Pholcodine cough medicines withdrawn in UK over allergy fears

In March, the Medicines and Healthcare products Regulatory Agency (MHRA) advised that pholcodine-containing cough and cold medicines were to be removed from the UK market as a precautionary measure.

Pholcodine can be used to treat a dry cough in adults and children over six years and, in combination with other active substances,  to treat symptoms of cold and influenza. It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.

The withdrawal is a result of a series of studies which identified a link between pholcodine and an increased risk of the very rare event of a severe allergic reaction (anaphylaxis) to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery. Allergy UK was the only patient organisation involved in meetings with the Royal College of Anaesthetists which led to this landmark withdrawal after findings of a new study published in September 2022 further strengthened the evidence of this link.

Pholcodine can be found in some cough and cold relief solutions, and capsules, cough syrups, linctus, and solutions especially those aimed at dry tickly coughs. Pholcodine should be clearly stated as an ingredient on the packaging or the patient information leaflet inside the packaging. In the UK, medicines that contain pholcodine cannot be bought off the shelf; they are usually stored behind the counter at the pharmacy and so need to be requested and approved by the pharmacist. This is because they are not suitable for everyone, especially people with respiratory problems such as asthma.

Some of the medicines which contain pholcodine include:

  • Boots Day Cold & Flu Relief Oral Solution (BOOTS)
  • Boots Dry Cough Syrup 6 Years+ (BOOTS)
  • Boots Night Cough Relief Oral Solution (BOOTS)
  • Care Pholcodine Oral Solution Sugar Free
  • Covonia Dry Cough Sugar Free Formula
  • Cofsed Linctus
  • Day & Night Nurse Capsules (GSK)
  • Day Nurse Capsules (GSK)
  • Day Nurse (GSK)
  • Dry tickly cough
  • Galenphol Linctus
  • Galenphol Paediatric Linctus
  • Galenphol Strong Linctus
  • Pholcodine Oral Solution
  • Pholcodine Linctus
  • Pholcodine Linctus BP
  • Strong Pholcodine Linctus BP

The risk of an allergic reaction is very small, so most people will have no problems, but there is a slight risk for people requiring surgery. Dr Alison Cave, MHRA Chief Safety Officer, explains, ‘If you have an operation scheduled using general anaesthesia, tell your anaesthetist if you think you have used pholcodine, particularly in the past 12 months. The anaesthetist will be well placed to take this into account. Anaesthetists are highly trained in managing anaphylaxis.’

Pharmacists are well placed to advise on alternative treatments if required. There are plenty of cough and cold medicines that don’t contain the ingredient pholcodine, as well as other practical remedies to soothe coughs and colds.

Most coughs and colds will clear within a few weeks; however, anyone experiencing a persistent cough that does not improve or if breathing is affected should seek medical advice.