> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Immediate-Release Opioids Now Under REMS
- URL: https://www.fdaweb.com/immediate-release-opioids-now-under-rems/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142382

FDA has approved a final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) that now applies to immediate-release opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting opioid analgesics that have been subject to a REMS since 2012, according to an agency [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620935.htm?utm%5Fcampaign=09182018%5FPR%5FFDA%20takes%20new%20steps%20to%20encourage%20appropriate%20opioid%20prescribing&utm%5Fmedium=email&utm%5Fsource=Eloqua&elqTrackId=EEB51520CC58AB93D3A3D13E410CD44A&elq=089877a1612e44d7b6e53044720e2acc&elqaid=5122&elqat=1&elqCampaignId=4096) that includes a link to the REMS.

For the first time, FDA says, the REMS program requires that training be made available to healthcare providers who are involved in managing patients with pain, and not just to prescribers. And the REMS requires that the education cover broader information about appropriate pain management, including alternatives to opioids for treating pain. Through the new REMS, FDA also approved new product labeling containing information about the healthcare provider education available through the new REMS.