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Experts Urge Stern ADHD Drug Warnings

Surprise Vote Follows Preliminary Study Suggesting Risks

Preliminary Study of Risks continued...

The FDA has received about 20 reports of sudden deaths in adults and children taking Adderall, the most popular stimulant medication for ADHD. Those reports prompted the Canadian government to order Adderrall XR, the drug's extended-release form, off the shelves last February. The drug was returned to pharmacies over the summer with new safety warnings.

More than 4% of children and adolescents -- an estimated 2.5 million in total -- take stimulant drugs for ADHD. More than 1 million prescriptions are written each month for adults, a market that has nearly doubled in the last four years.

Todd Gruber, MD, vice president of Ritalin manufacturer Novartis, said his company has reviewed more than 50 years of side-effect reports stemming from Ritalin.

"There does not appear to be any increase in cardiovascular events associated with methylphenidate [Ritalin] use when viewed in the context of rates in the general population," Gruber told the committee.

Matt Cabrey, a spokesman for Shire Pharmaceuticals, which makes Adderall, said the company believes its current label is appropriate. "Our goal is to ensure that patients and physicians have all the information they need," he said.

Panel: Don't Wait to Warn

Adderall and Adderall XR already carry boxed warnings alerting patients to the potential for abuse and that overuse can lead to heart attacks and strokes.

But several experts said the FDA should not wait for the results of a new FDA study to warn the public about the risk. Several also recognized that their actions were drastic.

Panelist Steven Nissen, MD, said even if the risks are small, the consequences of severe cardiovascular side effect are so dire that the public should be warned now. Potentially elevated heart risk was most profound for adults, who are already at a higher risk than children for heart attacks and strokes.

"I think we need to tell people because the message isn't out there, given the enormous increase in the use of the drugs particularly among adults," said Nissen, a cardiologist at The Cleveland Clinic. "I want to cause people's hands to tremble a little bit before they write that [prescription]. The only way I know how to do that is to put it in a black box."

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