The Food and Drug Administration wants 14 drugmakers to check their study data to see if use of epilepsy drugs results in suicidal behavior or thoughts. The FDA requested the reviews last month and gave the drugmakers six months to respond.The request is similar to one the FDA made in 2003 regarding antidepressants and suicidal behavior in children. That review resulted in a “black box” warning, the FDA’s toughest, on the drugs’ labels last year. This is only the second review of that type, says Robert Temple of the FDA’s Center for Drug Evaluation and Research.U.S. sales of anti-seizure drugs, including No. 1-seller Neurontin, made by Pfizer, and No. 2 Topamax from Ortho-McNeil Pharmaceutical, were the fifth-largest drug category last year, says research firm IMS Health. That’s largely because they’re used for many ailments other than epilepsy, which affects an estimated 2.7 million Americans. Neurontin is most often prescribed for pain. Topamax also prevents migraines.
