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Volume 354:1445-1448 April 6, 2006 Number 14 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) voted by a narrow margin — eight to seven — to recommend a "black-box" warning describing the cardiovascular risks of stimulant drugs used to treat attention deficit–hyperactivity disorder (ADHD). This action was unexpected, largely because the FDA had not requested a review of current labeling for this class of drugs; it had merely asked for recommendations of approaches to studying the cardiovascular risks associated with these drugs. The committee, however, decided to take an independent course. As a consultant to this . . . [Full Text of this Article]

Source Information

Dr. Nissen is the interim chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, Cleveland, and was a consultant to the FDA's Drug Safety and Risk Management Advisory Committee for the hearings on ADHD drugs.

This article was published at www.nejm.org on March 20, 2006.

An interview with Dr. Nissen can be heard at www.nejm.org.

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