As of April 5, 2023, marketing authorizations for syrups containing pholcodine are definitively withdrawn in France due to a risk of a serious allergic reaction. Names and instructions.
After having them suspended in September 2022, theMedicines Agency announces that from April 5, 2023 “marketing authorizations (AMM) for medicines containing pholcodine (syrups) are withdrawn in France”. This measure follows the European Commission decision to withdraw the marketing authorizations for these medicines, in accordance with the opinion issued by the European Medicines Agency. THE Pholcodine-based syrups should no longer be used and returned to pharmacies. At the origin of this drastic decision, A risk of cross-allergic reaction with muscle relaxants. “According to a new study, taking the drug pholcodine, used against cough, exposes you to a significant risk of having a serious allergy to curares, indicated during general anesthesia, even if the anesthesia takes place several weeks later taking the medicine” explains the ANSM.
What are the pholcodine syrups marketed in France?
The medicines concerned by the withdrawal from the French market are:
- Dimetane without sugar 133 mg/100 ml, syrup (Biocodex)
- Biocalyptol 6.55 mg/5 ml sugar free syrup sweetened with sodium saccharin and liquid maltitol (Zambon)
- Biocalyptolsyrup (Zambon)
- Pholcodine Biogaran 6.55 mg/5 ml, syrup (Biogaran)
Pholcodine-based syrups have been used so far to soothe dry coughs and irritated coughs in adults and children over 30 months and over 15 kg. In France, they can only be dispensed by prescription since 2011.
What should I do with my pholcodine cough syrups?
Patients are asked to no longer use these specialties and to return the boxes in their possession to the pharmacy. Other medications are available for dry cough and/or irritation. Consult your doctor or pharmacist, he can advise you on an alternative taking into account your medical history.
Sources:
Risk of serious allergy to muscle relaxants when using cough syrups containing pholcodine: suspension of marketing authorizations and withdrawal of batches, ANSM, 5 April 2023
Pholcodine: Suspension of marketing authorizations and withdrawal of all boxes of syrup containing pholcodine due to a risk of cross-allergy with muscle relaxants. September 8, 2022.
Risk of serious allergy to muscle relaxants when using cough syrups containing pholcodine, ANSM, 1/09/22