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  • FDA Date: 05/26/2017

    Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS

    Goal of the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS Program

    The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

    REMS Elements

    • Medication Guide

    • Elements to Assure Safe Use