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FDA Panel Urges Restrictions on Acetaminophen

The panel said prescription drugs such as Vicodin and Percocet, which combine acetaminophen with stronger narcotics, should be pulled off the market because of their role in deadly overdoses.

“I think we have to send the message that there are problems with this medication,” Winifred Landis, an Indiana pharmacist on the panel told a two-day public meeting to discuss possible FDA action, Reuters reported.

Acetaminophen remains the leading cause of liver failure in the United States, according to the FDA. Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products.

The panel stopped short of urging a ban on over-the-counter cough, cold and other medications that combine acetaminophen with other ingredients, but said such products should come in lower doses.

The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ TheraFlu, combine acetaminophen with other ingredients that treat cough and runny nose.

Acetaminophen is found in popular over-the-counter medications such as Tylenol and Excedrin.

However, the highest dose of acetaminophen currently on the market should only be available with a doctor’s prescription, the panel said, and only one concentration of children’s liquid should be sold.

The FDA is not required to follow the advice of its panels, though it usually does.

Such painkillers are safe when used as directed and liver damage is rarely seen, the agency said. But acetaminophen is the leading cause of acute liver failure in the 1,600 cases seen each year in the United States, according to a 2007 Centers for Disease Control and Prevention estimate.

Consumers sometimes take too much of the drug either by taking the wrong dose or unknowingly taking it via the growing number of products such as cough and cold medicines that contain acetaminophen, the FDA said.

“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, according to the Associated Press.

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.