WASHINGTON - Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned yesterday in an alert to doctors.
The FDA analyzed almost 200 studies of 11 antiseizure drugs, some of which have been on the market for decades. The studies tracked nearly 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 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.
Antiseizure drugs are used for a variety of illnesses in addition to epilepsy. The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.
The FDA began investigating whether epilepsy drugs pose any suicide risk in 2005. It analyzed data from 11 well-known antiseizure drugs, including Pfizer Inc.'s Neurontin, Novartis AG's Tegretol, and Abbott Laboratories' Depakote - but the FDA 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.
The FDA did not respond to requests for comment about how patients should interpret the warning. An FDA spokeswoman said only that patients should ask a doctor before making medication changes.