MISC FEVER4 - Children's Motrin Causes Severe Side Effects

Motrin is a brand name for Ibuprofen (Advil, etc)

http://www.wnbc.com/health/4030295/detail.html

Lawsuit Claims Children's Motrin Causes Severe Side Effects

POSTED: 3:37 pm EST December 28, 2004

UPDATED: 5:09 pm EST December 28, 2004

LOS ANGELES -- The parents of a 7-year-old girl on Tuesday sued the makers of Children's Motrin and
several other companies that distribute the painkiller, claiming their daughter lost her eyesight and suffered
other severe side effects after taking the medication.

The lawsuit, filed on behalf of Sabrina Brierton Johnson of Los Angeles, seeks unspecified compensatory and
punitive damages against New Jersey-based health care giant Johnson & Johnson, subsidiary McNeil
Consumer & Specialty Pharmaceuticals, and several other firms, including retailers Ralphs Grocery and
Albertsons Inc.'s Sav-On pharmacies.

Johnson & Johnson is based in New Brunswick, N.J.

In their lawsuit, Kenneth and Joan Brierton Johnson accuse the defendants of negligence, breach of warranty
and of concealing from consumers and doctors potential health risks of taking the flu and pain medication,
specifically the risk of developing two disorders -- Stevens-Johnson Syndrome and Toxic Epidermal
Necrolysis -- which are typically caused by an adverse reaction to a drug or virus.

Sabrina took Children's Motrin drops on Sept. 8, 2003, after she came home from school complaining of a
fever. The girl had no known drug allergies, according to the suit filed in Los Angeles County Superior
Court.

The next morning, she woke up with a high fever and other symptoms, including a pink coloration in her eyes
and sores in her mouth. She was hospitalized, but a day later she was blind in both eyes.

Doctors later concluded Sabrina had contracted Stevens-Johnson Syndrome from taking Children's Motrin,
according to the lawsuit. Since then, Sabrina has undergone multiple eye surgeries.

"In the name of children everywhere, our family wants Children's Motrin taken off the market until it carries a
warning label about the risk of Stevens-Johnson Syndrome and describes its symptoms," the girl's mother
said in a statement.

The complaint also alleges the companies knew of a connection between the medication and the disorders
from their own clinical tests dating back to the late 1980s, and even included warnings of such risks with the
drug before it became available without a prescription.

The retailers who sold Children's Motrin and another defendant, Cardinal Health Inc., knew or had reason to
know the drug had "design flaws," the lawsuit also claims.

Bonnie Jacobs, a spokeswoman for Fort Washington, Pa.-based McNeil, which manufactures Children's
Motrin, said McNeil and Johnson & Johnson were aware of a report that a 7-year-old girl allegedly developed
Stevens-Johnson Syndrome after taking the medication.

"As the makers of Children's Motrin products, we are deeply concerned by all matters relating to our products
and we are investigating the situation," Jacobs said.

She declined to discuss the case further.

Representatives of Sav-On and pharmaceutical distributor McKesson Corp., also a defendant, declined to
comment citing company policy against discussing pending litigation.

Messages left at the offices Dublin, Ohio-based Cardinal Health and Kroger Co.'s Ralphs chain were not
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immediately returned Tuesday.

A similar lawsuit was filed against the makers of Children's Motrin in March 2003. In that federal lawsuit,
filed in San Jose, the parents of a then 9-year-old girl alleged the medication left their daughter unable to see,
speak or eat, and accused Johnson & Johnson and McNeil of failing to adequately test the drug for over-the-
counter use and to properly warn the public.
© 2004 by The Associated Press. All rights reserved. This material may not be published, broadcast,
rewritten or redistributed.

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The PubMed search
ibuprofen AND stevens AND johnson
generated 7 citations (1-7).

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&
db=PubMed&list_uids=15289784&dopt=Abstract

1: J Pediatr. 2004 Aug;145(2):273-6.

Acute vanishing bile duct syndrome after ibuprofen therapy in a child.

Taghian M, Tran TA, Bresson-Hadni S, Menget A, Felix S, Jacquemin E.

Pediatric Unit, Vesoul Hospital, Vesoul, France.

We report the case of a 10 year-old girl who had Stevens-Johnson syndrome and cholestasis after ibuprofen
therapy. Liver histology was compatible with vanishing bile duct syndrome. She received ursodeoxycholic
acid, and liver tests normalized within 7 months. This report confirms that ibuprofen may induce acute
vanishing bile duct syndrome.

PMID: 15289784 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Link&
db=PubMed&dbFrom=PubMed&from_uid=15289784
and http://www.kluweronline.com/article.asp?PIPS=362257&PDF=1

2: Dig Dis Sci. 2001 Nov;46(11):2385-8.

Stevens-Johnson Syndrome and cholestatic hepatitis.

Morelli MS, O'Brien FX.

Department of Internal Medicine, Section of General Internal Medicine, Wake Forest University School of
Medicine, Winston-Salem, North Carolina 27157, USA.

Stevens-Johnson Syndrome (SJS) is a rare but severe dermatological condition that typically occurs after the
ingestion of medications such as nonsteroidal drugs, antibiotics, and anticonvulsants. Extracutaneous
manifestations of the syndrome can occur and may involve the conjunctiva, trachea, buccal mucosa,
gastrointestinal tract, and genitourinary tract. Cholestatic liver disease, which may precede the skin
manifestations of SJS, has been reported to occur in SJS, but the medical literature has only 10 case reports
describing this phenomenon (1-9). We report the case of a 19-year-old female with SJS and cholestatic liver
disease. A discussion of the underlying pathophysiology of SJS and its treatment follows.

PMID: 11713940 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&
db=PubMed&list_uids=10583942&dopt=Abstract

3: Int J Dermatol. 1999 Nov;38(11):878-9.

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Pentoxyfylline in toxic epidermal necrolysis and Stevens-Johnson syndrome.

Sanclemente G, De la Roche CA, Escobar CE, Falabella R.

PMID: 10583942 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&
db=PubMed&list_uids=9865869&dopt=Abstract

4: Int J Dermatol. 1998 Nov;37(11):833-8.

Drugs causing fixed eruptions: a study of 450 cases.

Mahboob A, Haroon TS.

Department of Dermatology, King Edward Medical College/Mayo Hospital, Lahore, Pakistan.

BACKGROUND: Drug eruptions are among the most common cutaneous disorders encountered by the
dermatologist. Some drug eruptions, although trivial, may cause cosmetic embarrassment and fixed drug
eruption (FDE) is one of them. The diagnostic hallmark is its recurrence at previously affected sites.
OBJECTIVE: We evaluated 450 FDE patients to determine the causative drugs.
RESULTS: The ratio of men to women was 1:1.1. The main presentation of FDE was circular
hyperpigmented lesion. Less commonly FDE presented as: nonpigmenting erythema, urticaria, dermatitis,
periorbital or generalized hypermelanosis. Occasionally FDE mimicked lichen planus, erythema multiforme,
Stevens-Johnson syndrome, paronychia, cheilitis, psoriasis, housewife's dermatitis, melasma, lichen planus
actinicus, discoid lupus erythematosus, erythema annulare centrifugum, pemphigus vulgaris, chilblains,
pityriasis rosea and vulval or perianal hypermelanosis. Cotrimoxazole was the most common cause of FDE.
Other drugs incriminated were tetracycline, metamizole, phenylbutazone, paracetamol, acetylsalicylic acid,
mefenamic acid, metronidazole, tinidazole, chlormezanone, amoxycillin, ampicillin, erythromycin,
belladonna, griseofulvin, phenobarbitone, diclofenac sodium, indomethacin, ibuprofen, diflunisal, pyrantel
pamoate, clindamycin, allopurinol, orphenadrine, and albendazole.
CONCLUSIONS: Cotrimoxazole was the most common cause of FDE, whereas FDE with diclofenac
sodium, pyrantel pamoate, clindamycin, and albendazole were reported for the first time. FDE may have
multiform presentations.

PMID: 9865869 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Link&
db=PubMed&dbFrom=PubMed&from_uid=15289784

5: Gastroenterology. 1998 Sep;115(3):743-6.

Drug-associated acute-onset vanishing bile duct and Stevens-Johnson syndromes in a child.

Srivastava M, Perez-Atayde A, Jonas MM.

Combined Program in Gastroenterology, Department of Medicine, Children's

Hospital, Boston, Massachusetts, USA.

Acute vanishing bile duct syndrome is a rare but established cause of progressive cholestasis in adults, is
most often drug or toxin related, and is of unknown pathogenesis. It has not been reported previously in
children. Stevens-Johnson syndrome is a well-recognized immune complex-mediated hypersensitivity
reaction that affects all age groups, is drug or infection induced, and has classic systemic, mucosal, and
dermatologic manifestations. A previously healthy child who developed acute, severe, rapidly progressive
vanishing bile duct syndrome shortly after Stevens-Johnson syndrome is described; this was temporally
associated with ibuprofen use. Despite therapy with ursodeoxycholic acid, prednisone, and then tacrolimus,
her cholestatic disease was unrelenting, with cirrhosis shown by biopsy 6 months after presentation. This case
documents acute drug-related vanishing bile duct syndrome in the pediatric age group and suggests shared
 4
immune mechanisms in the pathogenesis of both Stevens-Johnson syndrome and vanishing bile duct
syndrome.

PMID: 9721172 [PubMed - indexed for MEDLINE]

http://jama.ama-assn.org/cgi/content/abstract/252/11/1433

6: J Am Acad Dermatol. 1985 May;12(5 Pt 1):866-76.

Cutaneous reactions to nonsteroidal anti-inflammatory drugs. A review.

Bigby M, Stern R.

The nonsteroidal anti-inflammatory drugs are one of the most commonly prescribed classes of drugs used in
medical practice. This review discusses the diverse cutaneous reactions associated with nonsteroidal anti-
inflammatory drugs. Adverse cutaneous reactions occur most frequently with benoxaprofen, piroxicam,
sulindac, meclofenamate sodium, zomepirac sodium, and phenylbutazone. The most serious adverse
cutaneous reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, appear to be most often
associated with sulindac and phenylbutazone. Tolmetin and zomepirac sodium, two structurally similar
pyrrole derivatives, have been associated with a disproportionate number of cases of anaphylactoid reactions.
Among the currently marketed nonsteroidal anti-inflammatory drugs, piroxicam appears to have the highest
rate of phototoxic reactions. This phototoxic eruption is most often vesiculobullous.

PMID: 3159761 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Link&
db=PubMed&dbFrom=PubMed&from_uid=12139898

7: N Y State J Med. 1978 Jul;78(8):1239-43.

Stevens-Johnson syndrome plus toxic hepatitis due to ibuprofen.

Sternlieb P, Robinson RM.

PMID: 276660 [PubMed - indexed for MEDLINE]

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http://www.stevensjohnsonsyndrome.com/children's_motrin_advil.htm
GO TO WEBPAGE for links to these articles

Children's Motrin and Advil

Children's Motrin / Advil Related Information

Parents of stricken girl sue makers of Children's Motrin

SARATOGA PAIR CLAIM MEDICINE LEFT 9-YEAR-OLD UNABLE TO SEE, SPEAK, EAT
By Linda Goldston Mercury News
The parents of a 9-year-old Saratoga girl have sued the makers of Children's Motrin,
claiming the flu and pain medication caused the extreme allergic reaction that left their daughter, Kaitlyn
Langstaff, unable to see, speak or eat.

The lawsuit filed in U.S. District Court in San Jose also alleges that the manufacturer of the drug failed to
adequately test it for over-the-counter use with children and failed to warn the public of potentially fatal
reactions to Children's Motrin.

Children's Motrin (Ibuprofen) Oral Suspension, Junior Strength Motrin Chewable Tablet, Junior Strength
Motrin Tablets & Drops, Company: McNeil Consumer Products Company
Application No.: 20-516/S4, 20-601/S2, 20-602/S3 & 20-603/S2, U.S. Food and Drug Administration,
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Center for Drug Evaluation and Research, Approval Date: August 13, 1999
Stevens-Johnson syndrome treatments and Related Information

Stevens-Johnson syndrome plus toxic hepatitis due to ibuprofen, PubMed, National Library of Medicine,
New York State Journal of Medicine July;78(8):1239-43, Sternlieb P, Robinson RM. Nassau Hospital,
Mineola, New York

Acute and Chronic Respiratory Complications of Toxic Epidermal Necrolysis., PubMed, National Library of
Medicine, J Burn Care Rehabilitation 1996 May-Jun;17(3):237-40, R.A. McIvor, MD; J. Zaidi, MD; W. J.
Peters, MD; R.H.Hyland, MD. Division of Respirology, University of Toronto, and the Ross Tilley Burn
Centre, Wellesley Hospital, Toronto, Ontario, Canada.

Bronchiolitis obliterans in children with Stevens-Johnson syndrome: follow-up with high resolution CT.,
PubMed, National Library of Medicine, Pediatrics Radiology 1996;26(1):22-5, M.J. Kim and K.Y. Lee.
Department of Diagnostic Radiology, Severance Hospital, 134 Seodaemoon-gu, Shinchon-dong, Seoul 120-
752, Korea.
Drug-associated acute-onset vanishing bile duct and Stevens-Johnson syndromes in a child. PubMed,
Srivastava M, Perez-Atayde A, Jonas MM. Combined Program in Gastroenterology, Department of
Medicine, Children's Hospital, Boston, Massachusetts, USA., Gastroenterology. 1998 Sep;115(3):743-
6.PMID: 9721172.

Esophageal Involvement in Stevens-Johnson Syndrome., PubMed, National Library of Medicine, Endoscopy

2001 Jun;33(6):550-3, Lamireau T, Leaute-Labreze C, Le Bail B, Taieb A., Division of Pediatric
Gastroenterology, Children 's Hospital, Bordeaux, France. thierry.lamireau@chu-bordeaux.fr. Division of
Pediatric Dermatology, Children's Hospital, Bordeaux, France, Laboratory of Pathology, Pellegrin's Hospital,
Bordeaux, France.

Stevens-Johnson Syndrome and Cholestatic Hepatitis., PubMed, National Library of Medicine, Digestive
Diseases and Sciences, Vol. 46, No. 11 (November 2001):2385-8, Michael S. Morelli, MD and Francis X.
O'Brien, MD. Department of Internal Medicine, Section of General Internal Medicine, Wake Forest
University School of Medicine, Winston-Salem, North Carolina 27157, USA.

Intravenous ulinastatin therapy for Stevens-Johnson syndrome and toxic epidermal necrolysis in pediatric
patients. Three case reports., PubMed, National Library of Medicine, Int Arch Allergy Immunol 2002
Jan;127(1):89-94, Inamo Y, Okubo T, Wada M, Fuchigami S, Hashimoto K, Fuchigami T, Takahashi S,
Sawada S, Harada K, Department of General Pediatrics, Nihon University Nerima-Hikarigaoka Hospital,
Nihon University School of Medicine, Tokyo, Japan. y-inamo@pb3.so-net.ne.jp