Syrups containing pholcodine may no longer be authorized in France

The marketing authorizations for cough syrups containing pholcodine could be delayed in France in the face of a “significant risk» Allergy during anesthesia.

The marketing authorizations for cough syrups containing pholcodine could be delayed in France in the face of a “significant risk“Severe allergy to muscle relaxants during anesthesia, announced Monday, August 29, the National Agency for the Safety of Drugs.

According to a new study, taking a pholcodine-based cough medicine puts you at significant risk of severe allergy to muscle relaxants, which is indicated during general anesthesia, even if the anesthesia occurred several weeks after taking the drug‘ said the health department.

The syrups concerned are Dimetane without sugar (Biocodex), Biocalyptol and Biocalyptol without sugar (Zambon), Pholcodine (Biogaran). Since 2011, already because of this possible risk, syrups based on this opioid, used to calm dry cough and irritation in adults and certain children (over 30 months and over 15 kg), can only be sold on prescription in France.

A reminder in early September

In light of the preliminary results of a safety study in France, following a European assessment, the ANSM is now considering “their unfavorable risk-benefit ratio“, in view of “the non-essential nature of these syrups and the existence of therapeutic alternatives“.”Therefore, we plan to suspend the marketing authorizations (AMM) for pholcodine-based cough syrups in France and to recall all these syrups in early September.‘ writes the Drug Enforcement Agency.

For patients who are using or have used a cough syrup containing pholcodine: “No specific monitoring is currently recommended“, according to the ANSM. In the case of general anesthesia, the anesthetist may ask the patient if they have already taken this type of syrup. Otherwise, the patient is asked to inform him. The ANSM urges anesthesiologists and ventilators to ask patients if they have previously taken this type of syrup, and for physicians and pharmacists to educate patients who have previously taken this syrup about the risk of cross-reaction to muscle relaxants in the event of general anesthesia.

In April 2020, during the Covid-19 epidemic, the risk of a severe allergic reaction associated with pholcodine prompted the ANSM to recommend that these cough syrups should not be used. In January 2022, the Pharmacovigilance Committee of the European Medicines Agency (EMA) recommended updating the Summaries of Product Characteristics and Package Leaflets of pholcodine-based medicines to include a warning about the risk of overdose and cross-reactions with muscle relaxants, particularly based on new ones Data.

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