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Pain Management Health Center

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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.

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