FDA Advisers Urge Smaller Doses of Ace...(em vulnerable to dangerously high levels...),Health

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Despite more than five years of FDA-sponsored consumer education campaigns, "recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity [liver damage] continue to occur," last month's report said.

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 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 presc
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