FDA: Antiepileptic Drugs May Increase Risk of Suicidality

February 1, 2008

Patients taking antiepileptic medications for epilepsy, bipolar disease, migraine and other conditions may be at increased risk of suicidality, according to a physician alert issued Jan. 31 by the U.S. Food and Drug Administration.

FRIDAY, Feb. 1 (HealthDay News) -- Patients taking antiepileptic medications for epilepsy, bipolar disease, migraine and other conditions may be at increased risk of suicidality, according to a physician alert issued Jan. 31 by the U.S. Food and Drug Administration (FDA).

The action came after the FDA analyzed 199 randomized, placebo-controlled studies of 11 antiepileptic drugs involving 27,863 treated patients and 16,029 controls. During the studies, there were four completed suicides among patients versus none among controls, and 105 reports of suicidality among patients versus 35 among controls. The FDA investigators estimated that antiepileptic treatment was associated with an extra 2.1 incidents of suicidality per 1,000 patients.

Because of these findings, the FDA is working on labeling changes with manufacturers of the 11 studied medications -- carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakote ER, Depakene, Depacon) and zonisamide (Zonegran) -- and expects that the labeling changes will eventually apply to all antiepileptic medications.

"We want health care professionals to have the most up-to-date drug safety information," Russell Katz, M.D., director of the Division of Neurology Products in FDA's Center for Drug Evaluation and Research, said in a statement. "This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals informed of new safety data."

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