Epilepsy Drugs Do Not Require Black-Box Warning, says Panel

Epilepsy drugs tend to raise suicidal tendencies in patients but those are not severe enough to call for FDA’s toughest warning label – the ‘Black Box’ warning on the drugs, said a U.S health advisory panel on Thursday.

The 20-member panel voted 14 - 4, with 3 abstentions, in favor of 11 anti-seizure drugs studied by the FDA. The study revealed that the risk for suicidal behavior tied to the drugs was not too high, which led the members to vote against the black box warnings.

Earlier this year, FDA had reviewed 199 studies, comparing the drugs to placebos. Patients taking the drugs were found to have about twice the risk of suicidal behavior compared with those taking a placebo.

"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, said during a late-afternoon teleconference on Thursday.

He suggested that labels for all these anti-epileptic drugs must include a box warning, and also that patients should be provided with a “medication guide describing these events with each prescription refill," he said.

The FDA panel which included neurologists, psychiatrists and statisticians, agreed to a certain extent as they backed the idea of sending a medication guide to doctors, carrying details of the suicide risks.

However, the risk of suicidal tendencies from epileptic drugs was passable so they could do without the black box warning.

"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.

"We take the committee's recommendations very seriously," Katz said, but added that a discussion would be required to decide if FDA should follow the committee's recommendation against a black box warning.

The drugs reviewed by the FDA include:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR),
Felbamate (marketed as Felbatol),
Pregabalin (marketed as Lyrica),
Lamotrigine (marketed as Lamictal),
Levetiracetam (marketed as Keppra),
Oxcarbazepine (marketed as Trileptal),
Gabapentin (marketed as Neurontin),
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Tiagabine (marketed as Gabitril),
Topiramate (marketed as Topamax),
and Zonisamide (marketed as Zonegran).