Cough syrup made with codeine could be made prescription-only following concerns it is addictive and can lead to serious health problems.

Most people get coughs when they have caught a cold – and over the counter medicines like syrups are used as a suppressant.

Codeine linctus is an oral solution or syrup with the active ingredient codeine phosphate and is used to stop a dry cough.

The Medicines and Healthcare products Regulatory Agency (MHRA) said it has received 116 reports of recreational drug abuse, dependence and/or withdrawal as a result of codeine medicines, including codeine linctus, since 2018.

There were also 277 serious and fatal adverse reactions to medicines containing codeine in 2021 and 243 in 2022 – and there have already been 95 cases so far this year.

As a result, the UK medicines safety regulator has launched a consultation on the reclassification of codeine linctus to a prescription-only medicine.

Dr Alison Cave, MHRA chief safety officer, said: “Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health consequences.

“Every response received will help us to develop a broader view on whether codeine linctus should be restricted to prescription-only status.

“We want to hear from members of the public, health professionals and others who would be affected by this potential change so we can make a properly considered decision for the benefit of patients, carers, and healthcare professionals across the UK.”

Pharmacists have welcomed the move, saying there is “insufficient robust evidence for the benefits of codeine linctus in treating coughs safely and appropriately”.

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Professor Claire Anderson, president of the Royal Pharmaceutical Society, said: “We welcome the MHRA consulting in this area, to understand the impact of this potential change on pharmacists, pharmacy teams and the public.

“Medicines should maximise benefits to patient health with minimum risk. We believe there is insufficient robust evidence for the benefits of codeine linctus in treating coughs safely and appropriately. We also have significant concerns about its misuse and addictive potential, as well as the risk of overdose.

“There are many non-codeine based products available for the treatment of dry cough. With studies showing up to 60% of people are genetically predisposed to opioid dependence, the role of codeine linctus in treating what is ultimately a self-limiting condition is questionable.”

The consultation will run for four weeks until 15 August.

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