Published online July 1, 2005
PEDIATRICS Vol. 116 No. 1 July 2005, pp. 195-204 (doi:10.1542/peds.2005-0074)
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SPECIAL ARTICLE

The Food and Drug Administration’s Deliberations on Antidepressant Use in Pediatric Patients

Laurel K. Leslie, MD*, Thomas B. Newman, MD, MPH{ddagger}, P. Joan Chesney, MD§ and James M. Perrin, MD||

* Children’s Hospital, Child and Adolescent Services Research Center, San Diego, California
{ddagger} Departments of Epidemiology and Biostatistics and Pediatrics, University of California, San Francisco, California
§ Department off Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee
|| MGH Center for Child and Adolescent Health Policy, Harvard Medical School, Boston, Massachusetts

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.

Key Words: depression • pediatrics • children • adolescents • antidepressants • suicide • regulation • mental health • FDA

Abbreviations: FDA, Food and Drug Administration • MDD, major depressive disorder • DD, dysthymic disorder • BPD, bipolar disorder • CBT, cognitive behavioral therapy • SSRI, selective serotonin reuptake inhibitor • FDAMA, Food and Drug Administration Modernization Act • BPCA, Best Pharmaceuticals for Children Act • MHRA, Medicines and Healthcare Products Regulatory Agency • TADS, Treatment for Adolescents With Depression Study

Accepted Mar 30, 2005.




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