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

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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.’ ‹’ ‹