FDA urged to require black-box warnings on ADHD drugs

02/10/2006 | Washington Post (tiered subscription model), The

An FDA advisory group assigned to discuss ways of assessing drug risks instead urged the agency to require black-box warnings on the labels of methylphenidate drugs, including Concerta, Methylin and Ritalin, and amphetamines such as Adderall. The panel voted 8 to 7 for the warnings after reviewing reports associating the attention-deficit hyperactivity disorder drugs with heart attacks and toxic reactions. Advisers said part of their decision rested on the view that the drugs are being overprescribed, noting about 10% of 10-year-old American males are taking them and the number of adult users is growing rapidly.

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