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ADHD drug cardiac safety

Executive Summary

FDA's Drug Safety & Risk Management Advisory Committee will discuss studies to assess the risk of adverse cardiovascular outcomes with drugs for attention deficit/hyperactivity disorder on Feb. 9. Adderall XR added warnings about cardiovascular events in certain patients in 2004 and the drug was suspended by Health Canada for several months in 2005. FDA has been looking at psychiatric and cardiovascular events across the entire category of ADHD drugs, which include J&J's Concerta, Novartis' Ritalin and Focalin, and Lilly's Strattera (1"The Pink Sheet" Oct. 3, 2005, p. 8). The meeting will take place at the Holiday Inn in Gaithersburg, Md., beginning at 8 a.m. [Editor's note: To 2watch a webcastor order a video/DVD of this and other meetings, visit]...

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