Information by Drug Class > Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids

Information by Drug Class > Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids

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 products¹). 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.

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Additional Information

• Questions and Answers: FDA approves a Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics²
  7/9/2012
• Blueprint for Prescriber Continuing Education (PDF - 104KB)³
• FDA introduces new safety measures for extended-release and long-acting opioid medications⁴
  FDA news release (7/9/2012)
• FDA Works to Reduce Risk of Opioid Pain Relievers⁵
  FDA Consumer Update

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Background and Historical Information

• Historical Information on REMS for ER/LA Opioid Drugs⁶