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).
Patients have been told to talk to a pharmacist, their GP or their surgical team if they have any questions.
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.
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 for patients who present with a new dry cough or who are currently taking pholcodine.
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
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
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 Penny Ward, independent pharmaceutical physician, and visiting professor in pharmaceutical medicine at King’s College London, said: ‘MHRA have today advised that cough medicines containing pholcodine should be taken off the market due to a very small (<1:10,000) but clear risk that people that have taken cough medicines containing this medicine might suffer a serious allergic reaction (anaphylaxis) if they need to have a general anaesthetic including a muscle relaxant within 12 months of having taken the cough medicine.
The decision to withdraw these medicines was taken following the release of data from the ALPHO study, a case control study which conducted in France, she explained.
Professor Ward said: ‘MHRA have come to this decision because there is no clear method which can be used to decrease the very small – but potentially life threatening – risk of serious allergic reactions among patients receiving a muscle relaxing treatment during a general anaesthetic other than by removing the medicine from the market.
‘Although pholcodine is effective in suppressing cough, most illnesses causing coughs will recover, even if not treated, within 1-2 weeks and other medicines which can sooth cough are available if needed. Coughs and colds are common illnesses and although people who know they might need a general anaesthetic for a planned surgical procedure could avoid using pholcodine containing medicines, because the risk lasts for a very long time – 12 to 36 months after exposure – and also because surgery requiring use of a muscle relaxant might be needed in an emergency – appendicitis for example – it is not easy to reduce this risk simply by warning people about it. Indeed, the risk has been known about and information has been included in the prescribing information for more than 10 years.
She also highlighted that ‘following pholcodine containing medicines being removed from the market in Norway the risk of serious allergic reactions to muscle relaxants given during a general anaesthetic fell very markedly’.
‘For all these reasons, MHRA has decided that taking these medicines off the market completely is preferable,’ she said.
However she said it ‘should be emphasized that this risk is very small – less than 1/10,000 people given a muscle relaxant during a general anesthetic would experience the reaction – but it can be life threatening if it occurs’.
‘Pholcodine containing medicines are otherwise well tolerated by the many thousands of adults and children that have taken them.
‘Anyone that has any cough or cold remedies in their medicine cupboard should check to see if any contain pholcodine and if so get rid of them. Anyone that has taken a cough or cold remedy recently and is going to have a general anaesthetic should tell the doctor/nurse that they might have taken pholcodine – this also applies if the cough medicine was taken anytime within 12 months prior to an anaesthetic procedure in the future.’
A version of this article was first published by Pulse’s sister title The Pharmacist
