The U.S. Food and Drug Administration has announced significant opioid pain medication labeling changes to better emphasize and explain the risks associated with their long-term use. This action follows a May 2025 Public Advisory Committee meeting that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients using opioids over extended periods. You can read the full announcement in the FDA’s article FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks and review details of the meeting in the May 5, 2025 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.

FDA Commissioner Marty Makary, M.D., M.P.H., called the opioid epidemic “one of the cardinal failures of the public health establishment,” noting that while the labeling change is important, modernizing approval processes and post-market monitoring is equally critical to preventing similar crises.

Key updates to the labeling requirements include:

• Clearer risk information: Summarizing study results on addiction, misuse, and overdose during long-term use.
• Dosing warnings: Stronger guidance that higher doses come with greater risks.
• Clarified use limits: Removing language that could be misinterpreted to justify indefinite use.
• Treatment guidance: Reinforcing that long-acting or extended-release opioids should be considered only when other treatments are inadequate.
• Safe discontinuation: Reminders not to abruptly stop opioids in dependent patients.
• Overdose reversal agents: Expanded information on medicines that can reverse opioid overdoses.
• Drug interactions: Enhanced warnings about combining opioids with nervous system depressants, now including gabapentinoids.
• More overdose risks: New information on toxic leukoencephalopathy, a serious brain condition.
• Digestive health: Updates on opioid-related esophagus issues.

Additional details can be found in FDA Slaps Stronger Warnings on Opioids, which outlines further changes aimed at preventing substance misuse and addiction.

Pain is real, and it is different for every individual. No one should have to live with pain if there are pharmacological and non-pharmacological ways to manage it. Now is a good time to review your pharmacy reports and evaluate whether your pain management program is truly meeting residents’ needs. Talk to residents and families, document the effectiveness of medications, and don’t continue administering without supporting evidence. Consider tools like the 0–10 pain scale or the Wong-Baker Faces Pain Rating Scale for residents with cognitive impairment.

Making pain management a priority isn’t just about avoiding citations—it’s about ensuring residents aren’t experiencing unmanaged pain. And with the new opioid pain medication labeling changes, this is the perfect time to revisit your practices.

Stay well and stay informed!