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ADHD in Children Health Center

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New Warnings Urged for ADHD Drugs

FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms

Cardiovascular Risks

A separate expert panel last month surprised regulators by urging new "black box" warnings of cardiovascular risks in the growing number of adults taking stimulant ADHD drugs.

The drugs are known to increase blood pressure and pulse, and the recommendation came after preliminary reports suggesting that heart attacks and strokes were far more common in adults taking the drugs than in individuals who don't.

Experts said that such a warning was not warranted in children, since reports showed little sign that the drugs increase cardiovascular risk in otherwise healthy kids.

"In the general run-of-the-mill kid I think they're generally well tolerated. I don't there's much risk at all if they don't have a heart condition," said John W.M. Moore, a pediatric cardiologist at the Mattel Children's Hospital at UCLA and a member of the panel.

Four sudden heart deaths were reported in children taking Adderall XR. Panelists said the events were most likely due to undiagnosed heart disease in the children. The risk of stimulant medications in such children should be added to labels, experts said.

Matthew Cabrey, a spokesman for Adderall manufacturer Shire Pharmaceuticals, said that the company "agrees with and is supportive" of calls to highlight adverse events that can occur with use of the drug.

The FDA has not yet issued a decision on last month's call to add black box heart warnings for adults.

"We have some work to do in adults," said Robert Temple, MD, the FDA's director of medical policy.

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