After reviewing medicines and syrups containing pholcodine, used in adults and children to treat dry cough, the European Medicines Agency (EMA) has decided to prohibit all applications for placing on the market in the European Union. Indeed, these syrups could cause a dangerous allergic reaction in case of general anesthesia.
“Available data have shown that the use of pholcodine within 12 months prior to general anesthesia with neuromuscular blocking agents (NMBAs) is a risk factor for developing an anaphylactic reaction.” a “sudden, severe and life-threatening allergic reaction to NMBAs“, says the communicated of the EMA.
Only prescribed by prescription, pholcodine-based syrups were previously used to soothe dry coughs and irritating coughs in adults and children over 30 months.
Products already banned in France
In France, the marketing authorizations for all pholcodine-based medicines have been suspended since September 8, 2022, “as a precaution and pending a European reassessment on the risk of allergic cross-reaction with curares”, had then indicated the National Agency for the Safety of Medicines (ANSM).
“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 has several weeks after taking the drug. Given the non-essential nature of these syrups and the existence of therapeutic alternatives, we believe that their benefit/risk ratio is unfavourable.“, had then explained the National Agency for the Safety of Medicines (ANSM) in a press release. Consequently:
- Healthcare professionals should no longer prescribe or dispense these drugs;
- In the event of anesthesia and/or use of muscle relaxants, health professionals should inquire about the consumption of pholcodine, even old, by patients;
- Patients must stop their treatment and return it to the pharmacy for destruction.
What are the syrups concerned?
- Biocalyptol 6.55 mg/5 ml without sugar, syrup sweetened with sodium saccharin and liquid maltitol (Zambon)
- Biocalyptol, syrup (Zambon)
- Dimetane without sugar 133 mg/100 ml, syrup (Biocodex)
- Pholcodine Biogaran 6.55mg/5ml, syrup (Biogaran)
What if I have already taken this type of syrup?
If you use or have already used this type of syrup, there is no particular monitoring recommended at this time. However, if you have to undergo general anesthesia, remember to inform the anesthesiologist if he does not ask you about this himself.
Source :
- EMA recommends withdrawal of pholcodine medicines from EU market, European Medicines AgencyDecember 2, 2022
