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FDA to Change Opioid Labeling Rules to Emphasize Long-Term Risks

UNITED STATES, JUL 31 – The FDA mandates opioid labels to highlight addiction, misuse, overdose, and other risks from long-term use based on data from two large postmarketing studies.

  • The FDA revealed it is requiring safety labeling changes to opioid pain medications to emphasize long-term risks, following a review of new data and public feedback.
  • Following a May advisory committee meeting and review of postmarketing requirements PMR 3033-1 and PMR 3033-2, the FDA mandated safety label updates for opioids.
  • Among the required changes, prescription opioid labels will include clearer risk summaries on addiction, overdose, and misuse, with stronger warnings on higher doses and drug interactions with gabapentinoids, FDA said.
  • In response, the FDA sent letters to applicants outlining labeling changes, and the impact remains unclear.
  • The FDA has also required a prospective, randomized, controlled clinical trial to examine benefits and risks of long-term opioid use, though the public health impact remains unclear.
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FDA to change opioid labeling rules to emphasize long-term risks

(The Center Square) – The U.S. Food and Drug Administration plans to require new labels on all opioid pain medications that emphasizes long-term risks associated with the use of the drugs.

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MedPage Today broke the news in New York, United States on Thursday, July 31, 2025.
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