Health

Antiepileptic drugs get new warnings

NEWS IN BRIEF — Posted Jan. 12, 2009

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The Food and Drug Administration announced Dec. 16, 2008, that the labels of antiepileptic drugs are now required to include information about an increased risk of suicidality.

This class of drugs, which includes carbamazepine and clonazepam along with many others, is used to treat epilepsy, various psychiatric disorders and migraine headaches.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression; suicidal thoughts or behavior; or any unusual changes in mood or behavior," said Russell Katz, MD, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research. "Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

The agency took this action after reviewing 199 studies of 11 drugs in this class showing that these medications were associated with a near doubling of the risk of suicidal behavior or thoughts. This translates to one additional case in every 500 treated patients. The reason for the phenomenon is unknown.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2009/01/12/hlbf0112.htm.

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