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Depression Pill Approved for Children But Probe Continues

by The Kid's Doctor Staff

Lexapro, a drug often used to treat depression in adults, has won federal approval for use in adolescents. The approval comes despite a five-year probe by federal prosecutors accusing the drug maker of wrongly attempting to sway pediatricians to prescribe the drug.

Lexapro’s approval was based on favorable results in two clinical trials, one involving adolescents taking Lexapro and another involving children and adolescents taking chemically similar Celexa.

Forest Laboratories, Inc., the maker of Lexapro, said the drug was approved by the Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 years and as a maintenance therapy, meaning to maintain control of symptoms.

Forest had been accused by the U.S. Justice Department of wrongly attempting to sway pediatricians to prescribe both Lexapro and Celexa, including inducements like spa visits, fishing trips and tickets to sporting events and Broadway shows. The federal complaint accused Forest of pushing aside a study showing that Celexa was ineffective for pediatric use and instead urging its sales staff to promote a second, more positive study.

New York-based Forest said depression affects approximately 2 million adolescents in the United States and that Lexapro is on the second anti-depressant approved for younger patients.

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