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Doctors Urge FDA to Update Painkiller Label with Limits

July 25, 2012 — In an attempt to bring increased awareness to the issue of overuse and abuse of prescription painkillers, a group of 35 doctors has sent a citizen petition to the U.S. Food and Drug Administration (FDA), asking the agency to change labeling directions. The doctors are asking for the FDA to limit the approval for treatment of “severe” pain, except in the case of cancer patients, and also limit the dosages for non-cancer pain and the duration of treatment.

Doctors would still be allowed to prescribe the painkillers “off-label” whenever they wish, but it would limit the ability of drug companies to market the products.

Narcotic painkillers are currently approved by the FDA to treat “moderate to severe” pain. The doctors would like to limit this to “severe” pain, except in the case of cancer patients, who could be prescribed a narcotic painkiller for less serious pain.

The FDA does not often make significant label changes on the basis of citizen petitions. The agency also frequently waits months or years to respond. However, the petition does raise awareness about the risks associated with long-term use of the drugs at high doses.

Drug-maker Purdue Pharma has already paid nearly $20 million to settle OxyContin lawsuits brought by 26 states and the District of Columbia. The states complained that Purdue engaged in illegal off-label marketing when they convinced doctors to prescribe OxyContin every eight hours, instead of the 12-hour dose approved by the FDA. As part of the settlement, Purdue agreed to only market the drugs according to their FDA-approved indications. Further limiting the labels would further limit Purdue’s ability to market the drugs.

Although prescription painkillers are often prescribed long-term to treat chronic pain, neither Purdue nor other drug companies have ever performed significant safety studies to determine the risks and benefits of long-term painkiller use. Independent studies have linked long-term use of the drugs to sleep apnea, reduced hormone production, and increased risk of falls and hip fractures in the elderly. Opioid painkillers also cause about 15,000 overdose deaths every year, mostly among addicts abusing the drugs.

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