FDA Should Change Labels On Opioid Painkillers to Deter Misprescribing

Labels on opioid pain medications (oxycodone [OXYCONTIN, ROXICODONE INTENSOL], for example) should be revised to prevent overprescribing, a broad coalition of doctors, researchers, public health officials and Public Citizen said in a July 2012 petition to the U.S. Food and Drug Administration (FDA). If the requested changes (detailed below) are adopted, drug companies no longer would be able to promote these pain medications as safe and effective for long-term use by noncancer patients.

 

The petition states that opioid labels are especially broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Currently, the labels on opioid analgesics simply state that they are approved for moderate to severe pain. The requested changes relate only to when opioids are used for noncancer pain. The coalition is calling for striking the term “moderate,” adding a suggested maximum dose equivalent to 100 milligrams of morphine and inserting a suggested duration of use. To learn more about the dangers of opioid medications, please see our discussion about this class of drugs.

 

The petition was signed by 37 prominent experts, including leaders in the fields of pain medicine, addiction and primary care; the health commissioners of New York City and New York state; researchers; and program directors at public interest groups, including Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. These co-signers believe that preventing drug companies’ aggressive promotion of these medications for moderate pain will help curtail overprescribing. According to the Centers for Disease Control and Prevention, excessive prescribing of opioid analgesics is fueling an epidemic of addiction and overdose deaths.

 

Drugmakers prefer nonspecific FDA-approved labels because with them manufacturers can encourage use of opioids for an indefinite period of time and for a wide range of common problems. The proposed label changes would have serious implications for drugmakers because federal law prohibits this “off-label advertising.”

 

 

According to Dr. Jane Ballantyne, a pain specialist at the University of Washington in Seattle and a co-signer of the petition, “A form of constraint that controls overuse while preserving opioids for patients in need can only be a positive step towards more rational and safer prescribing.”

 

Over the past 15 years, Purdue Pharma, maker of OXYCONTIN, and other opioid manufacturers have sponsored a campaign to encourage widespread, long-term prescribing of opioids for common chronic conditions like fibromyalgia and low back pain. Previously, doctors had been reluctant to use opioids long-term because they were worried about causing addiction. But misleading company-sponsored education campaigns reported that addiction was rare and that withholding opioids was cruel.

 

The coalition of experts who signed the petition believes that these labels must be changed to reflect existing medical evidence. The long-term effectiveness and safety of opioid analgesics has not been established by scientific studies, and recent research questions these outcomes with extended use, particularly at higher dosages.

 

“[Overprescribing] of opioids is harming many chronic pain patients,” states Dr. Edward Covington, director of the Neurological Center for Pain at the Cleveland Clinic. “The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long-term.” He continued, “The issue is tricky, because a subset of chronic pain patients benefit from chronic opioids, usually in low to moderate doses, and it is important that access is not restricted for those who show lasting benefit. The label change we’re requesting balances the need to preserve access for these patients with the need to reduce overprescribing.”

 

Although the proposed label changes would limit the way drug companies promote opioid analgesics, doctors would continue to prescribe these drugs based on their clinical judgment, assessment of each patient’s needs and the patient’s response to treatment. Weighing these factors is called “off-label prescribing” and is considered appropriate, even though off-label advertising is prohibited.

 

Dr. Lewis Nelson, an emergency physician and medical toxicologist at New York University Langone Medical Center, explained that “[i]t’s time to close the loophole on opioid labels,” which he says amount to “a mechanism that allows drug companies to promote opioids for unproven uses.” Physicians would be wrong to assume that the current indications on the labels are evidence-based regarding safety and efficacy.