Skip to content

    Pain Management Health Center

    Font Size

    FDA Urges Tighter Controls on Certain Painkillers

    Large supplies of often-abused drugs such as Vicodin should be harder to obtain, agency says


    The new regulations could take effect as early as next year, Woodcock said. The U.S. Department of Health and Human Services must approve the recommendation before it can be adopted by the U.S. Drug Enforcement Administration, which has been pushing for tougher regulation of hydrocodone medications.

    Patients currently can refill a prescription for a drug containing hydrocodone five times during a six-month period before having to return to their doctor for a new prescription.

    The new regulations would cut that period down to three months before a new prescription is required.

    Public health experts supported the FDA's decision.

    "There's no question that these are important changes in the right direction," said Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins School of Public Health in Baltimore. "The FDA plays a critical role in helping to reduce the toll that this epidemic has taken. The clinical community and public health community will welcome these changes."

    However, Alexander said doctors and regulators need to keep an eye on problems for patients that result from the tighter control.

    "The bottom line is these kind of complex policies are often hard to predict," he said. "They can have both intended or unintended consequences."

    Earlier this year, an FDA advisory panel voted 19 to 10 in favor of reclassifying hydrocodone-based painkillers as Schedule II drugs.

    1 | 2

    Today on WebMD

    pain in brain and nerves
    Top causes and how to find relief.
    knee exercise
    8 exercises for less knee pain.
    acupuncture needles in woman's back
    How it helps arthritis, migraines, and dental pain.
    chronic pain
    Get personalized tips to reduce discomfort.
    illustration of nerves in hand
    lumbar spine
    Woman opening window
    Man holding handful of pills
    Woman shopping for vegetables
    Sore feet with high heel shoes
    acupuncture needles in woman's back
    man with a migraine