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

Also recommends dosing limits for OTC products that contain acetaminophen, like Tylenol or Excedrin, because of link to liver damage.

TUESDAY, June 30 (HealthDay News) -- Popular prescription drugs like Vicodin or Percocet, which combine acetaminophen with an opiate narcotic, should be banned, and the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin, should be lowered, a U.S. Food and Drug Administration advisory panel urged Tuesday.

The panel's recommendations followed the release of an FDA report last month that found severe liver damage, and even death, can result from a lack of consumer awareness that acetaminophen -- which is easier on the stomach than such painkillers as aspirin and ibuprofen -- can cause such injury.

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

"It seems to me that problems with opiate combinations are clearly more prevalent," Dr. Lewis S. Nelson, chairman of the FDA's Drug Safety and Risk Management Advisory Committee, said during a Tuesday press conference held after the two-day meeting.

Explaining the panel's 20-17 vote to ban prescription acetaminophen/opiate drugs, Nelson said, "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 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 the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint of what the agency might do with the advisory panel'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.

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

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.

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-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.

Teperman disagreed.

"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."

More information

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



SOURCES: June 30, 2009, press conference with Sandra L. Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA, and Lewis S. Nelson, M.D., associate professor, Department of Emergency Medicine, NYU Langone Medical Center, and chairman, Drug Safety and Risk Management Advisory Committee, FDA; also 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; June 30, 2009, news release, Consumer Healthcare Products Association; May 28, 2009, news release, U.S. Food and Drug Administration; Associated Press


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