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Medical News and Perspectives
November 19, 2003

FDA Alert on Antidepressants for Youth

JAMA. 2003;290(19):2534. doi:10.1001/jama.290.19.2534

The US Food and Drug Administration (FDA) has issued an alert about a possible link between antidepressant drug treatment for pediatric patients with major depressive disorder (MDD) and increased prevalence of suicidal thinking and suicide attempts.

In an October 27 "Public Health Advisory," the FDA notified physicians about preliminary data from a review of studies suggesting an excess of reported suicidal ideation and suicide attempts for pediatric patients receiving certain antidepressant drugs in clinical trials compared with those assigned to placebo. The FDA has completed a preliminary review of 20 placebo-controlled studies involving more than 4100 pediatric patients for eight antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the "pediatric exclusivity provision" of the FDA Modernization Act. The provision provides marketing incentives—6 months of exclusive sales—to manufacturers who conduct studies of drugs in children.

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