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 ne...

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Bibliographic Details
Published in:Pediatrics (Evanston) 2005-07, Vol.116 (1), p.195-204
Main Authors: Leslie, Laurel K, Newman, Thomas B, Chesney, P. Joan, Perrin, James M
Format: Article
Language:English
Subjects:
Adolescent
Antidepressants
Antidepressive Agents - adverse effects
Antidepressive Agents - therapeutic use
Child
Company legal issue
Depression (Mood disorder)
Depression, Mental
Drug Approval
Drug therapy
Health aspects
Humans
Investigations
Labeling
Mental depression
Mental health
Pediatrics
Pharmaceutical industry
Suicide
Suicides & suicide attempts
Teenagers
Testing
United States
United States Food and Drug Administration
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Summary: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.
ISSN:0031-4005
1098-4275
DOI:10.1542/peds.2005-0074