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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
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WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

THURSDAY, Oct. 24 (HealthDay News) -- The U.S. Food and Drug Administration has recommended tighter controls on prescriptions for painkillers such as Vicodin and Lortab that contain the powerful narcotic hydrocodone.

The change will cut in half the number of refills that patients can get before seeing their doctor to get a new prescription, the agency said Thursday.

Patients also will have to take a prescription to their pharmacy to have it filled, rather than have a doctor call it in.

The FDA announced that it will also ask in mid-December that all prescription medications containing hydrocodone be reclassified as "Schedule II" medications.

As Schedule II drugs, these painkillers will be subject to the same type of strict control as other narcotics with the highest potential for abuse, including OxyContin, methadone, fentanyl, Adderall and Ritalin.

The FDA has been spurred to action by epidemic levels of prescription drug abuse in the United States, said Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research.

The agency struggled over the impact that the change might have on patients, she said, but decided that public health concerns have become paramount.

"These are very difficult tradeoffs that our society has to make," Woodcock told The New York Times. "The reason we approve these drugs is for people in pain. But we can't ignore the epidemic on the other side."

One out of every five Americans has used prescription drugs for non-medical purposes at some time, according to the U.S. National Institutes of Health. Some 22 million Americans have misused prescription painkillers since 2002.

About 131 million prescriptions for medications containing hydrocodone were issued to an estimated 47 million patients in 2011. According to government estimates, that's equivalent to about 5 billion pills, the Times reported.

Dr. Lynn Webster, president of the American Academy of Pain Medicine, said: "This decision will mean there will be far less hydrocodone prescribed, and far less of it diverted [for abuse]. There will be an increase in health care costs due to more frequent office visits and co-pays, but it will take a bite out of the prescription drug crisis. We can't have status quo. We can't be doing what we have been doing for the last two decades."

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