Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids
On July 9, 2012, FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications.
ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions (list of ER/LA opioid products). The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overdose, and death.
The REMS is part of a multi-agency Federal effort to address the growing problem of prescription drug abuse and misuse. The REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain.
New Safety Measures Announced for Extended-release and Long-acting Opioids
Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
7/9/2012; updated 3/1/2013
List of Extended-Release and Long-Acting Opioid Products Required to Have an Opioid REMS(PDF - 25KB) Blueprint for Prescriber Continuing Education(PDF - 270KB)
FDA introduces new safety measures for extended-release and long-acting opioid medications
FDA news release (7/9/2012)
FDA Works to Reduce Risk of Opioid Pain Relievers
FDA Consumer Update
- ER/LA Opioid Analgesics REMS (PDF - 2.4MB)
Includes current medication guides for ER/LA opioids
- July 9, 2012 Medication Guide Template for ER/LA Opioid Analgesics REMS (PDF - 47KB)