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Epilepsy Drugs Prompt Warning

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The Associated Press

Published: February 1, 2008

WASHINGTON - Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned Thursday in an alert to doctors.

The FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.

Very rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients did face about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. Four people in the drug-treated groups committed suicide, and none taking placeboes.

What that means: For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, the FDA said.

Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that carry a risk of suicide.

The FDA analyzed data from 11 well-known anti-seizure drugs including Neurontin, Tegretol and Depakote.

Skipping epilepsy medication can result in seizures. An FDA spokeswoman said that patients should ask a doctor before making medication changes, but the agency's letter to doctors advised them to:

•Balance the risk with the patients' need for the drug.

•Tell patients and their families about the risk so they can be aware of changes.

•Make sure patients and families know to contact a doctor if someone experiences common suicide warning signs, such as talking or thinking about hurting themselves, becoming preoccupied with death, or depression.

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