TITLE

Black box warnings to be added to all antidepressants

PUB. DATE
October 2004
SOURCE
Drug Topics;10/25/2004, Vol. 148 Issue 20, p8
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
This article reports that a Public Health Advisory has been issued by the U.S. Food and Drug Administration announcing its multi-pronged strategy to warn the public about the increased risk of suicidality in children and adolescents being treated with antidepressant medications. The agency is directing all manufacturers to add a black box warning to the labels of all antidepressants to describe this risk and stress the need for close monitoring of patients started on these medications. The labeling changes apply to all antidepressants because the currently available data are not adequate to exclude any single medication from the increased risk of suicidality.
ACCESSION #
15028725

 

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