2 FROM THE 5 PPM TREATMENT GROUP. A COMPLETE SUMMARY OF ADVERSE EVENTS,
SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT.
MEDICAL HISTORY NOT PROVIDED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
47907
Episode Date:
04/02/2007
Package ID: A 5
Source Report ld:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13 PPM; ORAL- APRIL 2, 2007*- APRIL 16, 2007
Extra Label:
None
Reason For Use:
Health Status:
CVM _Report. rep
US200702513
555PP6
#Treated:
450
#Reacted: 12
#Died:
12
Species: TURKEY
Age: 20 WK
Weight:
UN
Page: 225
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Unknown
Gender: Male
ON 07/16/07, MS. KATHY VANNATTA, ELAN CO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
REPORTED THAT 12 BIRDS DIED; 2 FROM THE CONTROL GROUP, 3 FROM THE 5 PPM GROUP, 3 FROM THE 9 PPM
TREATMENT GROUP, AND 4 FROM THE 13 PPM TREATMENT GROUP. A COMPLETE SUMMARY OF ADVERSE
EVENTS, SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
47907
Episode Date:
06/05/2007
Package ID: A 6
Source Report Id:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13 PPM; ORAL- JUNE 5, 2007*- JUNE 19, 2007
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _ Report.rep
None
Good
Owner
Unknown
Unknown
US200702514
555PP6
#Treated:
450
#Reacted: 7
#Died:
7
Species: TURKEY
Age: 15 WK
Weight:
UN
Gender: Female
Page: 226
ON 07/16/07, MS. KATHY VANNATTA, BLANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
REPORTED THAT 7 BIRDS DIED; 2 FROM THE CONTROL GROUP, 1 FROM THE 5 PPM TREATMENT GROUP, 1 FROM
THE 9 PPM TREATMENT GROUP, AND 3 FROM THE 13 PPM TREATMENT GROUP. A COMPLETE SUMMARY OF
ADVERSE EVENTS, SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
Foreign
Zip:
Episode Date:
06/20/2007
Package ID: A 7
Source Report Id:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13 PPM; ORAL- JUNE 20, 2007*- JULY 4, 2007
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
RESEARCH STUDY T4VCA0622
Good
Owner
Unknown
Unknown
US200702516
555PP6
#Treated:
450
#Reacted: 6
#Died:
6
Species: TURKEY
Age: 20 WK
Weight:
UN
Gender: Male
ON 07/16/07, MS. KATHY VANNATTA, BLANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
CLINICAL STUDY. DURING STUDY T4VCA0622, 6 BIRDS DIED. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE
REPORTED THAT 6 BIRDS DIED; 1 FROM THE CONTROL GROUP, 0 FROM THE 5 PPM TREATMENT GROUP, 1 FROM
THE 9 PPM TREATMENT GROUP, AND 4 FROM THE 13 PPM TREATMENT GROUP. A COMPLETE SUMMARY OF
ADVERSE EVENTS, SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT. GUARANTEE
CLAIM.
CVM _Report. rep
Page: 227
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
Episode Date:
05/07/2007
Package ID: A 8
Source Report Id:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13 PPM; ORAL MAY 7, 2007*- MAY 21, 2007
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Owner
US200702517
555PP6
#Treated:
450
#Reacted: 6
#Died:
6
Species: TURKEY
Age: 20 WK
Weight:
UN
Gender: Male
ON 07/16/07, MS. KATHY VANNATTA, ELANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED A
REPORTED THAT 6 BIRDS DIED; 4 FROM THE CONTROL GROUP, AND 2 FROM THE 13 PPM TREATMENT GROUP. A
COMPLETE SUMMARY OF ADVERSE EVENTS, SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE FINAL
STUDY REPORT. GUARANTEE CLAIM.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
CVM _Report. rep
Source Report ld:
US200702518
Country:
United States NDC:
State:
MINNESOTA
Zip:
55108
Product Lot No:
555PP6
Report Qualitv: Average
Episode Date:
05/09/2007
#Treated:
#Reacted:
Dose Description: 0, 5, 9, 13 PPM; ORAL-MAY 9, 2007*- MAY 23, 2007
Species:
Extra Label: None Breed:
Reason For Use:
Age:
Weight:
Health Status:
Good
Gender:
Concomitants: No
Page: 228
450
8
8
TURKEY
Not specified
15 WK
UN
Female
REPORTED THAT 8 BIRDS DIED; 3 FROM THE CONTROL GROUP, 2 FROM THE 9 PPM TREATMENT GROUP, AND 3
FROM THE 13 PPM TREATMENT GROUP. A COMPLETE SUMMARY OF ADVERSE EVENTS, SERIOUS AND NON-
SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT. GUARANTEE CLAIM.
Causality
Assessment
0
Time
To Onset
5 SE
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
UNKNOWN
Zip:
XX XXX
Episode Date:
06/03/2007
Dosage: Various
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200702433
UNKNOWN
#Treated:
#Reacted:
800
800
Page: 229
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (all other)
VARIOUS DOSES; ORAL- 5/5/07- 6/2/07
Various
Good
Owner
Unknown
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
PIG
Other (pig)
6 MO
270 LB
Group (m & f)
ON JULY 16,2007, MR. DUSTIN FORD, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN PIGS. ON MAY 5, 2007,
PREMIUM STANDARD FARMS BEGAN A 28 DAY FARM TRIAL IN WHICH 1200 PIGS WERE DIVIDED EQUALLY INTO 3
GROUPS EACH RECEIVING A DIFFERENT RATIONS. ONE GROUP WAS A CONTROL GROUP WHOSE RATION
CONTAINED NO RACTOPAMINE, ANOTHER GROUP WAS FED A RATION THAT CONTAINED RACTOPAMINE AT 4.5
GITON AND THE LAST GROUP WAS FED A RATION THAT CONTAINED RACTOPAMINE AT 6.75 G/TON. BOTH THE 4.5
GITON AND 6.75 G/TON RACTOPAMINE INCLUSION GROUPS HAD REDUCED JAPANESE COLOR SCORES AT 86.78 AND
84.05, RESPECTIVELY, AS COMPARED TO THE CONTROL GROUP, WHICH WAS SCORED AT 88.3.
Causality
Assessment
0
Time
To Onset
28 DA
Clinical Detail:
D COLON,ABN
Source:
Country:
United States
State:
ILLINOIS
Zip:
61081
Episode Date:
07/01 /2007
Dose Description: 9.0 G/TON; ORAL; DATE UNK
Extra Label:
Species subgroup
Reason For Use:
Health Status:
Good
Administered By:
Owner
CVM _Report. rep
Source Report ld:
US200702698
NDC:
Product Lot No:
REQNOTPROV
#Treated:
2
#Reacted: 2
#Died:
0
Species: PIG
Age: 5 MO
Weight: 230 LB
Gender: Female
Concomitants: No
Page: 230
ADVERSE EXPERIENCES: ON AUGUST 1, 2007, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN GILTS. ON AN
UNKNOWN DATE, AN UNKNOWN PIG BREEDER MISTAKENLY FED 2 REPLACEMENT GILTS RACTOPAMINE AT 9
OlTON. AFTER CONSUMING THERA TION FOR APPROXIMATELY ONE WEEK, THE GILTS BECAME STIFF.
Causality
Assessment
Time
0 1 WK G STIFFNESS
Source:
Country:
United States
State:
INDIANA
Zip:
46340
Episode Date:
07/22/2007
Dosage: Unknown
Dose Description: UNK DOSE, ORAL; UNK DATE
Extra Label:
Unknown
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants:
No
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200702695
UNKNOWN
#Treated:
4
#Reacted: 4
#Died:
2
Species: PIG
Age: 6 MO
Weight: 260 LB
Gender: Unknown
ADE: ON AUGUST 1, 2007, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN SHOW PIGS. DURING THE WEEK OF JULY 22, 2007
THROUGH JULY 28, 2007,4 SHOW PIGS DEVELOPED TREMORS, PYREXIA AND ATAXIC IN THE HIND QUARTERS.
TWO OF THE PIGS DIED ACUTELY AFTER EXHIBITING SIGNS AND THE REMAINING 2 PIGS WERE EXAMINED BY
THE ATTENDING VETERINARIAN WHO FOUND THAT BOTH PIGS WERE FEBRILE. ONE OF THE PIGS HAD
INCREASED RESPIRATORY SOUNDS. DR. TROXEL REPORTED THAT 3 OF THE PIGS, 1 THAT DIED AND THE
REMAINING 2 LIVE PIGS, HAD BEEN CONSUMING A RATION THAT CONTAINED RACTOP AMINE AT AN UNKNOWN
LEVEL PRIOR TO EXHIBITING SIGNS. DR. TROXEL ALSO STATED THAT THE OWNERS BELIEVED THAT SOMEONE
MALICIOUSLY FED TOXIC DOSES OF RACTOPAMINE TO THEIR PIGS.
REVIEWER'S NOTE: THERE IS NO STATED AMOUNT OF PA YLEAN 9 FED TO THESE PIGS SINCE IT WAS THOUGHT TO
BE A POISONING; THEREFORE, I AM UNABLE TO ASSESS DOSE AND ELU. ALSO NO DATE OF ADMINISTRATION IS
CVM _Report.rep
EVIDENT.
Causality
Assessment
-9
0
0
0
0
0
Drug Name:
Time
To Onset
NA
UN
UN
UN
UN
UN
RACTOPAMINE
Clinical Detail:
G DEATH
G FEVER, BODY
N ATAXIA
N TREMBLING
R SOUND ABN, RESPIRATORY
Page: 231
Source:
Country:
United States
Source Report ld:
NDC:
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Zip:
52577
Product Lot No:
06/01 /2007
Recommended dose
Oral (in dry feed)
6.75 G/TON; ORAL- 6-1-07
None
Good
Owner
Medium
No
US200702671
UNKNOWN
#Treated:
15000
#Reacted: 0
#Died:
0
Species: PIG
Age: 6 MO
Weight: 275 LB
ADE: ON JULY 31,2007, MS. SARA MCKAY, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE IN PIGS. ON
APPROXIMATELY ruNE 1, 2007, MAHASKA PORK INCREASED THE LEVEL OF RACTOP AMINE IN THE FINISHING
RATION FROM 4.5 G/TON TO 6.75 G/TON. FROM THE TIME OF THE INCREASE TO APPROXIMATELY JULY 1, 2007, DR.
J.D. FIECHTNER, ATTENDING VETERINARIAN, REPORTED AN INCREASE IN THE NUMBER OF DEAD PIGS.
HOWEVER, SINCE APPROXIMATELY JULY 1, 2007. DR. FIECHTNER REPORTED THAT THE NUMBER OF DEAD PIGS
HAD DECREASED.
CVM _Report. rep
Causality
Assessment
0
Time
To Onset
1 MO
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
OHIO
Zip:
45846
Episode Date:
08/ 10/2007
Dose Description: ORAL;UNK
Source Report ld:
US200702817
NDC:
Product Lot No:
REQ, NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 232
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
UNK
Unknown
Owner
Unknown
Unknown
Age:
Weight:
Gender: Unknown
UN
UN
ON 8/1 0/07, MS SHARI WESTERFELD, BLANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN PIGS. DUIRING A MEETING W/
COOPER F AMRS' EMPLOYEES, A PIG LOADER STATED THAT RACTOPAMINE FED TO PIGS "MAKES THEM CRAZY".
NO OTHER INFO WAS PROVIDED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
N HYPERACTIVITY
Source:
Country:
State:
United States
MINNESOTA
Zip:
55077
CVM _ Report.rep
Source Report ld:
US200702925
NDC:
Product Lot No:
NOT PROVIDED
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
08/15/2007
Unknown
Oral (all other)
PO, 7113-8/ 12/07
Unknown
#Treated:
#Reacted:
#Died:
Species:
Breed:
EFFICIANCY AND INCREASED CARCASS LEANESS
Age:
Weight:
Good
Gender:
Owner
Unknown
Unknown
Page: 233
2
2
0
PIG
Other (pig)
NA
265 LB
Male, neutered
ON 08/17/07, ELAN CO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG EXPERIENCE
INVOLVING RACTOPAMINE HYDROCHLORIDE IN SHOW PIGS. ON APPROXIMATELY 07/13/07, MR. TODD WICKER
BEGAN FEEDING 2 SHOW BARROWS A RATION THAT CONTAINED RACTOP AMINE AT AN UNKNOWN LEVEL. ON
08/ 12/07, MR. WICKER STOPPED FEEDING THE RACTOPAMINE, AFTER THE ANIMALS HAD BEEN SHOWN AT THE
FAIR. ON APPROXIMATELY 08115/07, THE PIGS BEGAN TO SHOW SIGNS OF STIFFNESS IN THEIR JOINTS.
Causality
Assessment
0
Time
To Onset
1 MO
Clinical Detail:
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
07/3112007
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Dose Description: 0, 5, 9, 13PP; PO; UNK DATES OF ADMIN
Extra Label:
Species
Reason For Use:
Health Status:
Good
Administered By:
Owner
CVM _Report. rep
US200702883
UNKNOWN
#Treated:
396
#Reacted: 18
#Died:
13
Species: TURKEY
Age: 20 WK
Weight:
UN
Gender: Male
Page: 234
Concomitants:
Unknown
ON 08/14/07, MS. KATHY VANNATTA, ELANCO ANIMAL HEALTH REGULATORY AFFAIRS MANAGER, REPORTED
INVESTIGATIONAL NEW ANIMAL DRUG) ON GROWTH PERFORMANCE IN TOM FINISHING TURKEYS. A COMPLETE
SUMMARY OF ADVERSE EVENTS, SERIOUS AND NON-SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY
REPORT. GUARANTEE CLAIM.
Causality
Assessment
Time
0 UN G DEATH
Source:
Country:
United States
State:
INDIANA
Zip:
46501
Episode Date:
05/01/2007
Dose Description: ORAL; UNKNOWN
Extra Label:
Species
Reason For Use:
UNKNOWN
Health Status:
Fair
Administered By:
Owner
Concomitants: Yes
RUMENSIN/TYLAN, PO, UNK DOSE/DATES
Source Report ld:
US200702979
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
2
#Reacted: 2
#Died:
2
Species: CATTLE
Age: VA
Weight:
UN
ON 08-22-07, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING RACTOPAMINE HCL, TYLOSIN PHOSPHATE, AND MONENSIN SODIUM. IN APPRO X MAY
2007, DR MIKE MCCAY, SHOW STEER OWNER, HAD A 7 MONTH OLD SHOW CALF DIE PERACUTEL Y. DR RICHARD
LEEPER, ATTENDING VET, PERFORMED A POST MORTEM EXAM AND FOUND THE LUNGS TO BE CONGESTED WITH
BLOOD. ON APPROX 08-17-07, MR MCCAY HAD A 1.5 YEAR OLD SHOW STEER DIE PERACUTEL Y AND ON A POST
MORTEM EXAM, DR LEEPER FOUND BLOOD CONGESTED LUNGS. AT THE TIME OF DEATH, BOTH STEERS WERE
CONSUMING A RATION THAT CONTAINED RACTOPAMINE, TYLOSIN, AND MONENSIN. ALL AT UNK LEVELS.
CVM _ Repmt. rep
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
0 UN R CONGESTION, LUNG(S)
Source:
Country:
State:
United States
PENNSYLVANIA
Zip:
18964
Episode Date:
08/29/2007
Dosage: Unknown
Dose Description: UNK DOSE, REGIMEN, AND DATES
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US2007031 08
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 235
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
Unknown
Age:
Weight:
Gender: Unknown
UN
UN
ON 8-29-07, DR SCOTT CARR, ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT, REPORTED A POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING RACTOPAMINE HCL IN PIGS. MR JEFF ARNER, DIRECTOR OF HOG
PROCUREMENT AT LEIDY'S PACKING, REPORTED THAT PIGS ON RACTOPAMINE WERE HYPERSENSITIVE, MORE
DIFFICULT TO HANDLE AND HAD AN INCREASED RATE OF FRACTURED LIMBS.
Causality
Assessment
0
0
0
Time .
To Onset
UN
UN
UN
Clinical Detail:
G ADVERSE DRUG REACTION
G BEHAVIOR DISORDER
M BONE,ABN
Source:
Country:
CVM_Report.rep
United States
Package ID: A 1
Source Report ld:
NDC:
US200703121
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Zip:
50511
Product Lot No:
NOT PROVIDED
07/09/2007
#Treated:
Recommended dose
#Reacted:
Oral (all other) #Died:
VARIOUS IN TRIAL; PO; 6113/07-7/9/07
Species: PIG
Page: 236
750
27
Reason For Use:
WEIGHT PERFORMANCE
Health Status:
Fair
Age:
Weight:
Gender:
6 MO
200 LB
Group (m & f)
Administered By:
Owner
Vet Opinion: Low
RESEARCH STUDY: RACTOPAMINE IN PIGS. A TOTAL OF 750 PIGS WERE USED IN THE TRIAL, T4V190707. 21 OF
THEM WERE LIGHT WEIGHT AND SORTED OFF AS CULLS. WHEN THE PIGS WERE SHIPPED TO TYSON FOODS,
MADISON, NE 3 DAYS AFTER THE END OF THE STUDY ON 7112, 6 ANIMALS WERE SORTED OUT AS LOW VALUE. 3
WERE CONSIDERED SUBSTANDARD W/ INGUINAL HERNIAS, 2 WERE FATIGUED BUT LATER RECOVERED, AND 1
PIG WAS FOUND DEAD ON THE TRUCK AT ARRIVAL.
NOTE: TRIAL DATES ARE LISTED AS 6/13/07-7/9/07. I USED 6113/07 AS THE START DATE FOR PRODUCT
ADMINISTRATION AND CODED FROM THIS DATE.
Causality
Assessment
Time
0 30 DA G DEATH
0 30 DA G WEAKNESS
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
CVM _Report. rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
CA200700069
NOT PROVIDED
Page: 237
04116/2007
Dose Description: 0, 5,9 13 PPM; PO; 8116/07*-8/30/07
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Owner
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
450
3
TURKEY
Not specified
Female
15 WK
UN
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOP AMINE HYDROCHOLORIDE IN TURKEYS IN A
CLINICAL STUDY. DURING STUDY T4VCA0703, 1 BIRD DIED. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE
THE CLINICAL EFFECTS OF 2% RACTOPAMIONE HYDROCHLORIDE TYPE A MEDICATED ARTILE (E.G. ,
INVERTIGATIONAL NEW ANIMAL DRUG) ON GROWTH PERFORMANCE IN HEN TURKEYS. A COMPLETE SUMMARY
OF ADVERSE EVENTS, SERIOUS AND NON SERIOUS WILL BE SUBMITTED IN THE FINAL STUDY REPORT.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
United States
State:
IOWA
Zip:
50538
Episode Date:
07/20/2007
Route: Unknown
Dose Description: HUMAN EXPOSURE
Extra Label:
Species
Reason For Use:
ACCIDENTAL HUMAN EXPOSURE
Health Status:
Unknown
CYM _ Report.rep
Source Report Id:
US200703030
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
2
#Reacted: 2
#Died:
0
Species: HUMAN
Age: UN
Weight:
UN
Gender: Male
Page: 238
Administered By:
Vet Opinion:
Concomitants:
Owner
Not applicable
Unknown
ON 8/27/07, THE ROCKY MOUNTAIN POISON AND DRUG CENTER (RMPDC) CONTACTED BLANCO ANIMAL HEALTH
REGARDING A POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN
HUMANS. ON 8/24/07, MR. l /3 J ( & ) OF FARMER COOPERATIVE, CONTACTED THE RMPDC AND
REPORTED THAT TWO OF HIS MALE EMPLOYEES THAT COULD HAVE BEEN EXPOSED TO RACTOPAMINE HAVE
HAD HEART ATTACKS IN THE PAST MONTH. THE RMPDC CLOSED THE CASE FOLLOWING THE CALL.
UPDATE 9/5/07, RMPDC LEFT MESSAGE REQUESTING A RETURN CALL WITH MORE INFORMATION ON EMPLOYEES,
SPECIFICALLY TRYING TO DETERMINE IF HEART ATTACKS ARE FELT TO BE RELATED TO PRODUCT, WHAT WERE
CIRCUMSTANCES OF EXPOSURE (INHALATION, DERMAL), WHEN DID EXPOSURES OCCUR IN RELATION TO
SYMPTOM ONSET, OTHER PRODUCTS IN USE AT THE SAME TIME, TREATMENTS GIVEN, ADMITTED TO HOSPITAL,
CURRENT CONDITIONS.
UPDATE 9/6/07, CALL BACK FROM . I 1-3 ) ( _(.,._ ) HIS EMPLOYEES HAD NOT HANDLED PA YLEAN FOR OVER 6
MONTHS PRIOR TO THEIR HEART ATTACKS. HE DOES NOT BELIEVE THAT THEIR SYMPTOMS WERE RELATED, BUT
IS CONCERNED AND WANTS MORE INFORMATION ON SAFE HANDLING TO PROTECT EMPLOYEES AT OTHER
PLANTS THAT ARE ACTIVELY HANDLING LARGE AMOUNTS OF IT. HE HAS INFORMATION FROM THE VETERINARY
COMPENDIUM AND HIS PRODUCT INFO MSDS. HE IS LOOKING FOR MORE SPECIFIC INFORMATION TO PROTECT
HIS EMPLOYEES. HE SPOKE TO A VETERINARIAN WITH THE BLANCO ANIMAL HEALTH WHO REFERRED HIM TO
THE HUMAN MEDICAL LINE. ONE EMPLOYEE HAD THE HEART ATTACK A MONTH AGO AND THE OTHER A FEW
MONTHS BEFORE THAT. HE IS A WARE THAT ONE MD DETERMINED THE HEART ATTACK WAS DUE TO A PIECE OF
PLAQUE THAT BROKE OFF OF AN ARTERY. HE IS NOT SURE WHAT CAUSED THE OTHER EMPLOYEE'S SYMPTOMS.
Causality
Assessment
0
-9
Time
To Onset
UN
NA
Clinical Detail:
C HEARTDISORDER
G HUMAN EXPOSURE
Source:
Country:
State:
United States
MINNESOTA
Zip:
55057
Report Qualitv: Average
Episode Date:
08/20/2007
Dosage:
Unknown
Route:
Oral (all other)
Dose Description: ORAL- 7/30/07- 8/20/07
Extra Label:
Unknown
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN, FEED EFFICIENCY
AND INCREASED CARCASS LEANNESS
Health Status:
Good
CVM _Report. rep
US200703249
REQ, NOT PROVIDED
#Treated:
1200
#Reacted: 1200
#Died:
0
Species: PIG
Age: UN
Weight:
270 LB
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
No
Page: 239
ON SEPTEMBER 7, 2007, MR. MARK RINGKOB, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
APPROXIMATELY JULY 30,2007, THE HOLDEN FARMS BEGAN AN ON-FARM RACTOPAMINE FEEDING TRIAL.
THREE GROUPS OF FINISHING PIGS (600 HD/GROUP) WERE EACH ASSIGNED TO A TREATMENT GROUP-CONTROL (0
G/TON), 6.75 G/TON RACTOPAMINE OR 9.0 G/TON RACTOPAMINE- AND FED FOR 21 DAYS. ON APPROXIMATELY
AUG 20,2007, THE PIGS WERE WEIGHED. MR. EICK NANKIVIL, OWNER, STATED THAT HE KNEW WHICH PIGS WERE
FED RACTOPAMINE BECAUSE THEY WERE FLIGHTY AND DIFFICULT TO MOVE TO THE SCALES WHILE THE
CONTROL GROUP DID NOT HAVE THESE BEHAVIORS. THERE WERE NO DOWNER PIGS OR DEATHS.
Causality
Assessment
Time
Source:
Country:
State:
United States
IOWA
Zip:
50035
Episode Date:
09/12/2007
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 GM/TON AND 6.75 GM/TON ORAL 7/2007*
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
RESEARCH STUDY
Unknown
Other
Missing information
Unknown
US200703380
NOTPRVD
#Treated:
192
#Reacted: 2
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
UN
POST APPROVAL STUDY-EFFECT OF PAYLEAN FEEDING LEVEL ON STRESS RESPONSES OF HEAVY-WEIGHT PIGS
DURING HANDLING AND TRANSPORT
T4V170711
PERSON RESPONSIBLE, DR. MATT RITTER
THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE IMP ACT OF FEEDING PA YLEAN AT LEVELS COMMONLY
USED IN COMMERCIAL PRACTICE (4.5 AND 6.75 G/TON) ON THE METABOLIC AND BEHAVIORAL RESPONSES TO A
SIMULATED HANDLING AND TRANSPORTATION MODEL.
CVM _Report. rep
Page: 240
A TOTAL OF 288 BARROWS WILL BE USED IN THIS STUDY. THERE ARE 12 GRPS OF 8 PIGS TREATED WITH
PAYLEAN 4.5 OlTON, 12 GRPS OF 8 PIGS WITH 6.75 OlTON, AND 12 GRP OF 8 PIGS IN THE NEG CONTROL GRP. ON
9112107, 1 PIG IN 6.75 OlTON TREATMENT GRP WAS REPORTED TO EXHIBIT OPEN MOUTH BREATHING AND SKIN
DISCOLORATION. THE PIG WAS SNARED, RECTAL TEMP WAS TAKEN AND BLOOD WAS TAKEN. UPON MOVING THE
PIG BACK TO ITS PEN, THE PIG BEGAN SOME MUSCLE TREMORS. THE PIG WAS KEPT IN A SEPARATE PEN FOR 20
MIN AND WAS FULLY RECOVERED, THEN WAS PLACED BACK TO ITS ORIGINAL PEN.
ON 9113107, 1 REPORT WAS SENT TO ELANCO ANIMAL HEALTH US GREENFIELD, PHARMACOVIGILANCE TO REPORT
1 PIG IN 4.5GITON TREATMENT GROUP SHOWED MUSCLE TREMORS AND OPEN MOUTH BREATHING. THIS PIG RAN
THRU THE HANDLING MODEL USING THE AGGRESSIVE TREATMENT. IT RAN THRU THE 1ST 4TH LAPS BUT IN THE
5TH AND FINAL LAP IT BEGAN TO SLOW DOWN. IT MANAGED TO FINISH THE TEST, HOWEVER, IT HAD MUSCLE
TREMORS AND OPEN MOUTHED BREATHING. IT WAS GIVEN 5 MIN REST AND CHECK 30 MIN LATER. IT APPEARED
TO BE NORMAL AGAIN. MORE INFO WILL BE REPORTED THRU STUDY FINAL REPORT.
REVIEWER: ESTIMATED ONSET.
Causality
Assessment
0
0
0
Time
To Onset
2 MO
2 MO
2 MO
Clinical Detail:
SKIN ABNORMAL
N TREMBLING
R DYSPNEA
Source:
Country:
State:
United States
ILLINOIS
Zip:
61853
Episode Date:
0512012007
Dose Description: 4.5 OlTON; ORAL UNKNOWN
Extra Label: None
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Unknown
Administered By:
Owner
US200703452
RQST NOT PRVD
#Treated:
100
#Reacted: 30
#Died:
0
Species: PIG
Breed: Other (pig)
Age: VA
Weight:
450 LB
ON 9120107, DR. SCOTT CARR, ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT, REPORTED A POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN PIGS. SINCE APPROX. 512007, MR
CRAIG HARVEY, MANAGER AT PINE RIDGE FARMS SWINE PACKERS, REPORTED THAT THE CULL PIGS BEING
CVM _Repo1t.rep
Page: 241
PROCESSED THAT HAD BEEN FED A RATION CONTAINING RACTOP AMINE WERE MORE EXCITABLE AND
DIFFICULT TO HANDLE
MEDICAL HISTORY
RQST, NOT PROVIDED
Causality
Assessment
Time
0 UN N HYPERACTIVITY
Source:
Country:
United States
State:
MICHIGAN
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
09/13/2007
Not applicable
Oral (all other)
ORAL UNKNOWN
Species
48824
Reason For Use:
Health Status:
Unknown
Administered By:
Not applicable
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
US200703345
RQST NOT PRVD
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
HORSE
Quarter horse
Female
15 YR
UN
ON 9/13/2007 ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG EXPERIENCE
INVOLVING RACTOPAMINE HYDROCHLORIDE IN A HORSE. ON AN UNKNOWN DATE, A HORSE BELONGING TO AN
UNKNOWN OWNER WAS SEEN EATING A PIG RATION THAT CONTAINED RACTOPAMINE AT AN UNKNOWN
LEVEL. ON AN UNKNOWN DATE AFTER CONSUMING THE PIG RATION, THE HORSE DEVELOPED LAMINITIS
MEDICAL HISTORY
RQST, NOT PROVIDED
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G LAMINITIS
Source:
CVM _ Report.rep
Country:
United States
Source Report ld:
NDC:
US200703414
Page: 242
State:
ILLINOIS
Zip:
61853
Product Lot No:
NOT PROVIDED
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/20/2006
Not applicable
Oral (in dry feed)
20 PPM OTHER 4/2006-10/2006
Species subgroup
RESEARCH STUDY
Unknown
Veterinarian
Missing infom1ation
Unknown
#Treated:
323
#Reacted: 65
#Died:
41
Species: PIG
Breed: Other (pig)
Age: VA
Weight: VA
PILOT FIELD STUDY: THE EFFECTS OF RACTOPAMINE HYDROCHLORIDE ADMINISTERED TO GILTS IN EARLY
GESTATION ON PROGENY GROWTH AND RESPONSIVENESS TO RACTOPAMINE IN LATE FINISHING STUDY NO
T4V170514. PERSON RESPONSIBLE, DR SCOTT CARR
THE PURPOSE OF THIS STUDY WAS TO PROVIDE INFORMATION REGARDING GROWTH PERFORMANCE, AVERAGE
DAILY FEED CONSUMPTION, GAIN EFFICIENCY AND FEED EFFICIENCY OF PROGENY DERIVED FROM GILTS
ADMINISTERED RACTOPAMINE HYDROCHLORIDE (PA YLEAN) BETWEEN DAYS 25 AND 50 OF GESTATATION AND
TO PROVIDE INFORMATION ON THE RESPONSIVENESS OF PROGENY DERIVED FROM GILTS ADMINISTERED
P A YLEAN BETWEEN DAYS 25 AND 50 OF GESTATION TO PA YLEAN SUPPLEMENTATION FOR THE LAST 28 DAYS
PRIOR TO MARKET.
THIS STUDY WAS TERMINATED ON 3/21106 DUE TO PRRS VIRUS INFECTION. HOWEVER, SINCE SOWS HAD BEEN
EXPOSED TO PA YLEAN, THEIR PIGLETS WERE STILL MONITORED FOR ADVERSE EVENTS AND OTHER CLINICAL
SIGNS.
THERE WERE 66 ADVERSE EVENTS REPORTED FROM THE PIGLETS OF SOWS THAT WERE TREATED WITH 20 PPM
PA YLEAN. 22 OF THEM WERE BORN DEAD, 8 WERE BORN PREMATURE AND THEN DIED, 3 WERE FOUND DEAD, 8
WERE EUTHANIZED. THE REST WERE EITHER LAID ON BY THE SOW, ATTACKED BY THE SOW, SCROTAL
RUPTURE, THIN STARVATION, OR POOR GROWTH.
THERE WERE 77 CASES REPORTED FROM THE PIGLETS OF SOWS THAT WERE IN THE NEGATIVE CONTROL
GROUP. 14 WERE BORN DEAD, 8 BORN PREMATURE AND THEN DIED, 9 WERE FOUND DEAD AND 9 WERE
EUTHANIZED. THE REST OF THEM WERE EITHER LAID ON BY SOW OR ATTACKED BY SOW, SCROTAL RUPTURE,
THIN STARVATION, THIN POOR GROWTH, LEG DEFORMITY OR BLOATED.
Causality
Assessment
0
0
CVM _Report. rep
Time
To Onset
UN
UN
Clinical Detail:
D BLOAT
G DEATH
0 UN G POOR PERFORMANCE
0 UN X BIRTH WEIGHT LO
0 UN X BIRTH, PREMATURE
0 UN X DEATH(NEWBORN)
0 UN X DEATH(STILLBORN)
Drug Name:
RACTOP AMINE
Source:
Country:
State:
United States
ILLINOIS
Zip:
61853
Episode Date:
09119/2007
Dose Description: 0 TO 20 PPM ORAL 6/2006-6/2007
Extra Label:
Species subgroup
Reason For Use:
RESEARCH STUDY
Source Report ld:
NDC:
Product Lot No:
US200703415
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species: PIG
Breed: Other (pig)
Age:
Weight:
Page: 243
427
102
89
VA
VA
Health Status:
Good
Administered By:
Vet Opinion:
Concomitants:
Veterinarian
Missing information
Unknown
PILOT EFFICACY STUDY: THE EFFECTS OF RACTOPAMINE HYDROCHLORIDE ADMINISTERED TO FEMALES IN
EARLY GESTATION ON PROGENY GROWTH AND RESPONSIVENESS TO RACTOPAMINE IN LATE FINISHING STUDY
NO T4V170606. PERSON RESPONSIBLE, DR SCOTT CARR
THE PURPOSE OF THIS STUDY IS TO PROVIDE INFORMATION REGARDING GROWTH PERFORMANCE, AVERAGE
DAILY FEED CONSUMPTION, GAIN EFFICIENCY AND FEED EFFICIENCY OF PROGENY DERIVED FROM FEMALES
ADMINISTERED RACTOPAMINE HYDROCHLORIDE (PA YLEAN) BETWEEN DAYS 25 AND 50 OF GESTATATION AND
TO PROVIDE INFORMATION ON THE RESPONSIVENESS OF PROGENY DERIVED FROM FEMALES ADMINISTERED
P A YLEAN BETWEEN DAYS 25 AND 50 OF GESTATION TO PA YLEAN SUPPLEMENTATION FOR THE LAST 28 DAYS
PRIOR TO MARKET.
THERE WERE 102 CASES REPORTED FROM THE PIGLETS OF SOWS THAT WERE TREATED WITH 20 PPM PA YLEAN. 38
CVM _Report. rep
Page: 244
PIGLETS WERE STILLBORN, 10 WERE MUMMY, 33 WERE EUTHANIZED AND 8 WERE BORN DEAD. THE REMAINING
13 WERE LAID ON BY THE SOW OR HAD SCROTAL RUPTURE.
THERE WERE 102 CASES REPORTED FROM THE PIGLETS OF SOWS THAT WERE IN THE NEGATIVE CONTROL
GROUP. 26 WERE STILLBORN, 13 WERE MUMMY, 35 WERE EUTHANIZED AND 15 WERE FOUND DEAD. THE
REMAINING 13 WERE EITHER LAID ON OR SAVAGED BY THE SOW.
THE FINAL STUDY REPORT WILL BE AVAILABLE AT A LATER DATE AND THE ADVERSE EXPERIENCE INFO WILL
BE UPDATED.
Causality
Assessment
0
0
0
0
Drug Name:
Time
To Onset
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G DEATH
G DEATH(EUTHANIZED)
X DEATH(NEWBORN)
X DEA TH(STILLBORN)
Source:
Country:
United States
State:
IOWA
Zip:
50423
Episode Date:
09/24/2007
Dose Description: 9 G/TON; ORAL; 09-22-07 TO 09-24-07
Extra Label:
Species subgroup
Reason For Use:
LEFTOVER FEED FROM FINISHING PIGS
Health Status:
Unknown
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
Source Report ld:
NDC:
Product Lot No:
US200703533
NOT PROVIDED
#Treated:
1000
#Reacted: 25
#Died:
15
Species: PIG
Age: UN
Weight: 60 LB
ON 09-27-07, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING RACTOPAMINE HCL. ON 09-22 AND 09-23-07, FEEDER PIGS AT THE CHAD ARENDS'
FARM WERE FED A FINISHING FEED THAT CONTAINED 9G/TON OF RACTOP AMINE. THE FEED WAS CONSUMED
OVER THESE 2 DAYS AND ON 09-24-07, THE MANAGER OBSERVED THAT APPROX 20-25 PIGS HAD NEUROLOGICAL
SIGNS INCLUDING SITTING ON THEIR HAUNCHES, RECUMBENCY, SALIVATION, AND DISORIENTATION. OF THESE
CVM _Report. rep
Page: 245
25 AFFECTED PIGS, APPRO X 10-15 DIED. DR JIM DIEMER, ATTENDING VET, ADVISED A TX OF AMOXICILLIN IN THE
WATER AND PLANNED A TRIP TO THE FARM TO CHECK THE PIGS (ON 09-27-07). DR DIEMER STATED THAT HE
CONSIDERED RESTRICTED WATER AVAILABILITY TO BE THE CAUSE OF THE SIGNS IN THE PIGS. ELU: PIGS
WEIGHT
Causality
Assessment
0
0
0
0
0
Time
To Onset
2 DA
2 DA
2 DA
2 DA
2 DA
Clinical Detail:
D HYPERSALIV A TION
G DEATH
G POSTUREABN
G RECUMBENCY
N CONFUSION
0 2 DA N NEUROLOGICAL DISORDER
Source:
Country:
State:
United States
IOWA
Zip:
50035
Episode Date:
05/26/2007
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 OR 6.75G/TON; ORAL; 05-07* TO 06-07*
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
RESEARCH STUDY
Good
Owner
Missing information
Unknown
STUDY NUMBER: T4V190709
US200703710
NOT PROVIDED
#Treated:
984
#Reacted: 11
#Died:
9
Species: PIG
Breed: Other (pig)
Age: 150 DA
Weight:
VA
POST-APPROVAL STUDY: EFFECT OF PAYLEAN DOSE ON GROWTH AND CARCASS TRIALS IN FINISHING PIGS
RAISED UNDER COMMERCIAL CONDITIONS.
PERSON RESPONSIBLE: MATT RITTER, PHD
THE OBJECTIVE OF THIS STUDY IS TO DETERMINE THE EFFECTS OF P A YLEAN DOSE ON GROWTH PERFORMANCE
AND CARCASS TRAITS IN COMMERCIAL PIGS THAT HAVE OR HAVE NOT BEEN VACCINATED FOR PCV AD-2. TO
COMPARE THE ECONOMIC IMPACT OF FEEDING PAYLEAN AT 4.5 OR 6.75 G /TON (TX GROUP B&C) FOR 28 DAYS
CVM _ Repmt. rep
Page: 246
PRIOR TO BARN CLOSE-OUT VERSUS FEEDING A STANDARD FINISHING DIET WITHOUT ADDED NUTRITION.
FROM MAY 26 TO JUNE 9,2007, THERE ARE A TOTAL ON NINE ADVERSE EXPERIENCE EVENTS REPORTED IN THE
GROWTH PERFORMANCE PHASE. IN THE TX A GROUP (NEGATIVE CONTROL), TWO ANIMALS DIED AND ONE
REMOVED DUE TO LAMENESS. THE CAUSE OF THESE TWO DEATHS WERE HEMORRHAGIC BOWEL SYNDROME. IN
THE TX B GROUP (4.5G/TON PAYLEAN), THREE ANIMALS DIED (TWO DUE TO GASTRIC ULCER, ONE RESPIRATORY
CHALLENGE) AND ONE WAS REMOVED DUE TO LAMENESS. IN THE TX C GROUP (6.75 G/TON PA YLEAN), TWO
ANIMALS DIED. ONE WAS DUE TO HEMORRHAGIC BOWEL SYNDROME AND ONE DIED FROM GASTRIC ULCER.
FROM JUNE 14 TO 17, TWO PIGS DIED FROM THE B TX GROUP DURING THE TRANSPORTATION. ONE PIG SHOWED
CLINICAL SIGNS OF A GASTRIC ULCER THEN DIED LATER, AND THE OTHER BECAME LAME AND HAD TO BE
EUTHANIZED.
A FOLLOW-UP WILL BE CREATED WHEN THE STUDY FINAL REPORT IS AVAILABLE.
Causality
Assessment
0
0
0
0
0
0
0
Drug Name:
Time
To Onset
UN
UN
UN
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
D DIARRHEA, BLOODY
D GI, ABNORMAL
D ULCER(S), GI
G DEATH
G DEATH(EUTHANIZED)
G LAMENESS
R RESPIRATORY DISORDER
Source:
Country:
State:
United States
INDIANA
Zip:
46974
Episode Date:
03/05/2008
Dosage: Unknown
Dose Description: ORAL UNKNOWN DATE UNK DOSE
Extra Label:
Unknown
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN IMPOVED FEED
Health Status:
Good
CVM _Report.rep
US200802066
UNKNOWN
#Treated:
4000
#Reacted: 4000
#Died:
0
Species: PIG
Age: 7 MO
Weight: 290 LB
Gender: Unknown
Administered By:
Vet Opinion:
Concomitants:
Owner
Missing information
Unknown
Page: 247
ON MARCH 5/08, DR. SCOTT CARR, ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT, REPORTED POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING RACTOPAMINE HYDROCHLORIDE IN PIGS. DURING A PRODUCT
PRESENTATION MEETING ON MARCH 5/08, MR. JIM DALE, PORK PRODUCER, PROVIDED TO DR. CARR, LIMITED
INFORMATION PERTAINING TO RACTOPAMINE EVENTS THAT OCCURRED ON HIS FARM. ON AN UNKNOWN DATE,
MR. DALY BEGAN FEEDING THIS FINISHING HOGS A RATION THAT CONTAINED RECTOP AMINE AT AN UNKNOWN
LEVEL. MR. DALE SOMETIMES INCLUDED RACTOPAMINE IN THE FINISHING RATION AND SOMETIMES HE DID NOT
INCLUDE IT. MR. DALE OBSERVED THAT HOGS FED RACTOPAMINE WERE HARDER TO HANDLE (HYPERACTIVE),
HAD BEHAVIORAL PROBLEMS AND SORE JOINTS. THESE SIGNS WERE NOT OBSERVED IN PIGS THAT WERE NOT
FED RACTOPAMINE. MR. DALE CONTINUED TO FEED RACTOPAMINE. DR. CARR STATED THAT HE WAS UNABLE
TO OBTAIN FROM MR. DALE ANY ADDITIONAL INFORMATION ABOUT THESE EVENTS
Causality
Assessment
Time
0 UN G LAMENESS
Source:
Country:
State:
United States
CALIFORNIA
Zip:
93274
Episode Date: 05/ 13/2007
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 130 PPM; ORAL- MAY 8, 2007-MAY 22, 2007
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species
RESEARCH STUDY
Good
Veterinarian
Unknown
Unknown
US20080231 0
555PP6
#Treated:
256
#Reacted: 5
#Died:
5
Species: TURKEY
Age: 20 WK
Weight:
19 KG
Gender: Male
ON 03111108, US PHARMACOVIGILANCE WAS INFORMED OF AN ADVERSE EVEN IN RESEARCH STUDY T4V060518.
MR. DAN IVERS, ASSOCIATE SR. SCIENTIST FOR ELANCO ANIMAL HEALTH REPORTED THE ADVERSE EVENT.
CVM _Report.rep
Page: 248
STUDY TITLE: NON-CLINICAL LABORATORY STUDY (GLP): SAFETY EVALUATION OF RACTOPAMINE IN FINISHING
TOM TURKEYS.
PERSON RESPONSIBLE: DR. RAYMOND POHLAND
STUDY OBJECTIVE: TO DETERMINE THE TOXICITY, IF ANY, ASSOCIATED WITH FEEDING RACTOPAMINE
HYDROCHLORIDE (RAC) AT 1 OX THE PROPOSED DOSE TO NICHOLAS AND HYBRID FINISHING TOM TURKEYS
DURING THE FINAL 14 DAYS OF THE PRODUCTION CYCLE (I.E. SLAUGHTER)
RESEARCH STUDY T4V060518 STARTED ON 04/30/07 AND ENDED 05/22/07 (FROM ACCLIMATION TO NECROPSY).
DURING THE STUDY, THERE WERE TWO GROUPS OF TURKEYS RECEIVING RACTOPAMINE (130 PPM AND 13 PPM)
AND A CONTROL GROUP RECEIVING 0 PPM OF RACTOP AMINE. FOR THE GROUP RECEIVING THE 13PPM OF
RACTOPAMINE, THERE WERE NO ADVERSE EVENTS REPORTED. WITHIN THE 128 TURKEYS RECEIVING
RACTOP AMINE 130 PPM, FIVE BIRDS WERE REMOVED FROM THE STUDY. THREE OF THE BIRDS DIED. BIRD 4277
DIED ON 05/ 14/07, BIRD 4026 DIED ON 05119/07 AND BIRD 4321 DIED ON 05/21107. TWO BIRDS (4742, 4295) WERE
REMOVED DUE TO LABORED BREATHING AND EUTHANIZED FOR NECROPSY. ALL OF THE BIRDS RANGED IN AGE
FROM 20-22 WEEKS AND WEIGHED 19KG.
NO ADDITIONAL INFO IS EXPECTED.
Causality
Assessment
0
Time
To Onset
22 DA
Clinical Detail:
G DEATH
0 UN R DYSPNEA
Source:
Country:
State:
United States
IOWA
Zip:
52216
Episode Date:
02111 /2008
Dose Description: 4.5 G/TON 1-21-2008 - 3-3-2008
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE WEIGHT GAIN IMPROVED FEED
EFFICIENCY AND INCRESED CARCASS LEANESS
Health Status:
Good
Administered By:
Owner
Concomitants: No
CVM _Report. rep
US200802156
UNKNOWN
#Treated:
1600
#Reacted: 65
#Died:
25
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight: 290 LB
Gender: Unknown
Page: 249
ADE
ON MARCH 7 2008 MS.ABBY ANDERSON BLANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A
POTENTIAL ADE INVOLVING RACTOPAMINE HYDROCHLORIDE IN PIGS. ON AN UNKNOWN DATE DIRCKS FARM
PORK PROCEDURES BEGAN MAKING CHANGES TO THE TYPE OF GENETICS THAT WAS IN THEIR PIG HERD. THE
CHANGE WAS FROM AN UNKNOWN LINE TO PIC380 GENETICS. DURING THAT TIME DIRCKS FARM CONTINUED TO
FEED THEIR FINISHING PIGS A RATION THAT CONTAINED RACTOPAMINE AT 4.5 G/TON. DOUG HOFFMAN
MANAGER OF DIRKS FARM REPORTED THAT AS THE NEW GENETIC LINE BECAME MORE PREVALENT IN THE
HERD, THE INCIDENT OF DOWNER AND DEAD FINISHING PIGS INCREASED. ON MARCH 3, 2008 DIRCKS FARM
DISCONTINUED THE USE OF RACTOPAMINE. SINCE DISCONTINUING RACTOPAMINE, DIRCKS FARM REPORTED
THAT THE INCEDENT OF DOWNER AND DEAD PIGS HAD RETURNED TO NORMAL.
ON MARCH 20, 2008 MS ABBY ANDERSON ELAN CO ANIMAL HEALTH SALES REP OBTAINED ADDITONAL
INFORMATION CONFIRMING EXPOSURE WITH IDENTIFIED PATIENT INFORMATION FROM APPROXIMATELY FEB
11 TO FEB 29 2008 DIRCKS FARM NOTED THE INCREASE IN DOWNER AND DEAD PIGS. THERE WERE
APPROXIMATELY 1600 HEAD IN THE FINISHING GROUP WHERE THE PROBLEMS WERE NOTED, THE PIGS WERE
HEAVY WEIGHT PIGS (APPRO X 290LBS) AND THE HERD WAS NOT A NEW GENETIC LINE. AT THE TIME OF THE
REPORT, DIRECKS FARM REPORTED THAT 800 PIGS THAT HAD CONSUMED RACTOPAMINE HAD BEEN PROCESSED
THAT THE PROBLEMS WERE NOTED DURING TRANSPORT TO PROCESSING AND THAT APPROXIMATELY 25 PIGS
HAD DIED AND 40 PIGS HAD GONE DOWN IN THE GROUP 800. NO FURTHER INFORMATION INFORMATION
EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
PENNSYLVANIA
Zip:
19318
Episode Date:
12/31/2007
Dose Description: 4.5 G/TON 211 /2008 - 2/29/2008
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
EFFICIENCY AND INCREASED CARCASS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
Fair
Owner
Unknown
Yes
US200802965
NOT PROVIDED
#Treated:
400
#Reacted: 400
#Died:
6
Species: PIG
Age: UN
Weight: 240 LB
Page: 250
TYLOSIN 100 GM/TON; STARTED 12110/07
2 TYLOSIN 40 GM/TON; 12/31107-1/31/08; ALTERATING WITH
3 TIAMULIN (UNK LEVEL) ON WEEKLY BASIS 12/31107-1131108
4 TYLOSIN 100 GM/TON + RACTOPAMINE AT 4.5 GM/TON 2/8/08
ON MARCH 19, 08, MS. MARY ANN OELKE, ELANCO ANIMAL HEALTH INTERNAL SALES ASSOCIATE, REPORTED A
POTENTIAL LACK OF EFFECTIVENESS INVOLVING TYLOSIN PHOSPHATE AND A POTENTIAL ADVERSE EVENT
INVOLVING RACTOP AMINE HYDROCHLORIDE IN SWINE. ON APPROXIMATELY DEC 10, 07, MR. HERMAN
MANBECK, PORK PRODUCER, BEGAN FEEDING A GROUP OF 400 PIGS A RATION INTENDED TO DELIVER TYLOSIN
AT 100 G/TON AS TREATMENT FOR LOOSE STOOLS. FROM APPROXIMATELY DEC 31, 07 UNTIL APPROXIMATELY
JAN 31, 08, MR. MANBECK ALTERNATED (AT WEEKLY INTERVALS) THE PIGS' RATION FROM ONE THAT
CONTAINED TYLOSIN AT 40 G/TON TO ONE THAT CONTAINED TIAMULIN (LEVEL UNKNOWN). DURING THE
ALTERNATION OF RATIONS, A SMALL NUMBER OF PIGS (NUMBER UNKNOWN) CONTINUED TO HAVE LOOSE
STOOLS. ON APPROXIMATELY FEB 1, 2008, MR. MANBECK ADDED RACTOPAMINE AT 4.5 G/TON TO THE PIGS'
RATION. SHORTLY AFTER ADDING RACTOPAMINE TO THERA TION (EXACT TIME UNKNOWN), MORE OF THE PIGS
(NUMBER UNKNOWN) DEVELOPED LOOSE STOOLS. ON APPROXIMATELY FEB 8, 2008, AT THE DIRECTION OF DR.
PAUL PITCHER, ATTENDING VETERINARIAN, MR. MANBECK CHANGED THE PIGS' RATION TO ONE THAT
CONTAINED TYLOSIN AT 100 G/TON AND RACTOPAMINE AT 4.5 G/TON. AS OF APPROXIMATELY FEB 29, 2008 6 PIGS
HAD DIED AND THE REMAINDER OF THE HERD HAD BEEN PROCESSED. NO ADDITIONAL INFORMATION
EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D DIARRHEA, MILD
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
47601
Episode Date:
06/01 /2000
Dose Description: 4.5 G/TON; PO- 6/00*
Extra Label: None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
INCRESASED RATE OF WEIGHT GAIN, IMPROVED FEED
Health Status:
Good
CVM _ Report.rep
US200804293
NOT PROVIDED
#Treated:
120000
#Reacted: 12000
#Died:
0
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
270 LB
Page: 251
Administered By:
Owner
Concomitants: No
ON 4/29/08, MR. TERRY COFFMAN, ELANCO ANIMAL HEALTH SALES REP, REPORTED A POTENTIAL ADE INVOLVING
RACTOPAMINE HYDROCHLORIDE IN FINISHING PIGS. MR. TERRY WEISHEIT, PORK PRODUCER, HAS BEEN FEEDING
RACTOP AMINE ( 4.5 G/TON FOR 21 DAYS) IN THE FINISHING RATION SINCE APPROXIMATELY 6/00. MR. WEISHEIT
FINISHES APPROXIMATELY 160, 000 PIGS A YEAR AND HAS OBSERVED, ON OCCASION, THAT RACTOPAMINE FED
PIGS APPEARED SLOWER, STRESSED AND MORE HYPERACTIVE AND HYPEREXCITED WITH LOADED IN TRUCKS.
THE NUMBER OF PIGS AFFECTED WAS APPROXIMATELY 2 PER LOAD OR A TOTAL OF 1% OF ALL THE PIGS
FINISHED. THE FARMS' GENETICS WERE FROM TWO PIC SIRE LINES (#280 AND #380) AND THE PIGS FROM THE #380
LINE MOST OFTEN HAD THE SIGNS. AT THE TIME OF THE REPORT, MR. WEISHEIT HAD DECIDED TO DISCONTINUE
THE #380 SIRE LINE. RACTOPAMINE WAS CONTINUED IN THE FEED. THE ANIMALS WERE SLAUGHTERED,
THEREFORE NO FURTHER INFO IS EXPECTED.
**REVIEWER NOTE: ACTUAL# TREATED= 1,200,000. (WAS NOT ABLE TO FIT ACTUAL VALUE IN ALLOTTED
FIELD).
"SLOWER" CODED AS LETHARGIC.
Causality
Assessment
Time
0 UN G DEPRESSION/LETHARGY
0 UN G DISTRESS
Source:
Country:
State:
United States
IOWA
Zip:
XX XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
01 /01 /2000
Recommended dose
Oral (in dry feed)
4.5 G/TON, 2000*
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
CVM _ Repmt. rep
US200802715
NOT PROVIDED
#Treated:
540
#Reacted: 21
#Died:
21
Species: PIG
Age: UN
Weight:
260 LB
Page: 252
Concomitants:
Unknown
ON MARCH 31, 2008, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS.
UPDATED: 16-MAY-2008: ON 14 MAY 2008 UPDATE INFORMATION WAS OBTAINED. MR. ED KLEINWORTREPORTED
THAT IN APPROXIMATELY LATE 2000, A PORK PRODUCER THAT HE KNEW (NAME WITHHELD BY MR. KLEINWORT)
WAS FEEDING PA YLEAN TO HIS FINISHING PIGS AT A RATE OF 4.5 G/TON. THE PRODUCER SHIPPED 3 LOADS OF
THE PIGS FOR PROCESSING (APPROXIMATELY 180 PIGS/LOAD) AND IN EACH LOAD, 6-7 PIGS DIED FORM STRESS.
MR. KLEINWORT RECOMMENDED THAT THE PRODUCER INCLUDE VITAMIN E IN THE PA YLEADN RATION TO AID
IN THE REDUCTION OF STRESS. MR. KLEINWORT STATED THAT THE PRODUCER BEGAN ADDING
APPROXIMATELY 1 LB OF VITAMIN E TO A TON OF PA YLEAN FEED AND HE NO LONGER HAD PIGS, DIE. THE
PRODUCER HAS CONTINUED TO FEED PA YLEAN. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
IOWA
Zip:
52649
Episode Date:
05/23/2008
Dose Description: 6.5G/TON; ORAL; 05-24-08
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
EFFICIENCY; AND INCEASED CARCASS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No
US200805460
REQ, NOT PROVIDED
#Treated:
8
#Reacted: 8
#Died:
8
Species: PIG
Breed: Other (pig)
Age: 130 DA
Weight: 265 LB
ON 05-27-08, MS OELKE, ELANCO ANIMAL INTERNAL SALES ASSOCIATE, REPORTED A POTENTIAL ADE
INVOLVING P A YLEAN (RACTOPAMINE HCL) IN PIGS. ON APPRO X 05-09-08, MS DYER, SWINE PRODUCER, BEGAN
FEEDING HER PIGS A RATION THAT CONTAINED PAYLEAN AT 4.5G/TON. ON 05-23-08,2 PIGS DIED AND ON 05-27-
08 ANOTHER PIG DIED. MS DYER REPORTED THAT THE PIGS DEVELOPED PINK SPOTS ON THEIR SKIN AND THEN
DIED. MS DYER ALSO REPORTED THAT SHE HAD PERFORMED POST MORTEM EXAMS OF THE DEAD PIGS AND
FOUND NO SIGNS OF GI PATHOLOGY. AT THE TIME OF THE REPORT, AN ADDITIONAL PIG HAD THE PINK SPOTS
ON ITS SKIN AND MS DYER WAS TX THE PIG BY ISOLATING IT AND FEEDING A RATION WITHOUT P A YLEAN. MS
CVM _ Rep01t.rep
Page: 253
DYER STATED THAT SHE THOUGHT THE P A YLEAN WAS CAUSING THE SPOTS AND THE DEATHS. MS DYER ALSO
REPORTED THAT SHE HAD BEEN FEEDING P A YLEAN TO HER PIGS FOR YEARS AND THAT SHE HAD ALWAYS SEEN
PROBLEMS (NO DETAILS GIVEN) ASSOCIATED WITH FEEDING PA YLEAN. MS DYER CONTINUED TO FEED HER PIGS
PAYLEAN.
UPDATE: ON 06-03-08 UPDATE INFO WAS OBTAINED. MS DYER REPORTED THAT SHE BEGAN FEEDING HER PIGS
P A YLEAN AT 6.5G/TON ON 05-24-08 AND THAT SINCE THAT TIME A TOTAL OF 8 PIGS DEVELOPED PETECHIAE AND
DIED. MS DYER REPORTED THAT SHE HAD ALSO NOTED THAT PAYLEAN CAUSED THE PIGS TO ACT CRAZY,
HUDDLE TOGETHER, AND TO STRESS EASILY. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
0
0
0
0
0
Drug Name:
Time
To Onset
UN
14 DA
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G BLD(PETECHIAE)
G DEATH
LESION(S), SKIN
SKIN ABNORMAL
N HYPERACTIVITY
N NERVOUSNESS
Source:
Country:
United States
State:
MICHIGAN
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
06/20/2008
Not applicable
Oral (all other)
ORAL; 06-19-08
Species
xxxxx
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Not applicable
Unknown
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200807007
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
DOG
Terrier, yorkshire
10 WK
UN
Unknown
ON 06-20-08, MR TERRY COFFMAN, ELANCO ANIMAL HEALTH SALES REP, REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING P A YLEAN (RACTOPAMINE HCL) IN A YORKSHIRE TERRIER PUPPY. ON 06-19-08,
MR CHRIS KENYON, DOG OWNER, FOUND HIS PUPPY EATING A TYPE B SUPPLEMENT INTENDED TO DELIVER
CVM _ Repmt.rep
Page: 254
APPROX 11.25MG OF PAYLEAN PER OUNCE OF SUPPLEMENT. MR KENYON REPORTED THAT HE HAD OBSERVED
THE PUPPY FOR THE REST OF THEDA Y AND NEVER NOTICED ABNORMAL SIGNS IN THE PUPPY. ON THE MORNING
OF 06-20-08, MY KENYON FOUND THE PUPPY DEAD. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
Time
0 1 DA G DEATH
Source:
Country:
State:
United States
SOUTH DAKOTA Zip: 57366
Episode Date:
05119/2008
Dose Description: 4.5 G/TON; ORAL; 5/5/08* - 5119/08
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WEIGHT GAIN, IMPROVED FFED
EFFICIENCY AND INCREASED CARCAS LEANNESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
No
US200807741
REQ, NOT PROVIDED
#Treated:
180
#Reacted: 20
#Died:
20
Species: PIG
Breed: Other (pig)
Age: VA
Weight: 260 LB
ON 7/3/08, MR. MATT SCHNEIDER, BLANCO ANIMAL HEALTH SALES REP, REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISIHNG PIGS. ON 5119/08,
APPROXIMATELY 180 PIGS ON A PARKWAY LL CONTRACT FARM WERE BEING SORTED AND LOADED ON A TRUCK
FOR SHIPPING. DURING THE SORTING PERIOD, 18 PIGS BECAME RECUMBENT AND DIED. WHILE LOADING, 2
MORE PIGS BECAME RECUMBENT AND DIED IN THE AISLE. THE PIGS HAD BEEN FED A DIET THAT INCLUDED
PA YLEAN AT 4.5G/TON FOR APPROXIMATELY 2 WEEKS PRIOR TO BEING MARKETED. THE FARM HAD BEEN
FEEDING P A YLEAN TO OTHER GROUPS OF FINISIHNG PIGS FOR AN UNSPECIFIED PERIOD WITHOUT INCIDENCE
AND THE ENVIRONMENTAL CONDITIONS ON 5119/08 WERE UNREMARKABLE. MR. SCHNEIDER STATED THAT THE
FARM HAD RECENTLY INTRODUCED DIFFERENT GENETICS (DUTCH FARMS GENETICS) INTO THE HERD AND THAT
THIS WAS BEING CONSIDERED IN THE REVIEW OF THE EVENT. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
0
CVM _ Report.rep
Time
To Onset
UN
UN
Clinical Detail:
G DEATH
G RECUMBENCY
Page: 255
Source:
Country:
United States
State:
INDIANA
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
07110/2008
Not applicable
Oral (all other)
ORAL; 07-10-08
Species
46835
Reason For Use:
Health Status:
Good
Administered By:
Owner
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200808046
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
DOG
Bulldog, american
Male
3 YR
109.5 LB
ON 07-10-08, THE ANIMAL PRODUCT SAFETY SERVICE (APSS) CONTACTED ELANCO ANIMAL HEALTH REGARDING
A POTENTIAL ADE INVOLVING PAYLEAN (RACTOPAMINE HCL) IN AN AMERICAN BULLDOG. ON 07-08-08, DR
KITSON, EMERGENCY VET, CONTACTED THE APSS AND REPORTED THAT A DOG HAD POTENTIALLY EATEN
12.5LBS OF PAYLEAN (9G/LB). AT THE TIME OF THE REPORT, EMESIS INDUCTION HAD BEEN ATTEMPTED BUT IT
WAS NOT KNOWN IF THE ATTEMPT WAS SUCCESSFUL. THE DOG HAD NOT EXHIBITED ANY ABNORMAL SIGNS.
UPDATED: 07-25-08: ON 07-23-08, UPDATE INFO WAS OBTAINED. CORRECTION, THE INITIAL INTERACTION WITH
DR KITSON WAS ON 07-10-08. ON 07-15-08, THE APSS CONTACTED DR KITSON WHO OPTED TO FAX PATIENT'S
RECORDS TO THE APSS. THE DOG, OSO, ATE APPROX 12.5LBS IF A PREMIXED PRODUCT THAT CONTAINED
P A YLEAN AT AN UNK LEVEL. MS PENNY ALLES, DOG OWNER, INDUCED VOMITING AND THE DOG VOMITED
APPROX 8LBS OF THE PREMIX. MS ALLES THEN TOOK THE DOG TO THE EMERGENCY VET. ACCORDING TO THE
DOG'S MEDICAL RECORD, ON THE MORNING OF 07-10-08, THE DOG WAS MONITORED FOR ABNORMAL SIGNS AND
WAS TX WITH ACTIVATED CHARCOAL AND IV FLUIDS. ON THE EVENING OF 07-10-08, WHILE AT THE
EMERGENCY FACILITY, THE DOG DEVELOPED INJECTED MUCOUS MEMBRANES AND WAS TACHYCARDIC. ON 07-
11-08, THE DOG RECOVERED COMPLETELY AND WAS DISCHARGED TO THE OWNER. NO FURTHER INFO IS
EXPECTED.
Causality
Assessment
0
-9
0
Time
To Onset
36 HR
NA
36 HR
Clinical Detail:
C TACHYCARDIA
G CONGESTION, MUCOUS MEM
CVM _ Report.rep
Page: 256
N 140863 L 397 Package ID: A 1
Country:
United States NDC:
State:
NORTH CAROLINA
Zip:
27606
Product Lot No:
Episode Date:
06110/2008
Dose Description: 4.5 G/TON; ORAL, 06/10/2008-07/08/2008
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
None
Good
Owner
No
US200806966
NOT PROVIDED
#Treated:
700
#Reacted: 700
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight: 220 LB
Gender: Female
ON 06/20/08, MR. DARYL THEIS, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING PA YLEAN (RACTOP AMINE HYDROCHLORIDE) IN GILTS. ON
APPROXIMATELY 06/10/08, A HEARD OF 700 GILTS, BELONGING TO GOLDSBORO MILLING, WERE STARTED ON A
RATION THAT CONTAINED PAYLEAN AT 4.5 G/TON. ON 06119/08, DR. CHRIS PARKS, NUTRITIONIST, REPORTED THAT
THE HERD OF GILTS, WERE URINATING AND DEFECATING IN THEIR FEEDERS.
UPDATED 07/22/08: ON 07/22/08 UPDATE INFORMATION WAS OBTAINED. DR. CHRIS PARKS REPORTED THAT THE
GILTS WERE CONTINUED ON PAYLEAN (FED AN AVERAGE OF 21-28 DAYS TOTAL), THE FEEDERS WERE CLEANED
OUT AND AN ADJUSTMENT WAS MADE TO THE POSITION OF THE FEEDERS TO REDUCE THE INCIDENCE OF
SOILING. DR. PARKS INDICATED THAT THE GILTS BEHAVIOR WAS MOST LIKELY DUE TO THE CHANGE IN THEIR
DIET BUT BY APPROXIMATELY **06/15/08**, THE GILTS HAD STOPPED THE BEHAVIOR AND WERE CONSUMING
THE PAYLEAN WITHOUT INCIDENT. NO FURTHER INFORMATION IS EXPECTED.
**REVIEWER NOTE: DATE PROVIDED OF 06115/08 APPEARS TO BE AN ERROR AND SHOULD MOST LIKELY READ
"07 /15/08".
Causality
Assessment
0
0
Time
To Onset
9 DA
9 DA
Clinical Detail:
G BEHAVIOR DISORDER
G ELIMINATION ABN
CVM _ Report.rep
Source:
Country:
United States
Source Report ld:
NDC:
US20081 044 7
State:
ILLINOIS
Zip:
62231
Product Lot No:
RQST BUT NOT PRVD
Episode Date:
Dosage:
Route:
Dose Description:
08/19/2008
Missing information
Oral (in dry feed)
UNKNOWN
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 257
0
0
0
Extra Label: None Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No
Age: UN
Weight:
UN
Gender: Unknown
ON 8/19/2008 DR. MATT RITTER, ELANCO ANIMAL HEALTH TECH CONSULTANT, REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING PA YLEAN ( RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON 8/ 19/2008, AN UNNAMED
ANIMAL HANDLER AT MASCHNOFF PORK PRODUCERS COMMENTED THAT P A YLEAN MAKES PIGS CRAZY. NO
FURTHER INFO EXPECTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
N DEMENTIA
Source:
Country:
State:
United States
UNKNOWN
Zip:
xxxxx
Episode Date:
08/13/2008
Dose Description: 4.5G/TON ORAL 7/24/2008-8/13/2008
Extra Label: None
CVM _Report. rep
Source Report Id:
US20081 03 7 6
NDC:
Product Lot No:
RQST BUT NOT PRVD
#Treated:
360
#Reacted: 7
#Died:
7
Species: PIG
Breed: Other (pig)
Age: UN
Page: 258
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
No
Weight:
Gender:
255 LB
Group (m & f)
ON 8/18/2008. DR. KERRY KEFFABER, ELANCO HEALTH TECH CONSULTANT, REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING PA YLEAN ( RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON APPROX. 8113/2008, 2
TRUCK LOADS OF FINISHING PIGS ( 360 HD TOTAL) FROM AN UNKNOWN OWNER WERE SHIPPED FOR PROCESSING.
SOME TIME DURING THE SHIPPING, 7 OF THE PIGS SUATAINED FRACTURES TO THEIR LEGS. ALL OF THE PIGS
THAT WERE SHIPPED HAD BEEN ON A RATION WITH P A YLEAN FED AT 4.5G/TON FOR 20 DAYS PRIOR TO SHIPPING.
DR. KEFF ABER STATED THAT THE FINISHING RATION WOULD CONTINUE TO INCLUDE P A YLEAN AND THAT THE
CALCIUM-PHOSPHOROUS RATIO IN THERA TION WAS BEING CONSIDERED AS A POSSIBLE CAUSE OF THE
FRACTURE LEGS. THE 7 PIGS WERE EUTHANIZED AT THE PLANT. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
Time
To Onset
20 DA
Clinical Detail:
M BONE,ABN
Source:
Country:
State:
United States
IOWA
Zip:
50542
Episode Date:
07/28/2008
Dose Description: 4.5G/TON ORAL 6/2008-7/2008
Extra Label: None
Package ID: A 3
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Concomitants: No
CVM _Report. rep
US20081 0334
RQST BUT NOT PRVD
#Treated:
3000
#Reacted: 50
#Died:
50
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight: 260 LB
Page: 259
ON 8/ 18/2008, MS MARY ANN OELKE, ELANCO ANIMAL HEALTH INTERNAL SALES REP, REPORTED A POTENTIAL
ADVERSE DRUG EXPERIENCE INVOLVING P A YLEAN ( RACTOP AMINE HYDROCHLORIDE) IN FINISHING PIGS. AT
APPROX. THE END OF JUNE, 2008, MR KEVIN RASMUSON, PORK PRODUCER BEGAN FEEDING HIS FINISHING PIGS A
RATION THAT CONTAINED PA YLEAN AT 4.5 G/TON. APPRO X. DURING THE LAST WEEK OF WL Y 2008, 50 OF THE
PIGS DEVELOPED DYSPNEA, ERYTHEMA AND DIED ( 15 ON THE FARM AND 35 DURING TRANSPORT). MR.
RASMUSON DISCONTINUED FEEDING PA YLEAN ON THE FARM . NO FURTHER INFO IS EXPECTED
Causality
Assessment
0
0
0
Time
To Onset
1 MO
1 MO
1 MO
Clinical Detail:
G DEATH
I CONGESTION, SKIN
R DYSPNEA
Source:
Country:
United States
State:
INDIANA
Zip:
46140
Episode Date:
07/13/2008
Dosage: Unknown
Dose Description: SEE NARRATIVE ORAL UNKNOWN
Extra Label:
None
Reason For Use:
RESEARCH STUDY
Health Status:
Unknown
Administered By:
Owner
Concomitants: No
Source Report ld:
US200808135
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
0
#Reacted: 0
#Died:
0
Species: PIG
Age: UN
Weight: UN
ON 7111/2008, ELAN CO ANIMAL HEALTH BECAME A WARE OF AN ADVERSE EVENT OCCURING IN PIGS
ADMINISTERED RACTOPAMINE AS PAYLEAN. DR. DAN IVERS, BLANCO ANIMAL HEALTH SCIENTIST ATTENDED
THE ADSA-ADAS SEMINAR DURING THE WEEK OF 7111/2008. DURING THIS SEMINAR THE FOLLOWING STUDY INFO
WAS SHARED:
THE EFFECT OF RACTOPAMINE, GENDER AND SOCIAL RANK ON AGGRESSION AND PERIPHERAL MONOAMINE
. LEVELS IN FINISHING PIGS. R POLETTO, JP GARNER, HW, ~ H E N G , BT RICHERT AND JN MARCHANT-FORDE,
PURDUE UNIVERSITY, WEST LAFAYETTE, IN USDA-ARS-LBRU, WEST LAFAYETTE, IN
THE AIM OF THIS STUDY WAS TO EVALUATE EFFECTS OF A 'STEP-UP':RACTOPAMINE ( RAC) FEEDING PROGRAM
ON HOME PEN AGGRESSION AND PERIPHERAL LEVELS OF TRYPTOPHAN, SEROTONIN ( 5HT), DOPAMINE
CVM _Report. rep
Page: 260
(DA)NOREPINEPHRINE ( NE) AND EPINEPHRINE (EP) IN FINISHING PIGS. 32 PIGS ( 16 BARROWS AND 16 GILTS) WERE
ASSIGNED AS EITHER CONTROL (CTL) OR RAC TREATMENT ( PEN=4/GENDER). TREATED ANIMALS WERE FED RAC
AT 5PPM FOR 2 WK, THEN 10 PPM FOR ADDITIONAL 2 WKS. THE DOMINANT AND SUBORDINATE IN EACH PEN
WERE DETERMINED AT ASSIGNEMENT BY THE PROPORTION OF ENCOUNTERS WON OR LOST OVER 36H.
BEHAVIOR IN THE HOME PEN WAS CONTINUOUSLY RECORDED ONCE A WEEK FOR 5 WK TO DETERMINE# OF
BITES (B), HEAD KNOCKS ( HK), AND PURSUITS (P). BLOOD WAS COLLECTED FROM EACH ANIMAL ONCE A WK
FOR 5 WK, STARTING PRIOR TO DIETARY TREATMENT AND LEVELS OF TRP, 5HT, DA, NE AND EP WERE MEASURED
USING HPLC. A 2X2X2 FACTO RIAL ANALYSIS WAS COMPUTED WITH REPEATED MEASURES MIXED MODELS USING
INDIVIDUALS AS UNITS. GILTS SHOW MORE B PER COMPARED TO BARROWS. COMPARED TO BASELINE, RAC-FED
GILTS INCREASED B WHILE OTHERS (P<0.05). CTL BARROWS SHOWED THE LOWEST# OF HK, WITH OTHERS
SHOWING SIMILAR COUNTS, PURSUITS INCREASED GREATLY FROM BASELINE IN RAC-FED GILTS, BUT
DECREASED FOR OTHERS (P<O.Ol. OVERALL, GILTS SHOWED MORE TOTAL ACTIONS PER AGGRESSIVE
INTERACTION THAN BARROWS AND RAC-FED GILTS HAD AGILTSREASE IN THE TOTAL NUMER ACTION
PERFORMED (P<0.01).
RAC FED GILTS HAD LOWER 5HT COMPARED TO RAC FED BARROWS ( P=0.08) AND OVERALL, TRP AND 5HT
LEVELS INCREASED UP TO D11 THEN PLATEAUED (DAY P<0.01). DOMINANT RAC PIGS HAD HIGHEST
CONCENTRATION OF NE ( P<0.05) AND DOMINANT BARROWS HAD HIGHER EP LEVELS THAN SUBORDINATE ONES (
P ,0.05), BUT EP CONCENTRATIONS WERE SIMILAR IN GILTS REGARDLESS OF SOCIAL STATUS. GILTS, ESPECIALLY
RAC FED GILTS SHOWED MORE AGGRESSIVE BEHAVIOR WHICH MAY BE LINKED TO LOWERE 5HT AVAILABILITY,
LEADING TO INCREASED PRODUCTION COSTS AND IMPAIRMENT OF WELFARE. NO FURTHER INFO EXPECTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
N AGGRESSION
Source:
Country:
State:
United States
Episode Date:
06110/2008
Dose Description: 4.5G/TON; PO- 6/10/08-7/8/08
Extra Label:
None
PackageiD: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
Good
Owner
No
US200806966
UNKNOWN
#Treated:
700
#Reacted: 700
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 6 MO
Weight: 220 LB
Gender: Female
Page: 261
ON 6/20/08, MR. DARYL THEIS, ELANCO ANIMAL HEALTH SALES REP, REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN GILTS. ON APPROXIMATELY 6110/08, A
HERD OF 700 GILTS, BELONGING TO GOLDSBORO MILLING, WERE STARTED ON A RATION THAT CONTAINED
PAYLEAN AT 4.5G/TON. ON 6/19/08, DR. CHRIS PARKS, NUTRITIONIST, REPORTED THAT THE HERD OF GILTS, WERE
URINATING AND DEFECATING IN THEIR FEEDERS.
UPDATE 7/22/08: ON 7/22/08 UPDATE INFORMATION WAS OBTAINED. DR. CHRIS PARKS REPORTED THAT THE GILTS
WERE CONTINUED ON P A YLEAN (FED AN AVERAGE OF 21-28 DAYS TOTAL), THE FEEDERS WERE CLEANED OUT
AND AN ADWSTMENT WAS MADE TO THE POSITION OF THE FEEDERS TO REDUCE THE INCIDENCE OF SOILING.
DR. PARKS INDICATED THAT THE GILT'S BEHAVIOR WAS MOST LIKELY DUE TO THE CHANGE IN THEIR DIET BUT
BY APPROXIMATELY 6115/08, THE GILTS HAD STOPPED THE BEHAVIOR AND WERE CONSUMING THE P A YLEAN
WITHOUT INCIDENT. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D DEFECATION ABN
G URINATION ABN
Source:
Country:
State:
United States
LOUISIANA
Zip:
71222
LACKS DETAIL
Episode Date:
01/0112008
Dosage: Unknown
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: UNK LEVELS W/IN FEED; 11/07*-12/07*
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Good
Owner
No
US200812692
REQ, NOT PROVIDED
#Treated:
#Reacted:
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 11 MO
Weight: 200 LB
Gender: Female
ON 9/24/08, MS. MANDY VERDIN, PIG OWNER, REPORTED A POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING
P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN A SHOW PIG. IN APPROXIMATELY 12/08, MS. VERDIN PURCHASED
A GILT THAT HAD PREVIOUSLY BEEN FED A RATION THAT CONTAINED P A YLEAN AT AN UNKNOWN LEVEL.
FROM APPROXIMATELY 1/08 TO 5/08, MS. VERDIN WAS UNSUCCESSFUL AT GETTING THE GILT BRED. ON 611 /08,
THE GILT WAS SLAUGHTERED. MS. VERDIN CONTACTED TECHNICAL SERVICES TO DETERMINE IF THE PAYLEAN
COULD HAVE AFFECTED THE GILT'S ABILITY TO BREED. NO FURTHER INFORMATION IS EXPECTED.
CYM _Report. rep
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
X REPRODUCTION DISORDER
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Source Report ld:
NDC:
Product Lot No:
Episode Date:
Dosage:
Route:
Dose Description:
10/08/2008
Unknown
Oral (in dry feed)
ORAL; 5 MGIKG FOR 2 WEEKS, THEN 10 MG/KG FOR 2
WEEKS; UNKDATES
US200813525
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
Page: 262
32
32
0
Extra Label: Unknown Breed: Unknown (pig)
Reason For Use:
RESEARCH STUDY
Age: UN
Weight:
UN
Health Status:
Unknown
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Unknown
ON 10/7/08, ELAN CO ANIMAL HEALTH WAS MADE A WARE OF THE FOLLOWING POTENTIAL ADVERSE EVENT BY A
COMPANY EMPLOYEE. A JOURNAL ARTICLE CONTAINING THE FOLLOWING INFO WAS PROVIDED:
1: J ANIM SCI 9/2/08
EFFECTS OF A "STEP-UP" RACTOPAMINE FEEDING PROGRAM, GENDER AND SOCIAL RANK ON GROWTH
PERFORMANCE, HOOF LESIONS AND ENTEROBACTERIACEAE SHEDDING IN FINISHING PIGS.
POLETTO R. ROSTAGNO MH, RICHERT BT, MARCHANT-FORDE JN
USDA-ARS LIVESTOCK BEHAVIOR RESEARCH UNIT, WEST LAFAYETTE, IN 47907
INCREASING CONCERN FOR ANIMAL WELL-BEING AND FOOD SAFETY HAS STIMULATED THE INVESTIGATION OF
FEED ADDITIVES SUCH AS RACTOP AMINE (RAC), A BET A-AGONIST WIDELY USED TO IMPROVE PRODUCTION
PERFORMANCE OF FINISHING PIGS. THE OBJECTIVE OF THIS STUDY WAS TO DETEREMINE EFFECTS OF RAC
FEEDING, DELIVERED AS A "STEP-UP" PROGRAM (5 MG/KG FOR 2 WK FOLLOWED BY 10 MG/KG FOR 2WK), ON
GROWTH PERFORMANCE, ENTEROBACTERIACEAE SHEDDING, INCLUDING SALMONELLA, AND HOOF LESIONS,
ALSO TAKING INTO ACCOUNT GENDER AND SOCIAL RANK OF PIGS. A TOTAL OF 64 BARROWS AND GILTS
(BALANCED BY TX AND GENDER) WERE ASSIGNED TO PENS OF 4 (BY GENDER) AS EITHER CONTROL (CTL) OR RAC
TX. SOCIAL RANKS (DOMINANT, INTERMEDIATE, AND SUBORDINATE) OF PIGS IN EACH PEN WERE DETERMINED
BY BEHAVIOURAL OBSERVATION DURING 48 H POST-MIXING. FECAL SAMPLES WERE COLLECTED ONCE/WK FOR
5 WK. AT SLAUGHTER THE 32DOMINANT AND SUBORDINATE BARROWS AND GILTS (16/GENDER) WERE
EXAMINED FOR HOOF LESIONS AND LUMINAL CONTENTS FROM ILEUM, CECUM, AND RECTUM WERE
COLLECTED. PIGS FED RAC HAD INCREASED GROWTH PERFORMANCE (P < 0.05) WI SOCIAL RANK OF ANIMALS
AFFECTING OVERALL ADG (P <0.05). GILTS GAINED MORE BACKF AT THAN BARROWS WHEN COMPARING TO
CVM _Report. rep
Page: 263
BASELINE VALUES AT BOTH 10 (TH) AND LAST RIBS (P <0.05), WHILE LOIN EYE AREA INCREASED AT SIMILAR
RATE FOR BOTH BARROWS AND GILTS (P > 0.10) . NO SIGNIFICANT EFFECT OF RAC FEEDING WAS FOUND ON
BACKFAT OR LOIN EYE AREA (P > 0.10).
AT SLAUGHTER, RAC-FED PIGS HAD GREATER LIVE BW (P < 0.05) . DESPITE THE POS EFFECTS OF RAC FEEDING ON
GROWTH PERFORMANCE, PIGS FED THE COMPOUND HAD A GREATER FREQUENCY OF FRONT AND REAR HOOF
LESIONS AS DID BARROW AND DOMINANT INDIVIDUALS (P <0.05). DETECTABLE LEVELS OF SALMONELLA
SHEDDING WERE NOT IDENTIFIED AT ANY TIME DURING THE EXPERIEMENT. ENTEROBACTERIACEAE SHEDDING
LEVELS FROM RAC-FED PIGS PEAKED AT THE FIRST WEEK OF FEEDING, AND PROGRESSIVELY DECREASED UNTIL
SLAUGHTER. AT SLAUGHTER, RECTAL AND CECAL ENTEROBACTERIACEAE LEVELS WERE LOWER IN RAC-FED
PIGS THAN IN CTL PIGS (P <0.05), SOCIAL RANK TENDED TO AFFECT GUT ENTEROBACTERIACEAE POPULATION OF
BARROWS MORE THAN IN GILTS (P <0.1 0). THE EFFECTS OF RAC FEEDING ON HOOF SOUNDNESS AND
ENTEROBACTERIACEAE POPULATIONS IN THE GASTROINTESTINAL TRACT OF FINISHING PIGS WARRANT
FURTHER INVESTIGATION. IT IS ALSO PROPOSED THAT THE INTERGRATION OF THE INDIVIDUALS' SOCIAL RANK
STATUS INTO FUTURE STUDIES SHOULD BE CONSIDERED, AS IT MAY AFFECT TX RESPONSES.
THIS IS NOT AN ELANCO ANIMAL HEALTH STUDY, THEREFORE NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
D GI, ABNORMAL
G HOOF DISORDER
Source:
Country:
State:
United States
ILLINOIS
Zip:
62301
Episode Date:
10/21/2008
Dose Description: 9G/TON; PO; UNKDATES
PackageiD: A 1 Corrsp Date: 11106/2008
Source Report ld:
US200814259
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
#Reacted:
#Died:
Species: PIG
4
2
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Unknown
Age: UN
Weight: 256 LB
Gender: Unknown
ON 10/21108 EUROFINS- AVTECH LABORATORIES CONTACTED ELANCO ANIMAL HEALTH REGARDING A
POTENTIAL LOE INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. A CONTACT AT ADM
ALLIANCE REPORTED THAT A CUSTOMER, WHO PURCHASED P A YLEAN FEED AT THE FARMER'S COOP
CVM _ Report.rep
ASSOCIATION, DID NOT SEE THE RATE OF WEIGHT GAIN IN HIS PIGS THAT HE EXPECTED.
Page: 264
UPDATED 11/3/08: FEED ASSAY RESULTS REPORTED THAT PA YLEAN WAS PRESENT IN THERA TION AT 6.7 G/TON.
THE RESULT WAS BELOW ACCEPT ABLE LIMITS (EXPECTED LEVEL 9 G/TON).
Causality
Assessment
Time
Source:
Country:
State:
United States
UNKNOWN
Zip:
XX XXX
Episode Date:
08/15/2008
Dose Description: 4.5 G/TON; PO; 8/1 5/08
Extra Label: None
PackageiD: A 2
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
No
US200812770
REQ, NOT PROVIDED
#Treated:
2400
#Reacted: 15
#Died:
0
Species: PIG
Age: UN
Weight:
UN
ON 9/25/08, MS. AMANDA TOLLEFSON, BLANCO ANIMAL HEALTH INTERNAL SALES ASSOCIATE, REPORTED A
POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING
PIGS. ON APPROXIMATELY 8/15/08, MR. MARK DEDECKER, PORK PRODUCER, BEGAN FEEDING HIS FINISHING PIGS
A RATION THAT CONTAINED PA YLEAN AT 4.5 G/TON. MR.- DEDECKER REPORTED THAT SINCE BEGINNING OF THE
PAYLEAN RATION 12 TO 15 PIGS HAD GONE DOWN AND 4 OF THE PIGS HAD LEG INJURIES.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G LEG DISORDER
G RECUMBENCY
CYM _ Repmt.rep
Source Report ld:
US200802719
Country:
United States
NDC:
State:
ILLINOIS
Zip:
61238
Product Lot No:
NOT PROVIDED
Episode Date:
12/05/2008
#Treated:
#Reacted:
Dose Description: 4.5- 9.0 G/TON; PO 3/2112008*
Species: PIG
Page: 265
30
30
30
Extra Label: None Breed: Unknown (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Yes
TYLAN 40, PO, UNK DOSE, 3/21108*
Age:
Weight:
Gender:
2 BMD (BACITRACIN METHYLENE DISALICYLATE), PO, UNK DOSE, 3/21/08*
3 CTC (CHLOTETRACYCLINE), PO, UNK DOSE, 3/21108*
4 LINCOMIX, PO, UNK DOSE, 3/21108*
UN
UN
Unknown
ON MARCH 21, 2008, ELAN CO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING RACTOP AMINE HYDROCHLORIDE.
UPDATED 05-DEC-2008: THE ELANCO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED THAT THE
PRODUCER STATED THAT PAYLEAN FED AT 4.5 G/TON INCREASED THE NUMBER OF PIGS WITH HYPERACTIVITY
AND THAT THE "DUMB" OR ANXIOUS PIGS EXPERIENCED A 2X INCREASE IN THEIR ANXIOUS BEHAVIOR. BMD
(BACITRACIN METHYLENE DISALICYLATE) ADDED TO THE PA YLEAN FEED APPEARED TO HAVE A CALMING
EFFECT ON THE PIGS HOWEVER, CTC (CHLORTETRACYCLINE), LINCOMIX (LINCOMYCIN), AND TYLAN (TYLOSIN
PHOSPHATE) ADDED TO THE P A YLEAN FEED INCREASED HYPERACTIVITY IN THE PIGS (ACTUAL START DATE
UNK DATE REPORTED IS AN ESTIMATE) . WHEN PAYLEAN WAS INCLUDED AT 9 G/TON THE PRODUCER REPORTED
THAT 30 PIGS DIED. THE PRODUCER PROVIDED GENERAL COMMENTS REGARDING PAYLEAN USE IN HIS PIGS AND
BUT COULD NOT PROVIDE NUMBERS OF ANIMALS TX OR AFFECTED (OTHER THAN DEATHS) OR THE DATES OF TX
(ACTUAL START DATE UNK, DATED REPORTED IS AND ESTIMATE) AND OF THE EVENTS. INFORMATION ON PRE-
EXISTING MEDICAL CONDITIONS WAS NOT PROVIDED. NO FURTHER INFORMATION IS EXPECTED.
Causality Time
0 UN G DEATH
0 UN N APPREHENSION
CVM _Report. rep
Page: 266
Source:
Country:
State:
United States
IOWA
Zip:
50581
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
12/04/2008
Recommended dose
Oral (all other)
4.5 G/TON; PO
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
Unknown
US200816050
REQ, NOT PROVIDED
#Treated:
2400
#Reacted: 5
#Died:
5
Species: PIG
Breed: Other (pig)
Age: 4 MO
Weight:
185 LB
EXPERIENCE INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON 11129/08, SMITH-HEALY, PORK
PRODUCER, BEGAN FEEDING FINISHING PIGS A RATION THAT CONTAINED PA YLEAN AT 4.5 G/TON. ON 12/4/08, 5
PIGS WERE FOUND DEAD. ON POST MORTEM EXAMINATION, THE ATTENDING VETERINARIAN FOUND THE PIGS
HAD MOIST LUNGS. ON APPROXIMATELY 12/5/08, PA YLEAN WAS REMOVED FROM THERA TION. NO FURTHER
Causality
Assessment
0
0
Time
To Onset
5 DA
5 DA
Clinical Detail:
G DEATH
R PR-LUNG(S), EDEMA
Source:
Country:
State:
United States
KANSAS
Zip:
67647
Episode Date:
12/01/2008
CVM _Report. rep
Source Report Id:
US200816254
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
1500
Page: 267
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Recommended dose
Oral (in dry feed)
4.5G/TON 1211/08*-12/4/08*
None
INCREASED RATE OF WEIGHT GAIN, IMPOVED FEED
Good
Owner
Unknown
Unknown
ADVERSE EXPERIENCES
#Reacted: 1500
#Died:
0
Species: PIG
Age: 24 WK
Weight:
220 LB
Gender: Unknown
ON 18-DEC-2008, AN ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS. ON AN
UNKNOWN DATE, A PRODUCER TOOK DELIVERY OF FEED INTENDED TO CONTAIN PAYLEAN AT 4.5 G/TON AND
BEGAN FEEDING IT (ACTUAL START DATE UNKNOWN, DATE REPORTED IS AN ESTIMATE.) TO TWO GROUPS OF
FINISHING PIGS (1200 HEAD IN ONE LOCATION, 300 HEAD IN SECOND LOCATION). THREE AND A HALF DAYS
PASSED BETWEEN DELIVERY OF THE FEED AND DISCOVERY THAT THE PIGS WERE OFF THE FEED. THE FEED WAS
REMOVED AND FRESH FEED WAS PROVIDED (UNKNOWN IF PA YLEAN WAS INCLUDED). NO DEATHS OCCURRED
AND NO INTERVENTION WAS REQUIRED. INFORMATION ON PRE-EXISTING MEDICAL CONDITIONS AND
CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED.
UPDATED 13-JAN-2009: ON 08-JAN-2009 UPDATE INFORMATION WAS OBTAINED. THE ELANCO TECHNICAL
CONSULTANT REPORTED THAT THE START DATE FOR THE PAYLEAN RATION WAS APPROXIMATELY 01-DEC-2008
AND IT WAS DISCONTINUED ON APPROXIMATELY 04-DEC-2008. THIS WAS THE FIRST DELIVERY OF PA YLEAN TO
THESE PIGS.
UPDATED 13-JAN-2009: FEED ASSAY RESULTS FOR 3 SAMPLES REPORTED THAT PAYLEAN WAS PRESENT IN THE
RATION AT 4.7, 5.5, AND 3.6 G/TON. THE RESULTS WERE WITHIN ACCEPTABLE LIMITS. FEED ASSAY RESULTS FOR 2
SAMPLES REPORTED THAT PAYLEAN WAS PRESENT IN THE RATION AT 2.2 AND 3.0 G/TON. THE RESULTS WERE
BELOW ACCEPTABLE LIMITS. NO FURTHER INFORMATION IS EXPECTED.
Causality
Assessment
0
Time
To Onset
3 DA
Clinical Detail:
G OFFFEED
Source:
Country:
State:
United States
IOWA
Zip:
52654
Episode Date:
07/01/2008
Route:
CYM _Report. rep
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200900 181
NOT PROVIDED
#Treated:
#Reacted:
#Died:
106104
912
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
4.5 G/TON 7/ 1/08 - 10/31/08
None
EFFICIENCY AND INCREASED CARCASS
Good
Owner
Yes
Species:
Breed:
Age:
Weight:
Gender:
TYLAN 40. 40G/LB PO 40G/TON WL Y 1, 2008- OCTOBER 31, 2008
ADVERSE EXPERIENCES
Page: 268
265
PIG
Unknown (pig)
UN
260 LB
Group (m & f)
ON 09-JAN-2009, AN ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS. DURING THE
MONTHS OF WL Y, AUGUST, SEPTEMBER, AND OCTOBER, 2008, A PRODUCER FED PA YLEAN TO FINISHING PIGS AT
A RATE OF 4.5 G/TON FOR 20-30 DAYS BEFORE PROCESSING. THE PRODUCER REPORTED THAT THE EXPECTED
RATE OF PIG DEATHS, ON ARRIVAL AT THE PROCESSING PLANT, WAS .15% OF THE PIGS PROCESSED PER YEAR
AND THE RATE FOR DOWNER (NON-AMBULATORY) PIGS WAS .33% OF THE PIGS PROCESSED PER YEAR. DURING
THE 4 MONTHS THAT PA YLEAN WAS FED, THE NUMBER OF DEADS AND DOWNERS AT THE PLANT INCREASED. IN
THE MONTH OF OCTOBER, 26, 526 PIGS WERE PROCESSED AND THE DEAD RATE WAS .25% AND THE DOWNER
RATE WAS .61 %. APPROXIMATELY 265 PIGS DIED AND 647 PIGS WERE DOWNERS DURING THE 4 MONTH PERIOD.
TYLAN WAS ALSO FED IN THE RATION AT 40 G/TON. HANDLING AND TRANSPORTATION OF PIGS WAS
CONSIDERED APPROPRIATE AND SEASONAL INFLUENCES WERE TAKEN INTO CONSIDERATION. INNOV-2008,
PAYLEAN WAS NO LONGER FED THE DEAD/DOWNER RATES RETURNED TO NORMAL (.14% DEADS AND .28%
DOWNERS IN NOVEMBER). THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS. NO FURTHER INFORMATION IS
EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G DEATH
G RECUMBENCY
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
02/05/2009
CVM _ Report.rep
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US2009007 46
A484694
#Treated:
#Reacted:
0
0
Page: 269
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Product defect
Not applicable
Not applicable
Not applicable
Not applicable
No
ADVERSE EXPERIENCES
#Died:
0
Age: NA
Weight:
NA
ON 2/5/09, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL PRODUCT DEFECT INVOLVING A
PA YLEAN (RACTOPAMINE HYDROCHLORIDE) BAG. A CUSTOMER REPORTED THAT A BAG OF PA YLEAN APPEARED
TO HAVE NOT BEEN PROPERLY SEALED AND WAS OPEN AT ONE SEAM. THE BAG WAS RECEIVED BY THE
CUSTOMER ON 1/14/09 AND WAS FROM LOT# A484694. THE BAG STILL WEIGHED 25 LB.
ON 2113/09 UPDATED INFORMATION WAS PROVIDED BY ELANCO US COMPLAINT MANAGEMENT QA: THE
INVESTIGATION PERFORMED BY THE MANUFACTURING SITE CONCLUDED THAT THE SPLIT BAG WAS DAMAGED
IN TRANSIT. THERE MUST HAVE BEEN A WEAKNESS IN THE WELDED SEAM WHICH EVENTUALLY RUPTURED
UNDER PRESSURE FROM THE OTHER BAGS ON HIGHER LEVELS IN THE PALLET BOX. THE FACT THAT ONLY ONE
BAG WAS IMPACTED AND THAT THERE HAS ONLY BEEN ONE OTHER COMPLAINT OF A SIMILAR NATURE IN THE
PAST 5 YEARS, ALSO FOR ONE BAG, WOULD INDICATE THERE IS NOT AN INTRINSIC PROBLEM WITH THIS
PRODUCT. NO FURTHER INFORMATION EXPECTED.
Causality
Assessment
Time
0 NA P PD-CONT AINER(S), DAMAG
0 NA P PD-SEAL, ABN
Source:
Country:
State:
United States
NORTH CAROLINA Zip: X XXX X
Episode Date:
03/01/2009
Dose Description: 6.75 G/TON PO 1/1/2009
Extra Label:
None
CVM_Rep01t.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US20090 11 77
REQ/NOT PROV
#Treated:
360000
#Reacted: 36000
#Died:
0
Species: PIG
Breed: Other (pig)
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
EFFICIENCY AND INCREASED CARCASS LEANESS
Age:
Weight:
Good
Gender:
Owner
Unknown
Unknown
Page: 270
7 MO
265 LB
Group (m & f)
ON 13-MAR-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS. IN 2006, MURPHY BROWN BEGAN
FEEDING THEIR FINISHING PIGS PAYLEAN (DOSAGE UNK) IN THE RATIONS. IN 2009, THE FINISHING RATIONS
CONTAINED PAYLEAN AT 6.75 G/TON. BEGINNING ON 01-MAR-2009, THE PROCESSING FACILITY REPORTED THAT
IN 10% OF THE 30,000 PIGS PROCESSED DAILY, THE FAT SURROUNDING THE LOIN MEAT WOULD COME OFF WHEN
THE LOINS WERE REMOVED. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANT
PRODUCTS.
UPDATED 24-MAR-2009: ON 24-MAR-2009, UPDATE INFO WAS OBTAINED. THE ELANCO ANIMAL HEALTH SALES
REP REPORTED THAT NO ADDITIONAL INFO IS EXPECTED.
Causality
Assessment
Time
0 UN G MEATABN
Source:
Country:
United States
State:
UNKNOWN
Zip:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
0211112009
Recommended dose
Oral (in dry feed)
6.75 G/TON PO 2/5/2009
None
RESEARCH STUDY
Good
Staff
Missing information
Unknown
XX XXX
Source Report Id:
US200900809
NDC:
Product Lot No:
UNK
#Treated:
550
#Reacted: 5
#Died:
2
Species: PIG
Breed: Other (pig)
Age: 20 WK
Weight:
214 LB
Page: 271
ON 22 APRIL 2009, BLANCO ANIMAL HEALTH WAS MADE A WARE OF AN ADVERSE DRUG EVENT IN A RESEARCH
STUDY INVOLVING PA YLEAN.
STUDY TITLE: POST APPROVAL STUDY: IMPACT OF CLA AND RACTOPAMINE (PA YLEAN) ON GROWTH
PERFORMANCE AND FAT QUALITY CHARACTERISTICS IN FINISHING PIGS
STUDY OBJECTIVE: THE PRIMARY OBJECTIVE OF THIS STUDY IS TO EVALUATE THE FEEDING OF CONJUGATED
LINOLEIC ACID (CLA) IN CONJUNCTION WITH DDGS TO IMPROVE FAT QUALITY AND AVOID IODINE VALUES THAT
LEAD TO PACKER DISCRIMINATION OF DDGS-FED PIGS. THE SECONDARY OBJECTIVE IS TO CHARACTERIZE THE
INTERACTION OF CLA IN A TYPICAL SWINE GROW -FINISH SYSTEM THAT UTILIZES BOTH DDGS AND
RACTOP AMINE (RAC).
THIS STUDY HAS BEEN COMPLETED AND THE DATA HAS BEEN REVIEWED. FOLLOWING THE REVIEW OF THE
DATA, IT HAS BEEN DETERMINED THERE WERE SEVEN ADVERSE EVENTS OF WHICH FIVE WERE ADMINISTERED
PA YLEAN 9 AND TWO CONTROL ADVERSE EVENTS. THE ADVERSE EVENTS INVOLVING PA YLEAN 9 INCLUDED 2
DEATHS, 2 OBSERVED FOR LAMENESS AND ONE CHEWED RECTUM.
AS THE STUDY IS COMPLETE, NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
0
0
Time
To Onset
UN
UN
UN
Clinical Detail:
G BITING/CHEWING
G DEATH
G LAMENESS
Source:
Country:
State:
United States
IOWA
Zip:
50035
Episode Date:
01128/2009
Dose Description: 6.75 G/TON PO 11112009*-1/28/2009
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
INCREASED RATE OF WT GAIN, IMPROVED FEED
Health Status:
Good
CYM _Report. rep
US200902065
REQ NOT PROVIDED
#Treated:
4942
#Reacted: 118
#Died:
7
Species: PIG
Age: UN
Weight: 277 LB
Page: 272
Administered By:
Vet Opinion:
Concomitants:
Owner
Unknown
Unknown
01-MAY-2009, AN ELANCO HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON 28-JAN-2009 AND 16-FEB-2009,
WAKEFIELD PORK TRANSPORTED A TOTAL OF 5832 PIGS TO A PROCESSING SITE. OF THESE PIGS, 4942 PIGS HAD
BEEN FED PAYLEAN AT 6.75 G/TON FOR 20 TO 28 DAYS AND 890 PIGS HAD NOT BEEN FED PAYLEAN. ON ARRIVAL
AT THE PLANT, 2.25% (111) OF THE PAYLEAN FED PIGS WERE SLOW AND 0.14% (7) OF THE PIGS HAD DIED. IN THE
NON-PAYLEAN FED GRP, 1.12% (10) PIGS WERE SLOW AND 0.11% (1) PIGS HAD DIED. THE HERD HAD A HX OF
SWINE INFLUENZA (DETAILS NOT PROVIDED AND ACTUAL START DATE UNK, DATE REPORTED IS AN ESTIMATE).
INFO ON CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO FURTHER INFO IS EXPECTED.
MEDICALHX
SWINE INFLUENZA
Causality
Assessment
0
Time
To Onset
28 DA
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
PENNSYLVANIA
Zip:
18964
Episode Date:
0110112008
Dose Description: 4.5 G/TON PO 2000*
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Owner
Unknown
US200902365
REQNOTPROV
#Treated:
1000
#Reacted: 1000
#Died:
0
Species: PIG
Age: UN
Weight: 260 LB
ON 14-MAY-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL LACK OF EFFECTIVENESS
CVM _Report. rep
Page: 273
INVOLVING PAYLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. IN THE FALL OF 2008 (ACTUAL START DATE
UNK, DATE REPORTED IS AN ESTIMATE), A PORK PRODUCER HAD A GRP OF 1000 FINISHING PIGS THAT DID NOT
PRODUCE THE CUTOUT VALUE THAT HE EXPECTED. THE PORK PRODUCER STATED THAT HE HAS FED HIS
FINISHING PIGS A RATION THAT CONTAINED PAYLEAN AT 4.5 G/TON FOR MANY YRS (ACTUAL START DATE UNK,
DATE REPORTED IS AN ESTIMATE) AND HAS NEVER EXP A LOW CUTOUT VALUE. THE PORK PRODUCER
QUESTIONED IF THE OTHER COMPONENTS OF THERA TION WERE OF THE QUALITY THEY SHOULD HAVE BEEN
AND THE MANUFACTURING MILL REPORTED THAT PA YLEAN MAY HAVE CAUSED THE DECREASED VALUE. INFO
ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO
FURTHER INFO IS EXPECTED.
Causality
Assessment
Time
0 UN E INEFFECT
Source:
Country:
United States
State:
CALIFORNIA
Zip:
93905
Episode Date:
05/01/2009
Dose Description: UNK DOSE PO 5/2009*
Extra Label:
Species
Reason For Use:
Health Status:
Good
Administered By:
Not applicable
Concomitants: No
Package ID: A 1 Corrsp Date: 06/01 /2009
Source Report Id:
US200902378
NDC:
Product Lot No:
NOT PROVIDED
#Treated:
#Reacted:
#Died:
0
Species: DOG
Breed: Unknown (dog)
Age: 9 YR
Weight:
79 LB
ON 14-MAY-2009, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG EXP
INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN A DOG. A DOG PRESENTED WITH SEIZURES AT A
CLINIC, AFTER EATING P A YLEAN FEED OR FECAL MATTER FROM P A YLEAN FED PIGS.
UPDATED 15-MAY-2009: ON 14-MA Y-2009, THE ANIMAL PRODUCT SAFETY SERVICE (APSS) CONTACTED ELANCO
ANIMAL HEALTH REGARDING A POTENTIAL ADVERSE DRUG EXP INVOLVING P A YLEAN (RACTOPAMINE
HYDROCHLORIDE) IN A BOXER MIXED DOG. ON 14-MAY-2009, AN EMPLOYEE FROM THE VCA ALL PETS ANIMAL
HOSP CONTACTED THE APSS AND REPORTED THAT A DOG, JED, THAT MAY HAVE BEEN EXPOSED TO A PIG
RATION THAT CONTAINED PA YLEAN (LEVEL UNK) PRESENTED TO A VET HOSP FOR SEIZURES AND AGITATION.
THE CLINIC EMPLOYEE REPORTED THAT OVERNIGHT THE DOG HAD 3 SEIZURES AND THE AFTERNOON OF 14-
MAY-2009, THE DOG DEVELOPED AGITATION AND TACHYCARDIA. AT THE TIME OF THE CALL, APPROX 1 DAY
CVM _Report. rep
Page: 274
AFTER THE FIRST REPORTED SEIZURE, THE DOG HAD BEEN TREATED WITH PHENOBARBITAL WHICH MADE THE
DOG LESS ANXIOUS.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
C TACHYCARDIA
0 UN N APPREHENSION
0 UN N CONVULSION(S)
Source:
Country:
United States
State:
KANSAS
Zip:
66408
Episode Date:
02/01/2009
Dose Description: 4.5 G/TON PO 2/2009*-4/2009*
Extra Label:
None
Reason For Use:
Health Status:
Good
Administered By:
Not applicable
Vet Opinion: Low
Concomitants: No
Package ID: A 2
Source Report ld:
NDC:
Product Lot No:
US200902477
REQ/NOT PROV
#Treated:
2200
#Reacted: 800
#Died:
0
Species: PIG
Age: UN
Weight: 40 LB
ON 19-MA Y -2009, AN ELAN CO ANIMAL HEALTH TECHNICAL CONSULT ANT WAS CONTACTED REGARDING A
POTENTIAL ADVERSE DRUG EXP INVOLVING PA YLEAN (RACTOP AMINE HYDROCHLORIDE) IN FEEDER PIGS. IN
APPROX JAN-2009, A GRP OF FEEDER PIGS WERE PLACED IN A BARN THAT INADVERTENTLY HAD LEFTOVER
PA YLEAN FINISHING RATION IN THE FEEDERS. A SHORT PERIOD OF TIME AFTER BEING PLACED IN THE BARN
(TIME NOT SPECIFIED) THE PIGS DEVELOPED SORE FEET. THE PIG PRODUCER QUESTIONED WHETHER THE PIGS
ACCIDENTALLY CONSUMING THE PAYLEAN (ACTUAL START DATE UNK, DATE REPORTED IS AN ESTIMATE)
RATION COULD HAVE CONTRIBUTED TO THEIR DEVELOPMENT OF SORE FEET (ACTUAL START DATE UNK, DATE
REPORTED IS AN ESTIMATE). AT THE TIME OF THE REPORT THE PIGS HAD BEEN PROCESSED. THERE WERE NO
PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANT PRODUCTS.
UPDATED 22-MAY-2009: ON 21-MAY-2009, THE ATTENDING VET PROVIDED UPDATE INFO. ON 18-FEB-2009, THE
ATTENDING VET VISITED A PORK PRODUCER WHO HAD PLACED 1100 FEEDER PIGS INTO A HOUSE WHERE A
FINISHING RATION THAT CONTAINED PAYLEAN AT4.5 G/TON WAS INADVERTENTLY LEFT IN THE FEEDING BINS.
CVM _Report. rep
Page: 275
AT THE SAME TIME OF THE VET'S VISIT, THE PIGS HAD CONSUMED THE RATION AND APPROX 800 OF THE 1100
PIGS WERE SHOWING SIGNS OF LAMINITIS AND LAMENESS. THE VET TX THE HERD WITH ASPIRIN FOR 7 DAYS
AND TETRACYCLINE FOR 5 DAYS, BOTH DELIVERED IN THE WATER SOURCE. BY APPROX 13-MAR-2009, THE
SIGNS HAD RESOLVED IN ALL OF THE AFFECTED PIGS. IN APR-2009, THE SAME SCENARIO OCCURRED IN A DIFF
HOUSE ON THE PRODUCTION FACILITY. THE VET REPORTED THAT THERE WERE 1100 PIGS PLACED IN THE HOUSE
BUT HE COULD NOT PROVIDE INFO ON THE NUMBER OF AFFECTED PIGS AS HE HAD NOT EXAMINED THAT HERD.
THE SECOND HERD WAS NOT TREATED AND APPRO X 3 WEEKS AFTER DEVELOPING SIGNS, THE PIGS HAD
RECOVERED. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANT PRODUCTS. NO
FURTHER INFO IS EXPECTED.
Causality
Assessment
Time
0 UN G LAMENESS
0 UN G LAMINITIS
Source:
Country:
State:
United States
MISSOURI
Zip:
63456
Episode Date:
0511112009
Dose Description: 4.5 G/TON PO 4/30/2009-5/ 1112009
Extra Label:
None
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
Concomitants: No
US200902289
UNK
#Treated:
170
#Reacted: 170
#Died:
8
Species: PIG
Age: UN
Weight: 260 LB
Gender: Unknown
ON 27-APR-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. BEGINNING ON 30-APR-2009, A PORK
PRODUCER BEGAN FEEDING A GRP OF APPRO X 170 PIGS A RATION THAT CONTAINED PA YLEAN AT 4.5 G/TON. ON
11-MAY-2009, THE PIGS WERE TAKEN TO A PROCESSING FACILITY AND DURING UNLOADING, AN UNK NUMBER
OF THE PIGS WERE STAGGERING. THE LOAD OF PIGS WAS REJECTED BY THE PROCESSOR AND THE ANIMAL
OWNER WAS TOLD THAT THEY WERE REJECTED BECAUSE THEY WERE SHOWING SIGNS OF PA YLEAN TOXICITY.
INFO ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT
PROVIDED.
CVM _ Repmt.rep
Page: 276
UPDATED 28-MAY-2009: ON 28-MAY-2009, AN ELANCO ANIMAL HEALTH SALES REP PROVIDED UPDATE INFO.
UPON ARRIVAL TO THE PROCESSING FACILITY, 4 PIGS WERE DESCRIBED AS WILD-EYED AND CRAZY,
STAGGERING AND APPEARED TO HAVE JOINT ISSUES. THE SIGNS WERE CLASSIFIED AS CENTRAL NERVOUS
SYSTEM SIGNS THAT THE PROCESSING FACILITY REP DESCRIBED AS P A YLEAN TOXICITY. THE 4 PIGS WERE
EUTHANIZED AND CONDEMNED. ANOTHER 4 PIGS (CHOSEN AT RANDOM) WERE SLAUGHTERED AND TISSUE
SAMPLES WERE SUBMITTED FOR RACTOPAMINE LEVEL TESTING. REPORTEDLY ALL TISSUE SAMPLES TESTED
WERE WITHIN ACCEPTABLE LIMITS FORRACTOPAMINE LEVELS.
Causality
Assessment
0
0
0
0
0
Drug Name:
Time
To Onset
11 DA
11 DA
11 DA
11 DA
11 DA
RACTOP AMINE
Clinical Detail:
G DEATH(EUTHANIZED)
G STAGGERING
M JOINT DISORDER
N HYPERACTIVITY
Source:
Country:
State:
United States
NEBRASKA
Zip:
68901
Episode Date:
12/01/2007
Dose Description: 4.5 G/TON PO 12/07-1/08
Extra Label:
None
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
EFFICIENCY AND INCREASED CARCAS LEANESS
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Good
Other
No
US200903227
UNK
#Treated:
9750
#Reacted: 145
#Died:
145
Species: PIG
Breed: Other (pig)
Age: UN
Weight:
270 LB
ON 16-JUN-2009, AN ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE
DRUG EXP INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS. DURING DEC-2007
THROUGH JAN-2008, A PRODUCER RAN AN ON-FARM PAYLEAN FEEDING TRIAL. DURING THIS TIME, 9,750
FINISHING PIGS WERE FED PA YLEAN AT 4.5 G/TON. ANOTHER GRP OF PIGS, 12,500 HEAD, WERE NOT FED PA YLEAN
DURING THE TRIAL. AT THE TIME OF PROCESSING, 1.49% OF THE PAYLEAN FED PIGS WERE DEAD OR NON-
CVM _Report. rep
Page: 277
AMBULATORY ON ARRIVAL AT THE PLANT; 0.68% OF THE NON-PAYLEAN FED PIGS WERE DEAD OR NON-
AMBULATORY. THE PRODUCER DISCONTINUED THE FEEDING OF PAYLEAN. THE PIGS WERE DESCRIBED AS
BEING IN GOOD HEALTH PREVIOUSLY AND THERE WERE NO CONCOMITANT PRODUCTS. NO FURTHER INFO IS
EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G DEATH
N ATAXIA
Source:
Country:
State:
United States
UNKNOWN
Zip:
XX XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
06/25/2009
Unknown
Oral (in dry feed)
PO 2009*
Unknown
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
No
US200903485
UNK
#Treated:
0
#Reacted: 0
#Died:
0
Species: PIG
Age: UN
Weight:
UN
ON 25-ruN-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING PAYLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. A DEKALB FEEDS REP REPORTED THAT
PRODUCERS WERE RELUCTANT TO FEED RATIONS CONTAINING PAYLEAN BECAUSE THEY FELT PAYLEAN
INCREASED THE NUMBER OF DOWNER AND DEAD PIGS. THE DEKALB REP COULD NOT PROVIDE DETAILS ON ANY
SPECIFIC EVENTS INCLUDING DATES OF THE EVENTS, PA YLEAN INCLUSION RATES AND THE NUMBER OF
ANIMALS AFFECTED. INFO ON PRE-EXISTING MEDICAL CONDITIONS WAS NOT PROVIDED. NO FURTHER INFO IS
EXPECTED.
REVIEWER NOTE: PRODUCERS HAD NOT USED DRUG - CODED NO SIGNS
Causality
Assessment
CYM _Report. rep
Time
Page: 278
-9 NA G NO SIGNS
Source:
Country:
United States
State:
IOWA
Zip:
XX :XXX
Episode Date:
07/07/2009
Dose Description: 2.25 GPO 717/2009
Extra Label:
Species
Reason For Use:
Health Status:
Good
Administered By: Not applicable
Concomitants: No
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
US200903872
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
DOG
Retriever, chesapeake
bay
7 YR
125 LB
Male, neutered
ON 09-JUL-2009, AND ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADVERSE
DRUG EXP INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN A CHESAPEAKE BAY RET DOG. ON 17-
JUL-2009, A DOG, NAME UNK, WAS OBSERVED EATING APPROX .25LB OF A PAYLEAN CONCENTRATE (EST 2.25 GM
OF P A YLEAN). THE DOG WAS SLEEPY AND SLIGHTLY DEPRESSED THE REST OF THE EVENING BUT BY 08-JUL-
2009, THE DOG HAD RECOVERED. THERE WAS NO VET INTERVENTION OR TX. INFO ON PRE-EXISTING MEDIAL
CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
Time
0 12 HR G DEPRESSION/LETHARGY
Source:
Country:
CVM _ Rep01t.rep
United States
Package ID: A 1
Source Report Id:
NDC:
US200904115
State:
ILLINOIS
Zip:
xxxxx
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/ 17/2009
Recommended dose
Oral (in dry feed)
SEE NARRATIVE PO 2009*
None
Good
Owner
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 279
1600
1600
0
PIG
Unknown (pig)
UN
275 LB
Group (m & f)
ON 17-JUL-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. A PRODUCER REPORTED THAT PIGS FED
PA YLEAN WERE MORE DIFFICULT TO HANDLE AND ACT "CRAZY". THE PRODUCER WAS ONE IN A GRP OF
PRODUCERS THAT MANAGED FINISHING HERDS AND THE ONLY ONE TO COMPLAIN OF THIS PROBLEM. THE PIGS
WERE FED PA YLEAN AT 4.5 G/TON FOR APPROX 2 WKS AND THEN 9 G/TON FOR APPROX 2 WKS (ACTUAL START
DATE UNK, DATE REPORTED IS AN ESTIMATE).
INFO PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED.
NO FURTHER INFO IS EXPECTED.
Causality
Assessment
Time
Source:
Country:
State:
United States
ARKANSAS
Zip:
72762
Episode Date:
08/23/2009
CVM _ Repmt.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US200905191
UNK
#Treated:
#Reacted:
1280
42
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (in dry feed)
4.5 G/TON PO 8/9/09*-8/25/09
None
Unknown
Owner
Unknown
No
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 280
42
PIG
Unknown (pig)
Unknown
UN
UN
ON 27-AUG-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON APPROX 09-AUG-2009, A TYSON FACILITY
IN MISSOURI BEGAN FEEDING A GRP OF 1280 PIGS A RATION THAT CONTAINED PAYLEAN AT 4.5 G/TON. ON 23-
AUG-2009, 480 OF THE PIGS WERE TRANSPORTED TO A PROCESSING FACILITY IN ARKANSAS AND 18 OF THE PIGS
WERE DEAD ON ARRIVAL (DOA'S). ON 25-AUG-2009, THE REMAINING 800 PIGS WERE TRANSPORTED TO THE
FACILITY IN ARKANSAS AND 16 OF THE PIGS WERE DOA'S AND 8 PIGS WERE EUTHANIZED IMMEDIATELY AFTER
ARRIVING. TYSON QUESTIONED IF P A YLEAN COULD HAVE CONTRIBUTED TO THE DO A'S OR THE CONDITION
(DETAILS NOT PROVIDED) THAT LEAD TO THE PIGS BEING EUTHANIZED. INFO ON PRE-EXISTING MEDICAL
CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
Time
To Onset
16 DA
Clinical Detail:
G DEATH
0 16 DA G DEATH(EUTHANIZED)
Source:
Country:
State:
United States
INDIANA
Zip:
xxxxx
Episode Date:
05/01/2009
Dose Description: 4.5 G/TON; PO; 2005*- MAY 2009
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
CVM _Report. rep
US200905962
UNK
#Treated:
24000
#Reacted: 720
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 6 MO
Health Status: Good
Administered By:
Owner
Concomitants: No
Weight:
Gender:
Page: 281
250 LB
Group (m & f)
ON 23-SEP-2009, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXP
INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS. IN 2005, A PORK PRODUCER BEGAN
FEEDING FINISHING PIGS A RATION THAT CONTAINED PAYLEAN AT 4.5G/TON. BEGINNING IN APPROX MAY-2009,
APPROX 3% OF 24,000 FINISHING PIGS DEVELOPED JOINT AND LAMENESS PROBLEMS. THE SUPPLIER OF THE PIGS
(GENETIC LINE NOT KNOWN) FOR THE PRODUCER SUGGESTED THAT FEEDING PA YLEAN CAUSED THE SIGNS
SEEN IN THE PIGS. THE PRODUCER FELT THAT THE GENETICS WAS RESPONSIBLE FOR THE PROBLEMS SEEN AND
CONTINUED TO FEED PA YLEAN. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANT
PRODUCTS. NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G LAMENESS
M JOINT DISORDER
Source:
Country:
United States
State:
INDIANA
Zip:
46038
Episode Date:
07/01 /2006
Dose Description: SEE NARRATIVE, PO 6/1106-7/5/06
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM _Report. rep
None
RESEARCH STUDY
Unknown
Owner
Missing information
No
Source Report Id:
US200603122
NDC:
Product Lot No:
UNK
#Treated:
1113
#Reacted: 23
#Died:
23
Species: PIG
Age: UN
Weight: 200 LB
Page: 282
ON 12-0CT-2009, THE ELANCO ANIMAL HEALTH PHARMACOVIGILANCE TEAM WAS PROVIDED A FINAL STUDY
REPORT FOR T4V290607.
STUDY TITLE: POST APPROVAL STUDY- THE EFFECTS OF DIETARY RACTOPAMINE LEVEL AND FEEDING
DURATION ON THE PERFORMANCE AND CARCASS CHARACTERISTICS OF LATE FINISHING MARKET HOGS.
IN THE REVIEW OF THE FINAL STUDY REPORT, 23 ANIMALS DIED AFTER BEING ADM RACTOPAMINE. IN THE GRP
ADM 4.50 G/TON RAC 28D, 7 OUT OF 279 ANIMALS DIED. IN THE GRP ADM 6.75 G/TON RAC 28D, 5 OUT OF 277
ANIMALS DIED. IN THE GRP ADM 4.50 G/TON RAC 21D, 4 OUT OF 279 ANIMALS DIED. IN THE GRP ADM 6.75 G/TON
RAC 21D, 7 OUT OF 279 ANIMALS DIED.
AS THE STUDY IS COMPLETE, NO FURTHER INFO IS EXPECTED.
Causality
Assessment
0
Time
To Onset
UN
Clinical Detail:
G DEATH
Source:
Country:
United States
State:
OHIO
Zip:
xxxxx
Episode Date:
10114/2009
Dose Description: UNK DOSE; 1 0/14/2009*
Extra Label:
Species
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
ACCIDENTAL ANIMAL EXPOSURE (ORAL)
Health Status:
Unknown
Administered By:
Not applicable
Concomitants:
No
US200906592
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
DOG
Unknown (dog)
Unknown
UN
UN
ON 14-0CT-2009, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG EXP
INVOLVING P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN A DOG. ON AN UNK DATE (DATE PROVIDED IS AN
ESTIMATE) A DOG ATE APPRO X .5-1 LB OF PA YLEAN FEED (CONCENTRATION UNK). AT THE TIME OF THE CALL,
THE DOG WAS REPORTED TO BE LETHARGIC. INFO ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT
PRODUCTS WAS REQUESTED, NOT PROVIDED.
UPDATED 23-0CT-2009: ELANCO ANIMAL HEALTH HAS MADE THREE ATTEMPTS (21-0CT-2009, 22-0CT-2009,
AND 23-0CT-2009) TO OBTAIN UPDATE OR FOLLOW-UP INFO AND HAD NO SUCCESS. NO FURTHER INFO IS
CVM _Report. rep
EXPECTED.
Causality
Assessment
-9
0
Time
To Onset
UN
UN
Clinical Detail:
Page: 283
Source:
Country:
United States
State:
UNKNOWN
Zip:
XXX XX
Episode Date:
11123/2009
Dosage: Unknown
Dose Description: PO; 11117/09 - 11123/09*
Extra Label:
Unknown
Reason For Use:
UNK
Health Status:
Good
Administered By:
Veterinarian
Concomitants: No
POST APPROVAL RESEARCH STUDY: TITLE UNK.
STUDY NUMBER: T4VUS090014.
Source Report ld:
US200907 624
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
PIG
3
3
Unknown (pig)
Female
UN
VA
ON 23-NOV-2009, BLANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING PAYLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON 17-NOV-2009, THE RESEARCH
STUDY BEGAN. ON THE MORNING OF 23-NOV-2009, A GILT (#1221) WAS FOUND DEAD AND BLOATED. THE CAUSE
OF DEATH WAS REPORTED TO BE DUE TO HEMORRHAGIC BOWEL SYNDROME (HBS). THE GILT WAS IN THE
GREEN TX GRP.
UPDATED 01-DEC-2009. ON 30-NOV-2009, UPDATE INFO WAS OBTAINED. ON 24-NOV-2009, TWO GILTS WERE
REMOVED FROM THE STUDY. GILT #2367 (228LB) WAS REMOVED FROM PEN# 22 FOR LAMENESS. GILT #2040 (178
LB) WAS REMOVED FROM PEN# 18 FOR THINNESS, PALENESS, AND A SUSPECTED GASTRIC ULCER. BOTH GILTS
WERE FROM THE ORANGE TX GRP.
REVIEWER NOTE: DID NOT CODE FOR SUSPECTED ULCER
CVM _Report. rep
Causality Time
Assessment To Onset
0 6 DA
0 6 DA
0 6 DA
0 7 DA
0 7 DA
0 7 DA
Clinical Detail:
D BLD, GI
D BLOAT
G DEATH
G LAMENESS
G PALLOR
G WEIGHT LOSS
Page: 284
Source: Report from sponsor or distibutor of drug Source Report Id: US201000086
Country:
United States NDC:
State:
IOWA
Zip:
52563
Product Lot No:
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
0110112005
Recommended dose
Oral (all other)
4.5 G/TON; ORAL, 2005-2007
None
Good
Owner
Unknown
No
UNKNOWN
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
2000
40
40
PIG
Other (pig)
5.5 MO
260 LB
Unknown
ON 01106/10, AN ELANCO ANIMAL HEALTH INTERNAL SALES REPRESENTATIVE REPORTED A POTENTIAL ADVERSE
DRUG EXPERIENCE INVOLVING PAY LEAN (RACTOPAMINE HYDROCHLORIDE) IN FINISHING PIGS, IN 2005, A PORK
PRODUCER BEGAN FEEDING HIS PIGS PAY LEAN AT 4.5 G/TON DURING THE LAST 1 TO 3 WEEKS OF FINISHING. THE
PRODUCER REPORTED THAT THE PIGS THAT WERE FINISHED ON PAY LEAN WOULD BE "SO STRESSED" WHILE
BEING MOVED OR SORTED THAT THE PIGS WOULD LIE DOWN AND DIE. THE EVENT SEEMED TO OCCUR IN THE
LEANER PIGS WOULD DEVELOP BLOTCHY WHITISH/REDDISH SPOTS OVER THEIR BODIES. THE PRODUCER FED
PAY LEAN TO HIS FINISHING PIGS INTERMITTENTLY FROM 2005 TO 2007 AND REPORTED THE SAME EXPERIENCES
EACH TIME HE FED PAY LEAN. THE PRODUCER ESTIMATED HE LOST APPROXIMATELY 40 PIGS OVER THE 2 YEAR
PERIOD. IN 2007, THE PRODUCER DISCONTINUED PAY LEAN IN HIS FINISHING RATION. INFORMATION ON PRE-
EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO FURTHER
CVM _Report. rep
CMP:UNK
Causality
Assessment
0
0
0
0
Drug Name:
Time
To Onset
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G DEATH
G DISTRESS
G RECUMBENCY
I CONGESTION, SKIN
Page: 285
Source:
Country:
United States
State:
UNKNOWN
Zip:
XX :XXX
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Evaluation Comments;
10/01 /2009
Missing information
Oral (all other)
UNK DOSAGE - ORAL, 10/2009
Missing information
Good
Owner
Unknown
No
Source Report ld:
US20 1000245
NDC:
Product Lot No:
UNKNOWN
#Treated:
#Reacted: 0
#Died:
0
Species: CATTLE
Breed: Charolais
Age: UN
Weight:
UN
ON 01115110, AN ELAN CO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL LACK OF EFFECTIVENESS
INVOLVING PAY LEAN (RACTOPAMINE HYDROCHLORIDE) IN A STEER. IN 10/09, A SHOW STEER OWNER FED A
STEER PAY LEAN AT 562.5 MGIHDIDA Y FOR 5 DAY AND SAW NO EFFECT ON THE STEER. INFORMATION ON PRE-
EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO FURTHER
CMP:UNK
Causality
Assessment
0
Time
To Onset
NA
CVM _Report. rep
Clinical Detail:
Source:
Country:
United States
State:
MINNESOTA
Zip:
55903
Episode Date:
01/0112009
Dose Description: SEE NARRATIVE; 2009*
Extra Label:
Species subgroup
Reason For Use:
Health Status:
Good
Administered By:
Owner
Concomitants: No
Source Report Id:
US20 1000330
NDC:
Product Lot No:
UNKNOWN
#Treated:
#Reacted:
#Died:
Species: PIG
Breed: Other (pig)
Age:
Weight:
Gender: Male
Page: 286
0
UN
UN
ON 01-20-10, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADE INVOLVING PAYLEAN IN
PIGS. ON AN UNK DATE (DATE PROVIDED IS AN ESTIMATE), A GROUP OF BOAR PIGS WERE ACCIDENTALLY FED A
RATION THAT CONTAINED PA YLEAN AT EITHER 4.5 G/TON OR 6.5 G/TON. THE PIG OWNER REPORTED THAT THE
SPERM COUNT OF THE STUDS WAS DECREASED DURING THE TIME THE PIGS WERE CONSUMING THERA TION.
THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND INFO ON CONCOMITANT PRODUCTS WAS
REQUESTED, NOT PROVIDED.
REVIEWER'S NOTE: THIS IS NOT MARKETED FOR USE IN REPRODUCING STOCK BUT ONLY FINISHING SWINE
Causality
Assessment
Time
0 1 DA X FERTILITY, REDUCED
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Episode Date:
0110112009
Dosage: Missing information
CVM_Report.rep
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
US201000569
UNKNOWN
#Treated:
#Reacted:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Oral (all other)
ORAL, 2009*
#Died:
Species:
Missing information Breed:
UNKNOWN
Age:
Weight:
Unknown
Gender:
Owner
Unknown
Concomitants: No
Page: 287
0
PIG
Unknown (pig)
Unknown
UN
UN
ON 02/03110, ELANCO ANIMAL HEALTH WAS MADE AWARE OF AN ARTICLE WHICH REPORTED POTENTIAL
ADVERSE DRUG EXPERIENCES INVOLVING RACTOP AMINE HYDROCHLORIDE IN PIGS AND CATTLE AND
RECOMBINANT BOVINE SOMATOTROPIN IN CATTLE. THE ARTICLE REPORTED RACTOPAMINE HYDROCHLORIDE
WAS RESPONSIBLE FOR HYPERACTIVITY, MUSCLE BREAKDOWN AND 10 PERCENT MORTALITY IN PIGS. THE
ARTICLE WENT ON TO REPORT THAT RACTOPAMINE WAS ASSOCIATED WITH DOWNER ANIMALS, "TYING UP",
STRESS, SHAKING, VOMITING, DIFFICULT HANDLING AND DIFFICULT MOVING IN PIGS AND KNOWN TO CAUSE
HOOF PROBLEMS IN HOLSTEIN CATTLE. THE ARTICLE ALSO REPORTED GREATER LIVESTOCK DEATHS WERE
ASSOCIATED WITH THE USE OF RECOMBINANT BOVINE SOMATOTROPIN. (DATES AND ANIMAL NUMBERS WERE
NOT PROVIDED; DATES AND NUMBERS PROVIDED ARE ESTIMATES.) INFORMATION ON PRE-EXISTING MEDICAL
CONDITIONS AND CONCOMITANT PRODUCTS WAS NOT PROVIDED. NO FURTHER INFORMATION IS EXPECTED.
CMP:UNK
Causality
Assessment
0
0
0
0
0
0
0
0
0
Drug Name:
Time
To Onset
UN
UN
UN
UN
UN
UN
UN
UN
UN
RACTOP AMINE
Clinical Detail:
D VOMITING
G DEATH
G DIFFICULTY RISING
G RECUMBENCY
G RELUCTANT TO MOVE
G SHAKING
M MYOSITIS
N HYPERACTIVITY
N TREMBLING
Source:
Country:
State:
CVM _Report. rep
United States
UNKNOWN
Zip:
xxxxx
Source Report ld:
NDC:
Product Lot No:
US20 1 000621
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
01130/2010
Recommended dose
Oral (all other)
4.5 G/TON; PO- 1130110-215110
None
Good
Owner
Unknown
No
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
Page: 288
2400
70
70
PIG
Unknown (pig)
UN
260 LB
Group (m & f)
ON 2/8/2010, AN ELAN CO ANIMAL HEALTH SALES REPRESENTATIVE REPORTED A POTENTIAL ADVERSE DRUG
EXPERIENCE INVOLVING PA YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON 113012010, A PORK PRODUCER
BEGAN FEEDING A HOUSE OF FINISHING PIGS A NEW BATH OF FEED THAT CONTAINED P A YLEAN AT 4.5 G/TON. AS
OF 5/2/2010, THE PIGS' FEED INTAKE WAS BELOW THE EXPECTED LEVEL AND 70 PIGS HAD DIED. THE RATION WAS
REPLACED WITH A MEDICATION-FREE RATION. THE ATTENDING VET SUBMITTED UNK TISSUE SAMPLES TO
lOW A STATE UNIVERSITY AND PORCINE REPRODUCTIVE AND RESP SYNDROME (PRRS) VIRUS WAS DISCOVERED.
SINCE 2/5/2010, THE PIGS' MORTALITY RATE HAS DECREASED TO 0 AND FEED CONSUMPTION RETURNED TO
NORMAL. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND NO CONCOMITANT PRODUCTS.
UPDATED 2/1 5/2010: ON 2/15/2010, THE BLANCO ANIMAL HEALTH SALES REPRESENTATIVE PROVIDED UPDATE INFO
AND REPORTED THAT THE ATTENDING VET WAS ALSO HAVING THE TISSUE SAMPLES EVALUATED FOR SWINE
INFLUENZA VIRUS (SIV) AND THAT HE FELT THE PRRS AND SIV WERE MORE LIKELY TO BE CAUSING THE SIGNS
SEEN THAN PA YLEAN.
CMP:UNK.
Causality
Assessment
0
Time
To Onset
5 DA
Clinical Detail:
G DEATH
Source:
Country:
State:
United States
INDIANA
Zip:
XX XXX
Episode Date:
0110112009
Dosage: Missing information
CVM _ Rep01t.rep
Source Report ld:
US20 1000941
NDC:
Product Lot No:
UNK
#Treated:
#Reacted:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Oral (all other)
ORAL- 2009*
None
#Died:
Species:
Breed:
Age:
Weight:
Unknown
Gender:
Owner
Unknown
No
Page: 289
0
PIG
Unknown (pig)
Unknown
UN
UN
ON 3/1/2010, AN ELANCO ANIMAL HEALTH REP REPORTED A POTENTIAL ADVERSE DRUG EXPERIENCE INVOLVING
P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. A VET ASKED IF TOPMAX (RACTOP AMINE
HYDROCHLORIDE), AN ELANCO PRODUCT, CAUSED INCREASED AGGRESSION. THE VET STATED THAT HE HEARD
P A YLEAN CAUSED INCREASE AGGRESSION IN HOGS. THE VET PROVIDED NO DETAILS INCLUDING WHEN THE
EVENT OCCURRED, THE NUMBER OF ANIMALS AFFECTED (NUMBER PROVIDED IS AN ESTIMATE) OR THE
AMOUNT OF PA YLEAN FED. INFO ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS
NOT PROVIDED. NO FURTHER INFO IS EXPECTED.
CMP:UNK.
Causality
Assessment
-8
Time
To Onset
NA
Clinical Detail:
N AGGRESSION
Source:
Country:
State:
United States
MISSING INFORMA' Zip: X XXX X
Episode Date:
03116/2010
Dose Description: 4.5 OlTON; PO; 3/2010
Extra Label:
None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
CVM _Report. rep
US20 1 001999
UNKNOWN
#Treated:
100000
#Reacted: 240
#Died:
240
Species: PIG
Age: VA
Weight:
VA
Concomitants: No
Page: 290
ON 4/16/10, AN ELANCO ANIMAL HEALTH TECHNICAL CONSULTANT REPORTED A POTENTIAL ADE INVOLVING
P A YLEAN (RACTOPAMINE HYDROCHOLORIDE) IN PIGS. IN 3/2010, TRIOAKJFOODS BEGAN FEEDING THEIR
FINISHING PIGS A RATION THAT CONTAINED PAYLEAN AT 4.5 G/TON. FROM APPROX 3/16/10 TO 4/16110, TRIOAK
FOODS REPORTED DOUBLE THE NUMBER OF DEAD PIGS ON ARRIVAL AT THE PROCESSING FACILITY. EXACT
NUMBERS WERE NOT PROVIDED BUT TRIOAK FOODS PROCESSED APPOROX 100,000 PIGS DURING THE 30 DAY
PERIOD AND EXPECTED 0.12% OF THE PIGS TO HAVE DIED DURING TRANSPORT TO THE PROCESSING FACILITY.
INFO ON PRE-EXISTING MEDICAL CONDITIONS AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT
PROVIDED. NO FURTHER INFO IS EXPECTED.
CMP: UNKNOWN
Causality
Assessment
Time
0 UN G DEATH
Source:
Country:
United States
State:
IOWA
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
04/27/2010
Not applicable
Product defect
Not applicable
Not applicable
Not applicable
Not applicable
No
Zip:
50126
Source Report ld:
US201002276
NDC:
Product Lot No:
A683857
#Treated:
0
#Reacted: 0
#Died:
0
Age: NA
Weight: NA
ON 4/27/10, AN ELANCO ANIMAL HEALTH CUSTOMER SERVICE REP REPORTED A PRODUCT DEFECT INVOLVING
PA YLEAN (RACTOPAMINE HYDROCHOLORIDE) PACKAGING. ON 4/27/10, A PURCHASING AGENT FOR IVESCO
DISCOVERED A BAG OF PA YLEAN, FROM LOT NUMBER A683857, WITH SEAMS OF THE BAG COMING APART. THE
BAG HAD BEEN SHIPPED ON 4/5/10. NO FURTHER INFO IS EXPECTED.
ON 5/3/10 UPDATED INFO WAS PROVIDED BY ELAN CO US COMPLAINT MANAGEMENT QA: COMPLAINT INFO IS
A VAIL IN TRACKWISE RECORD TR#1275533. NO FURTHER INFO IS EXPECTED.
CVM _ Repott.rep
Causality
Assessment
0
Time
To Onset
NA
Clinical Detail:
P PD-CONT AINER(S), DAMAG
Page: 291
Source:
Country:
State:
United States
NEBRASKA
Zip:
xxxxx
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
03/ 16/2010
Missing infom1ation
Oral (all other)
UNK DOSE; 311 6/2010*- 4/27/2010
Missing information
Unknown
Owner
High
No
Source Report Id:
US20 1002266
NDC:
Product Lot No:
UNKNOWN
#Treated:
8
#Reacted: 8
#Died:
0
Species: HORSE
Breed: Thoroughbred
Age: VA
Weight:
UN
ON APRIL 27,2010, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADE INVOLVING
P A YLEAN (RACTOPAMINE HYDROCHLORIDE) IN THOROUGHBRED HORSES. ON APPROXIMATELY MAR 16, 2010, A
HORSE TRAINER BEGAN FEEDING PA YLEAN TO 8 MATURE HORSES REPORTEDLY TO INCREASE WEIGHT GAIN.
THE EXACT AMOUNT OF PA YLEAN FED WAS NOT KNOWN, HOWEVER, AN ATTENDING VET DESCRIBED THE
AMOUNT FED AS "A HANDFUL" OF PA YLEAN 9 (9 G/LB) FED ONCE DAILY TO EACH HORSE. AT AN UNK TIME AFTER
STARTING THE PAYLEAN, THE HORSES EXHIBITED SIGNS OF AGITATION AND HYPERACTIVITY, CHEWING ON
WOOD AND AN INCREASED RESTING HEART RATE. THE OWNER REMOVED THE HORSES FROM THE TRAINER'S
FACILITY AND DISCONTINUED THE PA YLEAN. THERE WERE NO PRE-EXISTING MEDICAL CONDITIONS AND INFO
ON CONCOMITANT PRODUCTS WAS NOT KNOWN.
CMP: UNKNOWN
Causality Time
0 UN c TACHYCARDIA
0 UN N NERVOUSNESS
CVM _Report. rep
Page: 292
Source:
Country:
State:
United States
INDIANA
Zip:
46140
Report Quality: Missing Infom1ation
Episode Date:
0511 9/2010
Dosage: Unknown
Source Report Id:
NDC:
Product Lot No:
Dose Description: 5 MG/KG X 2 WKS, THEN 10 MG/KG X 2 WKS
Extra Label:
Unknown
Reason For Use:
RESEARCH STUDY
Health Status:
Unknown
Administered By:
Unknown
Concomitants: No
US201002985
UNK
#Treated:
64
#Reacted: 64
#Died:
0
Species: PIG
Age: UN
Weight:
UN
ON 511 8110 ELANCO ANIMAL HEALTH REPORTED A POTENTIAL ADE IN A RESEARCH STUDY (LITERATURE REPORT)
INVOLVING P A YLEAN IN PIGS.
J ANIM SCI. 2010 MAR; 88 (3): 1184-94. EPUB 2009 NOV 20.
BEHAVIOR AND PERIPHERAL AMINE CONCENTRATIONS IN RELATION TO RACTOP AMINE FEEDING, SEX, AND
SOCIAL RANK OF FINISHING PIGS.
POLETTO R, MEISEL RL, RICHERT BT, CHENG HW, MARCHANT-FORDE JN.
USDA-ARS, LIVESTOCKBEHAVIORRESEARCHUNIT, WEST LAFAYETTE, IN 47907, USA.
ABSTRACT
AGGRESSION CAN IMPAIR PRODUCTIVITY AND WELL-BEING. THE ASSOCIATION BETWEEN AGGRESSION IN
FINISHING PIGS AND THE FEED ADDITIVE RACTOPAMINE (RAC), A BETA-ADRENORECEPTOR AGONIST, IS UNK
AND WARRANTS FURTHER INVESTIGATION. OUR GOAL WAS TO EXAMINE BEHAVIORAL ACTIVITY, INCLUDING
AGGRESSION, IN THE HOME PEN AND CONCENTRATIONS OF PERIPHERAL AMINES IN BARROWS AND GILTS,
TAKING INTO ACCOUNT DIET (RAC) AND SOCIAL RANK. SIXTY-FOUR FINISHING PIGS, HOUSED IN PENS OF 4 BY
SEX, WERE FED EITHER A CONTROL (CTL) OR RAC-ADDED (5 MG/KG FOR 2 WK PLUS 10 MG/KG FOR ANOTHER 2
WK) DIET. THE TOP DOMINANT AND BOTTOM SUBORDINATE PIGS IN EACH PEN WERE DETERMINED AT MIXING (2
WK PRETRIAL). THE BEHAVIOR OF ALL PIGS WAS RECORDED CONTINUOUSLY DURING THE PRETRIAL WEEK
(BASELINE) AND FOR THE FOLLOWING 4 WK. THESE BEHAVIORAL DATA WERE USED TO EVALUATE HOME PEN
AGGRESSION, INCLUDING THE NUMBER OF AGONISTIC INTERACTIONS (AINX) AND CONSTITUENT AGGRESSIVE
ACTIONS, DURING A 3-H PERIOD (0800 TO 1100 H) ONCE PER WEEK AND THEIR CHANGE IN RELATION TO THE
BASELINE. TIME-BUDGET BEHAVIORS AND POSTURES WERE ANALYZED OVER EIGHT 24-H PERIODS (2 D/WK)
USING 10-MIN INSTANTANEOUS SCAN SAMPLING THAT FOCUSED ON ONLY THE DOMINANT AND SUBORDINATE
PIGS IN EACH PEN. THESE 2 PIGS WERE ALSO SUBJECTED TO BLOOD COLLECTION ONCE PER WEEK DURING THE
TRIAL TO DETERMINE CONCENTRATIONS OF DOPAMINE, NOREPINEPHRINE, EPINEPHRINE, AND SEROTONIN (5-
CVM _ Report.rep
Page: 293
HT) USING HPLC. GILTS PERFORMED MORE BITES AND TOTAL ACTIONS PER AINX THAN BARROWS, AND RAC-FED
GILTS INCREASED BITES AND PURSUITS, WHEREAS THESE BEHAVIORS DECREASED COMPARED WITH BASELINE
VALUES IN ALL OTHER SUBGROUPS (P < 0.05) . GILTS FED RAC INCREASED THE TOTAL NUMBER ACTIONS PER
AINX, WHEREAS THE OCCURRENCE OF AINX DECREASED FOR ALL SUBGROUPS (P < 0.01). OVERALL, RAC-FED
PIGS WERE MORE BEHAVIORALLY ACTIVE, SPENDING MORE TIME ALERT, BAR BITING, AND SHAM CHEWING
COMPARED WITH CTL PIGS (P < 0.05). THE DOMINANT RAC-FED PIGS TENDED TO HAVE THE GREATEST
NOREPINEPHRINE CONCENTRATIONS AMONG THE TESTED SUBGROUPS (P = 0.08). DOMINANT BARROWS HAD
GREATER EPINEPHRINE CONCENTRATIONS THAN SUBORDINATE BARROWS (P < 0.05). THE RAC-FED GILTS
TENDED TO HAVE LESSER 5-HT CONCENTRATIONS THAN CTL GILTS (P = 0.08), WHEREAS CONCENTRATIONS
WERE SIMILAR IN BARROWS (P > 0.1 0). GREATER ACTIVITY AND THE INCREASE IN ORAL-RELATED BEHAVIORS
OBSERVED IN RAC-FED PIGS MAY BE MEDIATED BY THE INCREASE IN AROUSAL CAUSED BY RAC. INTENSIFIED
AGGRESSION IN GILTS, ESPECIALLY WHEN FED RAC, MAY BE LINKED TO REDUCED CENTRAL 5-HT AND
GREATER NORADRENERGIC ACTIVITY, AND FURTHER RESEARCH ON BRAIN NEUROTRANSMITTERS IN GILTS IS
NEEDED.
THIS IS NOT AN ELANCO STUDY.
NO FURTHER INFO WAS PROVIDED.
FlU: (506) 6/22/ 10 IN 2009 32 CONTROL/32 RACTOPAMINE FED PIGS FOR 14 DAYS. FINDING: PIGS FED
RACTOP AMINE EXHIBITED MORE AGGRESSION AND DEVELOPED HOOF LESIONS.
CMP:UNK
Causality
Assessment
0
0
Time
To Onset
UN
UN
Clinical Detail:
G HOOF DISORDER
N AGGRESSION
Source:
Country:
United States
State:
IOWA
Zip:
50682
Episode Date:
05/06/2010
Dosage:
Missing infonnation
Dose Description: MISSING DOSAGE; 4/30/2010-2010
Extra Label:
Species subgroup
Reason For Use:
Health Status:
Unknown
Administered By:
Owner
Vet Opinion: Low
Concomitants: No
CVM _Report. rep
Source Report ld:
US201002648
NDC:
Product Lot No:
UNKNOWN
#Treated:
5
#Reacted: 5
#Died:
0
Species: PIG
Age: UN
Weight:
UN
Gender: Female, pregnant
Page: 294
ON MAY 10,2010, ELANCO ANIMAL HEALTH WAS CONTACTED REGARDING A POTENTIAL ADE INVOLVING
PAYLEAN (RACTOPAMINE HYDROCHLORIDE) IN PREGNANT SOWS. ON APPROXIMATELY APRIL 30, 2010, AN UNK
NUMBER OF SOWS WERE MISTAKENLY FED A RATION THAT CONTAINED P A YLEAN AT AN UNK LEVEL
(SUSPECTED TO BE 4.5 G/TON). IT WAS NOT KNOWN IF THERA TION WAS REMOVED OR COMPLETELY CONSUMED.
ON MAY 06, 2010, 5 OF THE SOWS DELIVERED STILLBORN OFFSPRING. THE ATTENDING VET REPORTED THAT THE
PIGS WERE BEING TESTED FOR PORCINE REPRODUCTIVE AND RESP SYNDROME (PRRS). THERE WERE NO PRE-
EXISTING CONDITIONS AND NO CON CO MIT ANT PRODUCTS.
CMP: UNKNOWN
Causality
Assessment
Time
0 6 DA X DEATH(STILLBORN)
Source:
Country:
State:
United States
IOWA
Zip:
50112
Episode Date:
0211 8/2008
Dose Description: 4.5 G/TON; ORAL 2118/08*
Extra Label: None
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Good
Administered By:
Owner
Concomitants: No
US200802155
REQ; NOT PROVIDED
#Treated:
2400
#Reacted: 231
#Died:
31
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 265 LB
ON MARCH 7, 2008, MS. ABBY ANDERSON, ELANCO ANIMAL HEALTH SALES REPRESENTATIVE, REPORTED A
APPROXIMATELY FEBRUARY 18, 2008, SYNERGY, PORK PRODUCERS, BEGAN SEEING AN INCREASED NUMBER OF
DOWNER AND DEAD PIGS IN 2 OF THEIR FINISHING BARNS. SINCE THAT TIME, SYNERGY RECORDED A 5%
INCREASED IN DOWNER PIGS AND A 1.3% INCREASE IN DEAD PIGS, APPROXIMATELY 120 AND 31 PIGS IN THE
HOUSES, RESPECTIVELY. ON MARCH 7, 2008, DURING A VISIT TO THE 2 FINISHING HOUSES, MS. ANDERSON NOTED
THAT AN ADDITIONAL APPROXIMATELY 80 PIGS (BOTH HOUSES COMBINED) HAD CRACKED FOOT PADS AND
MISSING OR TORN TOENAILS. SYNERGY FELT THE PROBLEMS SEEN WERE DUE TO A NUTRITIONAL DEFICIT AND
PLANNED TO ADD ZINC TO THE RATIONS IN AN ATTEMPT TO CORRECT THE PROBLEMS.
CVM _Report. rep
MEDICAL HISTORY
NONE
Causality
Assessment
0
0
0
0
Drug Name:
Time
To Onset
VA
UN
UN
UN
RACTOP AMINE
Clinical Detail:
G DEATH
G HOOF DISORDER
G NAIL DISORDER
G RECUMBENCY
Page: 295
Source:
Country:
State:
United States
MISSING INFORMA' Zip:
Episode Date:
06/07/2010
Dosage: Various
Dose Description: SEE NARRATIVE; 6/7/2010
Extra Label:
Various
Source Report Id:
NDC:
Product Lot No:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Owner
Unknown
US201004219
UNK
#Treated:
10000
#Reacted: 10000
#Died:
0
Species: PIG
Age: UN
Weight:
UN
ON JUNE 17, 2010, AN ELANCO ANIMAL HEALTH SALES REP REPORTED A POTENTIAL ADVERSE DRUG EXPERIENCE
INVOLVING PAYLEAN (RACTOPAMINE HYDROCHLORIDE) IN PIGS. ON APPROXIMATELY JUNE 7, 2010, A PORK
PRODUCER BEGAN FEEDING 10,000 PIGS A PA YLEAN FINISHING RATION (LEVEL LESS THAN 4.5 G/TON) AND
SLOWLY INCREASED THE P A YLEAN LEVEL TO 9 GITON. WHILE FEEDING THE P A YLEAN RATION, THE PRODUCER
REPORTED THAT THE PIGS WERE MORE EXCITABLE AND VOCAL. INFO ON PRE-EXISTING MEDICAL CONDITIONS
AND CONCOMITANT PRODUCTS WAS REQUESTED, NOT PROVIDED. NO FURTHER INFO IS EXPECTED.
CMP: UNK
Causality
Assessment"
CVM _Report. rep
Time
0 UN
0 UN
CVM _Report. rep
G VOCALIZATION
N HYPERACTIVITY
Page: 296
ADEREVIEWS
Report Source:
Country:
State:
ZIP:
ADE EPISODES
Dosage:
Administered By:
Extra Label:
Species:
Breed:
Gender:
Drug:
Source Report ID:
NDC:
Product Lot#:
Report Quality:
Age:
Weight:
Episode Date:
From To
Corr Date:
From To
Unit
ADE CONCOMITANTS
Status:
ADE ASSESSMENTS
Clinical Detail
Route:
Description:
6
Page: 1
Drug Name: RACTOPAMINE, TYLOSIN
Source:
Country:
United States
State:
ILLINOIS
Zip:
61254
LITTLE INFO
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
12/05/2002
Unknown
Oral (in dry feed)
SUSPECTED EXPOSURE/UNK AMT
Unknown
ACCIDENTAL
Unknown
Not applicable
Unknown
Source Report Id:
PAYUS02143
NDC:
Product Lot No:
UNK
#Treated:
20
#Reacted: 10
#Died:
0
Species: PIG
Age: 5 MO
Weight: 250 LB
UNK #TREATED OR REACTED. SUSPECTED INADVERTANT EXPOSURE. ON ARRIVAL AT PROCESSING PLANT "PIGS
ACTED AS IF THEY WERE ON RACTOPAMINE". FARM HAS COLLECTED FEED FROM FINISHING RATIONS FOR
TESTING.
Causality
Assessment
-8
Time
To Onset
NA
Clinical Detail:
G UNKNOWN
Source:
Country:
State:
United States
SOUTH DAKOTA
Zip:
xxxxx
OWNER REPORT
Episode Date:
02/ 14/2003
Package ID: A 1
Source Report Id:
NDC:
Product Lot No:
Dose Description: 4.5 GM/TON X 4 WEEKS; 2112/03 TO 3112/03
CVM _Report. rep
PAYUS03022
UNK
#Treated:
#Reacted:
#Died:
Species: PIG
2000
2000
0
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Unknown
Good
Owner
No Value
Breed:
Age:
Weight:
Gender:
Page: 2
Mixed (pig)
Unknown
UN
UN
BREED: SEGHERS-NEWSHAM. CM: EVIDENCE OF TAIL BITING BY ALL PIGS W/IN 2 DAYS OF STARTING
RACTPAMINE. NEW GENETIC STRAIN. FARM HAS FED RACTOPAMINE TO OTHERS W/0 SEEING TAIL BITING. ALSO
REPORTS THAT PIGS SQUEALED AS IF IN PAIN WHEN LEAVING THEIR PENS AT LOADING. NO DOWNERS OR
DEADS REPORTED.
Causality
Assessment
Time
To Onset
2 DA
4 WK
2 DA
4 WK
Clinical Detail:
G BITING/CHEWING
G PAIN
G TAIL DISORDER
G VOCALIZATION
Source:
Country:
State:
United States
KANSAS
Zip:
67871
VET REPORT
Episode Date:
04/22/2003
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: RACTOPAMINE 9GM/TON; TYLOSIN 100 G/TON; 4/21103
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
CVM_Report.rep
Species
ACCIDENTAL EXPOSURE
Good
Not applicable
Low
Unknown
PAYUS03026
UNK
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Gender:
0
DOG
9 YR
50 LB
Female, neutered
Page: 3
DOG ATE UNKNOWN AMOUNT OF SUPPLEMENT INTENDED FOR PIGS. CM: LETHARGIC AND BLOATED. RTX:
SURFACTANT, OBSERVED AT VET CLINIC THAT DAY. RELEASED THAT EVENING FULLY RECOVERED. CF:
SUPPLEMENT WAS OLD AND MOLDY. SIGNS POSSIBLY DUE TO MOLDY FEED.
Causality
Assessment
0
-9
0
0
Time
To Onset
12 HR
NA
12 HR
12 HR
Clinical Detail:
D BLOAT
G DISTENTION, ABDOMEN
Source:
Country:
State:
United States
ILLINOIS
Zip:
60934
NO ANIMAL NUMBERS
Episode Date:
05/14/2003
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 GM/TON RACT, 40 G/TON TYLOSIN X 3 WEEKS
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
Species subgroup
INC ADG, CARCASS LEANESS, PPE CONTROL
Good
Owner
No
PAYUS03031
UNK
#Treated:
100
#Reacted: 100
#Died:
0
Species: PIG
Breed: Other (pig)
Age: 3 MO
Weight: 260 LB
BREED: AUSGENE. CM: FINISHING PIGS ARE "OUCHY AND TENDERFOOTED"; PIGS GO DOWN IN THEIR LEGS. UNK
PERIOD OF TIME, UNK #ANIMALS. ELU: 260 LBS.
Causality
Assessment
Time
UN G HOOF DISORDER
UN G LAMENESS
UN G LOCOMOTION DISORDER
CVM _Report. rep
Page: 4
Country:
United States
State:
MINNESOTA
Zip:
OWNER
Episode Date:
11126/2004
56082
Package ID: A 1
Source Report ld:
NDC:
Product Lot No:
Dose Description: 4.5 GM/TON X 2 WEEKS, THEN 9 GMITON
Extra Label:
Species subgroup
Reason For Use:
Health Status:
Good
Administered By:
Owner
Vet Opinion: Low
Concomitants:
Corrsp Date:
12115/2004
US2004063 83
UNK
#Treated:
3000
#Reacted: 42
#Died:
25
Species: PIG
Breed: Other (pig)
Age: UN
Weight: 240 LB
BREED: PIC. FED 4.5 GM/TON FROM 1111-14/04 THEN INCREASED TO 9 GM/TON. SHIPPED A LOAD OF 146 PIGS ON
11126/04 THAT HAD 13 DEADS AND 4 SLOWS. THERE WAS NO OVERHEATING(NOVEMBER IN MN) AND THE PIGS
HAD BEEN SQUEALING AND APPEARED STRESSED. ANOTHER LOAD THAT SHIPPED 12/ 1104 HAD 9 DEADS AND 10
SLOWS. CF: THIS LOAD HAD AN AVG WEIGHT OF 275 LBS(LABEL INDICATION IS TO FEED TO PIGS FROM 150-240
LBS). 2 LOADS SHIPPED PRIOR TO 11126/04 W/0 PROBLEMS. ON 12/9/04 A LOAD OF 161 PIGS SHIPPED, A VG WEIGHT
248 LBS HAD 3 DEADS, 3 SLOWS. THIS GROUP HAD RESP DISEASE DURING THE FEEDING PERIOD. RECOMMENDED
FEEDING 4.5 GM/TON FOR 3 WEEKS THE 9 GM/TON FOR 2 WEEKS.
Causality
Assessment
2
2
2
2
Time
To Onset
4 WK
4 WK
4 WK
4 WK
Clinical Detail:
G DEATH
G RECUMBENCY
G STIFFNESS
G VOCALIZATION
Source:
Country:
United States
State:
CALIFORNIA
NO DOSAGE
CVM _ Repmt.rep
Zip:
93401
Source Report Id:
US200501971
NDC:
Product Lot No:
UNK
Episode Date:
Dosage:
Route:
Dose Description:
Extra Label:
Reason For Use:
Health Status:
Administered By:
Vet Opinion:
Concomitants:
07/0112005
Unknown
Oral (in dry feed)
711 /05 APPROX
None
#Treated:
#Reacted:
#Died:
Species:
Breed:
Age:
Weight:
Good
Gender:
Owner
Missing information
Unknown
Page: 5
2
0
PIG
Unknown (pig)
180 DA
220 LB
Female
SHOW PIG BECAME SHAKY AND HAD SHIFTING REAR LEG LAMENESS. PIG WAS IN SITTING POSITION,
RELUCTANT TO RISE AND EXERCISE BUT CONTINUED TO EAT AND WAS ALERT. FlU: 8/5/05: SUBM 10: REMOVED
RACTOP AMINE FROM THE RATION ON 7/13. GILT WAS ABLE TO WALK NORMALLY AND WAS BEING SHOWN AT
THE FAIR. DECHAL (+).
Causality
Assessment
3
3
3
CVM _ Repmt.rep
Time
To Onset
1 DA
1 DA
1 DA
Clinical Detail:
G LAMENESS
G RELUCT ANT TO MOVE
G SHAKING

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