The Food and Drug Administration's deliberations on antidepressant use in pediatric patients.
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.
Children's Hospital, Child and Adolescent Services Research Center, San Diego, California 92123, USA. lleslie@ucsd.edu
Laurel K
LK
Leslie
Thomas B
TB
Newman
P Joan
PJ
Chesney
James M
JM
Perrin
D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D017277:Drug Approval; D006801:Humans; D013405:Suicide; D014481:United States; D014486:United States Food and Drug Administration
D000928:Antidepressive Agents