The U.S. Food and Drug Administration is under growing pressure from other federal agencies to change the prescription guidelines for opioid painkillers – a move that could make opioids difficult to obtain for patients suffering from fibromyalgia, back pain, migraine and other common chronic pain conditions.
“These are dangerous medications. They should be reserved for situations like severe cancer pain,” said Thomas Frieden, MD, director of the Centers for Disease Control and Prevention.
Frieden made that comment last week during a press briefing on a CDC report on the growing number of American women who are dying from painkiller overdoses. Although he didn’t specifically address changing the prescription guidelines for opioids, Frieden made it clear he thinks painkillers are over-prescribed, often for conditions that don’t warrant them.
“I don’t think there’s any evidence of a big increase in need for prescription opioids. I think we need to better understand the risks and benefits of these medications, said Frieden. “Patients given just a single course may become addicted for life. I think there’s been a trend in the medical profession and we need to reverse that trend.”
Another CDC official went even further, suggesting that opioids should not be prescribed for chronic pain disorders such as fibromyalgia.
“I think part of what we see is other conditions like fibromyalgia, migraines, other specific types of conditions that may be more common among women, opioids are often used in those settings yet guidelines and other studies looking at the (effectiveness) of opioids in those conditions really doesn’t support their widespread use,” said Dr. Chris Jones, a CDC health scientist.
It was nearly one year ago that a group of doctors and public health officials, led by Physicians for Responsible Opioid Prescribing (PROP), petitioned the FDA to change the prescription guidelines – also known as the “labeling requirements” — for opioids.
The agency currently approves most opioids for “moderate to severe pain,” but the petitioners say that is an overly broad definition that has encouraged physicians to prescribe powerful pain medications to patients who don’t really need them. They want the word “moderate” dropped from the labeling requirements, so that opioids would only be indicated for treatment of cancer pain and severe non-cancer pain.
Doctors would still be able to prescribe opioids “off label” for moderate pain, but many would be reluctant to do so if the federal guidelines are changed.
Frieden was asked if opioids should not be used to treat moderate pain.
“In the data we have reviewed, we have not seen a clear indication of these drugs for other conditions,” the CDC director said. “What we really want to emphasize is the risks and the benefits. These are risky drugs and there are often other medications and other therapies, like physical therapy, exercise, cognitive therapy, that can be very important in addressing chronic pain.”
The FDA has held hearings and sought public comment on PROP’s petition, but has yet to make a ruling on its merits. The agency is under increasing pressure from Congress and some public health officials to take stronger measures against the abuse of painkillers. In 2010, over 16,000 Americans died from overdoses associated with opioid painkillers.
“If FDA appropriately applies existing federal law, they’ll revise opioid labels to reflect evidence that benefits may not outweigh risks when opioids are prescribed long-term for these conditions,” said PROP co-founder Dr. Andrew Kolodny.
National Pain Report asked Kolodny if Frieden’s comments were aimed at pressuring the FDA to act.
“No, this has nothing to do with inter-agency rivalry,” Kolodny replied in an email.
“Dr. Frieden’s views are informed by evidence suggesting that opioids should be avoided for axial low back pain, headaches and fibromyalgia, which encompass the vast majority of chronic pain patients. Experts in the field of pain, addiction, evidence-based medicine and primary care agree with him. Only drug companies, die hard opioid extremists and opioid-dependent pain patients (who are understandably fearful of being cut off from their supply) would argue with this.”
But critics of PROP’s petition say the extent of painkiller misuse and abuse in the U.S. has been exaggerated.
“Regardless of the CDC comments, I believe that the FDA will take a fair scientific look where such science exists. Dr. Frieden’s views are NOT supported by evidence suggesting that opioids should be avoided for certain chronic pain syndromes, and most experts in the field of pain, addiction, evidence-based medicine and primary care would disagree with him,” said Dr. Jeffrey Fudin, founder of Professionals for Rational Opioid Monitoring & Pharmaco-Therapy (PROMPT), which is lobbying the FDA to reject the PROP petition.
“I believe the FDA has not made a decision or near making such a decision on relabeling of opioids,” Fudin said in an email to National Pain Report. “At the very least, I trust the FDA has been carefully pondering the risks and benefits of such label changes over the past year, and although all of us have serious concerns, we have no evidence to show that relabeling will make things better or worse.”
“The DEA is concerned about the potential public health risks resulting from the abuse of opioid drug products. Additional regulatory measures are necessary for opioid formulations to adequately safeguard the American public,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control.
“The DEA hopes that FDA will implement suitable measures, such as labeling revisions, to help mitigate the adverse impact on the public health resulting from abuse of these products.”
A spokesman for the FDA said the agency could not comment on the issue because it is still under review. But a possible hint on what the FDA is considering may have come in an April speech by FDA commissioner Margaret Hamburg at a drug abuse summit.
Hamburg called the abuse of prescription drugs “a public health crisis of enormous and devastating proportion” and said her agency would take a number of steps to prevent abuse, including “modifying opioid labeling.”Tags: FDA, Labeling, painkillers, prop