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Commentary

The Revised Black Box Warning for Antidepressants Sets a Public Health Experiment in Motion

Andrew C. Leon, PhD

Published: July 16, 2007

Article Abstract

Because this piece does not have an abstract, we have provided for your benefit the first 3 sentences of the full text.

On May 2, 2007, the U.S. Food and Drug Administration (FDA) issued the revised black box warning for all antidepressants that will now apply to patients under 25 years of age:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.’ ‹’ ‹


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