FDA to Require Black Box Warning on All Immediate-Release Opioid Medications

Medicare Set-Aside Blog, MSP News, News and Events, Rx/Pharmacy on March 22, 2016 | Posted by Erin O'Neill, PA-C, JD

On Tuesday, March 22, 2016, the U.S. Food and Drug Administration (FDA) announced it will now require a black box warning on all immediate-release opioid medications. This warning will address issues regarding the risks of abuse, addiction, misuse, overdose and death. The FDA had indicated that immediate-release opioid medications should be reserved for individuals with severe pain which is not relieved by non-opioid analgesics or opioid combination products or individuals that cannot tolerate the alternative treatment options.  This most recent requirement is the latest step in the FDA’s plan to address the opioid epidemic. The FDA has also indicated they are continuing to monitor potentially serious interactions between opioid medications and benzodiazepines and may issue additional warnings in the future.