Pholcodine cough medicines withdrawn in UK over allergy fears
Health officials have withdrawn 20 brands of dry cough medicine amid concerns they can trigger sudden, lifethreatening allergic reactions in people who go on to have a general anaesthetic before surgery up to a year later.
Pharmacists have been ordered to stop supplying medicines that contain the cough suppressant pholcodine immediately and to quarantine all remaining stock before returning the products to the relevant supplier.
The move, described as a precaution on Tuesday, follows a review of safety data by the Medicines and Healthcare products Regulatory Agency. It found an increased risk of rare anaphylaxis in patients who had taken medicines containing pholcodine and later received neuromuscular blocking agents (NMBAs) used in general anaesthetics.
The UK government’s independent advisory body on the safety, quality and efficacy of medicines, the Commission on Human Medicines, recommended the products be recalled and withdrawn from the UK market after assessing the latest evidence.
“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,” the government alert states. The risk is low, however, at less than one in 10,000.
The alert continued: “NMBAs are used to relax the muscles during general anaesthesia for some surgical procedures. Based on advice from the independent advisory body, the Commission on Human Medicines (CHM), pholcodine-containing medicines are being withdrawn from the UK market as a precaution.”
The recall notice applies to 20 popular dry cough remedies including Boots Night Cough Relief Oral Solution,
Boots Day Cold and Flu Relief Oral Solution, Boots Dry Cough Syrup, Haleon’s Day and Night Nurse capsules (formerly GlaxoSmithKline’s), and other products from Thornton and Ross Limited, Bell Sons and Company (Druggists) Limited, Pinewood Laboratories Limited and LCM Limited.
People who are taking cough medicines, including tablets and syrups, are advised to check the packaging, label or patient information leaflet to see if pholcodine is listed as an ingredient. If it is, then pharmacists can advise on alternative medicines, the recall notice says.
Anyone who is due to have surgery should tell their anaesthetist beforehand if they believe they have taken pholcodine, particularly in the past 12
months. “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 notice adds.
The action comes more than three months after the European Medicines
Agency (EMA) recommended the withdrawal of all pholcodine-containing medicines from the EU market after its own review of the safety data. The EMA’s decision drew on results from the Alpho study, which found that the risk of NMBA-related anaphylaxis, a severe allergic reaction to NMBAs, was four times greater when patients had taken pholcodine.
Pholcodine has been used as a cough suppressant since the 1950s. The opioid goes to work in the brain, where it dials down the cough reflex by suppressing nerve signals that are sent to muscles used to produce a cough.
Prof Claire Anderson, the 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.
“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 up if possible and you can try paracetamol or ibuprofen, if suitable, to treat any pain. If your cough persists for longer than three to four 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,” she added.