Doctors Petition for New Prescription Painkiller Rules to Limit Abuse

In an effort to protect the public from prescription drug abuse, a group of 37 doctors and public health officials have petitioned the U.S. Food and Drug Administration to change the prescription guidelines for opioid painkillers.

They have asked the FDA to change the labeling for drugs like OxyContin and Opana, prohibiting use of the drugs for treatment of moderate pain, adding a maximum daily dosage and specifying that patients should only take them for 90 days if not under treatment for cancer-related pain.

By changing the labels of these prescription drugs, the group hopes to limit promotion of the drugs for non-approved uses by drug makers like Purdue Pharma, Pfizer and Endo Health Solutions. OxyContin and Opana, which are both extended-release painkillers, are marketed by Purdue Pharma and Endo Health for the treatment of moderate pain to severe pain. Doctors usually consider moderate pain to be rated between four and six on a scale of ten and do not believe that it warrants treatment with potentially habit-form narcotic drugs.
Changing the label of prescription drugs will not force doctors to change how they prescribe powerful painkillers, but it may discourage them using them for the treatment of common aches and pains. Other drugs that would be affected by the label change include short-acting painkillers like Vicodin and Percocet. These drugs combine a narcotic painkiller with an over-the-counter drug like acetaminophen.

FDA Petitioned by Doctors
The petition signers include leading addiction experts and health officials from the Mayo Clinic, Cleveland Clinic and the New York City Department of Health. The petition is the latest in a series of actions by citizens and lawmakers that are aimed at getting the FDA to address the growing problem of painkiller abuse and addiction. The Centers for Disease Control and Prevention has reported that prescription drug overdoses deaths from ¬†have increase by more than 400 percent in the past decade to about 15,000 deaths per year. According to Edward Covington, a director at the Cleveland Clinic, “Overprescribing of opioids is harming many chronic pain patients.”
The FDA has six months to approve, deny or make a preliminary response to the petition. A final ruling could take more than a year. Meanwhile, the FDA is targeting the lack of doctor training about the dangers involved in prescribing opioid painkillers. The agency ruled that more than 20 pharmaceutical companies that produce these drugs, including Purdue Pharma and Endo Health, must provide grants to pay for training programs for doctors.