Antitussive syrup primarily based on pholcodine: suspension of promoting authorization and withdrawal of all merchandise

Paris, Friday September 9, 2022 – The ANSM (Nationwide Company for the Security of Medicines) introduced yesterday that the advertising and marketing authorizations for all medicines primarily based on pholcodine (used as cough syrup) are suspended in France. ready for a European reassessment of the chance of allergic cross-reaction with muscle relaxants.

This choice follows the outcomes of a post-MA security research confirming the existence of an affiliation between earlier publicity to pholcodine and the chance of anaphylactic response to muscle relaxants.

Medical doctors are due to this fact invited to now not prescribe these medicine and pharmacists to now not dispense them. Sufferers should cease their therapy and return it to the pharmacy for destruction.

It is usually beneficial that within the occasion of anesthesia and/or use of muscle relaxants, well being professionals ask their affected person concerning the consumption of pholcodine, even previous.

These merchandise, already within the crosshairs since 2009 and accessible solely on prescription since 2011, had been the topic of an alert within the midst of a pandemic. A discover then advised to medical doctors to not prescribe it and to sufferers to not devour it.

4 medicine are involved:

– Dimetane with out sugar 133 mg/100 ml, syrup, Biocodex Laboratory

– Pholcodine Biogaran 6.55 mg/5 ml, syrup, Biogaran Laboratory

– Biocalyptol 6.55 mg/5 ml, sugar-free, sweetened syrup 200 ml bottle, Zambon Laboratory

– Biocalyptol syrup, Zambon Laboratory.

The three laboratories have already introduced that they’re recalling all of the batches current available on the market.

XB