Everything you need to know about cold and flu drug recall: When were risks first spotted?
More than a dozen cold and flu remedies are being rushed off the shelves for fear they could be deadly.
Twenty products are being withdrawn, including some from Day & Night Nurse and Covonia, as well as own-brand versions sold in Boots and Superdrug.
It comes after a review by the UK’s drug watchdog found that people taking medicines containing pholcodine have an increased risk of a fatal reaction when they are put under general anesthesia.
Pholcodine is most commonly found in household cough syrups, and the recall includes syrups and lozenges on shelves nationwide.
MailOnline has listed everything you need to know about the move.
Twenty products are being withdrawn, including those made by Day & Night Nurse and Covonia – as well as own-brand versions sold in Boots and Superdrug
Why have some cold and flu remedies been pulled from the shelves?
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is recalling all medicines containing pholcodine.
It comes after a review that raised concerns among patients taking the drug before being put under general anesthesia with neuromuscular blockers (NBAs).
NBAs are used to relax muscles during general anesthesia before some surgeries.
Those who took pholcodine in the 12 months before being exposed to NBAs were at increased risk of a life-threatening allergic reaction called anaphylaxis.
This causes a patient’s blood pressure to drop and the airways to narrow, blocking breathing.
The Commission on Human Medicine – an MHRA committee that advises on the safety, quality and efficacy of medicines – recommended that medicines containing pholcodine be recalled as a precaution.
Which products have been withdrawn?
Twenty drugs are affected by the move:
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
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
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
Pholcodine Linctus BP, PL 04917/0002
Strong Pholcodine Linctus BP, PL 04917/0005
Pholcodine Linctus, PL 12965/0030
Capsules for day and night nurses, PL 44673/0068
Capsules for day nurses, PL 44673/0069
Day Nurse, PL 44673/0075
Pholcodine is most commonly found in household cough syrups and the recall includes syrups and lozenges on shelves nationwide
What happens now?
These products will no longer be available in pharmacies.
Britons using tablets or syrups for coughs have been told to check the packaging, label or leaflet to see if pholcodine is a listed ingredient.
If so, they can talk to their pharmacist who can suggest a different medication.
They have also been advised to inform the anesthesiologist before surgery if they have taken any medicine containing pholcodine in the past 12 months.
Healthcare professionals have been told to stop supplying the products immediately and instead give patients other treatments for coughs, colds and flu.
Medics should also quarantine any supplies they have and return them to their supplier.
Doctors have been instructed to check that patients who will undergo general anesthesia with NBAs have taken pholcodine in the past 12 months and ‘remain vigilant’ for the risk of anaphylaxis.
What is Pholcodine?
Pholcodine is an opioid medicine approved for adults and children ages 6 and older to treat dry cough, cold, and flu symptoms.
It suppresses cough reflexes by reducing the nerve signals sent from the brain to the muscles involved in coughing.
Experts believe that since the chemical composition is similar to that of the anesthetics, it may cause some people’s immune systems to overreact, causing the anaphylactic shock.
Until now it was a pharmacy-only medicine in the UK, meaning it could only be sold or dispensed under the supervision of a properly trained healthcare professional.
Britons using tablets or syrups for coughs have been told to check the pack, label or leaflet to see if pholcodine is a listed ingredient
What’s the danger?
Health regulators are concerned about the risk of patients suffering from anaphylaxis while under general anesthesia.
Anaphylaxis is a serious and potentially life-threatening reaction. Every year about 20 to 30 Britons and about 100 Americans die as a result of anaphylaxis.
Symptoms include light-headedness, difficulty breathing, wheezing, rapid heartbeat, clammy skin, confusion, and loss of consciousness.
In addition to a reaction to medicines, it can also be caused by a food allergy or insect sting.
When was the risk first noticed?
Scientists have known about the risk of pholcodine interacting with NMBAs for more than a decade, after researchers in Norway realized that national deaths from anesthesia were 10 times higher than in Sweden, where pholcodine was less accessible.
Health chiefs in Norway subsequently removed pholcodine from sale and the number of deaths from allergies during surgery fell from about five a year to zero.
In 2014, the results of the ALPHO study in France, which looked at more than 500 patients who suffered allergic reactions to anesthesia, also concluded that those who had recently taken pholcodine were more likely to suffer.
However, the European Medicines Agency concluded that this was insufficient evidence and called for further investigation.
Subsequent research in Australia and New Zealand raised the same concerns.
In January 2022, a warning has been added to pholcodine-containing medicines with a warning of cross-reactivity with NMBAs.
And the MHRA launched a review of pholcodine last September.
It looked at updated results from the ALPHO study, which showed that those who took pholcodine within a year of anesthesia were 4.2 times more likely to experience anaphylaxis.
This study did not look at data beyond 12 months. But the Norwegian findings suggest the risk persists for up to three years.
What are other countries doing?
In December, the European Medicines Agency recommended that all pholcodine-containing medicines be withdrawn from the EU market.
The safety committee concluded that patients under general anesthesia had a higher risk of anaphylaxis in the 12 months after taking pholcodine.
Two weeks ago, Australia issued a national recall of 55 medicines containing pholcodine for the same reason.
Health chiefs said it was aware of 50 cases of this anaphylactic shock during general anesthesia related to pholcodine, including one death.