Following a review by the Medicines and Healthcare products Regulatory Agency (MHRA), all medicines containing pholcodine are being withdrawn from the UK as a precaution.
Products being removed from sale include Day and Night Nurse and a variety of Boots and Superdrug products.
The MHRA said: “Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.
“There is already a known 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.
The MHRA advises that pholcodine-containing cough and cold medicines are being removed from the UK market as a precautionary +measure.”
Dr Alison Cave, MHRA Chief Safety Officer added: “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.
“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.
“If you want more information or advice, please speak to your pharmacist.”
Medicines withdrawn from sale
Medicines containing pholcodine include:
The Boots Company PLC
Boots Night Cough Relief Oral Solution, PL 00014/0230
Boots Dry Cough Syrup 6 Years+, PL 00014/0523
Boots Day Cold & Flu Relief Oral Solution, PL 00014/0565
Thornton & Ross Limited
Cofsed Linctus, PL 00240/0097
Care Pholcodine 5mg/5ml Oral Solution Sugar Free, PL 00240/0101
Galenphol Linctus, PL 00240/0101
Galenphol Paediatric Linctus, PL 00240/0102
Galenphol Strong Linctus, PL 00240/0103
Covonia Dry Cough Sugar Free Formula, PL 00240/0353
Bell Sons & Company (Druggists) Limited
Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution, PL 03105/0059
Numark Pholcodine 5mg per 5ml Oral Solution, PL 03105/0059
Well Pharmaceuticals Pholcodine 5mg per 5ml Oral Solution, PL 03105/0059
Superdrug Pholcodine Linctus BP, PL 03105/0059
Strong Pholcodine Linctus BP, PL 03105/0060
Pinewood Laboratories Limited
Pholcodine Linctus BP, PL 04917/0002
Strong Pholcodine Linctus BP, PL 04917/0005
LCM Limited
Pholcodine Linctus, PL 12965/0030
Glaxosmithkline Consumer Healthcare (UK) Trading Limited
Day & Night Nurse Capsules, PL 44673/0068
Day Nurse Capsules, PL 44673/0069
Day Nurse, PL 44673/0075