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Page: << Prev | 1 | 2 | 3 The panel also voted to limit the maximum single dose of acetaminophen to 650 milligrams (two pills of 325 milligrams each). The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams (two 500-milligram pills). The 1,000-milligram dose should be available only by prescription, the panel said.
The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so, and Fishman predicted it would in this case as well.
"While it's very convenient to have them in one pill, safety trumps convenience," Fishman said.
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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 Tuesday 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 a 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 FDA should require new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.
More information
The U.S. National Library of Medicine has more on acetaminophen. Page: << Prev | 1 | 2 | 3
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