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Monday, Oct. 27, 2003

The agency said reports in the press and medical journals describe suicide attempts and suicides in children receiving antidepressants. Many such reports also have been submitted to the FDA.

Though the data do not clearly establish an association between the use of the drugs on trials and increased suicidal thoughts or actions by pediatric patients, FDA said it was impossible to rule out an association.

Determining if the drug was at fault is a problem, as suicide attempts also occur in patients with depression who are untreated.

Nevertheless, the FDA said it was issuing a public health advisory to alert physicians to reports of suicidal thinking and suicide attempts in clinical studies of various anti-depressant drugs in pediatric patients.

Only Prozac is approved for use in major depressive disorder among children, but physicians sometimes use other drugs approved for adults.

The FDA said it has completed a preliminary review of reports for eight anti-depressant drugs - citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine - in tests in children.

In addition to the advisory, the agency scheduled a meeting in February of its Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to discuss the question.

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