Biocalyptol cough syrup based on pholcodine could soon be withdrawn from sale in France because of a risk of serious allergy to muscle relaxants.
[Mise à jour le 5 septembre 2022 à 18h07] Pholcodine-based cough syrups such as Biocalyptol are in the hot seat. A new study reveals that it could 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, alerts 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” indicates the National Agency for the Safety of Medicines and Health Products. The Agency plans to suspend marketing authorizations in France pholcodine-based cough syrups and to perform a reminder early september. 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?
If using a pholcodine cough medicine:
► If you are going to have general anesthesia, tell your anesthesiologist.
► If you are not required to undergo a general anaesthetic, there is no particular monitoring recommended at the present time.
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. Source: Risk of serious allergy to muscle relaxants when using cough syrups containing pholcodine, ANSM, 1/09/22