Suicidality Alert on Antiepileptic Labels Likely to Be Broadened

Article excerpt

WASHINGTON -- Findings of an increased suicidality risk in patients given antiepileptics likely will lead to broad class labeling changes, the Food and Drug Administration said in an alert issued to health care professionals.

The agency, which issued the alert on Jan. 31, plans to discuss the data at an advisory committee meeting and will work with manufacturers of marketed antiepileptic drugs to include the new information on product labels, the alert said. Examining 199 placebo-controlled trials covering 11 drugs used to treat epilepsy as well as psychiatric disorders, the analysis found that patients receiving antiepileptic drugs had about twice the risk of suicidal behavior or ideation, compared with placebo.

The increased risk was observed as early as 1 week after starting the drug and continued through 24 weeks. Most trials did not extend longer, so conclusions beyond that point are difficult, the FDA said.

In the alert, FDA recommended that "all patients treated with antiepileptic drugs should be monitored for suicidality and other unusual changes in behavior. …