Panel Rejects Black Box Warning On Epilepsy Drugs, FDA Still Unsure

Voting against the notion, the Food and Drug Administration’s advisory panel today backed itself from the proposal to impose the black box warning – the agency's sternest warning – to the 11 epilepsy drugs being scrutinized for increased links with suicidal thoughts and behavior.

The 20-member advisory panel voted 14 to 4 with three abstentions against adding the toughest warning, stating ‘studies didn't show a high enough risk for suicidal behavior’.

Moreover, the addition of the sternest warnings could mean detaining epilepsy patients from being treated with effective drugs, the panel added.

However, the panel intends to send across a medication guide to all doctors to help inform them of the risks of suicide associated with the drugs.

To recall, earlier this week FDA announced it was considering a black box warning for the 11 commonly used epilepsy drugs after results of nearly 200 studies concluded that patients taking the drugs had twice the risk for suicidal tendencies than those taking a placebo.

"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," Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research stated before the scheduled meeting.

However on Thursday, agreeing to the recommendations in part the appointed advisory panel voted in favor of sending a medication guide to doctors detailing the suicide risks, but backed away from placing a "black box" warning stating despite the increased risk, suicidal behavior was still relatively rare.

Of the total 43,000 patients monitored in about 200 different studies, 30 taking epilepsy drugs attempted suicide, compared to six who were being administered placebos, the panel emphasized.

Novartis AG's Trileptal, Pfizer Inc's Lyrica , Lamictal by GlaxoSmithKline, Johnson & Johnson's Topamax, Cephalon Inc.'s Gabitril and Abbott Laboratories Inc's Depakote were among the few top-selling epilepsy drugs that were being reviewed for the black-box warning.

Normally administered for treating epilepsy, the drugs are also prescribed for a variety of other problems, including migraines and bipolar disorder.

Meanwhile, as following the committee’s recommendations is not an obligation for the FDA, though it invariably does so, whether it will accept the panel's recommendation against a black box warning, this time, is still to be seen.

"We take the committee's recommendations very seriously," Katz remarked.