FDA Mandates Major Opioid Label Revisions to Highlight Long-Term Risks
Pharmacy Times
AUGUST 7, 2025
Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. Expanded warnings include interactions with CNS depressants and rare outcomes like esophageal dysfunction, aligning with CDC's 2022 opioid prescribing guidelines.
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