MHRA’s precautionary decision on pholcodine-containing medicinal products

Following a review by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulator has taken the precautionary step to recall medicines containing pholcodine.This precautionary measure has been taken as there is an extremely small but increased risk of an anaphylactic reaction when:

  1. a person has taken pholcodine-containing medicinal products particularly in the past 12 months preceding surgery;
  2. and, where neuromuscular blocking agents were used during the surgical procedure.

If consumers have questions about any over-the-counter medicines containing pholcodine they can speak to their pharmacist for advice and information.The link between pholcodine-containing medicinal products and neuromuscular blocking agents has been under investigation for a number of years − it is a known risk.PAGB Chief Executive, Michelle Riddalls, said:

“We and our members put an absolute priority on patient safety. The risk in people who have used pholcodine is extremely small and the MHRA has taken this decision as a precaution.“This precautionary measure is an example of the robust safety measures that we have in place in the UK working effectively.“Our members are working very closely with MHRA, healthcare professionals and pharmacists to ensure that appropriate action is taken.“Pholcodine containing products have only been available for purchase in pharmacies and if people have any questions pharmacists are well placed to give advice and recommend alternative products.”

– Ends –

Notes to editors

PAGB, the consumer healthcare association, represents the manufacturers of branded OTC medicines, self-care medical devices and food supplements in the UK.For more information, please contact Farhana Hawthorn, Media and Public Affairs Manager,, 07522616526.

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