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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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