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10/29/2003

FDA Still Uncertain on Pediatric Suicide Risk

Cheryl A. Thompson

After a nearly five-month preliminary review of reports, the Food and Drug Administration (FDA) said Monday that it needs more data and analyses and a public discussion of the data before deciding whether children taking an antidepressant for the treatment of major depressive disorder are at increased risk of suicidal thinking and suicide attempts.

FDA in mid-June announced it had started reviewing reports of the possible increased risk of "suicidality" among persons younger than age 18 who take paroxetine as a treatment for major depressive disorder. That announcement came soon after an expert group in the United Kingdom's Department of Health began studying the safety of paroxetine, fluoxetine, and other selective serotonin-reuptake inhibitors when used by pediatric patients with major depressive disorder.

The preliminary review by FDA centered on data from 20 placebo-controlled studies of citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine in pediatric patients with major depressive disorder. No report of a completed suicide related to these studies has been submitted, the agency said.

Information from these studies, FDA said, was provided by the drugs' manufacturers in the hope of obtaining the agency's approval for the firms to market their product for use in the treatment of major depressive disorder in children.

Fluoxetine is the only drug among the eight under review that is already marketed for this use.

Wyeth Pharmaceuticals' application to market extended-release venlafaxine for the treatment of major depressive disorder in children was turned down earlier this year because the studies did not show the product worked better than placebo, according to FDA's executive summary (PDF) of its clinical review. The company in August changed its labeling for venlafaxine products to note increased reports of hostility, suicidal ideation, and self-harm in pediatric patients who participated in studies of the drug for treating major depressive disorder.

The public discussion is scheduled for Feb. 2, 2004, at a joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the pediatric subcommittee of the Anti-Infective Drugs Advisory Committee.