The U. S. Food and Drug Administration announced that it will ask epilepsy drug makers to add a label warning about the increased risk of suicidal thoughts for users of the antiepileptic drugs.

The warning based on advice of an FDA advisory panel won't be a "black box" warning and would apply to all antiepileptic medications including those used to treat psychiatric disorders, migraines, and other conditions, as well as epilepsy. This would include widely used medications such as clonazepam (Klonopin), phenytoin
(Dilantin) and topiramate (Topamax).

Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research said, "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." He added, "patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

This decision is based on the agency review of 199 clinical trials of 11 epilepsy drugs which showed that patients on those drugs had twice the risk of suicidal behavior and thoughts than those on a placebo. "We have concluded this was a real signal, and the signal applied to all drugs we studied," said Dr. Katz in July. "We propose that labels for all these antiepileptic drugs be changed to include a box warning, and patients should be given a medication guide describing these events with each prescription refill," he said.

Dr. Gholam Motamedi, director of clinical neurophysiology fellowship and epilepsy at Georgetown University Hospital in Washington, D. C., said it was "surprising to attribute suicide to the antiepileptic drugs per se, because a good number of these drugs are used in psychiatry for their positive effects on mood and depression. Nevertheless, this emphasizes the importance of screening for signs and symptoms of depression and suicidal tendencies in the epilepsy clinics."

"The better warning would be, in my opinion, to be sensitive to depression of other psychiatric symptoms in epilepsy patients and refer them to psychiatrists," he added.

According to the FDA, antiepileptic drugs are used to treat epilepsy, bipolar disorder, migraine headaches and other conditions. The warning includes a heightened risk to users of "suicidal thoughts and behaviors (suicidality)," the agency announcement said.