(Aug. 15, 2025) – Last week, the Food and Drug Administration
announced the agency is requiring safety labeling changes for all opioid pain medications. The labeling changes follow a May
public advisory meeting and are intended to explain and emphasize the risks associated with long-term use of opioids. The labeling changes are extensive and include clearer risk information, stronger warnings about higher doses, clarified use limits, treatment guidance and many more. For the full list, see the
FDA announcement. The FDA gave manufacturers thirty days to submit their labeling updates to the FDA for review.
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Karen Braman