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FDA Looks to Crack Down on Misuse of Opioid Painkillers
Date:4/20/2011

By Amanda Gardner
HealthDay Reporter

TUESDAY, April 19 (HealthDay News) -- U.S. health officials unveiled Tuesday a new plan to try to curb misuse of extended-release and long-acting opioid pain killers such as OxyContin, morphine and methadone.

The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the United States.

"This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, the agency that launched the new program.

For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, "have a much greater risk than immediate-release because they contain more medicine."

She did not rule out the possibility that the approach could be expanded to include immediate-release drugs in the future.

Right now, the action affects 16 companies that make both branded and generic products. The products affected are known under their generic names as hydromorphone, methadone, morphine, oxycodone, oxymorphone, transdermal fentanyl and transdermal buprenorphine.

According to Woodcock, about 23 million prescriptions are dispensed each year for extended-release and long-acting opioids, which represented about 10 percent of the opioid market in 2009.

But, abuse and misuse is also extensive, with the FDA estimating that 33 million Americans aged 12 and older used such a drug for non-medical purposes in 2007, up from 29 million people in 2002.

Some 50,000 emergency room visits in 2006 were related to opioids, officials said.'/>"/>

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