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    Painkiller Abuse on Rise, FDA Seeks to Increase Regulation

    By Jennifer Huddleston, staff writer    

    The U.S. Food and Drug Administration (FDA) recently announced plans to meet with certain opioid drug manufacturers and require them to help create a plan for reducing risks associated with the drugs. [1]

    The FDA announced it sent letters to 16 pharmaceutical companies that make 24 opioid drugs, including brand-name and generic versions of fentanyl, methadone, morphine and oxycodone, which come in pill and patch forms and usually include extended-release formulas.
    [2] , [3] The drugs are typically given to patients who need continuous treatment for severe chronic pain, such as cancer patients.

    The FDA will meet with these drug manufacturers March 3, 2009, to discuss a new requirement forcing the companies to implement risk-management plans that could include enhanced warning labels, instructions to physicians regarding the drugs and stricter limitations on which patients can receive the drugs.
    [4] It’s estimated that the FDA’s risk-management plans will take months to employ. [5]

    According to Dr. John Jenkins, director of the FDA’s Office of New Drugs, part of the Center for Drug Evaluation and Research, the FDA is taking action in response to the rising rates of abuse and misuse of these drugs over the past 10 years. Jenkins said the FDA will attempt to find a proper balance between justifiable patient needs for the drugs and the threat of abuse or misuse.
    [6]

    In 2007, approximately 21 million prescriptions for 3.7 million patients were issued for the painkillers targeted by the FDA’s new risk-management plans.
    [7]

    Recently, researchers from the Substance Abuse and Mental Health Services Administration released a report that said in 2007, 5.2 million Americans aged 12 or older reported using prescription painkillers in the past month for non-medical purposes.
    [8]

    “This is an ongoing problem that’s getting worse,” said Dr. Bob Rappaport, director of the FDA’s anesthesia drugs division.
    [9]

    Recent research also suggests that deaths from prescription drugs—mainly painkillers—are on the rise in the U.S.
    [10]

    According to FDA regulators, deaths due to these drugs are caused by inappropriate prescribing by physicians as well as abuse and misuse by patients. The FDA has documented cases of physicians prescribing these painkillers for unapproved uses, such as treating migraine headaches, and has also reported cases of patients chewing extended-release pills that are intended to be swallowed, which could cause an overdose.
    [11]

    The FDA plans to hold a public meeting in late spring or summer 2009 to gather ideas on the risk-management issues.
    [12]


    [1] “FDA Seeks Better Regulation of Painkillers.” HealthDay. Feb. 9, 2009.
    [2]  Ibid.
    [3] Perrone, Matthew. “FDA Seeks Plans to Reduce Misuse of Painkillers.” Newsweek. Feb. 9, 2009.
    [4]  Ibid.
    [5] “FDA Seeks Better Regulation of Painkillers.” HealthDay. Feb. 9, 2009.
    [6]  Ibid.
    [7]  Ibid.
    [8] Preidt, Robert. “Painkiller Abuse Increases Among Young Adults.” HealthDay. Feb. 9, 2009.
    [9] Perrone, Matthew. “FDA Seeks Plans to Reduce Misuse of Painkillers.” Newsweek. Feb. 9, 2009.
    [10] “Painkillers Linked to Increase in Overdose Deaths.” HealthDay. Dec. 9, 2008.
    [11] Perrone, Matthew. “FDA Seeks Plans to Reduce Misuse of Painkillers.” Newsweek. Feb. 9, 2009.
    [12]  Ibid.



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