FDA Adds Immediate-Release Opioids to REMS to Expand Training, Labeling

The FDA added immediate-release opioids to its risk evaluation and mitigation strategy (REMS) for opioid analgesics, saying the move will encourage “rational prescribing.”

Manufacturers of early-release/long-acting opioid analgesics have been subject to the REMS since 2012, but the addition of immediate-releases opioids — accounting for about 9 out of every 10 opioid drugs prescribed for outpatient use — means training must be available to prescribers and providers involved in pain management, along with educational materials that include alternatives to opioids.

The agency’s action introduces “a more stringent set of requirements” for immediate-release opioids, said FDA Commissioner Scott Gottlieb. “Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” he said. “This includes ensuring that prescriptions are written for only appropriate purposes and durations of use.”