FDA requires epilepsy drug makers to add warnings about serious side effects

12/16/2008

ROCKVILLE, Md. Manufacturers of drugs for epilepsy must include warnings that their use could increase the risk of suicidal thoughts and behaviors, the Food and Drug Administration announced Tuesday.

The FDA is requiring manufacturers to include the warnings in the labeling for the drugs, including those used to treat psychiatric disorders, migraine headaches and other conditions.

“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior or any unusual changes in mood or behavior,” FDA Division of Neurology Products director Russell Katz said in a statement. “Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their healthcare professional.”

The actions are based on the agency’s review of 199 clinical trials of 11 antiepileptic drugs that showed patients receiving the drugs had almost twice the risk of suicidal behavior or thoughts compared to those receiving a placebo.

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