Citation

Leslie LK, Newman TB, Chesney PJ, Perrin JM. Pediatrics 2005; 116(1): 195-204.

Affiliation

Children's Hospital, Child and Adolescent Services Research Center, San Diego, California 92123, USA. lleslie@ucsd.edu

Copyright

(Copyright © 2005, American Academy of Pediatrics)

DOI

10.1542/peds.2005-0074

PMID

15995053

PMCID

PMC1550709

Abstract

On February 2, 2004, the Food and Drug Administration organized a joint meeting of the Neuro-Psychopharmacologic Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to examine the occurrence of suicidality in clinical trials that investigate the use of the newer antidepressant drugs in pediatric patients. Committee members reconvened on September 13-14, 2004, and concluded that there was a causal link between the newer antidepressants and pediatric suicidality. This article provides a summary of the Food and Drug Administration deliberations for the pediatric clinician. We also provide research, regulation, education, and practice implications for care for children and adolescents who may be eligible for treatment with these medications.

Language: en