Saying it was time to “close the loophole” on narcotic painkillers, a coalition of doctors and public health officials is petitioning the Food and Drug Administration to change the prescription guidelines for opioid medicines. The move comes amid growing concern that the overprescribing and misuse of narcotic pain relievers has contributed to an epidemic of prescription painkiller abuse.
The FDA currently approves most opioid analgesics for “moderate to severe pain,” but the petitioners say that is an overly broad definition that has encouraged physicians to prescribe powerful narcotics for long periods to patients who don’t really need them.
“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 petition states. It calls on the FDA to change the guidelines so that opioids are only indicated for severe pain.
The petition is signed by 37 physicians, scientists, researchers and public health officials, including Dr. Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing, which lobbies against opioid abuse and overprescribing. Others who signed the petition are the New York City Health Commissioner and the New York state Commissioner of Health, as well as doctors associated with medical schools and prominent institutions such as the Mayo Clinic and the Cleveland Clinic. The lead petitioner is the watchdog group Public Citizen.
The petitioners say the prescribing of opioids has increased over the past 15 years, in response to a campaign by Purdue Pharma and other pharmaceutical companies that exaggerated the benefits of painkillers, while minimizing the risk of their long term use.
“Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain,” the petition says. “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.”
The petition calls for changing the labels on narcotic painkillers to eliminate the word “moderate,” and to include a maximum daily equivalent of 100 milligrams of morphine for a period of no more than 90 days to treat non-cancer pain. It does not request changes for treatment of pain in cancer patients.
Doctors would still be able to prescribe the drugs for “off-label” use, but drug makers would no longer be able to promote them for anything other than cancer pain or severe, non-cancer pain. Many chronic pain patients say it is already difficult to get prescriptions written or filled because recent crackdowns against pill mills and pharmacies have created a climate of fear among pain care providers.
“In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids,” petitioner Ed Covington, director of the Neurological Center for Pain at the Cleveland Clinic, said in a statement.
“It’s time to close the loophole on opioid labels,” said petitioner Lewis Nelson, MD, an emergency physician and medical toxicologist at NYU’s Langone Medical Center, who claims the current FDA guidelines create “a mechanism that allows drug companies to promote opioids for unproven uses.”
Purdue Pharma released a statement a statement calling the current guidelines “appropriate.”
“The FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate,” the company said. “We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges.”
Public Citizen said it would go to court if the FDA denies the petition or doesn’t hold an advisory panel hearing on the issue. The FDA has 180 days to approve, deny or provide a tentative response to the petition.