Food and Drug Administration
(FDA)
Center for Drug Evaluation and Research
(CDER)
and the
FDA Pediatric Advisory Committee
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
Chair, Psychopharmacologic Drugs
Advisory Committee (PDAC)
Introduction
of Committee
Conflict
of Interest Statement LT.
Anuja Patel, M.P.H.
Executive
Secretary, CDER, FDA
Director,
Office of Pediatric Therapeutics,
Office
of the Commissioner
Russell Katz,
M.D.
Director, Division of
Neuropharmacological Drug Products (DNDP), CDER, FDA
Team Leader, DNDP, CDER, FDA
Antidepressants (ADs) and Suicidal Behavior Epidemiologist, Division of Drug
Risk Evaluation,
Office of Drug Safety (ODS), CDER, FDA
Medical Officer, DNDP,
CDER, FDA
Classification Methodology Team Leader, Office of
Counter-Terrorism and Pediatric Drug Development (OCTAP), CDER, FDA
Food and Drug Administration
(FDA)
Center for Drug Evaluation and Research (CDER)
and the
FDA Pediatric
Advisory Committee
Pediatric Trials of Newer Antidepressants Senior
Medical Reviewer, DNDP, CDER, FDA
Current DNDP Analyses of Pediatric Epidemiologist,
Division of Drug Risk Evaluation, ODS,
Suicidality Data Sets CDER, FDA
Citalopram and
Escitalopram Jeffrey Jonas, M.D.
Pediatric Safety
Data Vice President, CNS, Forest
Laboratories, Inc.
Sertraline Use in Pediatric
Population: Charlotte Kremer, M.D.
A Risk Benefit Discussion Therapeutic Head,
Psychiatry, WWM,
Medical and Development Sciences, Pfizer, Inc.
Title to be Announced Joseph S. Camardo,
M.D.
Senior Vice President, Global Medical Affairs,
Wyeth Pharmaceuticals
Chair,
PDAC
Team Leader, DNDP, CDER, FDA
Summary Comments Wayne
Goodman, M.D.
Chair,
PDAC
Adjourn