EU bans potentially dangerous cough syrups

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The cough syrups containing pholcodine will soon be banned in the European Union, announced the European Medicines Agency (EMA), Friday, December 2.

Because ? They can cause an allergic reaction in case of general anesthesia. And this, even if they were consumed long before the anesthesia.

The use of pholcodine in the previous twelve months can cause, at the time of general anesthesia, an anaphylactic reaction, underlined the Agency.

In her press release, she recalls that anaphylactic shock is a “sudden, severe, life-threatening allergic reaction“. Given the seriousness of the situation, his decision will be applied as soon as he receives administrative approval (source 1).

Which syrups are concerned?

The syrups targeted by the EMA are notably marketed in France (by prescription) under the brands Zambon, Biocodex or Biogaran. They are used to soothe dry coughs and irritation coughs in adults and children over 30 months and over 15 kg.

But in view of recent data, in the heart of the Covid-19 epidemic, the French authorities already strongly advised against these treatments. More recently, in September 2022, the ANSM withdrew the marketing authorization (AMM) for these syrups due to the unfavorable risk-benefit ratio (source 2). Four syrups were then concerned:

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 6.55mg/5ml, syrup (Biogaran)

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