MHRA Alert – Prolonged-Release Opioids: Post-Operative Pain Indication Removed

Key Safety Update

The MHRA has removed the post-operative pain indication from all prolonged-release opioid medicines. This change reflects growing evidence of the risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment in this patient group.

What Has Changed

Prolonged-release opioid formulations are no longer licensed for the relief of post-operative pain. This applies across all prolonged-release opioid products currently authorised in the UK.

Clinical Implications

• Post-operative pain management should rely on multimodal analgesia strategies, including paracetamol, NSAIDs, regional anaesthesia, and short-acting opioids where clinically indicated
• Prolonged-release formulations are not appropriate for acute post-operative pain due to their pharmacokinetic profile and the risk of respiratory depression
• Clinicians should review prescribing practices and ensure patients transitioning from acute post-operative care are not inadvertently continued on prolonged-release opioids

Recommended Actions

• Review any current prescriptions of prolonged-release opioids in post-operative patients
• Ensure acute post-operative pain is managed using appropriate short-acting analgesics and multimodal approaches
• Communicate this change to relevant teams, including anaesthesia, surgery, and pain management services
• Update local protocols and formularies as needed

Further Information

Full details are available on the MHRA Drug Safety Update page.