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Consumer Update |
FDA issued new information on Jan. 31, 2008, to alert health care professionals about an increased risk of suicidal thoughts and behaviors in patients who take medications called antiepileptics. Such drugs treat epilepsy, bipolar disorder, migraine headaches, and other conditions.
FDA studied suicidality reports from 11 antiepileptic drug studies and found that patients taking antiepileptics have about twice the risk of suicidal thoughts and behaviors, compared with patients receiving an inactive substance (placebo). This risk corresponds to an estimated 2.1 per 1,000 more patients in the drug treatment groups who experienced suicidality than in the placebo groups.
FDA recommends that
Although only the following drugs were part of the analysis, FDA expects that all medications in the antiepileptic class share the increased risk of suicidality:
The agency will work with manufacturers of marketed antiepileptic drugs to include this new information in the labeling of these products. FDA anticipates that labeling changes will be applied broadly to the entire class of drugs.
An upcoming FDA advisory committee meeting will address these data.
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html
FDA Information for Healthcare Professionals: Suicidality and Antiepileptic Drugs
www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm
Date Posted: February 5, 2008
