All products containing pholcodine, including over-the-counter cough syrups, have been recalled due to a risk of anaphylaxis when the patient is also exposed to neuromuscular blocking agents (NMBAs).
The Medicines and Healthcare products Regulatory Agency said that the measure was a precaution based on a review of post-marketing safety data, which found that pholcodine use, particularly in the 12 months before general anaesthesia with NMBAs, was a risk factor for the patient developing an anaphylactic reaction to NMBAs.
While ‘the absolute risk in patients who have used pholcodine is very small’, given ‘the lack of identifiable effective measures’ to reduce this risk, the MHRA has issued a recall notice to withdraw all pholcodine-containing medicines from the UK market. This is in line with action already taken by the European Medicines Agency.
Pharmacies have been told to stop supplying pholcodine-containing medicines immediately, to quarantine all remaining stock and return it to suppliers.
They should also recommend alternative treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine.
Patients have been told to talk to a pharmacist, their GP or their surgical team if they have any questions.
The affected products 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
More information about the recall and advice for patients can be found on the MHRA website, while any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.
Professor Claire Anderson, president of the Royal Pharmaceutical Society (RPS) said that the withdrawal was necessary as 'safety of patients is paramount' and added: 'we support efforts to ensure that all medicines on the market are safe and effective.'
Michelle Riddalls, chief executive of PAGB which represents the interests of over-the-counter manufacturers said that PAGB and its members 'put an absolute priority on patient safety' and were working closely with MHRA, healthcare professionals and pharmacists to ensure that appropriate action is taken.
She added: 'The risk in people who have used pholcodine is extremely small and the MHRA has taken this decision as a precaution.
'This precautionary measure is an example of the robust safety measures that we have in place in the UK working effectively.'