On July 31, 2025, following a public advisory committee meeting in May, 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 including misuse, addiction, and both fatal and non-fatal overdoses.
These new labeling changes are part of the FDA's broader strategy to address opioid abuse, which also include expanding on the development of non-opioid analgesics to treat chronic pain.
Notable Opioid Labeling Changes Announced by the FDA July 31st, 2025
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 a long duration
Treatment Guidance: Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, 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: 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.
This summary is not a complete list of the FDA’s latest opioid labeling guidelines—the full list and additional information for providers can be found on the FDA’s website.
MyMatrixx by Evernorth Actions
MyMatrixx is dedicated to helping our clients monitor and manage the cost, utilization and safety of opioids and other pain medications within their claims and making sure our clients and the injured workers we serve are informed of the risks of opioids. If you have any questions about the FDA's new opioid labeling guidelines, please reach out to your MyMatrixx account team.