Pholcodine containing cough and cold medicines withdrawn from UK market

15th March 2023

Pholcodine containing medicines are being withdrawn in the UK by the MHRA after a review suggested the risks outweigh the benefits

Pholcodine is an opioid that is approved for use in adults and children over 6 years of age as a treatment for a dry or non-productive cough, although it is also present in other products as a treatment for cough and cold symptoms.

The MHRA in the UK has said that pholcodine containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review and will no longer be available from pharmacies. This decision was based on the potential for an interaction, giving rise to anaphylaxis, with neuromuscular blocking agents (NMBAs). This possible interaction has already been mentioned in the summary of product characteristics for pholcodine.

The MHRA review published on the 14th March 2023, states that recently completed ALPHO study, showed that use of pholcodine during the 12 months preceding anaesthesia was significantly associated with an increased risk of peri-anaesthetic anaphylaxis to NMBAs (adjusted odds ratio = 4.2, 95% CI 2.5 to 6.9).

While information on the risk from pholcodine use beyond 12 months was not available in the ALPHO study, evidence from a study in Norway, showed that IgE-mediated anaphylaxis to neuromuscular blocking agents, was still present, 3 years after withdrawal of pholcodine.

However, the MHRA does add that while the risk of an anaphylactic reaction to NMBAs in less than one case per 10,000 procedures, it still believes that it is necessary to withdraw pholcodine as a precautionary measure.

The action by the MHRA follows a similar move by the European Medicines Agency in December 2022.