The Medicines and Healthcare products Regulatory Agency (MHRA) is
consulting on the
reclassification of codeine linctus to a prescription-only
medicine. Codeine linctus is an oral solution or syrup with the
active ingredient codeine phosphate and is used to stop a dry
cough. The consultation has been launched after considering
multiple Yellow Card reports
that codeine linctus is being used recreationally for its opioid
effects, rather than for its intended use as a cough suppressant.
This medication is currently licensed as a pharmacy medicine,
which means that it is available to purchase over the counter in
pharmacies. If reclassified as a prescription-only medicine, all
strengths of codeine linctus will only be available upon
presentation of a prescription.
The MHRA would like to hear from a broad range of individuals for
their views on this potential change in classification.
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.
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 MHRA welcomes views as to whether codeine linctus should
become a prescription-only medicine, where access is only given
based on the prescribing judgement of a GP. The MHRA is committed
to ensuring the safe use of medicines, especially those that are
potentially extremely addictive.
The codeine linctus consultation will run
for four weeks and is open until 15 August 2023.
Additional information
- Codeine linctus is an opioid medicine which can cause
addiction.
- Codeine is broken down in the body into morphine, which is
thought to provide its main activity, however not everybody is
able to metabolise codeine. Conversely, others may break it down
much more quickly and experience significant side effects. As a
result, the risk that a person could become addicted or
experience toxic effects will differ between individuals.
- Codeine linctus may make a person feel dizzy and sleepy,
which can influence the ability to drive safely. It is an offence to drive if
codeine has affected someone’s ability to drive safely.
- Codeine linctus can slow down breathing rate, cause
constipation, allergic reactions, confusion and withdrawal
reactions after cessation. It may also cause the person to lose
sight of how much they have consumed, increasing the risk of
accidental overdose.
Notes to editor
- The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and medical
devices in the UK by ensuring they work and are acceptably safe.
All our work is underpinned by robust and fact-based judgements
to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health
and Social Care.
- This consultation will run for four weeks from 18 July 2023
to 15 August 2023.
- Since 2018, the MHRA has received 116 Yellow Card reports of
recreational drug abuse, dependence and/or withdrawal to codeine
medicines, including codeine linctus.
