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FDA Panel Urges Ban on Vicodin, Percocet
Date:6/30/2009

new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.

Speaking for the OTC drug industry, Lynda A. Suydam, of the Consumer Healthcare Products Association (CHPA), said her group was "pleased the committee did not recommend eliminating these important nonprescription products."

However, in a statement, she added that CHPA was "disappointed in [the panel's] divided vote to lower the maximum daily dose and the single dose of 1000 mg acetaminophen. There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."

Another expert took a different view. Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday's votes were very important to "people with arthritis because acetaminophen is a very commonly used medication to control pain."

"Lowering the maximum dose, providing that kind of guidance to patients, if it increases safety, would be something the arthritis community would support," he said. "Every person who takes this drug sees it as valuable, but they want clear guidance so they won't be harmed by the drug."

Dr. Lewis W. Teperman, director of transplant surgery and vice chairman of surgery at New York University School of Medicine, said he also 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 added that the vote to make the 1,000-milligram dose of acetaminophen available by prescription only would overburden the health-car
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