Drug Information Update - Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

Last week, the White House unveiled a multi-agency plan aimed at reducing the "epidemic" of prescription drug abuse in the US. In concert with the White House plan, the Food and Drug Administration (FDA) is announcing a new risk reduction program — called a Risk Evaluation and Mitigation Strategy — for all extended-release and long-acting opioid medications.

FDA experts say extended-release and long-acting opioids — including OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names — are extensively misprescribed, misused, and abused, leading to overdoses, addiction, and even deaths across the United States. FDA says a 2007 survey revealed that more than half of opioid abusers got the drug from a friend or relative.

Opioids — such as morphine and oxycodone — are used to treat moderate and severe pain. Over the past few decades, drug makers have developed extended-release opioid formulas to treat people in pain over a long period.

The new REMS plan focuses primarily on: educating doctors about proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely. As part of the plan, FDA wants companies to give patients education materials, including a medication guide that uses consumer friendly language to explain safe use and disposal.

For more information, please visit: Opiod REMS

List of Long-Acting and Extended-Release Opioid Products Required to Have an Opioid REMS:

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