Epilepsy drugs may raise suicide risks, FDA says

WASHINGTON — Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration (FDA) 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 16,000 given dummy pills, or placebos.

Rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients faced about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.

Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.

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

Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines and psychiatric diseases. The FDA found that drug-treated patients were at increased risk no matter their diagnosis but that the risk was highest for epilepsy patients.

The FDA analyzed data from 11 well-known anti-seizure drugs, including Neurontin, Tegretol and Depakote, but the agency said it expected the risk applied to every epilepsy drug. The FDA said it would work with manufacturers to add the warning to product labels.