FDA approves updated labeling for antiepileptic drugs

The FDA has approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (eg, migraines, neuropathic pain syndromes). The FDA also required development of a medication guide, to be issued to patients each time the product is dispensed.

Since issuing safety alerts on January 31, 2008 and December 16, 2008, the FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk associated with antiepileptic drugs. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm074939.htm.