Health authorities withdraw cough syrups in France due to allergy risk

The syrups which are based on pholcodine will no longer be sold. However, no immediate action is required if you have taken the medicine

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Four cough syrups in France have been withdrawn from sale due to a “severe risk” of allergies, health authorities have confirmed.

Medicines safety agency L’Agence nationale de sécurité des médicaments et des produits de santé (ANSM) has taken the action over the syrups which are based on pholcodine as this can later cause an allergy risk when taken before a medicine used in general anaesthetic.

In a statement, it said: “Syrups based on pholcodine are used to calm dry coughs and irritation coughs in adults and children aged over 30 months and weighing more than 15kg.”

It said that it had withdrawn the syrups because “taking one of these medicines exposes people to developing an allergy towards curare, which is used during general anaesthetic, even if the anaesthetic is being given several weeks after taking the [cough] medicine”.

The syrups being recalled are:

  • Di­mé­tane sugar-free 133 mg/100 ml, syrup (Bio­co­dex)
  • Bio­ca­lyp­tol 6.55 mg/5 ml sugar-free syrup, coloured with saccharin sodium and liquid maltitol (Zam­bon)
  • Bio­ca­lyp­tol, syrup (Zam­bon)
  • Phol­co­dine Bio­ga­ran 6.55 mg/5 ml, syrup (Bio­ga­ran)

The ANSM said: “Due to these new data, given the non-essential nature of these syrups and the existence of therapeutic alternatives, we consider that their benefit/risk ratio is unfavourable.

“As a result, we will suspend [their market authorisation] and perform a recall on all of these syrups at the start of September.”

Anyone who is using, or has used, a syrup based on pholcodine, is safe and there is “currently no particular action to take”, the ANSM said. However, it advised that “if you are later required to go under general anaesthetic, the anaesthetist may ask you if you have consumed this type of syrup”.

People are also invited to register on the Mon espace santé website, and indicate that you have taken a medicine based on pholcodine.

Health professionals have also been issued with recommendations to help minimise the risk. Medicines based on pholcodine will now pass to a prescription-only basis and doctors must communicate the risks.

The ANSM said it had been monitoring these syrups for several years before making the decision to take them off the market.

It said that its decision was also based on a European benefit-risk evaluation, following rising reports of anaphylaxis (severe allergic reaction) in France, and the publication of relevant studies in Norway and Sweden.

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