syrups containing pholcodine may no longer be authorized in France
Marketing authorizations for cough syrups containing pholcodine could be suspended in France in the face of a “significant risk» allergy during anaesthesia.
Marketing authorizations for cough syrups containing pholcodine could be suspended in France in the face of a “significant risk“Serious allergy to muscle relaxants during anesthesia, announced Monday, August 29 the National Agency for the Safety of Medicines.
“According to a new study, taking a medicine based on pholcodine, used against coughing, exposes you to a significant risk of having a serious allergy to muscle relaxants, indicated during general anesthesia, even if the anesthesia has takes place several weeks after taking the drug“Explains the health agency.
The syrups concerned are Dimetane without sugar (Biocodex), Biocalyptol and Biocalyptol without sugar (Zambon), Pholcodine (Biogaran). Since 2011, syrups based on this opioid, used to calm dry coughs and irritation in adults and certain children (over 30 months and over 15 kg), can only be delivered by prescription in France, already because of this possible risk.
A reminder at the beginning of September
Given the preliminary results of a safety study in France following a European assessment, the ANSM now considers “their unfavorable risk-benefit ratio“, considering “the non-essential nature of these syrups and the existence of therapeutic alternatives“. “Consequently, we plan to suspend the marketing authorizations (AMM) in France for pholcodine-based cough syrups and to carry out a recall of all these syrups at the beginning of September.“Writes the drug agency.
For patients who are using or have used a cough syrup containing pholcodine, “there is no particular monitoring recommended at this time“, according to the ANSM. In case of general anesthesia, the anesthesiologist can ask the patient if he has already taken this type of syrup. Failing this, the patient is asked to inform him. The ANSM calls on anesthetists-resuscitators to ask patients if they have already consumed this type of syrup, and on doctors and pharmacists to explain the risk of cross-reaction to muscle relaxants in the event of general anesthesia to patients who have already taken it.
In April 2020, during the Covid-19 epidemic, the risk of a serious allergic reaction linked to pholcodine had led the ANSM to recommend not to use these cough syrups. In January 2022, the European Medicines Agency (EMA) Pharmacovigilance Committee recommended updating the summaries of product characteristics and package leaflets of pholcodine-based medicines to include a warning about the risk of overuse and cross-reaction with muscle relaxants, based in particular on new data.
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