Based on that, the FDA advisory panel voted 21-16 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 the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint of what the agency might do with the advisory panel'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.
She added, "There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products. If we don't eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products.".
At the very least the agency should require
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