Cough medicine recall: range of cold medicines pulled from shelves over risk of severe allergic reaction

A number of medicines targeting dry coughs have been pulled from shelves, due to the risk of rare side effect.

Officials are recalling a number of treatments containing the cough suppressant pholcodine due to safety fears, after it was discovered some it could cause a severe allergic reaction in some people who take the medicines, up to a year before going under general anaesthetic.

The Medicines and Healthcare products Regulatory Agency (MHRA) said that, based on advice from the Commission on Human Medicines (CHM), the advisory body that provides expert advice on drug safety, it was recalling the products “as a precaution”.

Patients who are taking cough medicine have been advised to check whether pholcodine is a listed ingredient.

Why are medicines with pholcodine being recalled?

The MHRA said evidence has been found that people who had taken the cough medicines were at an increased risk of a severe allergic reaction - or anaphylaxis - when given general anaesthesia with neuromuscular blocking agents (NMBA).

NMBAs are in about half of the general anaesthetics given in the UK. The European Medicines Agency already recommended the withdrawal of pholcodine medicines from the European market in December last year, and products were recalled is Australia just weeks ago.

In the UK recall notice, the MHRA said: “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.”

It added: “Given the advice of the CHM and the lack of identifiable effective measures to minimise the increased risk of anaphylactic reactions to NMBAs, pholcodine-containing medicines are being withdrawn from the UK market and will therefore no longer be available in pharmacies.”

The MHRA said that all pholcodine-containing medicines are “pharmacy-only medicines” which means they will have only been sold or dispensed under the supervision of a suitably trained healthcare professional.

Healthcare workers have been told to stop supplying the products “immediately” and “quarantine all remaining stock”. Meanwhile, they have also been advised to check whether patients who are scheduled to undergo general anaesthesia with NMBAs have used pholcodine in the previous 12 months.

Patients have been told to check their medicines and talk to a pharmacists if they have concerns or want an alternative treatment. Surgical patients are being advised to tell their anaesthetist before an operation if they think they have taken pholcodine in the last year, or if they think they have taken one of the withdrawn medicines.

What are pharmacists saying?

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."

She urged everyone taking a cough medicine - including tablets and syrups - to check the packaging, label or patient information leaflet to see if pholcodine is a listed ingredient. "If it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you."

The risk to patients who have used pholcodine is very small, she said. "If you are due to have surgery, please speak to your pharmacist or medical team for advice.

A cough usually clears up within 3-4 weeks, Ms Anderson said, and can be treated with other cough medicines, or hot lemon and honey - except for babies under 1 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 3-4 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 said.

Which medicines are being recalled by the MHRA?

Made by Boots:

Made by Thornton & Ross:

Made by Bell Sons & Company:

Made by Pinewood Laboratories:

Made by LCM Limited:

Made by Glaxosmithkline (GSK) Consumer Healthcare: