Groups Petition FDA to Change Opioid Labeling, Limit Long-term Use for Chronic, Non-Cancer Pain

August 1, 2012 4:31 PM Topics: Controlled substances, Federal regulations, and Pain management

Groups representing health care providers, researchers, and public health officials submitted a petition (PDF) requesting FDA to change opioid drug labeling so that indications for use in treating chronic, non-cancer pain would be limited. Supporters hope that such a change could “reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids," as stated in the petition. Specifically, petitioners request that opioid labeling should indicate appropriateness for severe non-cancer pain, and that “moderate” be stricken from the indication. In addition, they request that the indicated maximum daily dose be the equivalent of 100 milligrams of morphine for non-cancer pain, with a maximum duration of 90 days for daily use. More information about the petition is available in a MedPage Today article.