FDA Alerts Doctors to New Suicide Warnings for Epilepsy Drugs

Bret Hanna

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The Boston Herald reports that the U.S. Food and Drug Administration is alerting doctors that there is an increased risk of suicidal tendencies associated with anti-seizure medications. Such drugs are commonly prescribed for seizure disorders, certain psychiatric disorders and nerve pain. Last December, the FDA announced that the warning would be required for the drugs, but it is now informing doctors of the specific warning which is increased "risk of suicidal thoughts or behavior in patients taking these drugs for any indication."

The new labeling requirements apply to approximately 20 medications including GlaxoSmithKline's Lamictal, Johnson & Johnson's Topamax and Pfizer's Lyrica. The FDA does not believe that the risk is significant but it is sufficient enough to trigger the new labeling. In addition, the FDA has posted the warning on its website and it is alerting doctors by letter. The drug manufacturers will be required to notify patients by pamphlet of the new warning, but the FDA stopped short of requiring that manufacturers issue the most serious alert, a "black box" warning.