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

Liver harm fears could lead to ban on Vicodin, Percocet, new dosing recommendations for Tylenol

TUESDAY, June 30 (HealthDay News) -- U.S. health advisers recommended on Tuesday to lower the maximum dose of over-the-counter acetaminophen -- the key ingredient in Tylenol, Excedrin and many other pain-killing medications, while urging a ban of prescription drugs like Vicodin or Percocet, which combine the painkiller with an opiate narcotic.

The vote followed the release of a U.S. Food and Drug Administration report last month. It found that severe liver damage and even death can result from a lack of consumer awareness that acetaminophen -- which is easier on the stomach than painkillers such as aspirin and ibuprofen -- can cause such injury.

The dangers from use or abuse of Vicodin and Percocet may be even more concerning, one panelist said.

"It seems to me that problems with opiate combinations are clearly more prevalent," Dr. Lewis S. Nelson, and associate professor in the Department of Emergency Medicine, at NYU Langone Medical Center and chairman of FDA's Drug Safety and Risk Management Advisory Committee said during a Tuesday afternoon press conference held after the meeting.

Explaining the panel's 20-17 decision to ban prescription acetaminophen/opiate drugs, Nelson said that, "there are many deaths that relate to problems with prescription opiate combination acetaminophen products, whereas the number of deaths clearly related to the over-the-counter products are much more limited."

But the FDA advisers also took aim at over-the-counter (OTC) acetaminophen products. The agency's report found that many people may consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.

Based on that, the FDA advisory panel voted 21-16 Tuesday to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams - equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.

The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.

The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.

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

Dr. Sandra L. Kweder, deputy director of CDC's Office of New Drugs, Center for Drug Evaluation and Research gave a hint of what the FDA may do with the committee'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 the press conference.

"The usual dose that people take probably ought to be lower in order to insure a greater margin of safety should people take more than is recommended on the label," she said. "That message was pretty clear."

"There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products," Kweder said. "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," she said.

At the very least the agency 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.

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 noted.

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

However, in a statement, she said 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 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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