Food and Drug Administration

Center for Drug Evaluation and Research (CDER)


Joint Meeting of the

CDER Psychopharmacologic Drugs Advisory Committee

and the

FDA Pediatric Advisory Committee


September 13-14, 2004


Holiday Inn

8120 Wisconsin Avenue, Bethesda, Maryland




Issue: Discussion of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD) and other psychiatric disorders.Preliminary risk data based on the classification of these adverse event reports by the pharmaceutical sponsors of these products were presented at the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee held on February 2, 2004.Since that meeting, experts in pediatric suicidality, assembled by Columbia University, have independently classified these reported events, and the FDA has conducted an analysis of these data.The committees will consider the results of FDAís analysis of these independently classified events and will consider what further regulatory action may be needed with regard to the clinical use of these products in pediatric patients. The committees will also consider further research needs to address questions on this topic.


September 13, 2004


††††† FDA Presentations


††††† Sponsor Presentations


††††† Open Public Hearing


††††† Chairís Summary




September 14, 2004


Committee Discussion