If 2 Painkillers Are Banned, What Next?
"We know that a significant number of patients don't follow doctor's directions, especially if they're in pain."
The FDA panel called for lowering the recommended maximum daily dose of nonprescription acetaminophen, which is currently 4 grams -- equal to eight 500-milligram pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.
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.
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.
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