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On September 8, 2022, the National Medicines Safety Agency suspended the marketing authorizations (AMM) for pholcodine-based cough syrups. In question ? The risk of a serious allergy to muscle relaxants in the event of anesthesia.
The ANSM (National Agency for the Safety of Medicines) announced it on September 1: pholcodine-based cough syrups, issued only on prescription since 2011, could be suspended. In question: the risk of causing a serious allergy in the event of general anesthesia. A decision recorded since September 8: the 4 syrups in question no longer have a marketing authorization. This decision gives rise to the recall of all batches of these syrups present in pharmacies, health establishments and wholesale distributors.
What are the syrups concerned?
These are four syrups based on pholcodine, used to soothe dry coughs and irritation coughs in adults and children over 30 months and over 15 kg. They are all currently prescribed by prescription.
- Dimetane without sugar 133 mg/100 ml, syrup (Biocodex);
- Biocalyptol 6.55 mg/5 ml without sugar, syrup sweetened with sodium saccharin and liquid maltitol (Zambon);
- Biocalyptol, syrup (Zambon);
- Pholcodine Biogaran 6.55 mg/5 ml, syrup (Biogaran).
What is the problem ?
According to the website of the National Medicines Safety Agency, new studies confirm risk-taking. “LTaking 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” she mentions, before specifying that this risk can occur even if the anesthesia takes place several weeks after taking the drug.
In fact, the agency considers that the benefit / risk ratio carried out in this case is unfavorable.As a result, we plan to suspend the marketing authorizations (AMM) in France for pholcodine-based cough syrups and to recall all of these syrups in early September.” announces the press release.
What if you use these syrups?
According to the ANSM press release, if you have bottles of pholcodine-based syrup in your family pharmacy, stop using them and bring them back to the pharmacy.
Did you use any of the products mentioned in the ad? Do not panic, however, no particular monitoring is currently recommended. However, people who have to undergo general anesthesia should talk to the anesthetist about it, if the question is not raised. The info can also be added to “My health space”.