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Suicide Warning Added To Epilepsy Drugs

By Chrissie Cole

pimg height="154" width="330" src="http://www.injuryboard.com/uploadedImages/InjuryBoardcom_Content/Blogs/News_Blog/News/FDA_logo.jpg" alt="" //p p /p p /p p align="center" style="text-align: center; line-height: 150%;" /p table width="200" cellpadding="0" border="0" align="right" class="MsoNormalTable" style="width: 150pt;" tbody tr style="" td style="padding: 0.75pt;" p align="center" style="text-align: center; line-height: 150%;"buLEARN MORE/u/b/p ul type="disc" style="margin-top: 0in;" li class="MsoNormal" style="color: rgb(66, 66, 66); margin-top: 2.25pt; margin-bottom: 2.25pt; line-height: 150%;"a href="http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html"FDA News Release/a/li li class="MsoNormal" style="color: rgb(66, 66, 66); margin-top: 2.25pt; margin-bottom: 2.25pt; line-height: 150%;"a href="http://www.epilepsyfoundation.org/"Epilepsy Foundation/a/li li class="MsoNormal" style="color: rgb(66, 66, 66); margin-top: 2.25pt; margin-bottom: 2.25pt; line-height: 150%;"NINDS on a href="http://www.ninds.nih.gov/disorders/epilepsy/epilepsy.htm"Epilepsy/a/li li class="MsoNormal" style="color: rgb(66, 66, 66); margin-top: 2.25pt; margin-bottom: 2.25pt; line-height: 150%;"WebMD on a href="http://www.webmd.com/epilepsy/news/20070705/epilepsy-linked-to-higher-suicide-risk"Epilepsy Linked to Higher Suicide Risk/a/li li class="MsoNormal" style="color: rgb(66, 66, 66); margin-top: 2.25pt; margin-bottom: 2.25pt; line-height: 150%;"InjuryBoard on a href="../../topic/epilepsy-overview.aspx"Epilepsy/a/li li class="MsoNormal" style="color: rgb(66, 66, 66); margin-top: 2.25pt; margin-bottom: 2.25pt; line-height: 150%;"InjuryBoard on a href="../../national-news/fda-alert-antiseizure-meds-linked-to-suicidal-thoughts.aspx?googleid=29370"Antiseizure Meds Linked to Suicidal Thoughts/a/li /ul p class="MsoNormal" style="margin-left: 0.5in; line-height: 150%;" /p p style="line-height: 150%;" /p p style="line-height: 150%;"IMAGE SOURCE: b style=""copy;/b Wikimedia Commons / U.S. Food and Drug Administration logo / author: a href="http://commons.wikimedia.org/wiki/Image:Food_and_Drug_Administration_logo.png"David Vasquez/a/p /td /tr /tbody /table p style="line-height: 150%;"a href="http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html"Federal health regulators/a are requiring makers of widely used epilepsy drugs to add a warning about a href="http://www.webmd.com/epilepsy/news/20081216/epilepsy-drugs-get-suicide-risk-warning"increased risk of suicidal thoughts and behaviors/a (suicidality) to the productsrsquo; prescribing information and labeling./p p style="line-height: 150%;"The action ndash; which wonrsquo;t be a ldquo;black boxrdquo; warning ndash; applies to all epilepsy drugs, even those used that are used to treat migraine headaches, psychiatric disorders and other conditions./p p style="line-height: 150%;"b style=""The following epilepsy medications are required to add warnings about the risk of suicidality:/b/p ul type="disc" li class="MsoNormal" style="line-height: 150%;" pCarbamazepine (marketed as Carbatrol, Equetro, a href="http://www.webmd.com/drugs/drug-1502-Tegretol+Oral.aspx?drugid=1502amp;drugname=Tegretol+Oral" chronic_id="" crosslinkid="31407" directive="friendlyurl" externalid="D9724D75D7AC4DBE" keywordid="25622" keywordsetid="6598" object_type="" path="/webmdhttp://www.webmd.com/drugs/drug-1502-Tegretol+Oral.aspx?drugid=1502amp;drugname=Tegretol+Oral"Tegretol/a, Tegretol XR)/p /li li class="MsoNormal" style="line-height: 150%;" pa href="http://www.webmd.com/drugs/drug-14403-Clonazepam+Oral.aspx?drugid=14403amp;drugname=Clonazepam+Oral" chronic_id="" crosslinkid="31210" directive="friendlyurl" externalid="94EF3E3BC2F341F0" keywordid="18521" keywordsetid="4810" object_type="" path="/webmdhttp://www.webmd.com/drugs/drug-14403-Clonazepam+Oral.aspx?drugid=14403amp;drugname=Clonazepam+Oral"Clonazepam/a (marketed as Klonopin)/p /li li class="MsoNormal" style="line-height: 150%;" pClorazepate (marketed as Tranxene)/p /li li class="MsoNormal" style="line-height: 150%;" pDivalproex sodium (marketed as Depakote, Depakote ER, Depakene)/p /li li class="MsoNormal" style="line-height: 150%;" pEthosuximide (marketed as Zarontin)/p /li li class="MsoNormal" style="line-height: 150%;" pEthotoin (marketed as Peganone)/p /li li class="MsoNormal" style="line-height: 150%;" pFelbamate (marketed as Felbatol)/p /li li class="MsoNormal" style="line-height: 150%;" pa href="http://www.webmd.com/drugs/drug-14208-Gabapentin+Oral.aspx?drugid=14208amp;drugname=Gabapentin+Oral" chronic_id="" crosslinkid="31257" directive="friendlyurl" externalid="DA05FC81AA8F48C8" keywordid="20451" keywordsetid="5245" object_type="" path="/webmdhttp://www.webmd.com/drugs/drug-14208-Gabapentin+Oral.aspx?drugid=14208amp;drugname=Gabapentin+Oral"Gabapentin/a (marketed as a href="http://www.webmd.com/drugs/drug-9845-Neurontin+Oral.aspx?drugid=9845amp;drugname=Neurontin+Oral" chronic_id="" crosslinkid="31341" directive="friendlyurl" externalid="E3F495B147584122" keywordid="23275" keywordsetid="5990" object_type="" path="/webmdhttp://www.webmd.com/drugs/drug-9845-Neurontin+Oral.aspx?drugid=9845amp;drugname=Neurontin+Oral"Neurontin/a)/p /li li class="MsoNormal" style="line-height: 150%;" pLamotrigine (marketed as Lamictal)/p /li li class="MsoNormal" style="line-height: 150%;" pLacosamide (marketed as Vimpat)/p /li li class="MsoNormal" style="line-height: 150%;" pLevetiracetam (marketed as Keppra)/p /li li class="MsoNormal" style="line-height: 150%;" pMephenytoin (marketed as Mesantoin)/p /li li class="MsoNormal" style="line-height: 150%;" pMethosuximide (marketed as Celontin)/p /li li class="MsoNormal" style="line-height: 150%;" pOxcarbazepine (marketed as a href="http://www.webmd.com/drugs/drug-17984-Trileptal+Oral.aspx?drugid=17984amp;drugname=Trileptal+Oral" chronic_id="" crosslinkid="31419" directive="friendlyurl" externalid="5944C864084F483E" keywordid="25868" keywordsetid="6682" object_type="" path="/webmdhttp://www.webmd.com/drugs/drug-17984-Trileptal+Oral.aspx?drugid=17984amp;drugname=Trileptal+Oral"Trileptal/a)/p /li li class="MsoNormal" style="line-height: 150%;" pPhenytoin (marketed as Dilantin Suspension)/p /li li class="MsoNormal" style="line-height: 150%;" pPregabalin (marketed as Lyrica)/p /li li class="MsoNormal" style="line-height: 150%;" pPrimidone (marketed as Mysoline)/p /li li class="MsoNormal" style="line-height: 150%;" pTiagabine (marketed as Gabitril)/p /li li class="MsoNormal" style="line-height: 150%;" pTopiramate (marketed as Topamax)/p /li li class="MsoNormal" style="line-height: 150%;" pTrimethadione (marketed as Tridione)/p /li li class="MsoNormal" style="line-height: 150%;" pZonisamide (marketed as Zonegran)/p /li /ul p /p p style="line-height: 150%;"** Some of those drugs are also sold generically./p p style="line-height: 150%;"An a href="../../topic/epilepsy-overview.aspx"epileptic/a has recurring a href="../../view.cfm/Topic=588"seizures/a that are caused by irregular electrical impulses in the brain. When the cause of epileptic seizures cannot be determined, certain a href="../../view.cfm/Topic=423"anti-seizure drugs/a may be prescribed to control their occurrence./p pstrongPatient Monitoring /strong/p pldquo;All patients treated with anti-seizure medications should be monitored for the appearance or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior,rdquo; said Russell Katz, M.D. in a a href="http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html"FDA news release/a./p pPatients currently taking anti-seizure drugs are advised not to make any changes in treatment prior to talking with their health care professional./p pThe agency issued a public health alert about the risks and asked health care professionals to help notify caregivers, patients and their families so that they may be monitored. The agency is also requiring the makers of epilepsy drugs to create a risk evaluation and management strategy, including a medication guide for patients that addresses the risk./p pMedication Guides are manufacturer-developed handouts given to patients, their families and caregivers when a medicine is dispensed. The guides contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications./p pPatients are advised to understand the suicide risk and the warning signs such as becoming preoccupied with death, worsening depression and giving away prized possessions./p pstrongThe FDA and Epilepsy Drugs/strong/p pThe agencyrsquo;s findings are based on a review of 199 clinical trials of 11 epilepsy medications. The review, released in January, showed that patients taking these drugs had nearly twice the risk of suicidal behavior or thoughts than patients taking a placebo./p pFour patients randomly assigned to take one of the anti-seizure drugs committed suicide. There were no suicides in the placebo group. But the findings were not sufficient to make conclusions about drugsrsquo; effects on completed suicides./p pThe biological reasons as to why anti-seizure medications increases the risk of suicidal thoughts and behaviors in some patients, is unknown./p pa href="../../national-news/fda-alert-antiseizure-meds-linked-to-suicidal-thoughts.aspx?googleid=29370"In January 2008/a, the agency alerted health care professionals that clinical trials of drugs used to treat epilepsy showed an increased risk of suicidal thoughts and behavior. The FDA held a panel meeting of independent experts to review data in July./p pThe panel agreed with the agency about the increased risk of suicidal thoughts and ideation and recommended warning about the associated risk in the drugsrsquo; labels in medication guides, not a ldquo;black boxrdquo; warning, the FDArsquo;s sternest warning./p p class="MsoNormal" style="line-height: 150%;"In 2007, more than 10 million Americans took FDA-approved epilepsy drugs. #/pa href="http://www.injuryboard.com/national-news/suicide-warning-added-to-epilepsy-drugs.aspx?googleid=253438"Originally posted/a at a href="http://www.InjuryBoard.com"InjuryBoard/a by a href="http://www.injuryboard.com/member-profiles/Chrissie-Cole"Chrissie Cole/adiv class="feedflare" a href="http://feeds.injuryboard.com/~f/IBnationalnews?a=j4SJO"img src="http://feeds.injuryboard.com/~f/IBnationalnews?i=j4SJO" border="0"/img/a a href="http://feeds.injuryboard.com/~f/IBnationalnews?a=HnXUO"img src="http://feeds.injuryboard.com/~f/IBnationalnews?i=HnXUO" border="0"/img/a a href="http://feeds.injuryboard.com/~f/IBnationalnews?a=f5UhO"img src="http://feeds.injuryboard.com/~f/IBnationalnews?i=f5UhO" border="0"/img/a /divimg src="http://feeds.injuryboard.com/~r/IBnationalnews/~4/487444061" height="1" width="1"/

Full post as published by InjuryBoard on December 16, 2008 (boomark / email).