Tighten Opioid Label Restrictions, Physicians Tell FDA

A coalition of 37 physicians that includes pain management and addiction experts petitioned the 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, toldMedscape 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."

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