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Pediatric ADHD drug safety

Executive Summary

FDA's Pediatric Advisory Committee will address neuropsychiatric and cardiovascular events possibly related to attention deficit/hyperactivity disorder drugs at a March 22 meeting. The meeting is a continuation of the discussion begun at a June 2005 meeting. At that time, the committee discouraged labeling changes to Johnson & Johnson's Concerta and other methylphenidate products to address psychiatric and cardiovascular events (1"The Pink Sheet" July 4, 2005, p. 3). The pediatric meeting will follow a Feb. 9 meeting of FDA's Drug Safety & Risk Management Advisory Committee on ADHD drug cardiovascular safety (2"The Pink Sheet" Jan. 9, 2006, In Brief). The meeting will be held at the Hilton in Gaithersburg, Md. beginning at 8 a.m...

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