Everything you need to know about the cold and flu recall: When were the risks first noticed? And what is the danger?

Everything you need to know about the cold and flu recall: When were the risks first noticed?  And what is the danger?

Cold and flu medicines are urgently being pulled from shelves for fear they could kill.

Twenty products are being withdrawn, including some from Day & Night Nurse and Covonia, as well as private label versions sold in Boots and Superdrug.

It comes after a review by the UK Pharmacopoeia found that people taking medicines containing pholcodine are at increased risk of having a fatal reaction when put under general anaesthetic.

Folcodine is most commonly found in household cough syrups, and the recall includes syrups and lozenges that are on store shelves across the country.

MailOnline has listed everything you need to know about moving.

Twenty products are being withdrawn, including those from Day & Night Nurse and Covonia -- as well as private label versions sold in Boots and Superdrug

Twenty products are being withdrawn, including those from Day & Night Nurse and Covonia — as well as private label versions sold in Boots and Superdrug

Why have some cold and flu medicines been taken off the shelves?

The UK Medicines and Healthcare products Regulatory Agency (MHRA), which oversees the safety of medicines used in the UK, is recalling all medicines containing pholcodine as a precaution.

This follows the advice of the Human Medicines Commission – an MHRA committee which gives advice on the safety, quality and effectiveness of medicines.

The review highlighted concerns for patients who took the drug before being placed under general anesthesia with neuromuscular blocking agents (NBAs). NBAs relax muscles for some surgeries.

Those who took pholcodine in the 12 months before exposure to NBAs had an increased risk of a life-threatening allergic reaction called anaphylaxis.

This causes the patient’s blood pressure to drop and the airways to narrow, blocking breathing. It can be life-threatening without prompt treatment.

Day & Night Nurse and Covonia cold and flu medicines are being withdrawn from the UK market for health reasons

Medical regulators have withdrawn the drugs from the UK market

Medical regulators have withdrawn the drugs from the UK market “following a precautionary review”, it was revealed today

Which products have been withdrawn?

Twenty medicines are affected by the move:

  • Boots Night Cough Relief Oral Solution, PL 00014/0230
  • Boots dry cough syrup from 6 years, PL 00014/0523
  • Boots Day Oral Solution for Colds and Flu, PL 00014/0565
  • Cofsed Linctus, PL 00240/0097
  • Care Pholcodine 5 mg/5 ml oral solution without sugar, PL 00240/0101
  • Galenpholl Linctus, PL 00240/0101
  • Galenphol Pediatric Linctus, PL 00240/0102
  • Galenphol Strong Linctus, PL 00240/0103
  • Covonia Sugar Free Dry Cough Formula, PL 00240/0353
  • 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
  • Pholcodine Linctus BP, PL 04917/0002
  • Strong Pholcodine Linctus BP, PL 04917/0005
  • Pholcodine Linctus, PL 12965/0030
  • Capsules for day and night care, PL 44673/0068
  • Day care capsules, PL 44673/0069
  • Day nurse, PL 44673/0075
Folcodine is most commonly found in household cough syrups, and the recall includes syrups and lozenges that are on store shelves across the country
Folcodine is most commonly found in household cough syrups, and the recall includes syrups and lozenges that are on store shelves across the country

Folcodine is most commonly found in household cough syrups, and the recall includes syrups and lozenges that are on store shelves across the country

What happens now?

These products will no longer be available in pharmacies.

Britons using cough tablets or syrup have been advised 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 for them.

They were also advised to tell an anesthetist before surgery if they had taken any medicine containing pholcodine in the past 12 months.

Health workers were ordered to immediately stop providing the products 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 review whether patients undergoing general anesthesia with NBAs have taken pholcodine in the past 12 months and to “remain vigilant” about the risk of anaphylaxis.

What is pholcodine?

Pholcodine is an opioid drug approved for adults and children 6 years of age 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 due to the similar chemical composition of anesthetics, some people’s immune systems may overreact and go into anaphylactic shock.

Previously in the UK it was a prescription medicine, meaning it could only be sold or dispensed under the supervision of a properly trained healthcare professional.

Britons using cough tablets or syrup are urged to check the packaging, label or leaflet to see if pholcodine is a listed ingredient
Britons using cough tablets or syrup are urged to check the packaging, label or leaflet to see if pholcodine is a listed ingredient

Britons using cough tablets or syrup are urged to check the packaging, label or leaflet to see if pholcodine is a listed ingredient

what is the danger

Health authorities are concerned about the risk of patients developing anaphylaxis under general anesthesia.

Anaphylaxis is a serious and potentially life-threatening reaction. About 20 to 30 Britons and about 100 Americans die each year from anaphylaxis.

Symptoms include light-headedness, difficulty breathing, wheezing, rapid heartbeat, clammy skin, confusion and loss of consciousness.

In addition to a reaction to medication, it can also be caused by a food allergy or an insect bite.

When was the risk first noticed?

Scientists have known about the risk of pholcodine reacting with NMBAs for more than a decade, after researchers in Norway found 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 allergy deaths during surgery dropped from around five a year to zero.

In 2014, the results of the ALPHO study in France, which examined more than 500 patients suffering from allergic reactions to anesthesia, concluded that those who had recently taken pholcodine were more likely to be affected.

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 label was added to medicines containing pholcodine warning of cross-reactivity with NMBAs.

And the MHRA launched a review of pholcodine last September.

Updated results from the ALPHO study were examined, showing that those who took pholcodine within a year of anesthesia were 4.2 times more likely to experience anaphylaxis.

This study did not consider data longer than 12 months. However, the Norwegian results suggest that the risk persists for up to three years.

What are other countries doing?

In December, the European Medicines Agency recommended withdrawing all medicines containing pholcodine 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 there had been 50 known cases of this anaphylactic shock during general anesthesia linked to pholcodine, including one death.

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