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Antidepressant Warnings On Pediatric Suicide Need Immediate Strengthening

Executive Summary

Strengthened warnings about the risk of suicide ideation and attempts among children taking antidepressant medications should be communicated to physicians and consumers as soon as possible, a joint FDA advisory committee told the agency Feb. 2

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FDA Will Strengthen Antidepressant Warnings; “Black Box” Not Certain

FDA will require stronger warnings on antidepressants regarding the risk of pediatric suicidality following a Sept. 13-14 advisory committee review of the issue, but the agency is not yet ready to say that a "black box" will be necessary

FDA Will Strengthen Antidepressant Warnings; “Black Box” Not Certain

FDA will require stronger warnings on antidepressants regarding the risk of pediatric suicidality following a Sept. 13-14 advisory committee review of the issue, but the agency is not yet ready to say that a "black box" will be necessary

Antidepressants and suicide

FDA's analysis of independently reviewed pediatric suicidality data for antidepressants will be discussed Sept. 13-14 during a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the newly formed Pediatric Advisory Committee. The meeting is a follow-up to a Feb. 2 meeting where advisory committee members expressed concern about the high degree of variability and lack of categorization of suicide-related events (1"The Pink Sheet" Feb. 9, 2004, p. 35). FDA's handling of the pediatric data has sparked Congressional inquiries. The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [To 2watch a webcast or order video/DVDs of this meeting, go to FDAAdvisoryCommittee.com.]...

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