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FDA orders new label warnings to curb the epidemic of painkiller overdoses and deaths

The Food and Drug Administration has issued new prescribing guidelines for opioid painkiller medications in order to lower the risk of overdose or addiction among patients. Opioid painkillers include drugs such as oxycodone, hydrocodone, morphine, fentanyl, and methadone.

The new FDA guidelines come at a time when deaths from prescription painkillers are at an all-time high. Deaths from painkiller overdose surpassed traffic fatalities in 2009 for the first time ever. According to the Centers for Disease Control and Prevention, more than 16,000 deadly painkiller overdoses occurred in 2010.

Under the new FDA guidelines, the companies who manufacture 20 long-acting painkillers will be required to rewrite the labels for these drugs so that they will be prescribed less frequently by doctors. Only patients who require around-the-clock pain management everyday over a long period of time and who cannot be treated with other pain medications will be allowed to take these extended-release, long-acting painkillers. The FDA is also requiring a black-box warning to pregnant women to alert them that the use of painkillers during pregnancy can lead to withdrawal symptoms in newborns.

The FDA will require the manufacturers of these medications to conduct safety studies in order to determine the doses and delivery methods that are most effective at preventing overdoses, addiction, and other side effects.

Some of the drugs that are affected by the new FDA warning include OxyContin, fentanyl (Duragesic patch), Methadone, Oxycontin, Opana ER, Embeda, and Palladone.

Commenting on the announcement, FDA spokeswoman Margaret Hamburg said that the new safety guidelines were needed because of the epidemic of prescription painkiller overdoses and deaths that has arisen over the last decade. “In 2010, an estimated 16,651 people died because of abuse and misuse of opioid drugs,” she 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.”