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6/19/2003

FDA Probes Pediatric Paroxetine Risks

Cheryl A. Thompson

Following recent actions by the United Kingdom's Department of Health, the U.S. Food and Drug Administration (FDA) announced today that it had started reviewing reports of a possible increased risk of suicidal thinking and suicide attempts among persons younger than age 18 who take paroxetine as a treatment for major depressive disorder.

FDA simultaneously advised parents and guardians of children and adolescents receiving paroxetine therapy for major depressive disorder to speak with their physician before stopping the medication. The FDA-approved labeling for paroxetine recommends that, to avoid withdrawal symptoms, therapy should be gradually decreased rather than abruptly halted.

GlaxoSmithKline, maker of the Paxil and Seroxat brands of paroxetine, said in a June 10 news release that the company supported the U.K. agency's advice for pediatric patients not to stop therapy with the medication without first consulting their physician. The company said none of the more than 1,000 pediatric patients in its clinical studies of paroxetine committed suicide, but there were differences between paroxetine-treated adolescents with depression and their placebo-treated peers in terms of suicidal thinking or suicide attempts.

FDA-approved labeling for Paxil states that the safety and effectiveness of paroxetine in pediatric patients has not been established. Labeling for Seroxat, the paroxetine product sold in the United Kingdom, was revised on June 6 and now states that "controlled clinical studies failed to demonstrate efficacy and do not support the use of Seroxat in the treatment of children and adolescents with Major Depressive Disorder." Further, the use of paroxetine in children and adolescents under age 18 is listed among the medication's contraindications.

An expert group in the Medicines and Healthcare products Regulatory Authority, part of the U.K. Department of Health, announced May 23 that it had started studying the safety of paroxetine, fluoxetine, and other selective serotonin-reuptake inhibitors, with particular attention to withdrawal reactions and reports of suicidal behavior.

In making today's announcement about paroxetine, FDA stated that fluoxetine is the only drug marketed in the United States for the treatment of major depressive disorder in children and adolescents ages 8-18.