FDA Votes Against Black Box On Epilepsy Drugs

FDA Votes Against Black Box On Epilepsy DrugsThe fear that anti-seizure drugs can increase suicidal tendencies in patients did not seem strong enough for a black box warning. A 20 member advisory panel to the Food and Drug Administration voted 14-4 against adding a "black box" warning to all anti-seizure drugs.

The experts felt the warning labels could inadvertently cause doctors and patients to abandon the treatments. Earlier this week, the FDA  had announced plans to add ‘black box’ warnings to epilepsy drugs, after a study found an increased risk in patients on medication compared to those on placebos.

Dr. Russell Katz, the director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, said, "We have concluded this was a real signal, and the signal applied to all drugs we studied, 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.

It was not certain that the FDA will follow the committee's recommendation against a black box warning, though Katz said, "We take the committee's recommendations very seriously.”

"If we have good drugs that are working, we have to be very careful about scaring patients into not taking them," said Rochelle Caplan, a professor of psychiatry at University of California, Los Angeles.

"It's not yet clear whether or not the black box has had any effect on what we care about most, which is suicide. We do know prescribing is down somewhat, but that could be a good thing or a bad thing, " felt Thomas Laughren, FDA director of psychiatry products.