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The 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.
The context: The changes follow a public advisory committee meeting in May that reviewed data showing serious risks for patients who use opioids over long periods.
The details: The labeling changes will include:
- 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 carry greater risks
- Clarified use limits: removing language that could be misinterpreted to support using opioids over indefinitely long duration
- Treatment guidance: reinforce that long-acting or extended-release opioids should only be considered when other treatments are inadequate
- Safe discontinuation: a reminder not to stop opioids suddenly in patients who may be dependent
- Information about overdose reversal agents
- Warnings about drug interactions, including for gabapentinoids
- More risks with overdose: information about toxic leukoencephalopathy (brain condition that may occur after overdose)
- Digestive health: updates about opioid-related problems with the esophagus
Read more: FDA to stress opioids’ risk of overdose, death in new medication safety labels
Published
August 2025