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2nd FDA Review Confirms Antidepressant Risks: Report

Aug 10, 2004 |

A second review by the U.S. Food and Drug Administration has confirmed earlier findings that children who use certain adult antidepressants are at an increased risk of suicide, the Washington Post reported Tuesday.

Six months ago, the agency was criticized for withholding results of the first internal review, which found that children who use certain antidepressants known as selective serotonin reuptake inhibitors (SSRIs) were more likely to have suicidal thoughts. Drugs in this class include brand names such as Paxil, Zoloft, and Celexa. Only one SSRI, Prozac, has been FDA-approved for pediatric use.

The newer analysis reached the same conclusion as the first, the newspaper said. Prepared by FDA medical reviewer Tarek Hammad, it found that children who used the antidepressants during clinical studies had 1.78 times the risk of making a suicide attempt or "making preparatory actions towards imminent suicidal behavior," compared to children who had taken a nonmedicinal placebo.

The FDA hasn't publicly disclosed either report, and doesn't plan to discuss the data until a scheduled meeting in September, the Post reported.

Nine months ago, British authorities first warned doctors not to prescribe SSRIs to people under age 18, noting a tendency among young users to contemplate or commit suicide. Critics of the FDA in Congress and elsewhere allege that the agency is moving too slowly in its investigations, and is keeping important information from the public.

Since the British announcement, the FDA has changed its requirements on SSRI labeling, warning that doctors should closely monitor young users particularly when they begin treatment or change doses.

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