FDA Panel Says No To Black Box Warning On Epilepsy Drugs
By Anna Boyd
10:12, July 11th 2008
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FDA Panel Says No To Black Box Warning On Epilepsy Drugs

The U.S. Food and Drug Administration’s recommendation to add a “black box” warning to some 11 epilepsy drugs letting patients know about the risk of suicidal thoughts or behavior was not approved by a U.S. health advisory panel formed by 21 members on Thursday.

The reason they gave was that this black box warning, the FDA’s sternest warning, would scary epileptic patients up to the point of denying treatment.

The FDA announced it was considering a black box warning in late January after an analysis of the agency involving 199 studies showed that 0.43 percent of patients on epilepsy drugs committed suicide or thought about doing so, compared with 0.24 percent of patients on a placebo.

The drugs targeted by the black box request involved top-selling GlaxoSmithKline PLC’s Lamictal and Pfizer Inc’s Lyrica. Other names included Johnson & Johnson’s Topamax, Abbot Laboratories Inc’s Depakote, Pfizer’s Neurontin, Meda AB’s Felbatol, UCB SA’s Keppra, Novartis AG’s Trileptal, Cephalon Inc.’s Gabritil, Eisai Co.’s Zonegran and carbamazepine sold by several drug makers. Some of these drugs are also used for migraines, certain nerve-pain disorders, and psychiatric disease such as bipolar disorder.

The FDA’s review found that only 8 of the 11 drugs showed an increased risk of suicide, while three did not. However, the agency wanted black box warnings for all of them, a request the advisory panel refused.

Rochelle Caplan, MD, a professor of psychiatry at University of California Los Angeles and a member of the expert panel said “we have to be careful about scaring the patients into not taking these drugs, and I think we have to be very thoughtful about that,” WebMD reports.

According to Dr. Russell Katz, director of the division of neurology products at the FDA’s Center for Drug Evaluation and Research 14 members of the panel voted against the black box warning, four voted for the warning and three abstained.

Although the panel’s members were against the black box warning, they voted in favor of sending a medication guide to physicians highlighting the increased risk of suicide in some patients.

More than 10 million Americans took FDA-approved epilepsy drugs in 2007.

 



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