FDA Announces Enhanced Warning Labels on Opioid Pain Medications

HealthDay News — The US Food and Drug Administration has announced that immediate-release opioid pain medications will get new boxed warnings about the dangers of misuse.

“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.”

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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.

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.


FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death. US Food and Drug Administration (FDA). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm. Accessed March 23, 2016.