HealthDay News – A class-wide change in safety labeling for all immediate-release (IR) opioids is now being required by the U.S Food and Drug Administration (FDA). The changes include a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death associated with these medications.

“We are at a time when the unfathomable tragedies resulting from addiction, overdose, and death has become one of the most urgent, devastating public health crises facing our country,” FDA Commissioner Robert Califf, MD, told reporters at a Tuesday news briefing. He said the agency is working with other agencies, drug makers, doctors, and patients “to prevent abuse, save lives and treat dependence while still providing patients in pain access to effective relief.”

The new labeling rules are mostly aimed at immediate-release versions of opioids. According to an FDA news release, the new label requirements include: a new boxed warning on the “serious risks of misuse, abuse, addiction, overdose, and death;” a new prescribing guideline that immediate-release opioids “should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated;” and labeling stressing the risk of neonatal opioid withdrawal syndrome in infants born to mothers who took opioids during their pregnancy.

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Besides this new labeling for immediate-release opioids, the FDA is also mandating other revised labeling for all opioids. All of these drugs will now include information on labels warning of potential harmful interactions of the drug with other medicines that can result in serotonin syndrome, the agency said. Labels will also warn of possible opioid effects on the endocrine system.

Summary and Clinical Applicability

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” Dr Califf said in the press release.

The FDA is also currently reviewing data regarding the potentially serious outcomes from concomitant benzodiazepine and opioid use. Once completed, the agency will alert prescribers of the risks involved with these medications.


U.S. Food and Drug Administration Press Release. FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death. Published March 22, 2016. Accessed March 22, 2016. Source Code.