Epilepsy drugs must carry a warning saying that they increase risk of suicide, US regulators said Tuesday.

 

The Food and Drug Administration followed recommendations from a panel of outside experts who met in July and agreed the drugs needed a warning but voted against a strong “black box,” the agency’s strictest caution. They feared that adding a black box warning on the drugs might scare patients from effective treatment.

 

The warning is the result of an FDA analysis of 199 clinical trials involving 11 anti-epileptic drugs, which concluded that patients taking the drugs had about twice the risk of suicidal behavior compared with patients taking a placebo. The mechanism linking the drugs with potential suicide risk remains unknown, the FDA said.

“We have concluded this was a real signal, and the signal applied to all drugs we studied,” Dr. Russell Katz, director of the division of neurology products at the FDA's Center for Drug Evaluation and Research, said in July.

The list of drugs to be added the warning includes: Carbatrol, Klonopin, Tranxene, Depakote, Zarontin, Peganone, Felbatol, Neurontin, Lamictal, Vimpat, Keppra, Mesantoin, Celontin, Trileptal, Dilantan Suspension, Lyrica, Mysoline, Gabitril, Topamax, Tridione, Zonegran. The review showed risk of suicide was only significant for Topamax and Lamictal. The drugs are used to treat epilepsy, bipolar disorder, migraine headaches and other conditions.

 

The FDA also said that patients, family members and caregivers should report any change in mood, behavior or actions of those taking the drugs. These could be signs that the drugs are actually increasing the risk of suicide. However, no patient should stop taking the drugs without consulting a doctor, the agency warned.