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Petition Seeks FDA Action on Narcotic Painkillers

Filed July 25th, 2012 Laurie

The Food and Drug Administration was asked Wednesday to consider changing the labeling on used on narcotic painkillers by nearly 40 doctors, researchers, and public health officials, a move that would make it harder for drug companies to market them for chronic, noncancer pain.

Thirty-seven people signed the petition, including many people associated with the reform group known as Physicians for Responsible Opioid Prescribing. The other signers are from various other institutions, including New York City Health Commissioner, the Cleveland Clinic, the Mayo Clinic, several universities, and the watchdog group, Public Citizen.

There is a growing concern in this country over a growing opioid epidemic in America, at least partly caused by the prescribing practices of many doctors. Over the past decade, prescriptions for opioid drugs like fentanyl and Oxycontin to treat chronic, noncancer pain have increased four times. There has also been a dramatic increase in opioid-related overdose deaths and in people seeking treatment for addiction.

Until the late 90s, opioids were used mainly for treating short-term pain, such as post-surgery pain and pain associated with cancer and end-of-life disease.

The petition calls for the labels to eliminate the word “moderate” and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain. Those uses would be considered “off-label.”

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