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FDA posts memo, questions on antiepileptic drugs

July 9, 2008 12:59 AM UTC

Thursday's joint meeting of FDA's Peripheral and Central Nervous System Drugs and Psycopharmacologic Drugs advisory committees will focus on the agency's proposal to place boxed warnings on labels of epilepsy drugs about associations with an increased risk of suicidality relative to placebo. The proposal is based on a previously released meta-analysis of 11 antiepileptic drugs (See BioCentury Extra, Thursday, June 12, 2008). A pooled analysis of the following drugs revealed a signal for suicidality, according to FDA: Felbatol felbamate from Meda (SSE:MEDA); Keppra levetiracetam from UCB (Euronext:UCB); Lyrica pregabalin from Pfizer (NYSE:PFE); Gabitril tiagabine from Cephalon (NASDAQ:CEPH); Topamax topiramate from Johnson & Johnson (NYSE:JNJ); and the generics carbamazepine; gabapentin; lamotrigine; oxcarbazepine; valproate; and zonisamide. FDA also will ask if the finding of increased risk of suicidality should apply to all chronically administered antiepileptic drugs, including those not part of the analyses. The briefing documents are available at ...