Safety withdrawal of pholcodine-containing cough and cold medicines
Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.
The Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of medicines under review and acts where necessary to protect patients and the public.
Following a comprehensive scientific safety review of the latest available data on the safety of pholcodine, together with advice from the independent Commission on Human Medicines, it has been concluded that the potential risks outweigh the benefits for these products.
There is already a known link between pholcodine and an increased risk of the very rare event of a severe allergic reaction (anaphylaxis) to muscle relaxants (neuromuscular blocking agents) that are used during general anaesthesia in surgery. In September 2022 the findings of a new study further strengthened the evidence of this link, but the overall risk is very small.
The MHRA advises that pholcodine-containing cough and cold medicines are being removed from the UK market as a precautionary measure.
Dr Alison Cave, MHRA Chief Safety Officer said,
“Safety is our top priority, and we keep the safety of medicines under continual review.
“Following a thorough scientific safety review of all the available evidence on pholcodine, together with advice from the independent Commission on Human Medicines, it has been recommended, as a precautionary measure, that these products should no longer be used.
“If you are taking a cough or cold medicine, 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 will suggest an alternative medicine.
“If you have an operation scheduled using general anaesthesia, tell your anaesthetist if you think you have used pholcodine, particularly in the past 12 months. The anaesthetist will be well placed to take this into account. Anaesthetists are highly trained in managing anaphylaxis.
“If you want more information or advice, please speak to your pharmacist.”
Further information
- See the MHRA Drug Safety Update
- Pholcodine is an opioid medicine that is used to treat a dry cough in adults and children over six years and in combination with other active substances, for the treatment of symptoms of cold and influenza. It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing.
- Neuromuscular blocking agents (NMBAs) are used in general anaesthesia to prevent spontaneous muscle movements and to improve operating conditions.
- Cumulative evidence supports an association of pholcodine use with anaphylactic reactions to certain anaesthetic agents. While anaphylaxis has potentially life-threatening consequences, it is a rare event, and the absolute risk remains very small even in association with pholcodine.
- The Medicines and Healthcare products Regulatory Agency 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 Commission on Human Medicines (CHM) advises ministers and the MHRA on the safety, efficacy and quality of medicines. The CHM is an independent advisory non-departmental public body, sponsored by the Department of Health and Social Care.