Some popular cough and cold medicines have been withdrawn from sale this week due to a risk of very rare allergic reactions.
Te Medicines and Healthcare products Regulatory Agency (MHRA) said products containing pholcodine should be pulled from shelves due to safety fears.
Patients who have taken cough medicine have been advised to check of it contains pholcodine.
Which cough medicines have been recalled?
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
Why have the medicines been pulled?
There are concerns that patients using the medicines may go on to experience a severe allergic reaction to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery.
Data showed that people who had taken the cough medicines had an increased risk of a severe allergic reaction (anaphylaxis) when given general anaesthesia with neuromuscular blocking agents (NMBA).
NMBAs are thought to be involved in about half of general anaesthetics given in the UK.
The MHRA said it was recalling the products “as a precaution” based on advice from drug safety advisory body the Commission on Human Medicines (CHM).
What did the MHRA say about pholcodine ?
Pholcodine is an opioid medicine that is used to treat a dry cough in adults and children over six years, and in combination with other substances, to treat cold and flu symptoms.
The European Medicines Agency recommended the withdrawal of pholcodine medicines from the European market in December last year.
In the UK recall notice, the MHRA said: “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.”
It added: “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.”
The MHRA said that all pholcodine-containing medicines are “pharmacy-only medicines” which means they will have only been sold or dispensed under the supervision of a suitably trained healthcare professional.
Supply of products to be halted ‘immediately’
Healthcare workers have been told by the MHRA to stop supplying medicines containing pholcodine “immediately” and to “quarantine all remaining stock”.
They have also been advised to check if patients due to undergo general anaesthesia with NMBAs have used pholcodine in the previous 12 months.
Patients should check the medicines they have taken and speak to pharmacists if they have any concerns or would like an alternative treatment.
Surgical patients are being advised to tell their anaesthetist before an operation if they think they have taken pholcodine in the last year, or if they think they have taken one of the withdrawn medicines.
“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,” said Professor Claire Anderson, president of the Royal Pharmaceutical Society.
“If it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.
“The risk to patients who have used pholcodine is very small. If you are due to have surgery, please speak to your pharmacist or medical team for advice.
“A cough usually clears up within three to four weeks. You can treat it with other cough medicines or hot lemon and honey (not suitable for babies under one year old).”
Patients should rest and try paracetamol or ibuprofen to treat any pain. If a cough continues for more than three to four weeks seek advice from a healthcare professional.
