The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a withdrawal notice for cough medicines containing pholcodine following a review of safety data. All pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.
The Commission on Human Medicines (CHM), the independent advisory body that provides expert advice on the safety, quality and efficacy of medicines, has considered evidence of an increased risk of the very rare event (estimated as 1 in 10,000) of anaphylaxis (severe allergic reaction) when exposed to neuromuscular blocking agents (NMBA), usually used in anaesthesia, and has advised that medicines containing pholcodine be withdrawn.
The available data has demonstrated that pholcodine use, particularly in the 12 months before general anaesthesia with NMBAs, is a risk factor for developing an anaphylactic reaction to NMBAs. All pholcodine-containing medicines are Pharmacy-only medicines and therefore should have only been sold or dispensed under the supervision of a suitably trained healthcare professional.
Healthcare professionals have been advised to stop supplying the products immediately, to quarantine all remaining stock and return it to their supplier. They should recommend appropriate treatment alternatives when counselling patients who may present with symptoms of cough, cold and flu.
The products affected 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
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
Pharmacists should consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking the medicines. Where appropriate, healthcare professionals should also check whether patients who are scheduled to undergo general anaesthesia with NMBAs have used affected medicines, particularly in the previous 12 months and remain vigilant for the risk of anaphylaxis in these patients. Patients should be advised to tell their anaesthetist if they think they have previously taken affected medicines.
Pholcodine-containing medicines are licensed to treat dry cough in adults and children over 6 years old. NMBAs are used to relax the muscles during general anaesthesia for some surgical procedures. Based on advice from the independent advisory body, the Commission on Human Medicines (CHM), affected medicines are being withdrawn from the UK market as a precaution.
If you are taking a cough medicine (including tablets and syrups), 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 can suggest a different medicine suitable for you.
Tell your anaesthetist before you have surgery if you think you have taken pholcodine, particularly in the past 12 months, or think you may have taken a pholcodine-containing product. There is no increased risk of allergic reactions, including anaphylaxis, with other allergens following pholcodine use and the absolute risk in patients who have used pholcodine is very small, but patients should talk to a pharmacist, their GP or their surgical team if they have any questions. Anaesthetists routinely manage the risk of allergic reactions during surgery.
Dr Leyla Hannbeck, from the Association of Independent Multiple Pharmacies, said it was a “big operation” to remove the products from pharmacy shelves, but stressed alternative cough and cold medicines were available.
“Pharmacies across the UK take patient safety very seriously and will be assisting with the recall of these products.
“Patients with coughs and colds should contact their local pharmacy for the best advice about the range of alternative products available,” she said.