Range of popular cough and cold remedies withdrawn due to allergy fears
Some popular cough and cold medicines have been withdrawn from sale because of the “very low” risk that some patients could experience a rare allergic reaction.
Watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), said products containing pholcodine should be withdrawn amid concerns that people who use them could experience a severe allergic reaction to muscle relaxants (neuromuscular blockers) containing the used during surgery during general anesthesia.
It is believed that about half of all general anesthetics use these blockers (aka NMBAs).
There is a risk of a severe allergic reaction (anaphylaxis) in people who have taken a cough or cold medicine containing pholcodine in the 12 months before surgery.
The risk to patients who have used pholcodine is very small. If you are about to have an operation, please contact your pharmacist or medical team
dr Alison Cave, MHRA’s Chief Safety Officer, said: “Safety is our top priority and we constantly review the safety of medicines.
“Following a thorough scientific safety review of all available evidence on pholcodine, together with advice from the Independent Medicinal Products Committee, it was recommended, as a precautionary measure, that these products should no longer be used.
“If you’re taking a cough or cold medicine, check the packaging, label, or leaflet to see if pholcodine is a listed ingredient.
“If this is the case and you have questions, you can speak to your pharmacist who will suggest you an alternative medicine.”
dr Cave said anyone who has to have surgery under general anesthesia should tell the anesthetist if they think they have used pholcodine, particularly in the past 12 months.
“The anesthetist will be well placed to accommodate that,” she said.
“Anesthesiologists are highly trained in dealing with anaphylaxis.”
The European Medicines Agency recommended the withdrawal of pholcodine drugs from the European market in December last year.
In the UK, healthcare workers have been told to stop supplying the products “immediately” and “quarantine any remaining stock”.
Professor Claire Anderson, President of the Royal Pharmaceutical Society, said: “If you’re taking a cough medicine (including tablets and syrup) check the packaging, label or leaflet to see if pholcodine is a listed ingredient – if so, and If you have any questions, you can speak to your pharmacist, who will be able to suggest another medicine that may be suitable for you.
“The risk for patients who have used pholcodine is very low. If you are about to have an operation, please contact your pharmacist or medical team.
“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 if possible and try acetaminophen or ibuprofen if necessary to manage pain. If your cough lasts longer than three to four weeks, contact a healthcare professional.
“This withdrawal is necessary because patient safety is paramount and we support efforts to ensure all medicines on the market are safe and effective.”
The drugs listed as being recalled by the MHRA are:
The Boots Company PLC
– Boots Night oral solution for cough, PL 00014/0230 – Boots Dry Cough Syrup from 6 years, PL 00014/0523 – Boots Day oral solution for cold and flu, PL 00014/0565
Thornton & Ross Limited
– Cofsed Linctus, PL 00240/0097 – Care Pholcodine 5 mg/5 ml oral solution, sugar-free, PL 00240/0101 – Galenphol Linctus, PL 00240/0101 – Galenphol Pediatric Linctus, PL 00240/0102 – Galenphol Strong Linctus, PL 00240 /0103 – Covonia Dry Cough Sugar Free Formula, PL 00240/0353
Bell Sons & Company (Drogists) Limited
– Pholcodine Linctus Bells Healthcare 5 mg per 5 ml oral solution, PL 03105/0059 – Numark Pholcodine 5 mg per 5 ml oral solution, PL 03105/0059 – Well Pharmaceuticals Pholcodine 5 mg per 5 ml 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
– Capsules for day and night creams, PL 44673/0068 – Capsules for day creams, PL 44673/0069 – Day creams, PL 44673/0075
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