Epilepsy Drugs May Face New Suicide Warnings

Scott Kappes

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A panel of outside experts is set to meet on July 10 to advise the FDA on how best to communicate to consumers elevated risks of suicidal thoughts and behavior associated with epilepsy medications. At the end of January the FDA warned healthcare providers of the increased risks. According to FDA spokesperson Sandy Walsh, further review of the data has confirmed a doubled risk of suicide and suicidal ideation associated with 11 epilepsy drugs and the agency now believes that all members of this class of medicines share the risks.

Products included in the review are Pfizer's Neurontin and Lyrica, J&J's Topamax, GlaxoSmithKline Plc's Lamictal, Meda AB's Felbatol, UCB SA's Keppra, Novartis AG's Trileptal, Cephalon Inc.'s Gabitril, Abbott Laboratories' Depakote, Eisai Co.'s Zonegran, and carbamazepine, sold by several drugmakers.

Drugmakers have expressed reluctance to accept the findings as truth claiming that the studies are flawed because they group data from several different medications. The panel will likely recommend adding the agency’s strongest, “black box,” warning to the label of these medications. The FDA is not required to follow the advise of outside panels but almost always does. Only time will tell what the future hold for these medications.