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November 5, 2003

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Suicidality May Occur in Children on Antidepressants for MDD

Medscape Staff Report

Oct. 27, 2003 Suicidality (both suicidal ideation and suicide attempts) in clinical trials of various antidepressant drugs in pediatric patients with major depressive disorder (MDD) has been reported, the U.S. Food and Drug Administration (FDA) said today.

Although "occurrences of suicidality are not unexpected in patients with MDD, preliminary data suggest an excess of such reports for patients assigned to several of these antidepressant drugs compared with those assigned to placebo," the FDA stated in a public health advisory posted on its Web site.

FDA has completed a preliminary review of the reports for eight antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine), which were studied under the pediatric exclusivity provision. Additional data and analysis, as well as a public discussion of available data, are needed, according to an e-mail sent today from MedWatch, the FDA's safety information and adverse event reporting program.

An advisory committee meeting will be held before the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee on Feb. 2, 2004.

Reviewed by Gary D. Vogin, MD

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