Pholcodine-based cough syrups soon banned in France?

THE ESSENTIAL

  • Pholcodine syrups are prescribed to soothe dry coughs and irritation coughs in adults and children over 30 months and over 15 kg.
  • Since 2011, these syrups can only be delivered on prescription in France.

Given the non-essential nature of these syrups (based on pholcodine, an antitussive morphine derivative) and the existence of therapeutic alternatives, we believe that their risk/benefit ratio is unfavourable, Explain the National Agency for the Safety of Medicines (ANSM) in a press release published this Thursday, September 1. As a result, we are considering suspending the marketing authorizations (MA) in France for pholcodine-based cough syrups”.

Significant risk of allergy…

According to the ANSM, the interaction between cough suppressants containing pholcodine and curares, neuromuscular blocking agents used during anesthesia, could cause a significant risk of allergy.

…several weeks later

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 takes place several weeks after taking the drug”, points out the press release.

No special monitoring

In detail, the syrups concerned are Dimetane without sugar (Biocodex), Biocalyptol and Biocalyptol without sugar (Zambon), Pholcodine (Biogaran). But the ANSM reassures patients: “If you are using or have used a cough syrup containing pholcodine, there is no special monitoring recommended at this time.”.

Inform the anesthesiologist

In the event of future general anesthesia, the health authority recommends that anesthetists-resuscitators ask their patients if they have already consumed this type of syrup. The latter are also invited to inform the health professional if the latter does not ask them. Finally, it is also possible to fill in My health space (“Medical profile”, then “Treatments”) that you have taken a pholcodine-based medicine.

A known risk

The risk of allergy was already known. In effect, in April 2020, the ANSM had issued, as a precautionary measure, a notice asking doctors not to prescribe these syrups and patients not to take them. For the moment, the suspension of marketing authorizations has not been recorded, but it could be decided in the weeks or months to come.






















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