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Safeguards for children taking antidepressant strengthened.

Publication: FDA Consumer
Publication Date: 01-JAN-05
Format: Online
Delivery: Immediate Online Access

Article Excerpt
The Food and Drug Administration has announced a strategy to warn patients, their caregivers, and physicians about the possibility of an increased risk of suicidal thoughts and behavior (suicidality) in children and adolescents being treated with antidepressant medications.

The agency's of...

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...definitive analysis studies that compared the effects of nine antidepressants with the effects of an inactive substance (placebo) showed that those who received the antidepressants had an increased rate of suicidal thinking and behavior. No suicides were seen in the more than 4,000 patients in these studies. Acting FDA Commissioner Dr. Lester M. Crawford emphasized the critical importance of closely observing all patients, particularly children and adolescents who are just beginning antidepressant therapy.

In October 2004, the FDA announced a multi-pronged strategy designed to provide important new information to patients, families, and health care providers on the increased risk of suicidal thoughts and behavior in children and adolescents treated with antidepressant drugs. In designing this effort, the agency considered how best to...

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