Range of popular cough and cold medicines withdrawn over allergy fears
Some popular cough and cold medicines have been withdrawn from sale over the “very small” risk some patients could suffer a rare allergic reaction.
Watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) said products containing pholcodine should be withdrawn over worries people using them may go on to experience a severe allergic reaction to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery.
Around half of all general anaesthetics are thought to use these blocking agents (also known as NMBAs).
The risk of suffering a severe allergic reaction (anaphylaxis) is thought to be among people who have taken a cough or cold product containing pholcodine in the 12 months prior to undergoing surgery.
Dr Alison Cave, MHRA chief safety officer, said: “Safety is our top priority, and we keep the safety of medicines under continual review.
“Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.
“If you are taking a cough or cold medicine, 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 will suggest an alternative medicine.”
Dr Cave said anyone due to have an operation under general anaesthesia should tell the anaesthetist if they think they have used pholcodine, particularly in the past 12 months.
“The anaesthetist will be well placed to take this into account,” she said.
“Anaesthetists are highly trained in managing anaphylaxis.”
The European Medicines Agency recommended the withdrawal of pholcodine medicines from the European market in December last year.
In the UK, healthcare workers have been told to stop supplying the products “immediately” and “quarantine all remaining stock”.
RPS President Professor Claire Anderson comments on the withdrawal of products containing pholcodine: "We support all efforts to ensure that medicines on the market are safe and effective."https://t.co/9DH8QSsMTh #RPSNews pic.twitter.com/E1kLqNp4ns
— Royal Pharmaceutical Society (@rpharms) March 14, 2023
Professor Claire Anderson, president of the Royal Pharmaceutical Society, said: “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.
“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).
“Rest up if possible and you can try paracetamol or ibuprofen, if suitable, to treat any pain. If your cough persists for longer than three to four weeks seek advice from a healthcare professional.
“This withdrawal is needed as safety of patients is paramount and we support efforts to ensure that all medicines on the market are safe and effective.”
The medicines listed by the MHRA as being recalled are:
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