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FDA Panel Urges Tough Controls on Acetaminophen Painkillers
Date:6/30/2009

for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.

Based on that, the FDA advisory panel voted 21-16 Tuesday to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams - equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.

The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.

The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Dr. Sandra L. Kweder, deputy director of CDC's Office of New Drugs, Center for Drug Evaluation and Research gave a hint of what the FDA may do with the committee's recommendations.

"I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen both for over-the-counter products and also prescription combination products," Kweder said during the press conference.

"The usual dose that people take probably ought to be lower in order to insure a greater margin of safety should people take more than is recommended on the label," she said. "That message was pretty clear."

"There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminop
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