FDA Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy

July 9, 2012
On July 9, 2012, the U.S. Food and Drug Administration (FDA) approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. 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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