Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 5/25/17

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

Open the Full REMS Notification

REMS Summary of Terms