FDA to investigate Antidepressant Reports Of Suicidality In Children

Reports of suicidal ideation and suicide attempts in pediatric patients receiving antidepressants for major depressive disorder will be discussed at a Feb. 2, 2004 joint meeting of FDA’s Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee. The committee will review the reports of suicidality from clinical trials of antidepressants and consider optimal approaches to analysis of the data. The group will also consider what regulatory action may be needed for clinical use of these products in pediatric patients and what further research is needed to address questions on the topic.