Antidepressant Use in Children", default", Adolescents, and Adults

(FDA) asks manufacturers of all antidepressant drugs and health care providers to include in their labeling a boxed warning and expanded warning, Because of an increased risk of suicidality (suicidal thinking and behavior) in children.

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 Reviews Data for Antidepressant Use in Adults. FDA Talk Paper (7/1/2005)
  Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications (issued 6/30/2005)
• Antidepressant Drugs that have Healthcare Professional and Patient Information Sheets (6/30/2005)
• FDA releases questions and answers concerning the use of the antidepressant drug Effexor (venlafaxine) and the class of antidepressant drugs known as selective serotonin reuptake inhibitors, or SSRIs in adults. Effexor Information (12/7/2004)
• FDA Launches a Multi-Pronged Strategy to Strengthen Safeguards for Children Treated With Antidepressant Medications. FDA Press Release (issued 10/15/2004)
• Labeling Change Request Letter for Antidepressant Medications (issued 10/15/2004)
• Labeling Template   (2/3/2005)
• Medication Guide Template (2/3/2005)
• List of drugs receiving a boxed warning, other product labeling changes, and a Medication Guide pertaining to pediatric suicidality (2/3/2005)

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: Suicidality in Children and Adolescents Being Treated With Antidepressant Medications (issued 10/15/2004)
• 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 July 12, 2005