FDA: Epilepsy Drugs Should Carry Suicidal Warning

By Anna Boyd
13:51, July 8th 2008
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FDA: Epilepsy Drugs Should Carry Suicidal Warning

The U.S. Food and Drug Administration says epilepsy drugs should carry a “black box” warning about the risk of suicidal thoughts and behavior.

The proposal has been released ahead of a meeting to be held on Thursday in which a panel of outside experts will discuss risks with drugs to treat the disease, which manifest by seizures that can cause involuntary movement or behavior.

According to government estimates, roughly 2.7 million Americans have epilepsy.

The FDA said all 11 epilepsy drugs included in the study should carry the black box warning, although three of them showed no clear sign of suicidal problems.

The FDA analysis on 199 studies found that 0.43 percent of patients on epilepsy drugs killed themselves or thought about doing so, compared with 0.24 percent of patients on a placebo.

GlaxoSmithKline Plc’s Lamictal and Pfizer Inc’s Lyrica are among the top-selling epilepsy drugs.

Others include Johnson & Johnson’s Topamax and Abbott Laboratories Inc’s Depakote. Additional drugs included in the FDA’s review are 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.

These drugs are also used for migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder.

“We are going to ask for a boxed warning on these drugs,” FDA representative Sandy Walsh said on Monday, according to Reuters.

“There seems to be no compelling reason to: 1) ignore what appears to be a very clear empirical finding of an increase in suicidality, despite no obvious explanation for this finding, or 2) not generalize the conclusion to other (anti-epilepsy drugs),” Dr. Russell Katz, head of the FDA's division of neurology products wrote in the memo addressed to the panel.

 

 



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