Epilepsy drugs to warn of suicide risk

WASHINGTON - Epilepsy drugs must carry a new warning about the risk of suicidal thoughts or actions, as urged by a Food and Drug Administration advisory panel in July.

The FDA disclosed changes to the drugs' prescribing information yesterday on its website. The FDA, in keeping with the recommendations of its outside advisers, rejected a proposal to require that the drugs carry the agency's strictest caution, outlined in a black box.

Earlier this year, the agency's reviewers said they found an 80 percent rise in suicidal thoughts or behavior when they combined data from 199 studies of 11 drugs, led by the top-selling Topamax, from Johnson & Johnson, and GlaxoSmithKline PLC's Lamictal, now available as a generic. Pfizer Inc. said its Lyrica and Neurontin pills were safe and that it was unfair to combine data for medicines that work differently.

"The risk of suicidal thoughts or behavior was generally consistent among the 11 drugs analyzed and was observed in patients who were treated for epilepsy, psychiatric disorders, and other conditions," the FDA said. One more case of suicidal impulses occurred in every 530 patients treated with an epilepsy drug than among those not being treated.

The agency's outside specialists agreed in July all epilepsy drugs raise the chance patients will consider suicide. They voted 14 to 4 against adding a new boxed warning to the drugs' prescribing information, saying that a prominent discussion of the risks may cause millions to shun needed treatment.

More than 2 million Americans have epilepsy, a brain disorder in which nerves sometimes signal abnormally.