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

d he supported the panel's decision to recommend lowering doses of acetaminophen.

"It's not that the doses can get you in trouble, but the very young and the very old can get into trouble easily," he said. Also if you are sick there is the danger of taking cold remedies that contain acetaminophen plus taking pure acetaminophen drugs as well, he noted.

But Klipper said the vote to make the 1,000-milligram dose of acetaminophen available only by prescription would overburden the health-care system. "Given the massive number of people who rely on this drug for pain control, making the maximum dose requiring a prescription, I think is going to place undo burden on the health-care system," he said.

On the other hand, Teperman supported the 1,000-milligram recommendation.

"The 1,000 milligram pill should never be at the patient's discretion. It should only be prescribed by a physician," Teperman said. "If you took an entire bottle of Tylenol Extra Strength, three days later you would be in a coma and needing a liver transplant."

Klippel said he'd like to see more education for consumers, alerting them to the potential dangers of acetaminophen. "Give consumers the benefit of the doubt," he said. "Consumers want to do the right thing, and if dosage in acetaminophen is important the consumer will follow."

More information

For more on acetaminophen, visit the U.S. National Library of Medicine.



SOURCES: John H. Klippel, M.D., CEO, Arthritis Foundation; Lewis W. Teperman, M.D., director of transplant surgery, vice chairman of surgery, New York University School of Medicine, New York City; May 28, 2009, news release, U.S. Food and Drug Administration; Associated Press


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