Class 2 Medicines Recall: Various Marketing Authorisation Holders, pholcodine-containing products, EL (23)A/09
Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.
MDR number
MDR 008-12/22
Company name
The Boots Company PLC
Product name
- 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
Product name
- 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
Product name
- 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
Product name
- Pholcodine Linctus BP, PL 04917/0002
- Strong Pholcodine Linctus BP, PL 04917/0005
LCM Limited
Product name
Pholcodine Linctus, PL 12965/0030
Glaxosmithkline Consumer Healthcare (UK) Trading Limited
Product name
- Day & Night Nurse Capsules, PL 44673/0068
- Day Nurse Capsules, PL 44673/0069
- Day Nurse, PL 44673/0075
Brief description of the problem
Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.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 the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn.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. Given the advice of the CHM, and the lack of identifiable effective measures to minimise the increased risk of anaphylactic reactions to NMBAs, pholcodine-containing medicines are being withdrawn from the UK market and will therefore no longer be available in pharmacies. All pholcodine-containing medicines are Pharmacy (P) only medicines and therefore have only been sold or dispensed under the supervision of a suitably trained healthcare professional.
Please see link to Drug Safety Update (DSU) for further information.
Advice for healthcare professionals
Stop supplying the above products immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. This recall applies to all batches currently within shelf-life for the products listed.
Healthcare professionals should recommend appropriate treatment alternatives when counselling patients who may present with symptoms of cough, cold and flu.
Pharmacists should consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Where appropriate, healthcare professionals should also check whether patients who are scheduled to undergo general anaesthesia with NMBAs have used pholcodine, 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 pholcodine.
Advice for patients
Following a scientific review by the MHRA on pholcodine-containing medicines, which are licensed to treat dry cough in adults and children over 6 years old, it has been found that there is evidence of an increased risk of the very rare event of anaphylaxis (a sudden, severe and life-threatening allergic reaction) in surgical patients who receive general anaesthesia involving neuromuscular blocking agents (NMBA). 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), pholcodine-containing 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.
Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
Further Information
For more information or, medical enquiries, please contact the respective companies below:
The Boots Company PLC
Boots Customer Care:
Telephone: 0345 0708090
Thornton & Ross Limited / LCM Limited
Telephone: 01484 848164
Email: thorntonross@medinformation.co.uk
Bell Sons & Company (Druggists) Limited
Qualified Person for Pharmacovigilance (QPPV): Mr Trevor Price:
Telephone: 0151 422 1216 / mobile: 07739 327 095
Email: trevor.price@bells-healthcare.com
Pinewood Laboratories Limited
Drug Safety & Information department, Wockhardt UK Limited:
Email: drug.safety@wockhardt.co.uk
Telephone: 01978 661261
Glaxosmithkline Consumer Healthcare (UK) Trading Limited
Contact Haleon consumer services:
Telephone: 0800 783 8881
Email: mystory.gb@haleon.com.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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