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Experts Urge Stern ADHD Drug Warnings

Surprise Vote Follows Preliminary Study Suggesting Risks
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FDA Reluctant

Officials said they would be reluctant to place a black box warning on the drugs' labels based on a theoretical risk. Such warnings could deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research.

"The absence of bona fide problems in your hand pushes against the box," Temple said. "We will also, frankly, worry about the possibility that overstatement can do active harm."

Temple said the agency would wait for the advice of a pediatric advisory committee in March before reaching a decision on new warnings. That panel consists of pediatricians and psychiatrists who are more likely to look favorably on the benefits of ADHD treatment.

Preliminary Study of Risks

The recommendation came after FDA scientists presented a preliminary study implicating stimulant drugs with a possible increased risk of heart attacks and strokes.

A study of approximately 676,000 patients found an elevated occurrence of heart attacks and strokes in adults taking ADHD drugs, including Adderall, Ritalin, and Concerta. Children on the drugs also showed a higher-than-expected number of strokes, though their rate of heart attacks was lower than expected.

Strattera, another drug used to treat ADHD, is not a stimulant but was also included in the study. The expert panel did not include Strattera in their recommendation to add a warning.

In all, the study found 49 cases of heart attacks in children and adolescents who had taken ADHD drugs. That's compared with 12 attacks expected in that age group, based on national health data.

In adults, 732 heart attacks were observed where only 218 were expected, and 401 strokes occurred where 164 were expected.

Researchers stressed that the findings were preliminary and, at this point, theoretical. The study did not determine whether or not patients were actually taking ADHD drugs when they died. It also did not account for existing health conditions or other drugs patients may have been taking.

"There's smoke. Does that mean there's fire, or not?" said David Graham, MD, an FDA safety reviewer who conducted the study. "Our concern is enough to motivate us to want to nail down the uncertainty."

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