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Regulatory UpdatesAug 24, 2026•1 min read

MHRA Removes Post‑Operative Pain Indication for All Prolonged‑Release Opioids

By the PharmaCountry team

The MHRA has withdrawn the licence indication for post‑operative pain from all prolonged‑release opioids, citing heightened risk of persistent use and opioid‑induced respiratory complications.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has removed the indication for the treatment of post‑operative pain from the licences of all prolonged‑release opioid medicines. The decision was taken because of an increased risk of persistent post‑operative opioid use (PPOU) and opioid‑induced ventilatory complications. The agency advises healthcare professionals to consider alternative analgesic strategies for post‑operative pain management and to be vigilant about the potential for long‑term opioid dependence and respiratory depression when prescribing prolonged‑release formulations.

Compiled by the PharmaCountry team · Source: MHRA

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