A number of dry cough medicines have been pulled from shelves due to a potential rare side effect.
Officials are recalling a number of treatments containing the cough suppressant pholcodine due to safety fears.
A rare side effect has been identified among people who take the medicines up to a year before going under general anaesthetic with a neuromuscular blocking agent.
The Medicines and Healthcare products Regulatory Agency (MHRA) said that, based on advice from the Commission on Human Medicines (CHM), the advisory body that provides expert advice on drug safety, it was recalling the products “as a precaution”.
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
Patients who are taking cough medicine have been advised to check whether pholcodine is a listed ingredient.
It said that post-marketing safety data identified evidence that people who had taken the cough medicines were at 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 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measures to minimise the increased risk of anaphylactic reactions to NMBAs, pholcodine-containing medicines are being withdrawn from the UK market and will therefore no longer be available in pharmacies.”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.
Healthcare workers have been told to stop supplying the products “immediately” and “quarantine all remaining stock”.
Meanwhile, they have also been advised to check whether patients who are scheduled to undergo general anaesthesia with NMBAs have used pholcodine in the previous 12 months.
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.
Professor Claire Anderson, president of the Royal Pharmaceutical Society, said: “All products containing the cough suppressant pholcodine have been withdrawn due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery.
“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 3-4 weeks. You can treat it with other cough medicines or hot lemon and honey (not suitable for babies under 1 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 3-4 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
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
