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FDA Revises Warnings on Painkillers in Light on Growing Addiction Epidemic

Sep 10, 2013 11:20 PM EDT
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The Food and Drug Administration is revisiting its label policies on prescription painkillers including OxyContin and morphin, in a bid to buckle down on the rising epidemic of prescription painkiller overdoses, the organization said Tuesday.

Previous warning labels for long-acting opioid pain relievers, which include forms of oxycodone, morphine and other narcotic medications, have previously said they are for the use of "moderate to severe pain." The new label will suggest the pain killers to only be used for "pain severe enough to require daily, around-the-clock" treatment, according to the FDA statement. Oxycontin, Opana ER, Embeda, Palladone and MS Contin fall into this class of drugs

"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities," FDA Commissioner Margaret Hamburg said in a press release.

The new label will also include a boxed warning about the risks of opioid withdrawal syndrome in infants who are exposed to the drugs during pregnancy, labor and nursing. Symptoms may include rapid breathing, trembling and poor feeding habits.

"These labeling changes describe more clearly the risks and safety concerns associated with 'extended release and long-acting' opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs," the FDA's Dr. Douglas Throckmorton said in a statement.

Although much of the misuse is illegal, even prescribed use can lead to addiction, overdose and death, Hamburg noted.

"In 2010, an estimated 16,651 people died because of abuse and misuse of opioid drugs," Hamburg said. "There is an increase of more than 300 percent over the past decade. And for each death there is an additional 10 treatment admissions, 32 emergency department visits and 825 nonmedical users of these drugs."

The most prescribed, According to IMS Health, the U.S. number one prescribed medication in 2012 was the opioid combination pill Vicodin and its generic equivalent, with 135 million prescription fillings in the year alone. Vicodin is a combination of hydrocodone and acetaminophen. The FDA's latest announcement does not affect Vicodin because it uses an immediate release formulation.

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