Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.
Concerns about the risk of anaphylactic reactions (sudden, severe and potentially fatal allergic reactions) triggered by certain medicinal products called neuromuscular blocking agents (NMBAs) have prompted the European Medicines Agency (EMA) to re-evaluate the benefit-risk balance of pholcodine-based medicinal products.
Pholcodine is a morphine derivative that is used to treat non-productive (dry) cough in children and adults. Pholcodine acts primarily on the central nervous system, which depresses the cough reflex.
Neuromuscular blocking agents (NMBAs) are used during general anaesthesia to prevent spontaneous muscle movements so that the operation can be executed under better conditions.
The re-evaluation was requested by the French National Agency for the Safety of Medicines and Health Products (ANSM) by initiating an emergency procedure at the European level following the preliminary results of a study conducted in France. These results suggest that the use of pholcodine up to 12 months prior to general anaesthesia may increase the risk of a neuromuscular blocking agent-induced anaphylactic reaction.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will now review all available data, examine their influence on the benefit-risk balance of pholcodine-based medicinal products and issue a recommendation on whether to maintain, modify, suspend or withdraw their marketing authorisation in Europe.
Pending the outcome of the evaluation by PRAC of the European emergency procedure, as a precautionary measure and given that pholcodine is used in benign respiratory diseases for which there are therapeutic alternatives, at the proposal of the FAMHP, the Minister of Public Health has suspended the dispensation of pholcodine-containing medicinal products by Ministerial Decree as of 1 October 2022. This concerns pholcodine-containing specialities as well as magistral and officinal preparations, which can no longer be dispensed by pharmacists as of 1 October 2022.
In Belgium, only one pholcodine-based medicinal product is marketed (Pholco-Méréprine Mono).
The FAMHP will keep healthcare professionals and patients informed of the conclusions of the European re-evaluation and the outcome of the emergency procedure.
Guidelines
In cases of anaesthesia and/or use of NMBA, healthcare professionals should inquire about patients' use of pholcodine, even in the past.
Healthcare professionals should no longer prescribe or dispense pholcodine-containing medicinal products.
Patients are advised to stop their pholcodine-based treatment and to contact their treating physician in order to find a therapeutic alternative.
More information
More information is available in EMA's public health communication.
More information is available on the EMA website.
The leaflets of medicinal products authorised in Belgium are available on the FAMHP website.
Reporting a side effect
Patients and healthcare professionals are encouraged to report side effects on this website.