Psychiatry

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FDA Advisors: Black Box Warnings Needed for SSRIs

KEY POINT

With FDA officials now acknowledging that 2% to 3% of children and adolescents exhibit suicidality during antidepressant therapy, members of two FDA advisory panels voted this month to recommend addition of black box warnings to product labeling of all current and future antidepressants.

SOURCES

FDA talk paper: FDA updates its review of antidepressant drugs in children: agency details plans to present data to advisory committees in September and seek advice on appropriate regulatory actions.

Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive–behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial. JAMA. 2004;292:807–20.