Class 2 Medicines Recall: Various Marketing Authorisation Holders, Pholcodine-Containing Products, EL (23)A/09

This article has been brought to you by Slough Borough Council's H&S Advisor Shameem Din for the attention of all Schools. 

We have received a notification from the Medicines and Healthcare products Regulatory Agency (MHRA) that following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.  Please can you share this information with parents and other relevant parties.

Brief description of the problem

Following a scientific review by the MHRA on pholcodine-containing medicines, which are licensed to treat dry cough in adults and children over 6 years old, it has been found that there is evidence of an increased risk of the very rare event of anaphylaxis (a sudden, severe and life-threatening allergic reaction) in surgical patients who receive general anaesthesia involving neuromuscular blocking agents (NMBA). NMBAs are used to relax the muscles during general anaesthesia for some surgical procedures. Based on advice from the independent advisory body, the Commission on Human Medicines (CHM), pholcodine-containing medicines are being withdrawn from the UK market as a precaution.  Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09

Advice for patients and consumers

  • If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient
  • if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.
  • Tell your anaesthetist before you have surgery if you think you have taken pholcodine, particularly in the past 12 months, or think you may have taken a pholcodine-containing product. There is no increased risk of allergic reactions, including anaphylaxis, with other allergens following pholcodine use and the absolute risk in patients who have used pholcodine is very small
  • Report any suspected side effects via the Yellow Card Scheme