Codeine linctus, an oral solution or syrup licensed to treat dry
cough in adults, is to be reclassified to a prescription-only
medicine due to the risk of abuse, dependency and overdose, the
Medicines and Healthcare products Regulatory Agency (MHRA)
announced today (20 February 2024).
Codeine linctus is an opioid medicine which has previously been
available to buy in pharmacies under the supervision of a
pharmacist but will now only be available on prescription
following an assessment by a healthcare professional.
Since 2019, there have been increasing reports in the media of
codeine linctus being misused as an ingredient in a recreational
drink, commonly referred to as ‘Purple Drank’.
The decision to reclassify the medicine has been made following a
consultation with independent experts, healthcare professionals
and patients. 992 responses were received.
The consultation was launched by the MHRA after Yellow Card
reports indicated instances of the medicine being abused, rather
than for its intended use as a cough suppressant.
Responses to the consultation identified the pressure pharmacists
were under to provide the medicine to those suffering from
addiction.
Dr Alison Cave, MHRA Chief Safety Officer, said:
“Patient safety is our top priority. Codeine linctus is an
effective medicine for long term dry cough, but as it is an
opioid, its misuse and abuse can have major health consequences.
“We would like to thank all the patients, independent experts and
health professionals who responded to our consultation.
“As a result, and taking into account the reports we have
received in relation to abuse, we have reclassified codeine
linctus to a prescription-only medicine for the benefit of
patients, carers and healthcare professionals across the UK.
“Codeine addiction can be a gradual process. If you have been
taking it for a long time and want to stop, you can talk to your
healthcare provider and reduce the amount you take slowly.
“If you feel that you are addicted or have concerns for someone
who has been using codeine linctus for too long, you can seek
advice on the NHS
website. Support groups and self-help groups are also
available such as Talk to
FRANK.
“We ask people to report any adverse reactions from codeine
linctus via the MHRA Yellow Card
scheme.”
Alternative non-prescription cough medicines are available for
short-term coughs to sooth an irritated throat, including honey
and lemon mixtures and cough suppressants.
Patients are urged to speak to a pharmacist for advice and not to
buy codeine linctus from an unregistered website as it could be dangerous.
Professor Claire Anderson, President of the Royal Pharmaceutical
Society, said:
“We welcome the decision to reclassify codeine linctus to a
prescription-only medication as a positive step to protect
patient safety.
“This decision not only addresses concerns about the misuse and
addictive potential of codeine linctus but also underscores the
importance of prioritising patient well-being.
“There are many alternative non-codeine-based products available
to treat a dry cough. As the most accessible of healthcare
professionals, community pharmacists and their teams will
continue to provide expert advice on managing dry cough and guide
people towards suitable treatments.”
Michelle Riddalls, Chief Executive Officer of PAGB, the consumer
healthcare association said:
“The over-the-counter (OTC) industry takes any issue relating to
patient safety very seriously. Following evidence of the
recreational use of codeine linctus, and in line with our
consultation response, we support the reclassification of codeine
linctus to a prescription-only medicine.
“Patient safety and wellbeing is paramount for manufacturers of
OTC medicines. Alongside the MHRA, companies that make OTC
products in the UK continually monitor the safety of medicines
via routine pharmacovigilance measures.
“The decision to reclassify codeine linctus demonstrates that the
reclassification system is effective; this will ensure that
people are only able to access medicines that allow them to
self-care safely.”
Notes to editor
Further information is available in the Drug Safety Update. -
The brands which will be reclassified are Codeine Linctus BP (LCM
Limited, and Pinewood Laboratories Limited), Bells Healthcare
Codeine Linctus 15mg/5ml Oral Solution (Bell Sons & Company
[Druggists] Limited), Care Codeine 15mg/5ml Oral Solution Sugar
Free (Thornton & Ross), Galcodine Linctus (Thornton &
Ross) and Pulmo Bailly (Dendron Brands Limited) - 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.
