FDA Orders Opioid Safety Label Overhaul on Long-Term Risks

The US FDA will require drugmakers to submit updated opioid labeling within 30 days for review, aiming to better reflect long-term use risks including addiction and overdose.

• FDA sent letters to relevant applicants outlining changes
• Labeling update follows advisory review and new data from FDA-mandated studies
• FDA also requiring a new randomized trial to study long-term opioid use directly
• Labeling changes to include:
  • Removal of language suggesting support for indefinite use
  • Highlights overdose reversal agents and risks from drug combinations
  • Clearer warnings on misuse, addiction and overdose risks

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