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PSYCHIATRIC TIMES www. psychiatrictimes.com

POINT/COUNTERPOINT
COUNTERPOINT Gun Control and the Second Amendment
by Joshua Horwitz, JD
Gun violence continues to destroy families and communities in the US on a daily basis. Dr Robertson offers the same Faustian bargain the National Rifle Association does. We are told that we must allow the massacre of innocent Americansincluding childrenwith easily obtained firearms because "it is the price we must pay for freedom." All those who have sworn the Hippocratic Oath to protect their patients should stand reso-

OCTOBER 2012

Gun Control
Continued from page 17

Dr Robertson has been in ciinicai practice since 1992 and is currentiy with Hendricks Therapy, His practice is open to patients of aii ages He.is a certified Suboxone prescriber and is aiso a consultant for several major pharmaceuticai companies. He reports no conflicts of interest concerning the subject matter of this article.

lute against this radical and morally bankrupt idea. .The insurrectionist interpretation of the Second Amendment dominates the modern pro-gun movement. This view posits that individuals should be allowed to prepare for war with their government as a counterbalance should it one day become "tyrannical." Citizens who care about our Constitution and the vast

LAMICTAL* (lamotrigine) Tablets LAMICTAL* (lamotrigine) Chewable Dispersible Tabiets LAMiCTAL* O D F " (iamotrigine) Oraily Disintegrating Tablets BRIEF SUMMARY ' Adult Population; Serious rash associated with hospitalization and discoritinuaticn ol LAMICTAL The following is a briel summary only; see fuli prescribing information for compiete product urred in 0.3% (11 of 3,348) of aduit patients who received LAMICTAL in premateting dinicai information '"sis o' epilepsy In the bipolar and ether mood disorders dinical trials, therateof seriousrashwas 0.08%(1 of 1,233)ofadultpatientswhoreceivedLAMiCTALasinitialmonotherapyand0.13%(2of , WARNING: SERIDUS SKIN RASHES 1,538) of adulf patients who received LAMICTAL as adjunetve therapy. No fatalities occurred among LAMICTAL* can cause serious rashes requiring hospitalization and discontinuation these individual. However, in woridwide postmaikeng experience,rarecases of rash-related death of treatment. The Incidence of these rashes, which have included Stevens-Johnson have been reported, but their numbers are too fewtepermit a preeise estimate of the rate. syndrome, is approximately 0.8% (8 per 1,000) in pdiatrie patients (2 to 16 years Among the rashes ieading to hospitalization were Stevens-Johnson syndrome, toxie epidermai of age) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3 per necrolysis, angioedema, and those associated with multiorgan hypersensitivity [see Warnings and 1,000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and Precautions (5.2)] other mood disorders, the rate of serious rash was 0.08% (0.8 per 1,000) in adult There is evidence that the inciusion of valproate in a niultidrug regimen increases the risk patients receiving LAMICTAL as initial monotherapy and 0.13% (1.3 per 1,000) of serious, potentially lite-threatening rash in aduits. Specilically, oi 584 patients administered in adult patients receiving LAMICTAL as adjunctive therapy, in a prospectiveiy LAMICTAL with valproate in epiiepsy elinieal trials, 6 (1%) were hospitalized in assoeiation foiiowed cohort of 1,983 pdiatrie patients (2 to 16 years of age) with epiiepsy taking with rash; in eontrast, 4 (0.16%) of 2,398 clinical trial patients and volunteers administered adjunctive LAMICTAL, there was 1 rash-related death. In worldwide postmarketing LAMiCTAL in the absence ol valproate were hospitalized. experience, rare eases of toxic epidermal necrolysis and/or rash-related death have Patients With Histen/ of Allergy or RashteOther Aniiepileptic Drugs (AEDs); The risk of been reported in aduit and pdiatrie patients, but their numbers are too few to permit nonserigus rash may be increased when the reeomniended iriitiai dose and/or the rate of dose a preeise estimate of the rate. escaiation of LAMICTAL is exceeded and in patients with a history of aliergy or rash to other AEDs. Other than age, there are as yet no faetors identified that are known to predlet the risk 5.2 Multiorgan Hypersensitivity Reactions and Organ Faiiure: Multiorgan hypersensitivity of oeeurrenee or the severity of rash eaused by LAMICTAL. Ttiere are suggestions, reactions, also known as Drug Reaction with Eosingphilia and Systemic Symptoms (DRESS), have yet to be proven, that the risk of rash may also be increased by (1) coadministration occurred with LAMiCTAL. Some have been fafai or lite threatening. DRESS typically, although of LAMICTAL with valproate (includes vaiproie acid and divaiproex sodium), not exclusively, presents with fever, rash, and/or lymphadenopalhy in association with other (2) exceeding the recommended initial dose of LAMiCTAL, or (3) exceeding the organ system invoiyement, such as hepatitis, nephritis, hmatologie abnormalities, myoearditis, recommended dose escalation for LAMiCTAL However, eases have oeeurred in the or myositis, somelinies resembling an acute viral infection. Eosinophilia is often present. This absence of these faetors. disorder is variable in its expression, and other organ systems not noted here may be involved. Nearly aii eases of iife-threatening rashes eaused by LAMICTAL have oeeurred Fataiities associated with aeute multigrgan failure and various degrees of hepatic lailure within 2 to 8 weeks of treatment initiation. However, isolated eases have oeeurred have been reported in 2 of 3,796 aduit patients and 4 of 2,435 pdiatrie patients who received after prolonged treatment (e.g., 6 months). Aeeordingly, duration of therapy eannot LAMICTAL in epilepsy elinieai trials. Rare fateiities from multiorgan failure have also been be reiied upon as means to prediet the potential risk heralded by the first appearanee reported in postmarketing use. of a rash. Isolated iiver failure without rash or involvement of other organs has aiso been reported Aithough benign rashes are also eaused by LAMICTAL, it is not possible to prediet with LAMICTAL. It is important to note that eariy manifestatigns ol hypersensitivity (e.g., lever, Iymphadenopathy) reiiabiy which rashes will prove to be serious or life threatening. Aeeordingiy, LAMICTAL should ordinariiy be diseontinued at the first sign of rash, unless the rash may be present even though a rash is not evident, if such signs or symptoms are present, the is elearly not drug reiated. Diseontinuation of treatment may not prevent a rash from patient shguid be evaiuated immediateiy LAMICTAL should be discontinued if an alternative beeomirig life threatening or permanently disabling or disfiguring [see Warnings and eticlogy lor the signs or symptgms cannot be established. . Prior to initiation of treatment with LAMICTAL, the patient should be Instructed that a Precautions (5.1)1 rash or other signs or symptoms of hypersensitivity (e.g., fever, Iymphadenopathy) may herald a serious medical event and that the patient should report any sueh oeeurrenee to 11NDICATIONS AND USAGE a physieian immediately. UMICTALis indicatedasadjunctivelherapyfcrthe foiiowing seizure partiai seizures primary generaiized tonic-clcnie seizures 5.3 Blood Dyserasias: There have been reports ol blood dyserasias that may or may not be associated with multigrgan hypersensitivity (also known as DRESS) [see Warnings and Precautions (5.2)] These have included neutropenia, leukgpenia, anemia, thrombgcytopenia, pancytgpenia, and, rarely, aplastic anemia and pure red eeii apiasia. 5.4 Suieidal Behavior and ideation: AEDs including LAMICTAL, increase the risk of in adults (s16 vears ^'^''-''^^i thgughts or behavigr in patients taking these drugs for any indicatign. Patients treated . , , . . , 1 . , . nhpnvtnin *''^ ^ ^ '"' ^"^ indicatign shguid be monitored ter the emergence or wgrsening gf pnenyrain, ijgpfgjjiQ^^ suieidal thoughts or behavior, and/gr any unusual changes in mggd gr behavior. 'M'?)

different AEDs showed that patients randgmizedteone of the AEDs had apprgximately twice the risk (adjusted Relative Risk 1.8,95% Ci;1.2,2.7) of suieidal thinking or behavior eompared te patients randomizedteplaeebo. In these trials, whieh had a median treatment duration ol 12 weeks, the estimated incidence ol suieidal behavigr or ideatign among 27,863 AED-treated patients was 1.2 Bipolar Disorder 0.43%, comparedte0.24% amgng 16,029 placebo-treated patients, representing an increase ol LAMICTAL is indkaled for the mairitenance treatment of Bipoiar I Disorder to delay the time to approximately 1 caseof suicidal thinking gr behavior for every 530 patients treated. There were" occurrence ol mgod episodes (depression, rnania, hypomania, mixed episodes) in aduits (a 18 years 4 suicides in drug-treated patients in the trials and none in piacebo-treated patients, but the ol age) treated fcr acute mcod episodes with standard therapy The effectiveness of LAMiCTAL in number gl events is too smali to ailow any conciusign abcut drug effect en suicide. the aeute treatment of mood episodes has not been established. The increased risk of suicidai thoughts or behavior with AEDs was obsen/ed as eariy as The effecliveriess ol LAMICTAL as maintenance treatment was established in 2 placebo- 1 week after starting treatment with AEDs and persisted for the duration oi treatment assessed. contrgiied trials in patients with Bipgiar i Disgrder as defined by DSM-iV [see Ciinicai Studies Beeause most trials ineiuded in the anaiysis did net extend beygnd 24 weeks, the risk of suicidal (14.2) of fuli prescribing information] The physieian whg eieets to prescribe LAMiCTAL for periods thoughts gr behavior beyond 24 weeks could not be assessed. extending beyond 16 weeks shouid perigdieaiiy re-evaiuate the iong-term usefulness of the dnig The risk gf suicidai thoughts or behavigr was generally consistent amgng drugs in the data for the individual patient. analyzed. The M i n g ol inereased risk yvith AEDs of varying mechanism of aetipn and acrgss a range gf indicaticns suggests that the risk appliesteaii /\EDs used lor any indieatign. The risk 4 CONTRAINDICATIONS did ngt vary substantiaily by age (5 tg 100 years) in the clinicai trials analyzed. LAMICTAL is eontraindicated in patents whg have demonstrated hypersensitivity to the drug or Table 1 shgws absolute and relative risk by indicatign fgr aii evaluated AEDs. its ingredients [see Boxed Warning, Wamings and Precautions (5.1,52)] Table 1. Risk by Indication for Antiepileptie Drugs in the Pooled Analysis 5 WARNINGS AND PRECAUTIONS Relative Risk; Risk Difference; 5.1 Serious Skin Rashes [see Boxed Warning]: Pdiatrie Pgpuiation; The ineidence ol Additionai Drug ineidenee of serigus rash associated with hgspitalizatign and diseontinuatior^ of LAMICTAL in a prospeetively Patients With Plaeebo Patients Drug Patients Events in Dnjg indication followed cohort of pdiatrie patients (2 te 16 years of age) with epilepsy receiving adjunetive Events Per With Events Per With Events Per Patients/Incidence therapy was approximateiy 0.8% (16 of 1,983). When 14 of these cases were reviewed by 3 1,000 Patients 1,000 Patients in Placebo Patients 1,000 Patients expert dermatologists, there was considerable disagreement as to their proper classificatign. To illustrate, gne dermatelggist considered none of the eases to be Stevens-Jghnsgn Epilepsy ' 2.4 3.4 3.5 1.0 syndrgme; angther assigned 7 gf the 14 to this diagngsis. There was 1 rash-reiated death in this Psychiatrie 5.7 1.5 2.9 8.5 1,983-patient cohort. Additionaily, there have been rare eases of texie epidermai neerolysis with Other 0.9 1.0 1.8 1.9 and without'permanent sequeiae and/gr death in US and foreign pgstmari<eting experience. 2.4 1.8 1.9 Totai 4.3 There is evidence that the ineiusion of valproate in a multidrug regimen increases the risk of serious, potentiaiiy iife-threatening rash in pdiatrie patients, in pdiatrie patients who used The relatiye risk for suicidai thoughts or behavior was higher in eiinical triais lor epilepsy valproate concomitantly, 1.2% (6 gf 482) experienced a serious rash cgmpared with 0.6% than in ciinicai trials for psychiatric or other conditions, but the absolute risk dilterences (6 of 952) patients ngt taking valproate. were simiiar for the epilepsy and psychiatrie indications.

OCTOBER 2012

POINT/COUNTERPOINT
power of the new nation between the states and the federal government. But he also made it clear that any opposition to federal tyranny would come from state militia forces "conducted by governments possessing their affections and confidence." - Our Founders saw what insurrection looked like during acts of armed mob violence such as Shays' Rebellion. It horrified them and was one of the chief reasons they gathered in Philadelphia to create a new system of government with a stronger, more capable federal government. Article 1, Section 8 of the Constitution makes it clear that the purpose of the militia is to "suppress insurrections," not to foment them. Remember, what looks like "tyranny" to one man might look like "health care reform" to another.

PSYCHIATRIC TIMES

19

psych iat riet i m es.com

array of rights it affords us might think twice before adopting this flawed and treasonous interpretation as their own. There is not one shred of evidence to suggest that the Second Amendment's purpose was to safeguard an individual right of insurrection. The amendment's author. Federalist James Madison, articulated that its purpose was to split the military

The comparison of contemporary Americans to the Nazis is not valid. The experience in Germany before World War II, far from providing validation to the insurrectionist argument, instead shows the danger of allowing political violence to influence the political process. Before Hitler's appointment as Chancellor,
(Please see Gun Control, page 20)

LAMICTAL* (lamotrigine) Tablets LAMICTAL* (lamotrigine) Chewable D spersible Tablets LAMICTAL* ODT'" (lamotrigine) Orally Disintegrating Tablets Anyone considering prescribing LAMICTAL or any otiier AED must balance the risk of suicidal In addition, a number of reports of variably defined episodes of seizure exacerbation (e.g., seizure ttioughts cr behavior with tfie risk of untreated illness. Epilepsy and many other illnesses for which clusters, seizure flurries) were made. AEDs are prescribed are themselves associated with morbidity and mortality and an increased c.|.| C,,AAO iiovi,iH ni>oih m cmiono, iciincDi. n,,,ino m ,,,= i,f risk of suidd^ thoughts and beham Should sutdal thoughts and behaiior emerge during d e S t o L Z CTA 20 sudden and u n e S ' ^ ^ ^ ^ ^ ^ ^' ' ' ^ "^^ '^^'^'^ seizure-related deaths in wfiich ttie seizure was not observed.

suightSoraidbea^
orworseningofttiesignsandsymptomsofdepression.anyunusuaichangesinmoodcrbehavior. S a t e s to S i d e n e e of sne^^^^^^^^^^ concem snouia oe reponed immediately to neaitncare providers g ^(g||y ^^^g^^ ,,(^1 ^^ ^^^^^ simiiar to that in the dinical development program for 5.5 Use in Patients With Bipolar Disorder: Acute Treatment of Mood Episodes: Safety and UMICTAt, to 0.005 for patients with refractory epilepsy). Consequently, whetfier these figures are effectiveness of LAMICTAL in the acute treatment of mood episodes have not been established, reassuring or suggest concem depends en the comparability of ffie populations reported upon to the Cfiildren and Adolescents (less than t8 years of agel: Safety and effectiveness of LAMICTAL cohort receiving LAMICTAL and the accuracy of the estimates provided. Protably most reassuring in patients below the age of t8 years witfi mood disorders have not been established [see is the similarity of estimated SUDEPratesin patients receiving LAfilCTAL and those receiving other Su/c/da/ Behamr arto ideatiort (5.4j;. Ciinicai Worsening and Suicide Risk Associated With AEDs, chemicaily unrelated to each other, tfiat underwent clinical testing in similar populations Bipolar Disorder: Patients with bipolar disorder may experience worsening of their depressive Importantly, tfiat drug is chemically unrelated to LAMICTAL. This evidence suggests, although it symptoms and/or the emergence of suicidal ideation and behaviors (suicidality) whether or not certainly coes not prove, that the high SUDEPratesreflect population rates, not a drug ettect

significant degree of suicidal ideation prior to commencement of treatment, and young aduits are 5.13 Binding in the Eye and Other Melanin-Containing Tissues: Because lamotrigine at an increased risk of suiddal thoughts or suicide attempts, arid should receive careful monitoring''"t's to melanin, it could accumulate in melanin-rich tissues over time. This raises the possibility that lamotrigine may cause toxicity in these tissues after extended use. Although during treatment [see Su'iddai Behavior and ideation (5.5]/. Consideration should be given to changing the therapeutic regimen, including possibly ophthalmologica) testing was pertormed in one controiied dinical trial, the testing was inadequate discontinuing the medication, in patients who experience dinical worsening (induding development '" exdude subtle effects or injury occurring after long-termexposure. Moreover, the capacity of of new symptoms) and/or the emergence of suiddal ideation/behavior espedally if these available tests to detect potentially adverse consequences, if any, of lamotrigirie's binding to melanin is unknown fsee Ciirtical P/ia/maco/pgy (12.2) of fuii prescribir\g intomation] symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Prescriptions for LAMICTAL should be written for the smallest quantity of tablets consistent with Accordingly, although there are no spedfic reconirnendations for periodic ophthalmoiogical good patient management in order to reduce iheriskof overdose. Overdoses have been reported monitoring, prescribers should be' aware of the possibility of long-temi cphthalmologic effects. for LAMICTAL, some of whidi have been fatal [see Oe/ttosagef)a/)J. 5.14 Laboratory Tests: The value of monitoring plasma concentrations of lamotrigine 5.6 Aseptic Meningitis: Ttierapy with LAMICTAL increases the risk of developing aseptic i" patiens treated witfi LAMICTAL has net been established. Because of the possible meningitis. Because of the potential for serious outcomes of untreated meningitis due to other pharmacckinetic interactions between lamotrigirie and other dnjgs induding AEDs [see Table causes, patients should also be evaluated for other causes of meningitis and tieated as appropriate. '5 under !^aimacoinetics (12.3) of fuil prescribing information], monitoring of the plasma levels "' lamctrigine arid concomitant drugs may be indicated, partieulariy during dosage adjustments. Postniariting inpdae pdiatrie adult patients taking g cases of aseptic p meningitis g have been reported p a and d adult patients taking LAMICTAL for various indications. Symptoms upon presentation have induded headache, fever, '" S^nerEl, dinical judgment should be exerdsed regarding monitoring of plasma levels of nausea, vomiting, and nuchalrigidity.Rash, phctophobia, myafgia, chilis, altered consdousness,lamotrigire and other drugs and whether or not dosage adjustments are necessary. and somnolence were also noted in some cases. Symptoms have been reported to occur within t day to one and a half months following the initiation of treatment. In most cases, symptoms were ^f i in the Warnings and Precautions reported to resolve after discontinuation of LAMICTAL. Re-exposure resulted in a rapi'd retum of .f l: Senous skin rashes [see Warnings and Precautions (5.1)] Muitiorgan symptoms (from within 30 minutes tot daytollowingre-initiat|-onof treatment) that weTe frequently S hypersensivity reactions arid organ failure (see Warnings and Precautions 5.2)1 Blood moresevei.SomeoffhepatientstreatedwithUMICTALwhodeveiopedasepticmeninpshad ^'^'gsias [see Wamirigs anPrecautior^ 5.3ji, Suicidal behavior and ideation/see Warnings underiying diagnoses of systemic lupus erythematosus or other autoimmune diseases. CeibispiJ fluk) (CSF) analyzed at Itie dme ef dinkal piBsentaticn inreportedcases was diaraderfeedbyamiidtom)erateVeocytosis,nomialgluceseLels,andmildtoieiateincrease s ? f fs.eel^assanP/Bca*ris5.9iy,Statusepilepticus( in protein. CSF wfite blood cell court cSffeSs show^ a predominance of neutiophils 1 a m ^ f^"'' S"''''" " P ' ' ' '^^^ '" eP'lepsy see Warnings and Precautions (5.11)]. of the cases, although a predominance of lymphocytes was reported in approximately one third of ihe 6.1 Clinical Trials: Because clinical trials are conduded under widely varying conditions, cases. Some patients also had new onset d signs and syrriptoms of involvement of other organs advei^e reaction rates obsen/ed in the dinical trials of a drug cannot be directly compared with (prEdominantty hepatic and renal involvement), which rnay suggest ihat in these cases the aseptic rates in tf-e clinical trials of another drug and may not reflect therates'observed in practice. meningitis observed was part of a hypeisensitvityneadicnseeHomJigsancfRsosuSonslS.j/ LAMIGTAL has been evaluated for safety in patients with epilepsy and in patients with 5.7 Potential Medication Errors: Medication errors involving LAMICTAL have occurred In SipojarJ Disorder. Adverse reactions reportedtoreach of these patient populaticns are particular, tfie names LAMICTAL or lamotrigine can be confused wSi the names of other commonly P i t i e d below. Excluded are adverse reactions considered too general to be intormative and usedmeditions.MedkalionenDrsmayalsooccurbetweenthedifferentfomiulaticnsofLAMiCTAL To reduce tfie potential of medication errors, write and say UMICTAL deariy. Depictions of the With Eiepsf. The most commonly cbserved (>5% for LAM CTAL and more common I AMlfTAi T h i k r ^ > h i n k i h i T h i t Hn i h n i i t i T W t h i H I '"" shapes thatservetoidentitySiedifferentpreSntationsof Sie drug and thusmayhelpSiucetfi risk "i^rapy m adults and not seen at an equn/alent frequency amorig placebo-Ueated patients a ' , somnoence, headache, diplopia, blurred vision, nausea, voniifing, ofmedicationerrois.ToaAidtfiemedicationerrorofusingthemongdrugorfomiulation,patients ' ^ T ^'^^ ^ *^^'^ J'^xia, blunred.vision, nausea, and vcmitng were dose-related. should be strongly advised to visually inspedtheirtablets to verity that tfieyie LAMICTAL, sallas tfiecorredformulaticnoftAMICTAL,eihtimetheyfilltheirprekription. . _ . ,, ,.,.' , cartwmazepine with LAflICTAL than in patients receiving other AEOs with LAMICTAL Clinical 5.8 Concomitant Use With Oral Contraceptives: Seme estrogen-containing oral data suggest a higher incidence ofrash,induding serious rash, in patients receiving concomitant contraceptives have been shown to decrease senim concentrations of lamotrigine [see inical valproate'than in patients not receiving valprcate [see Warnings and Piecautions (5.1)]. Pharmacology (12.3) of fuit presciibing information] Dosage adjustments will be necessary Approximately tt% cf the 3,378 adult patients who received LAMiCTAL as adjunctive l".?l?.P''i^"'^ '' ' " " '"' ^'"P estrogen-containing eral contraceptives while taking therapy in prmarketing clinical trials discontinued treatment because of an adverse reaction. LAMICTAL fseeOosage and/lm//i/srata2.()o/Mp/Bscnl)/n9;nfo/maSon;. During the week The adverse reactions most commonly assodated with discontinuation were rash (30%) of inactive hormone preparation ("pill-free" week) cf oral contraceptive therapy, plasma lamotriginedizziness (2.8%), and headache (2 5%) levels are expected to rise, as mudi as doubling at the end of the week. Adverse reactions in a dose-response study in aduits, tlie rate of discontinuation cf LAMICTAL for dizziness consistent with elevated levels of lamotrigine, such as dizziness, ataxia, and diplopia, could occur, ataxia, diplopia, blurred vision, nausea, and vomiting was dose-related. 5.9 Withdrawal Seizures: As with other AEDs, LAMiCTAL should not be abruptly discontinued. Monoerapy in Aduits With Epiiepsy: The most commonly obsen/ed (>5% for LAMICTAL In patients with epilepsy there is a possibility of increasing seizure frequency. In dinical trials in and more common ori drug than placebo) adverse reactions seen in association with the patients with Bipolar Disorder, two patients experienced seizures shortly after abrupt withdrawal ot "S^ "' LAMICTAL during the monotherapy phase ot the controlled trial in adults not seen at LAMICTAL; however, there were confounding factors that may have contributed to the occurrencean equivalent rate in the control group were vomiting, cocrdination abnormality, dyspepsia, of seizures in these bipolar patients. Unless safety concems require a more rapid withdrawal, "ausea, dizziness, rhinitis, anxiety, insomnia, infection, pain, weight decrease, chest pain, the dose of LAMICTAL should be tapered over a period of at least 2 weeks (approximately 50% and dysmencrrhea. The most commonly cbsen/ed (>5% for LAMICTAL and more commcn o" (irug than placebo) adverse reactions assodated with the use of LAMICTAL during the teiuon pet viee\i.) [see Dosage and Administration (2.1) of fuii prescribing informatm] 5.10 Status Epilepticus: V^id esSmates of the incidence of treatment-emergent status

teSeTated'Dafenfs''"releXi2ssTead1c'^^^^^^^^^^^

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PSYCHIATRIC TIMES www. psych at riet i m es.com

POINT/COUNTERPOINT
rights can be neither protected nor vindicated. The claim that governments with strong restrictions on firearms put citizens at risk for government genocide is entirely without basis. Dictators and strongmen kill their citizens. Democracies do notregardless of their gun laws. A study by Davenport and Armstrong' found that "democratic political systems have been found to decrease political bans, censorship, torture, disappearances, and mass killing, doing so in a linear fashion across diverse measurements, methodologies, time periods, countries, and contexts." Well-developed democracies remain the most effective means of preventing public and private violence. Allowing individuals to arm for a potential war against our govern-

OCTOBER 2012

Gun Control
Continued from page 19

the Nazi party had a larger body of men under arms than the German military itself, and frequently used violence to intimidate and kill its political opponents. The Weimar Republic taught us that if a government cannot maintain its monopoly on the use of force, then individual

ment serves only to increase the risk of civil war and diminish our cherished democratic institutions and rights as defined in the Constitution. Meanwhile, weak gun laws drafted and supported by insurrectionists are taking an enormous human toll, with more than 80 Americans dying daily from gunfire and another 200 suffering injuries. There is no other democracy on the face of earth that

LAMICf AL (lamotrigine) Tablets LAMICTAL* (lamotrigine) Chewable Dispersible Tablets LAMICTAL* O D F " (lamotrigine) Orally Disintegrating Tablets Approximately 10% of the 420 adult patients who received LAMICTAL as monotherapy in suicidal ideation. Respiratory: Epistaxis, bronchitis, dyspnea. Sk/n and Appendages: Contact premai1(eting clinical trials discontinued treatment because of an adverse reaction. The adverse dermatitis, dry skin, sweating. Special Senses: Vision abriormality reactions rriost commonly associated with discontinuation were rash (4.5%), headache (3.1%), Incidence in Controiied Adjunctive Triais in Pdiatrie Patients With Epilepsy: Listed below are and astheriia (2.4%). adverse reactions that occurred in at least 2% of 339 pdiatrie patients with partial seizures or Adjunctive Therapy in Pdiatrie Patients With Epilepsy: The most mmonly observed (>5% for generalized seizures of Lennox-Gastaut syndrome, who received LAMICTAL up to 15 mg/kg/day LAMICTAL and more common on dmg than placebo) adverse reactions seen in association with or a maximum of 750 mg/day Reported adverse reactions were classified using COSTART the use of LAfiilCTAL as adjunctive treatment in pdiatrie patients 2 to 16 years of age and not terminology LAMICTAL was administered as adjunctive therapy to 168 patients; 171 patients seen at an equivalent rate in the control group were infection, vomiting, rash, fever, somnolence, received adjunctive placebo. accidental injury, dizziriess, diarrhea, abdominal pain, nausea, ataxia, tremor, asthenia, bronchitis, Treatment-Emergent Adverse Reaction Incidence in Placebo-Controlled Adjunctive Trials iiusynorome,anaoipiopia ..^ ^. , . ,. ., . , in Pdiatrie Patients With Epilepsy (Adverse reactions in at least 2% ot patients treated t P 1 . rSitodrli f^'^nnKnfAT"^ '"'T''h ""> ""AMICTAL and numerically mire frequent than in the placebo group are listed by Lennox-Gastaut syndrome, 4.2% of patients on LAMICTAL and 2.9% of pafienfs on placebo hodv cmtem with the incidence for LAMICTAL followed hv nlacehoV Bodu t a wholediscontinuedduefoadversereactions.Themostcommonlyreportedadversereaction^atledS^^^^^^^^^^ to t discontinuation d t t off LAMICTAL LAMICTAL was rash. h Rii ivndmmp (7fil Pain (S 41 Facial edema (? 11 PhrifO-cenciflvNv (?0V Cardiovacuiar' (2,1); Hemic and lym^haic: Lymphadenopathy (2, ); f^etabolic and a (2,0); Nervous system: Somnolence (17,15), Dizziness (14,4), Ataxia ControledAdiunctive Clinil Studies in Aduts m Epilepsy: Usted be^ow are treafme* 11,3), Tremor (10,1), Emotional lability (4 2), Gait abnormality (4,2), Thinking abnm^aity (3,2), ^^^^siar^ (21) f^ervousness (2,1), Vertigo (2,1); Respirato^r Pharyngitis (14,11), Bronchil R5). increased ugh (7,6), S i n u * (2,1), B o n t e p a s m (2,1); Skin: Rash (14,12), Eczema ICTAL In these studies, either LAfVllCTAL or placebo was added to the patient's Uroenital-(mlpanrtfpnialpnatpnt<;Ulrinarolrartinfertinnnol current AED therapy Adverse ^actions were usually mild to moderate in intensity L A k T A L " ' ^ M ^ S ^S^t reactions was administered as ad)unetive therapy to 711 patients; 419 patients received ad|unctive placebo, seen in assoeiation with the use of LAMICTAL as monotheranv (100 to 400 ma/davl in adult LAMICTAL as adiunetive therapy in prmarketing clinical mais disconinuedfreajient because of an adverse reaction. The adverse reac^^ns most common^ associated wrth discontinuation

, A??r'^V'f "' '"'' "^ff " f "'',.' ? 1' y^f i^ge who received S A r f b g ie ti efng ^^^^

P?SiltS p ? r ? H 'n h i r^

/ i h ' 18 " i o * s ' duration and numerical^ more frequent than in placebo-treated patients are

Palien s may have reported multipe adverse reactions dunng the study or atdisntinuation; thus, |nc|,je(| the s,i^^j 0, T,gg,j,.E'^ patients may be included in more than one category. Controlled Trials in Adults With Bipolar I Disorder that follows. Adverse reactions that occurred Treatment-Emergent Adverse Reaction Incidence in Placebo-Controlled Adjunctive Trials in at least 5% of patients and were numerically more common during the dose-escalation phase In Adult Patients With Epilepsy (Adverse reactions in at least 2% of patients treated with of LAMICTAL in these trials (when patients may have been receiving concomitant medications) LAMICTAL and nurnerically more frequent than in the placebo group are listed by body compared with the monotherapy phase were; headache (25%), rash (11%), dizziness (10%), system with the incidence for LAMICTAL followed by placebo): Body as a whole: Headache diarrhea (8%), dream abnormality (6%), and pruritus (6%). (29,19), Flu syndrome (7,6), Fever (6,4), Abdominal pain (5,4), Neck pain (2,1), Reaction During the monotherapy phase of the double-blind, placebo-controlled trials of 18 months' aggravated (seizure. exacertMlion) (2,1); Digestive: Nausea (19,10), Vomiting (9,4), Dianhea duration, 13% of 227 patients who received LAfVllCTAL (100 to 400 mg/day), 16% of 190 (6,4), Dyspepsia (5,2), Constipation (4,3), Anorexia (2,1); Musculoskeletal: Arthratgia (2,0); patients who received placebo, and 23% of 166 patients who received lithium discontinued Nervous: Dizziness (38,13), Ataxia (22,6), Somnolence (14,7), Incoordination (6,2), Insomnia therapy because of an adverse reaction. The adverse reactions which most commonly led to (6,2), Tremor (4,1), Depression (4,3), Anxiety (4,3), Convulsion (3,1), Irritabilrty (3,2), Speech discontinuation of LAMICTAL were rash (3%) and mania/hypomania/mixed mood adverse disorder (3,0), Concentration disturbance (2,1); Respiratory: Rhinitis (14,9), Pharyngitis (10,9), reactions (2%). Approximately 16% of 2,401 patients who received LAMICTAL (50 fo 500 mg/day) Cough increased (8,6); Skin and appendages: Rash (10,5), Pnjritus (3,2); Special senses: for Bipolar Disorder in prmarketing trials discontinued therapy because of an adverse reaction, Diplopia (28,7), Bluied vision (16,5), Vision abnormality (3,1); Urogenital (female patients only, most commonly due to rash (5%) and mania/hypomania/mixed mood adverse reactions (2%). n = 365, n = 207): Dysmenorrhea (7,6), Vaginitis (4,1), Amenorrhea (2,1). The overall adverse reaction profile for LAMICTAL was similar between females and males, Dose-Related Adverse Reactions From a Randomized, Placebo-Controlled Adjunctive ^^^^" ^'''^''V ^nd nonelderfy patients, and among racial groups. Trial in Adults With Epilepsy: In a randomized, parallel study comparing placebo Treatment-Emergent Adverse Reaction Incidence in 2 Placebo-Controlled Trials in (n = 73) and 300 mg/day (n = 71) and 500 mg/day (n = 72) of LAMICTAL, some of the Adults With Bipolar I Disorder (Adverse reactions in at least 5% of patients treated with more common drug-related adverse reactions were dose-related. The following adverse LAMICTAL (n : 227) as monotherapy and numerically more frequent than In the placebo reactions are listed by incidence (%) in placebo first, LAMICTAL 300 mg dose second, group (n - 190) are listed by body system with the incidence for LAMICTAL followed and LAMICTAL 500 mg dose third; Ataxia (10,10,28="), Blurred vision (10,11,25"), Diplopia by placebo.) Patients in these studies were converted to UMICTAL (100 to 400 mg/day) or (8,245,49''), Dizziness (27,31,54'"), Nausea (11,18,25=), Vomiting (4,11,18=). ^Significantly placebo monotherapy from add-on therapy with other psychotropic medications. Patients may greater than placebo group (P<0.05). "Significantly greater than group receiving LAfvllCTAL have reported multiple adverse reactions during the study; thus, patients may be included 300 mg (P<0.05). in more than one category. General: Back pain (8,6), Fatigue (8,5), Abdominal pain (6,3); The overall adverse reaction profile for LAMICTAL was siriiilar between females and males. Digestive: Nausea (14,11), Constipation (5,2), Vomiting (5,2); Nervous System: Insomnia (10,6), and was independent of age. Because the largest non-Caucasian racial subgr^oup was only 6% of Somnolence (9,7), Xerostomia (dry mouth) (6,4); Respiratory: Rhinitis (7,4), Exacerbation of patients exposed to LAMICTAL in placebo-controlled trials, there are insufficient data fo support cough (5,3), Pharyngitis (5,4); Skin: Rash (nonserious) (7,5), In the overall bipolar and other a statemerit regarding the distribution of adverse reaction reports by race. Generally, females mood disorders clinical trials, the rate of serious rash was 0.08% (1 of 1,233) of adult patients who receiving either LAMICTAL as adjunctive therapy or placebo were more likely to report adverse received LAMICTAL as initial monotherapy and 0.13% (2 of 1,538) of adult patients who reeeived reactions than males. The only adverse reaction for which the reports on LAMICTAL were greater LAMICTAL as adjunctive therapy [see Warnings and Precautions (5.1)]. than 10% more frequent in females than males (without a corresponding difference by gender on These adverse reactions were usually mild to moderate in intensity. Other reactions that placebo) was dizziness (difference = 16,5%), There was little difference between females and occurred in 5% or more patients but equally or more frequently in the placebo group included:' males in the rates of discontinuation of LAMICTAL for individual adverse reactions. dizziness, mania, headache, infection, influenza, pain, accidental injury, diarrhea, and dyspepsia. Controlled Monotherapy Trial in Adults With Partiai Seizures: Listed below are treatmerit- Adverse reactions that occurred with a frequency of less than 5% and greater than 1% of emergent adverse reactions that occurred in at least 5% of patients with epilepsy treated with patients receiving LAfktICTAL and numerically more frequent than placebo were: Gerjerat: monotherapy with LAMICTAL in a double-blind trial following discontinuation of either Fever, neck pain. Cart/ovascu/ar: Migraine. D/gesi/Ve: Flatulence./He/aWc and NuWtaa/: concomitant carbamazepine or phenytoin not seen at an equivalent frequency in the control Weight gain, edema. Muscu/oste/eia/.Arthralgia, myalgia. Nervous Sysiem; Amnesia, depression, group. Forty-three patients received monotherapy with LAMICTAL up to 500 mg/day; agitation, emotional lability, dyspraxia, abnormal thoughts, dream abnormality, hypoesthesia.44 received low-dose valproate monotherapy at 1,000 mg/day Patients in these studies were Respiratory: Sinusitis. Urogenital: Urinary frequency converted to LAMICTAL or valproate monof herapy from adjunefive therapy vnth eart)amazepine Adverse Reactions fallowing Abrupt DiscontnuaSon: In the 2 maintenanee trials, there was no or phenytoin. Pafienfs may have reported multiple adverse experienees during the study; thus, inerease in the incidence, severity, or type of adverse reacfions in Bipolar Disorder patients after patients may be included in more than one category. abnjptly tenninating therapy wifh LAMICTAL In clinical trials in patients with Bipolar Disorder, 2 Treatment-Emergent Adverse Reaction Incidence in Adults With Partial Seizures in a patients experieneed seizures shortly afferabnipt withdrawal of LAMICTAL, However, there were Controlled Monotherapy Trial (Adverse reactions in at least 5% of patients treated with confounding actors that may have contnbuted to the occurrence of seizures in fhese bipolar UMICTAL and numerically mrirs frequent than in the valproate group are listed by body P a " i f Warnings and Pmcautons(5.9j]. ^ ^ ^, ^,, ', ^ . . , , . , , , system with the incidence for UMICTAL followed by valproate): Body as a whole: Paul (5,0), , ^anisflfpomarjiaMixed Episodes: Durng the double-blind, placebocontroled diriieal trials Infection(5,2),Chesf pain(5,2); Digestive; Vomiting(9,0), Dyspepsia(7,2), Nausea(7,2); Metabolic ' " J ' P I isoider in which patents were converted to rjionotherapy with LAMICTAL 100 to and nutritional: Wei^t derease (5,2); NervousrCcijLatiZbnorinW (7,0), DizS'n^^ Anxiety (5,0), Insomnia (5,2); Respiratory: Rhinitis (7,2); Urogenital (female patients onV, n = 21, '. \ ! ^ F S ^ . ? T t T ^ , ?^^ reported as adverse reactions were 5% or patents treated n = 28)-Dysriienonhea(50) v ), " 3 i K= r, ' with LAMICTAL (n = 227), 4% for patients treated with lithium (n = 166), and 7% for patients treated Adverse reactions that occurred with a frequency of less than 5% and greater than 2% *Placebo(n = 190) In all bipolar ntrolled trials mbinaf adverse reacfions of mma(inctuding of patients receiving LAMICTAL and numerieally more frequent than placebo were; Body as * J " S " f ' ^^^ ' " " " l ^ ' ^ ' T ^ T ' ^ ^ ' J l E ' "'Parents treated * LAMiCJAL a Whoie: Asthenia, lever. Digestive: Anorexia, dry mouth, rectal herriorrhage, peptic ulcer, (n=956), 3% of patients treated with rithium(n=280), and 4% of patients treated with placebo (n=803). MefaWcandA/uinona/.Peripheraledema.A/ervoi/s^stem; Amnesia, ataxia, depression, 6.2 Other Adverse Reactions Observed in All Clinical Trials: LAMICTAL has been hypesthesia, libido inerease, decreased reflexes, increased reflexes, nystagmus, irritability, administered to 6,694 individuals for whom complete adverse reacfion data was captured during

OCTOBER 2012

POINT/COUNTERPOINT
lower rates of gun deata. Psychiatrists need to ask themselves this important question: Does it benefit their patients' health and safety to give themo anybody else' for that mattereasy access to all the firearms they want with few (if any) questions asked, or, would they benefit from laws that require universal, thorough background checks and restrictions on military-style firepower? In contemporary societywhere grotesque shootings are a daily feature of American lifethe answer is a matter of life and death.
Attorney Horwitz is Executive Director of the Coalition to Stop Gun Violence (http;//www. csgv. org). He is a visiting scholar at the Johns Hopkins Bloomberg School of Public Health and coauthor of the book Guns, Democracy,

PSYCHIATRICTIMES

21

www. psych iat rictimes.com

experiences this type of gun violence. We are the only free society that has yet to address this problem. A number of studies have demonstrated that gun ownership makes an individual and his loved ones far more likely to be victims of gunrelated homicides, suicides and accidental deaths. The data also show that states with comprehensive firearms regulations have consistently

and the Insurrectionist Idea (University of Michigan Press, 2009). He reports no conflicts of interest concerning the subject matter of this article. Reference
1. DavenportC, Armstrong DA II. Democracy and the violation of human rights; a statistical analysis from 1976 to 1996. Am J Polit Sei. 2004;48:538554. http://onlinelibrary.vi/iley.com/doi/10.1111/j. 0092-5853.2004.00086.x/abstract. Accessed September 21,2012. O

LAMICTAL (lamotrigine) Tablets LAMICTAL* (lamotrigine) Chewable Oispersible Tablets LAMICTAL' ODT (lamotrigine) Orally Disintegrating Tablets ali clinical trials, only some of which were placebo controlled. During these trials, all adverse Table 2 Established and Other Potentially Significant Drug Interactions (cont'd) reactions were recorded by the dinical investigators usirig terminology of their own choosing. To Effect on Concentration provide a meaningful estimate of the proportion of individuals having adverse reactions, similar Concomitant Dmg of Lamotrigine or Clinical Comment types of adverse reactioris were grouped into a smailer number of standardized categories using Concomitant Drug modified COSTART dictionary terminology. The frequencies presented represent the proportion of the 6,694 individuals exposed to LAMICTAL who experienced an event of the type cited on at Rifampin i lamotrigine Decreased lamotrigine AUC least one occasion while receiving LAMICTAL. Aii reported adverse reactions are included except approximately 40%. tfiose already listed in the previous tables or eisewhere in the labeling, those too general to be informative, and those not reasonably associated with the use of the drug. Vaiprcate T lamotrigine Increased lamotrigine Adveree reactions are further dassified within body system categories and enumerated in order concentrations slightly more than of decreasing frequericy using the following definitions; frequent adveise reactions are defined 2-fold. ? valproate Decreased valproate as those occurring in'at least 1/100 patients; infrsqueht adverse reactions are those occurring concentrations an average of in 1/100 to 1/1,000 patients; rare adverse reactions are those occurring in fewer than 1/1,000 25% over a 3-week period then patients. Bodv as a Whole; Infrequent: Aliergic reaction, chills, and malaise. Cardiovascular stabiiized in healthy volunteers; Svstem; Infrequent: Rushing, hot flashes, hypertension, palpitations, postural hypotension, no change in controlled clinical syncope, tachycardia, and vasodilation. Dermatolocical; infrequent: Acne, alopecia, hirsutism, triais in epilepsy patients. maculopapular rash, skin discoloration, and urticaria. Ram: Angioedema, erythema, exfoliatiye dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechiai rash, , ,,. . , ... , .j . , pustularrash,Stevens-Johnson syndrome, and vesialobuilous rash. Digestive System; tnfmquent t = Decreased (induces lamotngrne glucuronidation), Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, liver fundion tests ,' = ' ' l " f f ( " ' " " ' s iamotngine glucuronidation). abnormal, and mouth uiceratipn. flare; Gastrointestinal heriiorthage, glossitis, gum hemorrhage, ' ' ^ " " " " 9 oata. gum hypeiplasia, hematemesis, hemorrhagic colitis, hepatitis, melena, stomach ulcer, stomatitis, g ncp m SPECIFIC POPtJLATlONS and tongue edema. Endxrine System; flare; Goiter and hypothyroidism. Hmatologie and Lymphatic Svstem; infmquent: Ecchymosis and leukopenia. Rsre: Anemia, msinnphilia, fhrin 8.1 'regnancy: Teratogenic Effects; Pregnancy Category C. No evidence of decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic leratogs^nrcity was found in mice, rats, or rabbits when lamotrigine was orally administered anemia, petediia. and thrombocvtooenia. Metabolic and Nutritional Disorders; /nfrepueni; Aspartate 'o preg'ant animals dunng the penod of organognesis at doses up to 1.2, 0,5, and 1.1 transaminase increased, flare; Alcohol intolerance, all(aline phosphatase increase, alanine '""^S' Espectively, on a mg/rrf basis, the highest usual humari maintenance dose (i.e., transaminase increase, bilirubinemia, general edema, gamma glutamyl transpeptidase increase ^ mg'day). However, matemai toxicity and secondary fetal toxicity producing reduced fetal and hypergiycemia. Musculoskeletal Svstem; infrequent: Arthritis, leg cramps, myasthenia weight and/or delayed ossification were seen in mice and rats, but not in rabbits at these doses, and twitching, flare; Bursitis, musde atrophy, pathological fracture, and tendinous contracture. Teratology studies were also conducted using bolus intravenous adrninistration of the isethionate Nen/ous Svstem; Frequent: Confusion and paresthesia. infmquent: Akathisia, apathy, aphasia, 5^" ! lWgine in rats and rabbits. In rat dams administered an intravenous dose at 0.6 times central nervous system (CiVS) depression, depersonalization, dysarthria, dyskinesia, euphoria' ^^ '^'9'^?' "^"^1 human maintenance dose, the inddence of inlrauterine death without signs of hailudnations, hostility, hyperinesia, hypertonia, libido decreased, memory deaease, mind radngi leratogenidty was increased. movement disorder, myodonus, panic attad<, paranoid readion, peisonaiity disortler, psydiosis A belavioral teratology study was conducted in rats dosed during the period of organognesis, sleep disorder, stupor, and suiddal ideafion. flare; Choreoathetosis, delirium, delusions, dysphoria, ^^^^1^ postpartum, oNspnng of dams receiving 5 mg/kg/day or higher displayed a significantly dystonia, extrapyramidal syndrome, faintness, grand mat convulsions, hemiplegia, hyperaigesia, longer latent penod for open field exploration and a lower frequency of rearing. In a swimming hyperesthesia, hypokinesia, hypotonia, manic depression readion, musde spasm, neuralgia, maze t s t performed on days 39 to 44 postpartum, time to complefion was increased in offspring neurosis, paralysis, and peripheral neurifis. Respiratorv System; /nireijue/K; Yawn, flare; Heap and "' ''^"'- receiving 25 mg/kg/day. These doses represent 0.1 and 0.5 times the clinical dose on hvperventilation. Spedai Senses; Frequent: Amblyopia. infmquent: Abnomiality of amimmnrlatinn, a mg/rri basis, respectively. conjunctivitis, dry eyes, ear pain, photophobia, taste perversion, and tinnitus. Rare: Deafness, Lamstngine did not affect fertility, teratogenesis, or postnatal development wfien rats were lacrimation disorder, osdilopsia, parosmia, ptosis, strabismus taste loss uveitis and visual field ^ P"' '" ^ntl during mating, and throughout gestation and lactation at doses equivalent to defect. Urooenital Svstem; Infrequent: Abnomial ejaculation, hematuria, impotence, menonfiagia, "" ' " ' s the highest usual human maintenance dose on a mg/m" basis, poiyuria, and urinary incontinence, flare; Acute kidney failure, anorgasmia, breast abscess, breast ^^ pregnant rats were orally dosed at 0.1, 0.14, or 0.3 times the highest human neoplasm, creaSnine increase, cystitis, dysuria, epididymitis, female ladation, kidney failure, kidney maintenance dose (on a mg/irf basis) during the latter part of gestation (days 15 to 20), matemai pain nocturia urinary retention and urinary urgency toxicity and fetal death were seen. In dams, food consumption and weight gain were reduced, 6.3 Postmarketing Experience: The following adverse events(notlistedaboveindinicaltrials^2t7ir3"SSo'^^

studies, lamotrigine decreases fetal folate conceritrations inrats,an effect known to be associated with teratogenesis tifies the potentialriskto the fetus. Non-Teratoaenic Effects; As with other AEDs, physiological changes during pregnancy may affed larnolrigine concentratioris and/or therapeutic effect. Ttiere have been reports of deaeased 7 DRUG INTERACTIONS Significant dnjg interadions with lamotrigine are sunimarized in Table 2. Additional details of larnotrigine concentrafions during pregnancy and restorafion of pre-partum concentrations after these drug interaction studies are provided in the Ciinicai Pharmacology section [see Ciinicai deliveiy Dosage adjustments tnay be necessary to maintain dinical response. Pregiancy Exposure Reaistnf; To provide information regarding the effects of in utero Pharmacology (12.3) ottuli prescribing information] exposi/e to LAMICTAL, physicians are advised to recommend that pregnant patients Table 2. Established and Other Potentially Significant Drug Interactions taking LAMICTAL enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registiy. This can be done by caliing the toll-free number 1-888-233-2334, and must be Effect on Concentration done t ^ patients themselves. Information on the registry can also be found at the website Concomitant Drug of Lamotrigine or Clinical Comment http;//'ww,aedpregnancyregistry,org/. Concomitant Drug Physidaris are also encouraged to register patients in the Lamotrigine Pregnancy Registry; Estrogen<xintainingoral i lamotrigine Deaeased lamotripine levels enroiin-ent in this registry must be done prior to any prenatal diagnostic tests and before fetal contraceptive preparations approximately 50%. outcome is known. Physicians can obtain informafion by caiiing the Lamotrigine Pregnancy i levonorgestrel containirig30mcg Deaease in levonorgestrel Registry at 1-800-336-2176 (toll-free). component by 19%. ethir^estratfidand 8.2 Labor and Delivery; Tfie effed of LAMICTAL on labor and deliveiy in humans is unknown. 150ncglevonoigestrel 8.3 llursing Mothers: Lamotrigirie is present in milk from ladafing women taking LAMICTAL. Cartiamazepine(CB2) i lamotrigine Addition of carbamazepine Data from multiple smali studies indicate that lamotrigine plasma levels in human miik-fed infants and CBZ epoxide deaeases lamotrigine concentration approximately 40%. tiave been reported to be as high as 50% of the matemai serum levels. Neonates and young ? CBZ epoxide May increase CBZ epoxide levels. infants are at risk for fiigh senjrri levels because matemai serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but not later reduced to the pre-pregnancy dosage. Lamotrigine exposure is further increased due to the Phenobaitital/Primidone i lamotrigine Deaeased lamotrigine concentrafion approximately 40%. immaturity of the infant gluouronidafion capacity needed for dnjg dearance. Events induding apnea, drowsiness, and poor sucking have been reported in infants who have been human Phenytoin (PHT) i lamotrigine niilk-fe4 by mothers using lamotrigine; whether or not these events were caused by lamotrigine Decreased lamotrigine concentration approximately 40%, is unkcown. Human milk-fed infants should be closely monitored for adverse events resulfing from loiiotrigine. Measurement of infant semm levels should be pertormed to nile out toxidty if (cont'd)

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