July 2, 2009
FDA Panel Recommends Ban on 2 Painkillers
The New York Times:
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....
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 F.D.A. on problems arising from the extraordinary popularity of acetaminophen. In 2005, American 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 people die and 42,000 are hospitalized every year in the United States from overdoses.
In hopes of reducing some of these accidents, the committee voted 24 to 13 to recommend that the F.D.A. reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams, from 500. And members voted 21 to 16 to reduce the maximum daily dosage to less than 4,000 milligrams.
But they voted 20 to 17 against limiting the number of pills allowed in each bottle, with members saying such a limit would probably have little effect and could hurt rural and poor patients. Bottles of 1,000 pills are often sold at discount chains. “We have no data to show that people who overdose shop at Costco,” said Dr. Edward Covington, a panel member from the Cleveland Clinic Foundation. ...
In a statement, Johnson & Johnson, Tylenol’s maker, said it “strongly disagrees” with the proposed restrictions on acetaminophen, adding that they would be likely to “lead to more serious adverse events as consumers shift to other over-the-counter products,” like Advil and aspirin.
Linda A. Suydam, president of the Consumer Healthcare Products Association, said the committee had ignored studies showing that doses sold by her members — two pills of 500 milligrams, up to four times a day — were safe. “I think this is a very effective dose and one needed for individuals who experience chronic pain,” she said.
The committee also turned its attention to over-the-counter children’s medicines containing acetaminophen, voting 36 to 1 to limit them to a single formulation. Right now the liquids are sold in two different concentrations, leading to confusion among doctors and parents. “I don’t think it’s safe to have two formulations out there,” said Dr. Nelson, the acting chairman. . . .
Today's Diane Rehm Show has a further discussion of the FDA panel's recommendation:
PainKiller Safety: An update on recommendations to the Food and Drug Administration to restrict acetaminophen and ban the popular painkillers Percocet and Vicodin because of possible risks of overdose and liver damage. Guests: Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen; editor of WorstPills.org; Dr. Andrew Putnam, director, palliative care program at Lombardi Comprehensive Cancer Center at Georgetown University Medical Center; Linda Suydam, president, the Consumer Healthcare Products Association; Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs.
July 2, 2009 | Permalink
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