July 25, 2012 — A group of 35 doctors have filed a citizen’s petition with the U.S. Food and Drug Administration (FDA), asking the agency to make changes to the labeling on narcotic opioid painkillers. The group is attempting to raise awareness about the ongoing issue of overuse and abuse of prescription painkillers. The doctors are concerned about the lack of studies regarding the long-term use of high doses of opioid painkillers, and they want the FDA to limit the approval to “severe” pain only. Furthermore, they want the FDA to limit the dosage and duration of treatment. Exceptions would be made for cancer patients.
If the FDA did change the labels, it would limit the ability of drug companies to market the drugs for treatment of chronic pain. It would not limit the ability of doctors to prescribe the drugs “off-label,” which is their right.
The FDA has approved opioid painkillers for the treatment of “moderate to severe” pain. The petition is calling for the FDA to change this to “severe” pain only in non-cancer chronic pain treatment.
It is unlikely that the FDA will take action based upon the citizen’s petition. The agency often waits months or years to respond to such petitions. In the short term, however, the doctors achieve a goal of raising awareness about the problems of long-term use of high-dose narcotic painkillers in the treatment of chronic pain.
Drug companies that manufacture these products have been criticized for the way they marketed the drugs to doctors. After 26 states and the District of Columbia filed a lawsuit against Purdue for illegal off-label marketing of OxyContin, the drug-maker agreed to a $20 million settlement. The company was accused of promoting OxyContin for use in 8-hour doses, but the FDA only approved the drug for 12-hour doses.
The doctors who petitioned the FDA want the agency to impose further limits on the way the drug company can market opioid painkillers.
Prescription opioid painkillers are often used in the treatment of chronic pain, and they have been a mainstay of pain management therapy since the 1990s. However, Purdue and other drug companies that make these products have never conducted long-term, high-dose studies. Independent research has suggested they could increase the risk of sleep apnea, reduce hormone production, and increase an elderly person’s risk of falls and hip fractures.
Abuse and overuse of narcotic painkillers is also a serious concern. Tens of thousands of people are addicted to the drugs and require increasingly high doses to manage their chronic pain. Every year approximately 15,000 people die from overdoses of an opioid painkiller, though most of these deaths are among drug addicts.
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