Antidepressant Use in Children, Adolescents, and Adults

Food and Drug Administration (FDA) asks manufacturers of all antidepressant drugs to include in their labeling a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and additional information about the results of pediatric studies.

Current Information

• FDA Proposed Medication Guide: About Using Antidepressants in Children or Teenagers (posted 11/03/2004)
• FDA Press Release (issued 10/15/2004)
• Public Health Advisory: Suicidality in Children and Adolescents Being Treated With Antidepressant Medications (issued 10/15/2004)
• Labeling Change Request Letter for Antidepressant Medications (issued 10/15/2004)

Background Information

• September 13-14, 2004, Psychopharmacologic Drugs Advisory Committee,  Joint Meeting with the Pediatric Advisory Committee. Meeting Information
• FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees (9/16/2004)
• FDA Updates Its Review of Antidepressant Drugs in Children. FDA Talk Paper (issued 8/20/2004)
• Public Health Advisory: Worsening Depression and Suicidality in Patients Being Treated with Antidepressant Medications (issued 3/22/2004)
• FDA Issues Public Health Advisory on Cautions for Use of Antidepressants in Adults and Children. FDA Talk Paper (issued 3/22/2004)
• Background Information on the Suicidality Classification Project (issued 3/22/2004)
• Questions and Answers on Antidepressant Use in Children, Adolescents and Adults (issued 3/22/2004)
• February 2, 2004, meeting of the Psychopharmacologic Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee.
  • Notice of Meeting [HTML] or [PDF]
  • Amendment of Notice [HTML] or [PDF]
  • Briefing Information
  • Presentation Slides
  • Meeting Transcript [HTML] or [PDF] or [Word]
    • Concordance Index
• Pediatric Drug Development Web page

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Date created: March 22, 2004, updated November 3, 2004

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