Guest guest Posted March 22, 2004 Report Share Posted March 22, 2004 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 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, joint meeting of the Psychopharmacologic Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory. Notice of Meeting 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 PDF files, marked with an icon , require the free Adobe Acrobat Reader. Back to Top Back to Drug Information Date created: March 22, 2004 Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.