Dr Hilary has explained what people should do as several cough, cold and flu medicines have been taken off shelves in UK pharmacies. A review by the Medicines and Healthcare products Regulatory Agency (MHRA) has meant all medicines that contain an ingredient called pholcodine are currently being withdrawn.
Twenty medicines in total are being pulled from shelves, including common over-the-counter products such as Day and Night Nurse, and Covonia. Experts have made the decision following a review over the "very rare" risk of people experiencing an allergic reaction due to pholcodine when combined with general anaesthetic.
A statement on the official government website reads: "There is evidence that using pholcodine-containing medicines leads to an increased risk of the very rare event of an allergic reaction (anaphylaxis) in patients who receive general anaesthesia involving neuromuscular blocking agents (NMBAs) during surgery
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"Tell your anaesthetist before you have surgery if you have taken pholcodine, particularly in the past 12 months, or think you may have taken a pholcodine-containing product.
"There is no increased risk of allergic reactions, including anaphylaxis, with other allergens following pholcodine use and the absolute risk in patients who have used pholcodine is very small, but patients should talk to a pharmacist, their GP or their surgical team if they have any questions
The medicines being recalled include:
- Boots Night Cough Relief Oral Solution
- Boots Dry Cough Syrup 6 Years+
- Boots Day Cold & Flu Relief Oral Solution
- Cofsed Linctus
- Care Pholcodine 5mg/5ml Oral Solution Sugar Free
- Galenphol Linctus
- Galenphol Paediatric Linctus
- Galenphol Strong Linctus
- Covonia Dry Cough Sugar Free Formula
- Pholcodine Linctus Bells Healthcare 5mg Per 5ml Oral Solution
- Numark Pholcodine 5mg per 5ml Oral Solution
- Well Pharmaceuticals Pholcodine 5mg per 5ml Oral Solution
- Superdrug Pholcodine Linctus BP
- Strong Pholcodine Linctus BP
- Pholcodine Linctus BP
- Strong Pholcodine Linctus BP
- Pholcodine Linctus
- Day and Night Nurse Capsules
- Day Nurse Capsules
- Day Nurse
News of the medicines being pulled from shelves was discussed during today's episode of Good Morning Britain. Turning to Dr Hilary, host Susanna Reid asked: "These are very common products, I've got them in my medicine cupboard. So what is the reason we can no longer purchase them?"
Dr Hilary replied: "The reason they've been withdrawn is because there was a slight increased risk of anaphylaxis if you have a general aesthetic using muscle relaxants within a year after taking pholcodine. Now pholcodine has been around for 70 years, it is a very common ingredient. I have to say that this is a precaution. The risk of this anaphylactic reaction is very small.
"However, safety is paramount, and that's why the medicines and health care products regulatory agency has decided to withdraw these things from the shelves."
Susanna added: "I was thinking to myself, you'd have to have quite a sequence of events in order for this to be a risk. Because the allergic reaction is not to the ingredient in these products - you don't take this product and then have the allergic reaction.
"The danger is using one of these products then within the next year you might go into hospital and undergo general aesthetic with this other particular ingredient."
Explaining what people would need to do to lessen the risk of such a reaction, Dr Hilary said: "If you have an unexpected need for a general aesthetic, you tell the anaesthetist today, for example, that you might have taken pholcodine at some point in the previous year.
"And the anaesthetist will say, 'don't worry, we're quite confident and skilled in dealing with anaphylactic should it happen, we will be ready for that'. So it is not going to stop anyone from having an operation today at all. I have never seen this reaction in my 45 years of practise. Most doctors won't."
Ed Balls then asked what people should do if they already have a bottle or box of one of the 20 medicines being taken off shelves at home. Dr Hilary replied: "The advice that people are being given is to talk to your pharmacist or doctor and say, what are the alternatives to this?
"They will say 'give me that back, I'll dispose of that for you, there are plenty of alternatives - hot lemon and honey, steam inhalations, lozenges, Simple Linctus that don't contain pholcodine', which, after all, don't contain opioid so there are alternatives."
What is pholcodine?
Pholcodine is used as a cough suppressant. It is an opioid medicine approved in adults and children older than six years of age to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and influenza.
Pholcodine-containing cough and cold medicines are being withdrawn from sale as a precaution. They will no longer be available from pharmacies. Pholcodine-containing products have only been available in the UK for purchase in a pharmacy.
Pharmacists should provide advice to those who have any concerns about their medicine or would like to seek advice on alternative medicines or management of their symptoms.
Previous reviews have examined the link between prior use of pholcodine and an increased risk of anaphylaxis during general anaesthesia involving NMBAs. The potential for cross-reactivity between pholcodine and NMBAs was added to the product information for pholcodine-containing medicines in January 2022.
How small is the risk?
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.
"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. 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."
There is no increased risk of allergic reactions, including anaphylaxis, with other allergens following pholcodine use and the absolute risk in patients who have used pholcodine is very small, but patients should talk to a pharmacist, their GP or their surgical team if they have any questions
How to report suspected adverse drug reactions:
The government is urging people who suspect they've had adverse drug reactions to report it via the Yellow Card scheme. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
When reporting, please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.
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