- The Washington Times - Tuesday, June 30, 2009


Government experts said Tuesday that prescription drugs such as Vicodin and Percocet, which combine a popular painkiller with stronger narcotics, should be eliminated because of their role in deadly overdoses. The panel also recommended that the maximum dosage for Tylenol and dozens of other painkillers be reduced.

The Food and Drug Administration assembled the group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the country. Many patients find it easier on the stomach than other painkillers such as ibuprofen and aspirin, which can cause ulcers.

But despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the country, sending 56,000 people to the emergency room annually, according to the FDA.

During the series of votes Tuesday, the panel voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

The experts also voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication such as Extra Strength Tylenol. Acetaminophen is the key ingredient in Tylenol, Excedrin and other medications.

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.

A majority of panelists also said the 1,000-milligram dose should be available only by prescription.

Some experts complained, however, that the measure would create unnecessary work for doctors and patients.

“I think the drain on the health care system, which is already strained, would be enormous,” Dr. Robert Kerns of Yale University said.

The FDA is not required to follow the group’s advice, though it usually does.

Other drugs that could be withdrawn are combination medications, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.

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

But the industry group that represents Johnson & Johnson, Wyeth and other companies defended the products Monday, saying they pose a relatively small risk to patients.

Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.

The majority of deaths were caused by either single-ingredient drugs or prescription-strength combination drugs such as Endo Pharmaceutical’s Percocet, which combines oxycodone and acetaminophen.

Manufacturers could lose hundreds of millions of dollars in sales if combination drugs are pulled from the market. Total sales of all acetaminophen drugs reached $2.6 billion last year, with 80 percent of the market made up of over-the-counter products, according to IMS Health, a health care analysis firm.

“We believe there is a clear health benefit of over-the-counter combination products containing acetaminophen,” Linda Suydam, the group’s president, said Monday.

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