Les sirops antitussifs à base de pholcodine vont être à terme retirés du marché, en raison de leur risque d’allergie croisée grave avec certains produits utilisés en anesthésie, les curares. Une nouvelle étude atteste de ce risque important, même si l’anesthésie a lieu plusieurs semaines après la prise du sirop.
Retrait à venir pour certains antitussifs. L’Agence nationale de sécurité des médicaments et des produits de santé (ANSM) vient en effet d’annoncer la suspension d’autorisation de mise sur le marché (AMM) de quatre sirops à base de pholcodine (voir la liste ci-dessous).
Un rapport bénéfice/risque « défavorable »
Cette mesure, qui sera effective le 8 septembre 2022, devrait de fait aboutir au retrait de cette classe médicamenteuse, le message de l’ANSM étant aujourd’hui très clair et considérant que « compte tenu du caractère non indispensable de ces sirops et de l’existence d’alternatives thérapeutiques, leur rapport bénéfice/risque est estimé défavorable ».
De « potentiel » en 2020, le risque est désormais confirmé avec une nouvelle étude à l’origine du récent communiqué de l’ANSM qui précise que « la prise d’un de ces médicaments expose à un risque important de faire une allergie grave aux curares, indiqués lors d’une anesthésie générale, même si l’anesthésie a lieu plusieurs semaines après la prise du médicament ».
Les quatre sirops contre la toux concernés :
– Dimétane sans sucre 133 mg/100 ml, sirop (Biocodex) ;
– Biocalyptol 6,55 mg/5 ml sans sucre, sirop édulcoré à la saccharine sodique et au maltitol liquide (Zambon)
– Biocalyptol, sirop (Zambon)
– Pholcodine Biogaran 6,55 mg/5 ml, sirop (Biogaran)
Faire connaître le risque de réaction croisée aux curares en cas d’anesthésie générale
Ces produits, déjà dans le collimateur depuis 2009 et délivrables uniquement sur ordonnance depuis 2011, avaient déjà fait l’objet d’une alerte en pleine pandémie en 2020, période à laquelle, par mesure de précaution, un avis demandant alors aux médecins de ne pas en prescrire et aux patients de ne pas en prendre était paru.
Deux ans plus tard, l’ANSM renouvelle donc ses conseils auprès des patients (ne pas en prendre), et enjoint en plus les médecins et les pharmaciens à expliquer à ceux qui auraient déjà utilisé ces sirops le risque de réaction croisée aux curares en cas d’anesthésie générale. L’Agence insiste en demandant aux soignants de s’assurer que les patients ont bien compris l’importance de signaler au médecin anesthésiste l’utilisation, même ancienne, de ce type de sirop lorsqu’ils sont amenés à subir une anesthésie générale.
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