Common cough medicines recalled across Scotland and the wider UK over safety fears

Some over-the-counter cough medicines are being recalled over safety concerns, with fears of the “very small” risk some patients could suffer a rare allergic reaction.

The issue, according to medics, is an ingredient called pholcodine, which carries a very rare chance of causing allergic reactions in users who undergo anaesthesia.

People are being asked to check the packaging of any cough tablets or syrups they have at home to see if pholcodine is listed.

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Although the affected products do not need a prescription, they cannot be bought without first consulting a pharmacist.

Some over-the-counter cough medicines are being recalled over safety concerns.Some over-the-counter cough medicines are being recalled over safety concerns.
Some over-the-counter cough medicines are being recalled over safety concerns.

The risk of suffering a severe allergic reaction (anaphylaxis) is thought to be among people who have taken a cough or cold product containing pholcodine in the 12 months prior to undergoing surgery.

Dr Alison Cave, chief safety officer at watchdog the Medicines and Healthcare products Regulatory Agency, said: “Safety is our top priority, and we keep the safety of medicines under continual review.

“Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.

“If you are taking a cough or cold medicine, 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 will suggest an alternative medicine.”

Dr Cave said anyone due to have an operation under general anaesthesia should tell the anaesthetist if they think they have used pholcodine, particularly in the past 12 months.

The European Medicines Agency recommended the withdrawal of pholcodine medicines from the European market in December last year.

In the UK, healthcare workers have been told to stop supplying the products “immediately” and “quarantine all remaining stock”.

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Advice given to healthcare professions by the UK Government reads: “Pholcodine is an opioid medicine approved in adults and children older than six years of age to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and influenza.

“Previous reviews have examined the link between prior use of pholcodine and an increased risk of anaphylaxis during general anaesthesia involving neuromuscular blocking agents (NMBAs). The potential for cross-reactivity between pholcodine and NMBAs was added to the product information for pholcodine-containing medicines in January 2022.

“Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review which found that their benefits do not outweigh the increased risk of the very rare event of anaphylaxis to NMBAs used in general anaesthesia.

"Tell your anaesthetist before you have surgery if you have taken pholcodine, particularly in the past 12 months, or think you may have taken a pholcodine-containing product.”

The move comes after the Commission on Human Medicines (CHM) advised there was sufficient overall evidence for an association with pholcodine, although the absolute risk of anaphylaxis remains very small in patients who have taken pholcodine.

Anaphylaxis following use of NMBAs is roughly estimated as having an overall incidence of fewer than one case per 10,000 procedures.

Common medicines affected include:

  • Boots Night Cough Relief Oral Solution, PL 00014/0230
  • Boots Dry Cough Syrup 6 Years+
  • Boots Day Cold & Flu Relief Oral Solution
  • Cofsed Linctus
  • Care Pholcodine 5mg/5ml Oral Solution Sugar Free
  • Galenphol Linctus
  • Galenphol Paediatric Linctus
  • Galenphol Strong Linctus
  • Covonia Dry Cough Sugar Free Formula
  • Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution
  • Numark Pholcodine 5mg per 5ml Oral Solution
  • Well Pharmaceuticals Pholcodine 5mg per 5ml Oral Solution
  • Superdrug Pholcodine Linctus BP
  • Strong Pholcodine Linctus BP
  • Pholcodine Linctus BP
  • Strong Pholcodine Linctus BP

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