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These cough syrups could be withdrawn from the market: what you need to know

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Marketing authorizations for cough syrups containing pholcodine could be suspended in France in the face of a “significant risk” of allergy during anesthesia. (©Illustration/Adobe Stock)

The National Security Agency of medication and Health Products (ANSM) decided on Thursday 1er September 2022, “after a new study”, to say stop to syrups against cough based on pholcodine.

Since 2009, pholcodine used as an active ingredient in cough syrups has been under discussion. This drug “exposes to a significant risk of making a serious allergy to curares, indicated during general anesthesia, even if the anesthesia takes place several weeks after taking”, alerts the ANSM.

The public actor which allows, on behalf of the State, access to health products in France and which ensures their safety throughout their life cycle, plans to suspend their marketing authorizations in the coming days. , in the face of an unfavorable benefit-risk ratio.

Pholcodine-based syrups are used to calm dry coughs and irritation coughs in adults and children over 30 months and over 15 kg. In France, they can also only be issued on prescription since 2011.

A recall of these syrups could be operated these days

“Given the non-essential nature of these syrups and the existence of therapeutic alternatives”, indicates the health authority, a recall of all of these syrups could be made these days.

If you use or have used a cough syrup containing pholcodine, however, there is no specific monitoring recommended at this time.

If, however, you have to undergo a General anaesthesia, the anesthesiologist may ask you if you have already consumed this type of syrup. Remember to inform him directly if he does not ask you himself on this point, nevertheless insists the ANSM.

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Already in 2011, the French Agency for the Safety of Health Products (Afssaps) called on health professionals to be vigilant regarding pholcodine and the allergic accidents observed during anesthesia, citing different syrups:

  • Biocalyptol
  • Broncalene
  • Clarix
  • Codotussyl
  • Dimetane
  • Ephedromel
  • Flucalyptol
  • Hexapneumin
  • Humex
  • Myrtina
  • Polery
  • Pulmosodyl
  • Respilene
  • Rhinathiol

On the basis of the available data, the Committee for Medicinal Products for Human Use (CHMP) concluded in December 2011 that these medicinal products should be kept on the market due to the low level of evidence of the risk studied. But the studies went on.

In April 2020, in the context of the Covid-19 epidemicthis risk “had led us to recommend not using pholcodine-based syrups for the symptomatic treatment of coughs”, recalls the health authority.

Last January, the pharmacovigilance committee recommended updating the summaries of product characteristics and package leaflets of pholcodine-based medicinal products to include a warning about the risk of overuse and cross-reaction with muscle relaxants, based in particular on new data from the literature. Today, it is decided.

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