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FDA mandates suicide warning on AED labels

Posted by SLS on May 9, 2009, at 6:18:57

"May 7, 2009 The US Food and Drug Administration (FDA) announced May 5 that it has approved new labeling for antiepileptic drugs to include a warning about an increased risk for suicidality with these agents. Manufacturers will be required to include a warning about an increased risk for suicidal thinking and behavior in treated patients and to develop a medication guide to provide information on this risk to patients prescribed these drugs."

Anti-epileptic drugs (AED):

* Carbamazepine (Carbatrol, Shire; Equetro, Validus; Tegretol, Tegretol XR, Novartis).
* Felbamate (Felbato, Meda Pharmaceuticals).
* Gabapentin (Neurontin, Pfizer).
* Lamotrigine (Lamictal, GlaxoSmithKline).
* Levetiracetam (Keppra, UCB).
* Oxcarbazepine (Trileptal, Novartis).
* Pregabalin (Lyrica, Pfizer).
* Tiagabine (Gabitril, Cephalon).
* Topiramate (Topamax, Ortho-McNeil Neurologics).
* Valproate (Depakote, Depakote ER, Depakene, Depacon, Abbott Laboratories).
* Zonisamide (Zonegran, Eisai).


There is an ongoing debate regarding this action by the FDA that began over a year ago when the FDA first proposed that AEDs have a black box warning for suicide. Of course, the main argument against the FDA action is that too many people will decline to take potentially life-saving drugs for fear of the emergence of an adverse event for which there is still a paucity of data.

- Scott




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