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