FDA panel recommends banning two of the most popular painkillers

By GARDINER HARRIS, New York Times

Last update: June 30, 2009 - 10:44 PM

ADELPHI, MD. - A federal advisory panel voted narrowly Tuesday to recommend a ban on Percocet and Vicodin, two of the most popular prescription painkillers in the world, because of their effects on the liver.

The two drugs combine a narcotic with acetaminophen, the ingredient found in popular over-the-counter products like Tylenol and Excedrin. High doses of acetaminophen are a leading cause of liver damage, and the panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of these combination pills will be banned if the Food and Drug Administration heeds the advice of its experts. Vicodin and its generic equivalents alone are prescribed more than 100 million times a year in the United States.

Laureen Cassidy, a spokeswoman for Abbott Laboratories, which makes Vicodin, said, "The FDA will make a final determination, and Abbott will follow the agency's guidance."

The agency is not required to follow the recommendations of its advisory panels, but it usually does.

The panel's 20-17 vote to recommend a ban on the combination drugs was one of 11 it took at a meeting called to advise the FDA on problems arising from the extraordinary popularity of acetaminophen. In 2005, U.S. consumers bought 28 billion doses of products containing the ingredient.

While the medicine is effective in treating headaches and reducing fevers, even recommended doses can cause liver damage in some people. And more than 400 Americans die and 42,000 are hospitalized every year from overdoses.

The committee voted 24-13 to recommend that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500.

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