FDA Requiring Stronger Safety Labels for Opioid Medications

MONDAY, Aug. 4, 2025 (HealthDay News) -- The U.S. Food and Drug Administration announced it will now be requiring updated safety labels for all opioid pain medications to better highlight the risks of long-term use, including misuse, addiction, and overdose.The updated FDA opioid safety labeling is based on new data from two large postmarketing observational studies, which showed serious risks from long-term use. Citing these findings, public input, and the lack of strong evidence supporting long-term effectiveness, the FDA is updating opioid safety labels to support treatment decisions based on the latest evidence."The death of almost 1 million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment," FDA Commissioner Marty Makary, M.D., M.P.H., said in a statement. "This long-overdue labeling change is only part of what needs to be done -- we also need to modernize our approval processes and postmarket monitoring so that nothing like this ever happens again."The labeling changes will include clearer risk information; stronger dosing warnings; clarified use limits, including removing language that could be misinterpreted as supporting indefinite use; and treatment guidance, emphasizing that long-acting opioids should only be used when other treatments, including short-acting opioids, are ineffective.The labels will also address safe discontinuation; overdose reversal agents; drug interactions, including combining opioids with gabapentinoids; additional risks with overdose, highlighting new information on postoverdose toxic leukoencephalopathy; and digestive health, including updates about possible esophageal complications.The FDA is also requiring a new randomized, controlled clinical trial to directly assess the benefits and risks of long-term opioid use. The agency says it will closely monitor the trial's progress.More Information.Sign up for our weekly HealthDay newsletter

FDA Requiring Stronger Safety Labels for Opioid Medications

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