Antidepressant Use in Children, Adolescents, and Adults

The Food and Drug Administration (FDA) requests a Warning Statement in the labeling for certain antidepressants to encourage close observation of adult and pediatric patients treated with these agents for worsening depression or the emergence of suicidality.  The drugs that are the focus of this new Warning Statement include: Prozac (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone); and Remeron (mirtazapine). 

• Public Health Advisory (issued 3/22/2004)
• FDA Updates Its Review of Antidepressant Drugs in Children. FDA Talk Paper (issued 8/20/2004)
• 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 August 26, 2004

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