Petition aims to change opioid prescribing

A coalition of 37 doctors, researchers, and public health officials petitioned FDA on July 25 to tighten label restrictions for opioid analgesics in an effort to curb prescription drug abuse.

“If the requested changes were adopted, drug companies would not be able to claim that the pain medications are safe and effective for long-term use by non-cancer patients,” according to a statement from Public Citizen, the nonprofit advocacy group introducing the petition.

The label changes relate to opioids prescribed to patients with chronic non-cancer pain. According to the Office of National Drug Control Policy, prescriptions filled for opioid pain relievers dramatically increased between 1997 and 2007, with the average milligram-per-person use increasing over 400%. At the same time, there also has been a steady increase in overdose deaths involving opioids.

According to the petition, FDA approved extended-release opioids for moderate-to-severe pain when a continuous, around-the clock analgesic is needed long term. The verbiage is too broad, the petition states, and implies that FDA deems long-term opioid use to be safe and effective-a misperception that leads to over-prescribing.

The petition seeks to:

• Strike the term “moderate” from the indication for non-cancer pain.

• Add a maximum daily dose, equivalent to 100 mg of morphine for non-cancer pain.

• Add a maximum duration of 90 days for continuous (daily) use for non-cancer pain.

“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 states.

“The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long-term,” said Edward Covington, MD, director of the Neurological Center for Pain at the Cleveland Clinic, for Public Citizen. “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.”