FDA Orders Stronger Warning Labels About Suicidal Thoughts From Epilepsy Drugs

More than 20 anti-seizure drugs taken for epilepsy and other disorders must carry stronger warnings about the risk of suicidal thoughts and behaviors, the Food and Drug Administration has ruled.

The new FDA order comes just months after the agency issued a public health warning and said it planned to force the makers of antiepileptic drugs to update the labeling to include the risks of suicide. The FDA is now requiring stronger labeling warnings, but not the most prominent “Black Box Warnings.” An FDA advisory panel of medical experts in December 2008 recommended against requiring the strictest warnings because doing so could might undue alarm and cause patients to unnecessarily stop taking the drugs.

The new warnings must appear on the labels of Carbatrol, Celontin, Depakene, Depakote ER, Depakote sprinkles, Depakote tablets, Dilantin, Equetro, Felbatol, Gabitril, Keppra, Keppra XR, Klonopin, Lamictal, Lyrica, Mysoline, Neurontin, Peganone, Stavzor, Tegretol, Tegretol XR, Topamax, Tranxene, Tridione, Trileptal, Zarontin, and Zonegran. The generic equivalents of the brand-name drugs must also carry the warnings.

Studies have found, on average, one additional case of suicidal thoughts or behaviors in every 500 people taking the drugs, compared to patients taking placebo pills. While the risk of suicide from the drugs remains relatively low, the FDA also issued a letter to physicians about the possibility of increased suicidal tendencies.

In addition to epilepsy, anti-seizure drugs are given to millions of people suffering from migraines, nerve-pain disorders, bipolar disorder, and other mental illnesses. Antiepileptic drugs are big sellers in the United States, with sales of $11.3 billion in 2008.

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