FDA panel gives Ritalin warning

NEWS IN BRIEF — Posted Feb. 27, 2006

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A Food and Drug Administration advisory committee recommended Feb. 2 that stimulant drugs, including Ritalin (methylphenidate hydrochloride), which are commonly prescribed for attention-deficit/hyperactivity disorder, carry black-box warnings about potential cardiovascular problems.

Although committee recommendations are frequently heeded by the agency, Robert Temple, MD, director of both the FDA's Office of Medical Policy and of the Office of Drug Evaluation I, Division of Psychiatry Products, indicated that the agency would explore the issue further. He also noted that a pediatric advisory committee meeting in March likely would revisit label concerns.

"We don't want to over scare people," said Dr. Temple, indicating that ADHD is a serious condition and the risk versus the benefit of the drugs will need to be carefully weighed.

The FDA released information indicating there were 25 sudden deaths, many of them children, among people taking the stimulants.

The panel voted 8-7 in favor of black-box warnings. The panel also voted unanimously to recommend that patient guides be published to accompany each prescription. The drugs are taken by about 2.5 million children and 1.5 million adults.

Note: This item originally appeared at

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