These cough syrups could be withdrawn from the market: what you need to know

By Rédaction Actu Published on 4 Sep 22 at 11:28 Actu See my news Follow this media 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 Agency for the Safety of Medicines and Health Products (ANSM) decided, this Thursday, September 1, 2022, “after a new study”, to say stop to cough syrups containing of 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”, warns 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 a profit- unfavorable risk. Syrups based on pholcodine are used to soothe dry coughs and coughs of irritation in adults and children over 30 months and over 15 kg. In France, they can also only be delivered on prescription since 2011. A recall of these syrups could be made 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 operated these days. If you use or have already used a cough syrup containing pholcodine, there is however no particular monitoring recommended at the present time. However, if you are required to undergo general anesthesia, the anesthesiologist may ask you if you have already consumed this type of syrup. Remember to inform him directly if he does not question you himself on this point, nevertheless insists the ANSM. 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 Hexapneumine Humex Myrtine Polery Pulmosodyl Respilene Rhinathiol Medicines for Human Use (CHMP) concluded in December 2011 that these medicines should be kept on the market due to the low level of proof of the risk studied. But the studies followed one another. In April 2020, in the context of the Covid-19 epidemic, this risk “had led us to recommend not to use 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 medicines to include a warning about the risk of overuse and cross-reaction with curares, based in particular on new data from the literature. Today, it’s decided. Was this article useful to you? Note that you can follow Actu in the My Actu space. In one click, after registration, you will find all the news of your favorite cities and brands.