Drugs
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.
Additional Information
Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
7/9/2012Blueprint for Prescriber Continuing Education (PDF - 104KB)
7/9/2012FDA 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 - 1.3MB)
Updated 8/28/2012 Medication Guide Template for ER/LA Opioid Analgesics REMS (PDF - 47KB)- Medication Guides for ER/LA Opioids (PDF - 1.4MB)
Approval Letters
Background and Historical Information
Contact FDA
Division of Drug Information (CDER)
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