PRAC December 2022 – Recommendation of withdrawal of pholcodine medicines from European market
December 22, 2022
During its December 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has concluded its review of medicines containing pholcodine and has recommended the revocation of the European marketing authorisations for these medicines.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), has concluded its review of medicines containing pholcodine, which are used to treat non-productive (dry) cough in adults and children, and has recommended the revocation of the European marketing authorisations for these medicines.
During the review, the PRAC evaluated all available evidence including the final results of the ALPHO study, post-marketing safety data and information submitted by third parties such as healthcare professionals. The available data showed that use of pholcodine in the twelve months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction (a sudden, severe and life-threatening allergic reaction) to NMBAs.
As it was not possible to identify effective measures to minimise this risk, nor to identify a patient population for whom the benefits of pholcodine outweigh its risks, pholcodine-containing medicines are being withdrawn from the European Union market and will therefore no longer be available by prescription or over-the-counter.
Healthcare professionals should consider appropriate treatment alternatives and advise patients to stop taking pholcodine-containing medicines. Healthcare professionals should also check whether patients scheduled to undergo general anaesthesia with NMBAs have used pholcodine in the previous twelve months, and remain aware of the risk of anaphylactic reactions in these patients.
The PRAC recommendations will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for consideration at its next meeting in December 2022.
Information for patients
- A recent study showed that use of pholcodine-containing medicines, which are used to treat dry cough in adults and children, is linked to a risk of anaphylactic reactions (a sudden, severe and life-threatening allergic reaction) to certain medicines called neuromuscular blocking agents (NMBA) that are used in general anaesthesia.
- As no effective measures have been identified to minimise this risk, pholcodine medicines are being withdrawn from the European Union market.
- If you are taking pholcodine, talk to your doctor or pharmacist – they will suggest a different treatment.
- If you require general anaesthesia with NMBAs and have taken pholcodine in the past twelve months, talk to your healthcare professional and ask any questions you may have.
Information for healthcare professionals
- Results from the recent ALPHO study show that use of pholcodine during the twelve months preceding anaesthesia is linked to a risk of perianaesthetic anaphylactic reaction related to neuromuscular blocking agents (NMBAs).
- As no effective measures have been identified to minimise this risk, the marketing authorisations of pholcodine-containing medicines are being revoked in the European Union.
- Healthcare professionals should no longer prescribe or dispense pholcodine-containing medicines and should consider appropriate treatment alternatives. Patients should be advised to stop treatment with these medicines.
- For patients scheduled to undergo general anaesthesia with NMBAs, healthcare professionals should check whether patients have used pholcodine-containing medicines in the last twelve months and maintain awareness about potential perianaesthetic anaphylactic reaction related to NMBAs.
A direct healthcare professional communication (DHPC) including the above recommendations will be sent in due course to healthcare professionals prescribing, dispensing or administering these medicines. The DHPC will also be published on a dedicated page on the EMA website.
There is only one folcodine-based medicine on the market in Belgium: Pholco-Méréprine Mono. The delivery of this medicine has been suspended from 1 October 2022.
More information can be found on the EMA website.