Tighten Opioid Label Restrictions, Physicians Tell FDA

A coalition of 37 physicians that includes pain management and addiction experts petitionedthe US Food and Drug Administration (FDA) yesterday to tighten label restrictions for opioid analgesics as a way to combat the epidemic of addiction and fatal overdoses associated with these drugs.

Under the proposed label changes, opioids would no longer be indicated for moderate noncancer pain. The petition notes that moderate to severe pain is the FDA-approved indication for nearly all instant-release opioids as well as extended-release versions when 24/7 pain relief is needed for a long stretch of time. Such “overly broad indications” imply that the FDA has established that long-term use of opioids is safe and effective, the petition states. “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.”

In addition, the maximum daily dose would be the equivalent of 100 mg of morphine, and the maximum duration for continuous daily use would be 90 days under the proposed label changes. Both limits would apply to noncancer pain.

One of the petitioners, Andrew Kolodny, MD, president of Physicians for Responsible Opioid Prescribing, told Medscape Medical News that the label changes would not prevent physicians from prescribing opioids at doses and durations that they deem appropriate for patients on a case-by-case basis. However, the changes would limit claims that drug companies can make about their products.

“Right now, drug companies are promoting long-term opioids as proven safe and effective for chronic pain,” he said. “They’ll promote [them] for lower back pain, fibromyalgia, osteoarthritis, whatever they want…because the current label is like a blank check.”

“By prohibiting the aggressive marketing, we can reduce the overprescribing,” said Dr. Kolodny. Physicians who understand that opioids are not necessarily safe and effective long term may resort to other treatments such as behavior modification, physical therapy, and weight loss, he added.

Other physicians signing the petition include

• Roger Chou, MD, Associate Professor of Medicine, Oregon Health & Science University
• Edward Covington, MD, Director, Neurological Center for Pain, Cleveland Clinic
• Stuart Gitlow, MD, MPH, Acting President, American Society of Addiction Medicine
• Elinore McCance-Katz, MD, PhD, Professor, Department of Psychiatry, University of California–San Francisco
• Nirav Shah, MD, MPH, Commissioner, New York State Department of Health
• Sidney Wolfe, MD, Director, Health Research Group at Public Citizen

Label Change Called Necessary for Effective REMS

The petition to revise the label of opioid analgesics comes on the heels of a new FDA initiative to help turn the tide of the prescription painkiller epidemic, which is causing more fatal overdoses than cocaine and heroin combined, according to the US Centers for Disease Control and Prevention. Earlier this month, the FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids prescribed for moderate to severe chronic pain. More than 20 opioid manufacturers must make available to prescribers continuing education programs on the proper use of these drugs. This education will be funded through grants from manufacturers to continuing medical education providers, who will develop the training based on a blueprint for content provided by the FDA and will deliver the training.

Dr. Kolodny told Medscape Medical News that the REMS for opioids “isn’t going to help and could potentially make things worse.”

Without the label change sought by his coalition, he said, the REMS curriculum would still leave doctors “with the false impression that long-term opioid therapy was proven safe and effective.”

One company that would be affected by the envisioned label change is Purdue Pharma, the maker of controlled-release oxycodone (OxyContin), which is indicated for moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period. When asked to comment on the petition to the FDA, Purdue Pharma issued a statement saying, “[The] FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate.

“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,” the company added.

Ensure Opioid Availability for Legitimate Need, Cautions Pain Expert

One pain expert interviewed by Medscape Medical News sounded a cautionary note about the petition submitted to the FDA about revising opioid labels.

“I share the concern of this group,” said Charles Argoff, MD, a professor in the neurology department at Albany Medical College and director of the Comprehensive Pain Program at Albany Medical Center in New York. “However, we need to establish prospectively whether this approach accomplishes what this petition suggests it would. This group has yet to prove that the recommendations in the petition are appropriate recommendations.”

Any changes to opioid labeling must be anchored “in the highest-quality medical evidence,” said Dr. Argoff, a member of the editorial advisory board for Medscape Neurology. Otherwise, patients could suffer harm.

“We have a prescription drug abuse crisis…that we must combat,” he said. “But [the petition] does not address the millions and millions of people who have been appropriately prescribed this medication, who have been appropriately monitored, and who have lived a more functional life as a consequence. We need to ensure the availability of these drugs for patients who can benefit from them and establish concrete approaches to limiting the abuses and misuses.”

Dr. Argoff has spoken out in the past on the problem of “allowing physicians with insufficient training to prescribe medications that can kill people.” He reiterated that concern in his remarks on the opioid-labeling petition.

“To demonize the drug is ignoring the responsibility of the prescriber,” he said. (Robert Lowes)