FDA Wants Epilepsy Drugs To Carry Black-Box Warning

With recent evidence showing high association between epilepsy drugs and risk of suicidal thoughts and behaviors, the U.S. Food and Drug Administration officials will seek to include the Black box warning, the strongest alert possible, for 11 such drugs, the agency announced on Monday.

In a meeting scheduled for Thursday, an advisory panel of outside medical experts appointed by the FDA will look into the suicidal behavior associated with epilepsy drugs and check if the benefits reaped from the drug usage surpass the allied risks.

Lamictal by GlaxoSmithKline, Pfizer Inc's Lyrica, Johnson & Johnson's Topamax, Cephalon Inc.'s Gabitril, Novartis AG's Trileptal and Abbott Laboratories Inc's Depakote are among the few top-selling epilepsy drugs that would require updating their labels for the warnings.

According to an agency memo, the warnings would apply to all epilepsy drugs (including the 3 of the 11 drugs studied) that showed no clear signal of suicidal links.

The relatively new entrant in the market, Lyrica by Pfizer, is expected to be affected the most by the warning update, as compared to any other competitor drug, analysts feel.

Meanwhile disputing the FDA’s data, Pfizer maintains that its drug is safe and effective as currently labeled. Also, internal trials for Lyrica showed no links with a risk for suicidal behavior, the company emphasized.

Pfizer has disputed the FDA's data, saying its own information shows Lyrica isn't associated with a risk for suicidal behavior.

Pfizer maintains its drug is safe and effective, as currently labeled.

The Black Box Warning:
Black box warning is a type of warning that appears on the package insert for prescription drugs that indicates that the drug carries a significant risk of serious or even life-threatening adverse effects.

The strongest one put forward by the FDA, the warning can either be placed on the labeling of a prescription drug or in the literature describing it, depending upon the seriousness of the adverse effects.