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    U.S. Advisory Panel Votes to Eliminate, Reduce Certain Painkillers

    By Jennifer Huddleston, staff writer     

    A U.S. health advisory panel assembled by the Food and Drug Administration (FDA) voted June 30, 2009, to eliminate prescription drugs such as Vicodin and Percocet that combine acetaminophen with opiate narcotics and to reduce the maximum dose of over-the-counter (OTC) acetaminophen, such as Tylenol and Excedrin.

    The vote came about a month after the release of an FDA report that found many people consume larger amounts of the drug than recommended because they believe it will be more effective and are unaware of the potential for severe liver damage or death from acetaminophen overdoses.

    The 37-member panel convened to discuss recommendations on how to reduce the number of deadly overdoses attributed to acetaminophen annually. Each year, approximately 56,000 people go to the emergency room because of acetaminophen overdoses and of those, about 200 die.
    [1] According to a 2007 Centers for Disease Control and Prevention estimate, acetaminophen is the leading cause of the 1,600 cases of acute liver failure seen each year in the U.S. [2]

    The panel voted 20-17 to ban prescription acetaminophen and opiate combination drugs, citing FDA data that 60 percent of all deaths attributed to acetaminophen stem from prescription drugs. According to the FDA, these types of acetaminophen combination drugs were prescribed 200 million times in 2008.
    [3]

    If acetaminophen combination drugs such as Vicodin, which contains hydrocodone, and Percocet, which contains oxycodone, are taken off the market, patients could still be prescribed the acetaminophen and other ingredients separately, but they would have to take two pills instead of one combination drug.

    “While it’s very convenient to have them in one pill, safety trumps convenience,” said Scott Fishman, M.D., president of the American Pain Foundation and chief of the pain medicine division and a professor of anesthesiology at the University of California, Davis.
    [4]

    The rationale behind separating the drugs is that patients will be more attentive to the amount of acetaminophen they consume if they are taking it separately.

    While the FDA is not required to follow the panel’s recommendations, the agency usually does.

    “If we don’t eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products,” said Sandra L. Kweder, deputy director of the FDA’s Office of New Drugs at the Center for Drug Evaluation and Research.
    [5]

    The panel recommended that if the FDA does not eliminate the drugs, they should contain a black box warning, the most serious safety label assigned by the FDA.

    Members of the panel voted 21-16 to reduce the maximum daily dose of OTC acetaminophen from 4 grams, the equivalent of eight 500-milligram pills of Extra Strength Tylenol, but were asked not to recommend a new maximum daily dosage. They recommended that there be only one concentration of children’s liquid acetaminophen available.

    The panel also voted to limit the maximum single dose of acetaminophen to 650 milligrams and to make the 1,000-milligram dose, currently the highest single OTC dose, available only by prescription.

    While John H. Klippel, M.D., president and chief executive officer of the Arthritis Foundation, said the arthritis community would support lowering the maximum dose if it increases safety, he added that requiring a prescription for the 1,000-milligram dose would further overburden the healthcare system.
    [6]

    According to healthcare analysis firm IMS Health, sales for acetaminophen drugs totaled $2.6 billion in 2008, 80 percent of which came from OTC products.


    [1] The Associated Press. “FDA Panel Votes to Eliminate Vicodin, Percocet.” MSNBC. July 1, 2009.
    [2] Heavey, Susan. “Experts Urge Stronger Limits for Some Pain Drugs.” MedlinePlus. June 30, 2009.
    [3] The Associated Press. “FDA Panel Votes to Eliminate Vicodin, Percocet.” MSNBC. July 1, 2009.
    [4] “If 2 Painkillers Are Banned, What Next?” HealthDay. July 2, 2009.
    [5]  Ibid.
    [6] Reinberg, Steve. “FDA Panel Urges Ban on Vicodin, Percocet.” HealthDay. June 30, 2009.



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