Warnings, Columns-Drugs & Supplements, February 2006

FDA Recommends Black Box Warning for ADHD Drugs WASHINGTON, D.C. - The Food and Drug Administration voted to place a black box warning on Attention Deficit Hyperactivity Disorder drugs after reports of adverse cardiovascular events and death surfaced. On Feb. 10, the Drug Safety and Risk Management Advisory Committee voted 8-7 with one abstention to include the black box warning about an increased risk of cardiovascular problems and sudden death. The committee advised putting the warnings on methylphenidate drugs, including Novartis' Ritalin; ALZA Corp. and McNeil Pharmaceuticals' Concerta; Mallinckrodt Inc.'s Methylin; and Celltech Medeva's Metadate. …


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