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FDA panel wants to set new limits on liver-damaging acetaminophen

After decades of warnings about the dangers of acetaminophen, government experts are recommending sweeping changes in how Americans get the nation's most widely used painkiller.

In a series of votes, a Food and Drug Administration panel on Tuesday recommended lowering the maximum single and daily doses of acetaminophen, which is found in Tylenol, Excedrin and dozens of other medications. But in a more controversial move, the panel narrowly voted that prescription drugs like Vicodin and Percocet, which combine acetaminophen with stronger narcotics, should be eliminated.

The FDA assembled the 37-member panel to find ways to reduce liver damage associated with acetaminophen. The drug is the leading cause of liver failure in the United States, and acetaminophen overdoses send an estimated 56,000 people to emergency rooms annually, according to the FDA. About 200 die each year.

The FDA is not required to follow the advice of its panels, though it usually does. The agency gave no indication when it would act on the recommendations.

Area doctors and medical experts differed on the potential impacts of the panel's recommendations.

"Hopefully, this will bring awareness to the population that Tylenol isn't as safe as people think," said Bryon Petersen, an associate professor at the University of Florida who specializes in liver regeneration, repair and disease. "It is a very nasty drug if used improperly."

Dr. Drew Silverman of Tampa General Hospital doesn't believe that changing recommended dosages will have any impact.

"Patients don't follow labels," especially for over-the-counter pain medications, he said. "Patients tend to take more than the recommended dosage."

Silverman said he sees three to five patients a month in the Tampa General emergency room for acetaminophen overdoses. Pulling the products off shelves and keeping them behind drugstore counters would be a better step, he said.

"You should have to ask a pharmacist to get it, and answer questions first," he said.

Prescription pills

In voting to eliminate drugs such as Vicodin and Percocet, panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Prescription drugs containing acetaminophen were prescribed 200 million times last year.

"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

But many panelists opposed a sweeping ban on products that are so widely used to control severe, chronic pain.

Dr. Alfred Chapman, a pain management physician in Clearwater, called the recommendation "a tragedy."

"It's a very effective medicine for pain control," Chapman said of the combination products.

Chapman said he has found that drugs that combine a narcotic with acetaminophen work better than painkillers without acetaminophen. He noted that with straight narcotics, such as oxycodone and morphine, he has to prescribe larger doses to treat the same level of pain.

The panel, perhaps recognizing that the FDA may not yank the drugs entirely, also voted to recommend that if the drugs stay on the market, they should carry a black box warning, the most serious safety label available.

Chapman called that a better move.

"That would empower the patient," he said. "The patient would make an informed decision."

A trusted painkiller

Acetaminophen has been on the market for about 50 years, and has become one of the most widely used drugs in the United States, with more than 28 billion doses sold in 2005. Many patients find it easier on the stomach than painkillers such as ibuprofen and aspirin, which can cause ulcers.

The reason acetaminophen affects the liver is that it takes much longer to metabolize and clear itself from the body than other types of painkillers. Petersen cited an example of an individual who takes doses at 8 a.m., noon, 4 p.m. and 8 p.m.

"You've just taken four doses. But the dose you took at 8 in the morning could possibly still be there," he said. "As you keep taking more doses, you keep adding to the amount of acetaminophen in your system."

FDA's experts voted 21-16 to recommend lowering the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, though the group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull over-the-counter drugs like NyQuil and Theraflu, which combine acetaminophen with other ingredients that treat cold and flu symptoms.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But just 10 percent of acetaminophen-related deaths involve over-the-counter combination drugs, too small a threat to justify pulling them off shelves, panelists said.

And such a recall would have cost manufacturers plenty. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market comprised of over-the-counter products, according to IMS Health, a health care analysis firm.

"The acetaminophen people dodged a bullet," said Erik Gordon, a University of Michigan business professor who studies the biomedical industry.

Johnson & Johnson, the maker of Tylenol, closed at $56.80 a share, down 16 cents or .28 percent. Abbott Laboratories, which sells Vicodin, closed at $47.04 a share, down 78 cents or 1.63 percent. Endo Pharmaseuticals Holdings Inc., which sells Percocet, finished at $17.92, down 46 cents or 2.5 percent.

Information from the Associated Press was used in this report. Richard Martin can be reached at (727) 893-8330 or

FDA panel wants to set new limits on liver-damaging acetaminophen 06/30/09 [Last modified: Wednesday, July 1, 2009 12:33pm]
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