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August, 2004
 FDA Updates Its Review of
Antidepressant Drugs in Children
As part of its commitment to
keep the American public fully informed about the status of its
review of data concerning the use of antidepressants in pediatric
patients, the Food and Drug Administration (FDA) is issuing this
update to provide health care providers and patients with the most
current information on this topic.
FDA has completed a new analysis of
pediatric suicidality (suicidal thoughts and actions) data
submitted to the agency and will be posting its analysis on its
web site. FDA will also be posting on its web site additional
summaries of pediatric efficacy studies from drugs that have been
studied in depression in pediatric patients. Although specific new
labeling language has yet to be developed, FDA will assure that
the labels of the antidepressants used in pediatric patients
reflect the most recent information obtained from these studies
and analyses
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