FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications
Today’s action places immediate-release opioid analgesic drugs intended for use in an outpatient setting into agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy
September 18, 2018
Release
Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620935.htm
