July 26, 2012
FDA Receives Petition To Change Labels On Painkillers
Connie K. Ho for redOrbit.com — Your Universe Online
A group of clinicians, researchers, and health officials recently submitted a petition requesting the U.S. Food and Drug Administration (FDA) to regulate labels on opioid painkillers in an effort to stop abuse of the drugs.
In the petition, the authors describe how opioid labels are overly broad and simply state “moderate to severe pain.”
“These overly broad indications imply a determination by FDA that they are safe and effective for long-term use. As outlined below, an increasing body of medical literature suggests that long-term use of opioids may be neither safe nor effective for many patients, especially when prescribed in high doses,” the authors wrote in the letter.
According to the New York Times, the drugs can be placed into two categories. One category includes short acting drugs like Percocet or Vicodin, where a narcotic is mixed with an over-the-counter painkiller. The other category, which applies to drugs like fentanyl, methadone, and OxyContin, includes long-acting painkillers that have a pure narcotic.
One of the requests by the authors is that the term “moderate” be changed to include a suggested maximum dose equivalent to 100 milligrams of morphine with a suggested duration of use. They also state that the label changes are necessary to reflect new medical evidence. Scientific studies have not demonstrated the long-term effectiveness and safety of taking opiod painkillers.
“It´s clear that the short-term effects, on the basis for which they are approved and marketed, do not mirror their effects in long-term use. In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids,” explained Dr. Edward Covington, director of the Neurological Center for Pain at the Cleveland Clinic, in a prepared statement.
The authors of the letter were composed of 37 experts who specialize in pain, addiction, primary care, international medicine, anesthesiology, psychiatry, neurology, emergency medicine, toxicology or rheumatology and advocated changes that could reduce problems related to the prescription of high dosages. They believe that an increase in prescribing pain killers has related to a four-fold increase of deaths related to overdose of painkillers and a six-fold increase in the number of people who are seeking counseling related to addiction of painkillers. They also state that, based on medical and pharmacy records, two-thirds of patients who take painkillers on a daily basis for 90 days will continue to take painkillers five years later.
“These misperceptions lead to over-prescribing and high dose prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids,“ commented the authors in the petition.
With these changes, the experts believe that drug companies´ will be prevented from promoting the medications for moderate pain and be prohibited from overprescribing. The Centers for Disease Control and Prevention (CDC) state that overprescription can lead to addiction and deaths related to overdose.
“Over-prescribing of opioids is harming many chronic pain patients,” Covington commented in the statement. “The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long-term.”
According to Reuters, the FDA usually does not comment on petition and stated that the petitioners would receive a direct response. If the changes brought up by the authors are adopted by the FDA, drug companies like Endo Heath Solutions Inc., Pfizer Inc., and Purdue Pharma will no longer be able to state that pain medications can be used long-term in a safe and effective manner by non-cancer patients.