FDA Orders Suicide Warnings On Epilepsy Drugs

Law360 (December 17, 2008, 12:00 AM EST) -- Epilepsy drugs must now be labeled with warnings about the risk of suicidal thoughts and behavior associated with the medications, the U.S. Food and Drug Administration announced Wednesday.

Epilepsy-drug makers will also be required to submit risk evaluation and mitigation reports that include a medication guide for patients with information about suicide risks associated with anti-epileptic drugs, the FDA said.

The new labeling requirement will affect all anti-epileptic drugs, including Carbatrol, Klonopin, Tranxene, Depakote, Zarontin, Paganone, Felbatol, Neurontin, Lamictal, Vimpat, Keppra, Mesantoin, Celotin, Trileptal, Lyrica, Topamax,...
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