The absolute risk amounted to about 1 added case of suicidal thoughts or behaviors for every 500 patients taking the antiepileptic drugs versus placebo. The mechanism linking antiepileptic drugs with potetial suicide risk remains unknown, the FDA said.
"We have concluded this was a real signal, and the signal applied to all drugs we studied," Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, told reporters 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.
The advisory panel appeared to agree with him -- up to a point. It voted in favor of sending a medication guide to doctors detailing the suicide risks, but not the boxed warning. A majority of panel members voted against adding the black box warning, saying the studies didn't show a high enough risk for suicidal behavior.
"The general view of the committee was concern that patients or physicians would not prescribe these drugs in certain circumstances where they should," Katz said.
One specialist said Tuesday that he remained skeptical of any strong link between antiepileptics and suicide.
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."
He also pointed to studies that have shown that people with epilepsy tend to have a higher incidence of depression, which i
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