Welcome to the REMS website for Purdue's extended-release opioid analgesic products

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.

Purdue’s extended-release opioid analgesics are subject to the single, shared REMS for Extended-Release and Long-Acting (ER/LA) Opioid Analgesics. The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

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