FDA panel will review drug-associated suicidality study

Executive Summary

FDA will discuss the results of its analysis of suicidality from placebo-controlled trials of 11 drugs at a joint advisory committee meeting, which could lead to broad class labeling changes. Members of the Peripheral and Central Nervous System Drugs, Psychopharmacological Drugs, Pediatric, and Drug Safety and Risk Management Advisory Committees will meet July 10 to consider the analysis and determine whether any additional actions are necessary. Findings of increased risk of suicidality in patients taking antiepileptic drugs were noted in a MedWatch alert issued in January (1"The Pink Sheet," Feb. 4, 2008, p. 3)