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Epilepsy Drugs Suicide Warning Denied by FDA Advisory Panel

Filed July 11th, 2008 amy

So much for the black box warning for . An FDA advisory panel gave the warning of suicide risks linked to 11 epilepsy drugs a big thumbs down. The panel’s vote applies to drugs including Neurontin, Lyrica, and Topamax. All of the drugs are approved to treat epilepsy, but many are also used by doctors for a variety of other problems, including migraines and bipolar disorder.

Earlier this week, FDA officials proposed to place new warnings on the drugs and to force companies to issue new medication guides warning patients of potential risks. That was after an agency analysis of some 200 studies concluded that patients taking the drugs had nearly double the risk of suicidal thoughts or behaviors.

Eight of the 11 drugs showed an increased risk, while three did not. But the agency is still proposing to issue warnings on all of the drugs and possibly some older epilepsy drugs. The other drugs include Lamictal, valproate, oxcarbazepine (sold under the brand name Trileptal), Tegretol, tiagabine, zonisamide, levitiracetam, and felbamate.

Despite the increased risk, suicidal behavior was still relatively rare. Out of about 43,000 patients studied, 30 taking epilepsy drugs attempted suicide, vs. six who were taking placebos. Four patients on the drugs — but none taking placebo — completed suicide.

The advisory panel voted against placing a “black box” warning — the agency’s sternest warning — on the drugs. Experts still urged the FDA to place some type of new warnings on the drugs, but they didn’t decide what form that would take.

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