The Medicines and Healthcare Products Regulatory Agency (MHRA) have advised the withdrawal of a number of cough and cold medicines containing pholcodine.
Pholcodine, also known as morpholinylethylmorphine or homocodeine, is an opioid and cough supressant which can also have a sedative effect.
The medicines have been withdrawn after a comprehensive scientific review of the latest available data on the safety of pholcodine, and advice from the independent Commission on Human Medicines.
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The EU’s medicines regulator has already recommended the recall of cough and cold medicines containing pholcodine.
Which pholcodine-containing medications have been withdrawn?
The medications that have been withdrawn are:
- 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
- Covonia Dry Cough Sugar Free Formula
- Galenphol Linctus
- Galenphol Paediatric Linctus
- Galenphol Strong Linctus
- Haleon Day & Night Nurse Capsules
- Haleon Day Nurse Capsules
- Haleon Day Nurse
- Numark Pholcodine 5mg per 5ml Oral Solution
- Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution
- Pholcodine Linctus BP
- Strong Pholcodine Linctus BP
- Superdrug Pholcodine Linctus BP
- Well Pharmaceuticals Pholcodine 5mg per 5ml Oral Solution
An MHRA review found that the potential risks of the medicines outweigh their potential benefits.
What is the risk?
The review found that there is a small risk (less than 1 in 10,000) that some people may experience anaphylaxis (severe allergic reaction) if they subsequently have surgery and require an anaesthetic which involves the use of a muscle relaxant.
After consideration, the MHRA has advised that all pholcodine-containing cough and cold medicines are being removed from the UK market as a precautionary measure.
What should I do if I am taking a medication that has been withdrawn?
Dr Alison Cave, the MHRA’s Chief Safety Officer said: “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.”
