Cough syrup: Biocalyptol at the origin of curare allergies

The National Medicines Safety Agency is considering suspending marketing authorizations (MA) in France for pholcodine-based cough syrups, such as Biocalyptol, due to severe allergies.

Prescription only, pholcodine syrups are used to soothe dry coughs and irritating coughs in adults and children over 30 months.

After being alerted by the pharmacovigilance committee of the European Medicines Agency, which recommended including a warning on the leaflet on the risk of overconsumption and cross-reaction with muscle relaxants, the National Medicines Safety Agency (ANSM) considered in turn that the risk of serious allergy to curare played against the drug. It therefore plans to suspend the marketing authorizations (AMM) in France for pholcodine-based cough syrups.

“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 takes place several weeks after taking the drug.Given the non-essential nature of these syrups and the existence of therapeutic alternatives, we believe that their risk/benefit ratio is unfavorable. medicine (ANSM) in a press release.

What are the syrups concerned?

  • Biocalyptol 6.55 mg/5 ml without sugar, syrup sweetened with sodium saccharin and liquid maltitol (Zambon)
  • Biocalyptol, sirop (Zambon)
  • Dimetane without sugar 133 mg/100 ml, syrup (Biocodex)
  • Pholcodine Biogaran 6,55 mg/5 ml, sirop (Biogaran)

What if I have already taken this type of syrup?

The ANSM plans to recall pholcodine-based syrups from this month of September. If you use or have already used this type of syrup, there is no particular monitoring recommended at present. However, if you have to undergo general anesthesia, remember to inform the anesthesiologist if he does not ask you about this himself.

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