Daily Newsletter

18 July 2023

Daily Newsletter

18 July 2023

MHRA consults public on reclassification of codeine linctus

If reclassified, all strengths of the therapeutic will only be available on prescription.

July 18 2023

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is consulting health professionals and the public on the potential reclassification of codeine linctus to a prescription-only medicine.

The consultation is launched as the dry cough syrup received multiple Yellow Card reports that it is being misused and causing addiction due to its opioid effects.

Codeine linctus is intended to be used as a cough suppressant. It may also slow down breathing rate, cause allergic reactions, constipation and confusion and make a person feel dizzy and sleepy.

If it is reclassified, all strengths of the therapeutic would only be available on prescription.

MHRA chief safety officer Dr Alison Cave stated: “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.”

Set to run for four weeks, the consultation is open until 15 August 2023.

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

“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.”

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