FDA's new labeling guidelines take on prescription drug abuse epidemic

The Food and Drug Administration, in an attempt to curb nation-wide prescription painkiller abuse, has approved new labeling guidelines for extended-release and long-acting opioid pain relievers, such as Oxycontin.

Federal officials say prescription painkiller abuse has reached epidemic proportions. Nearly three out of four prescription drug overdoses are caused by prescription painkillers--also called opioid pain relievers, according to the Centers for Disease Control and Prevention. The unprecedented rise in overdose deaths in the United States parallels a 300 percent increase since 1999 in the sale of these strong painkillers, the CDC states. These drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined.

The longer acting and extended release formula opoids have been the main medication patients use to manage chronic pain for conditions such as cancer, according to Forbes. However, the article states patients with chronic non-cancer related pain, such as chronic arthritis or back pain, also rely on these medications, without data demonstrating efficacy on their long term use.

"The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use," said Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research in the FDA's announcement about the guidelines. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them."

But while the new guidelines are helpful, they don't go far enough, according to an opinion piece in the New York Times. The Physicians for Responsible Opioid Prescribing, an advocacy group based in New York, which was a driving force for the new guidelines, also wanted the FDA to set a maximum daily dose and a maximum duration of 90 days use for treating pain, the NYT reported. In addition, the FDA didn't approve the group's request to limit all opioid analgesics, including immediate-release forms like Vicodin and Percocet, which are typically taken for shorter periods to treat acute pain.

But hospitals in San Diego are taking on these drugs. KPBS reports that under the new voluntary guidelines, emergency departments will no longer dispense 30-day supplies of narcotics like Vicodin as well as long-term painkillers.

Prescription drug overdoses are the leading cause of accidental death in San Diego County, according to the article. To combat the problem, San Diego hospitals state patients who suffer from chronic pain will need to get a painkiller prescription from their regular physician, not the emergency room.

For more:
- read the new labeling guidelines
- here's information from the CDC on prescription painkillers
- check out the editorial in the New York Times
- read the Forbes article
- here's the KPBS article

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