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The Food and Drug Administration's deliberations on antidepressant use in pediatric patients

Laurel K Leslie1, Thomas B Newman, P Joan Chesney

  • 1Children's Hospital, Child and Adolescent Services Research Center, San Diego, California 92123, USA. lleslie@ucsd.edu

Pediatrics
|July 5, 2005
PubMed

Insights

The U.S. Food and Drug Administration (FDA) found a causal link between newer antidepressant drugs and suicidality in children and adolescents. This review summarizes FDA deliberations and implications for pediatric clinicians treating young patients.

Area of Science:

  • Neuroscience
  • Pediatric Psychiatry
  • Pharmacology

Background:

  • Concerns regarding the safety of newer antidepressants in pediatric populations.
  • The U.S. Food and Drug Administration (FDA) convened advisory committees to review suicidality data.

Purpose of the Study:

  • To summarize FDA deliberations on the link between newer antidepressants and pediatric suicidality.
  • To provide implications for pediatric clinicians regarding research, regulation, education, and practice.

Main Methods:

  • Joint meeting of the Neuro-Psychopharmacologic Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee.
  • Review of clinical trial data on newer antidepressant use in pediatric patients.

Main Results:

  • A causal link was established between newer antidepressants and increased suicidality in pediatric patients.
  • FDA advisory committees concluded a significant association requiring further attention.

Conclusions:

  • Pediatric clinicians must be aware of the FDA's findings on antidepressant-associated suicidality.
  • Implications for clinical practice, research, and regulatory oversight are discussed for the safe use of these medications in children and adolescents.

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