FDA Requires Major Changes to Opioid Pain Medication Labeling
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. Changes follow a public advisory committee meeting in May that reviewed data showing serious risks when opioids are used over long periods.
The updated labeling reflects data from two large FDA-required observational studies, which provided new data on how long-term opioid use can lead to serious side effects. FDA decided to require the following safety labeling changes to help healthcare professionals and patients make treatment decisions rooted in the latest evidence:
- Clearer risk information: A summary of study results showing the estimated risks of addiction, misuse and overdose during long-term use.
- Dosing warnings: Stronger warnings that higher doses come with greater risks, and that those risks remain over time.
- Clarified use limits: Removing language that could be misinterpreted to support using opioid pain medications over indefinitely long duration.
- Treatment guidance: Labels will reinforce that long-acting or extendedrelease opioids should be considered only when other treatments are inadequate.
- Safe discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
- Overdose reversal agents: Additional information on medicines that can reverse an opioid overdose.
- Drug interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system — now including gabapentinoids.
- More risks with overdose: New information about toxic leukoencephalopathy — a serious brain condition that may occur after an overdose.
- Digestive health: Updates about opioid-related problems with the esophagus
FDA has also required an additional prospective, randomized, controlled clinical trial to examine the benefits and risks of long-term opioid use, and will be closely monitoring the progress of the clinical trial to ensure its timely completion.
References
- U.S. Department of Health and Human Services. FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks, July 31, 2025. Accessed at www.hhs.gov/press-room/hhs-winds-downmrna-development-under-barda.html.