FDA Requires Updates to Opioid Pain Medication Prescribing Information

Published: 08/01/2025

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

According to the U.S. Food and Drug Administration (FDA) the initial approval for OxyContin did not have sufficient study data supporting its long-term use to treat pain in many patient populations for which it has been prescribed. Two recent FDA-required observational studies have provided new data on how long-term opioid use can lead to serious side effects. Based on review of the results of these recent studies, public comments and medical research the FDA has announced safety labeling change

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