The marketing authorizations for pholcodine-based syrups (Biocalyptol, etc.) are suspended from September 8, 2022, as a precaution and pending a European reassessment on the risk of allergic cross-reaction with the curares.
[Mise à jour le 8 septembre 2022 à 18h00] Pholcodine-based cough syrups such as Biocalyptol had been on the hot seat for a few days. The decision has fallen. L’ANSM announcement on September 8 the suspension of marketing authorizations for all pholcodine-based medicines (list below) as of September 8, as a precaution and pending a European reassessment of the risk of allergic cross-reaction with muscle relaxants. The healthcare professionals should no longer prescribe or dispense these drugs. The patients must stop their treatment and return it to the pharmacy for destruction. A study found that it may increase the risk of have a severe allergy to muscle relaxantsused during anesthesia during operations and even if the anesthesia takes place several weeks after taking the drug, alerted the Medicines Agency (ANSM) in a Sept. 1 statement. Curare is a derivative of plants from the Amazon rainforest that helpsget paralysis. The product is used exclusively in Anaesthesia and Intensive Care.
“Given the non-essential nature of these syrups and the existence of therapeutic alternatives, we believe that the risk-benefit ratio of these drugs is unfavorable“said the National Agency for the Safety of Medicines and Health Products.
What drugs are being recalled?
The drugs concerned 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)
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. Pholcodine-based syrups are used to soothe dry coughs and irritation coughs in adults and children over 30 months and over 15 kg. Since 2011, these drugs are only available in France on prescription.
Sources:
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