FDA Mandates Major Opioid Label Revisions to Highlight Long-Term Risks
Pharmacy Times
AUGUST 7, 2025
Extended-release opioids may now be labeled only when non-opioid therapies and immediate-release formulations prove lacking, and labels must caution against abrupt discontinuation in physically dependent patients due to potential withdrawal, uncontrolled pain, or suicidal thoughts. REFERENCES 1. Food and Drug Administration.
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