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.
On July 9, 2012, FDA approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications.
ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions. The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overuse, and death.
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.
For more information, please visit: ER/LA opioid REMS
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