Principe de précaution – Disponibles désormais que sur ordonnance, ces médicaments peuvent entraîner des effets secondaires rares mais graves.
Sortez vos mouchoirs : huit célèbres traitements anti-rhume ne sont désormais plus en vente libre. Considérés comme dangereux, les autorités sanitaires françaises rendent obligatoires à partir de ce mercredi la présentation d’une ordonnance en pharmacie pour se les voir délivrer.
Sont concernés Actifed Rhume, Actifed Rhume jour et nuit, Dolirhume Paracétamol et Pseudoéphédrine, Dolirhumepro Paracétamol Pseudoéphédrine et Doxylamine, Humex Rhume, Nurofen Rhume, Rhinadvil Rhume, Ibuprofène/Pseudoéphédrine, Rhinadvilcaps Rhume Ibuprofène/Pseudoéphédrine. Ces médicaments ont tous en commun de contenir la molécule pseudoéphédrine.
La balance bénéfice/risque
« Au regard d’une part des très nombreuses contre-indications, précautions d’emploi et des effets indésirables connus de la pseudoéphédrine et d’autre part du caractère bénin du rhume », l’Agence nationale de sécurité du médicament (ANSM) considère que « la possibilité d’obtenir ces médicaments sans avis médical fait courir un risque trop important aux patients », selon une décision dévoilée lundi.
Disponibles sous forme de comprimés, ces traitements – aussi vendus par spray nasal sur prescription – visent à décongestionner et désencombrer le nez. Mais ils font l’objet depuis plusieurs années de nombreuses critiques, à commencer par l’ANSM elle-même, car ils peuvent provoquer de graves effets secondaires comme des AVC et des infarctus.
En 2023, l’agence avait pour la première fois déconseillé explicitement leur utilisation. Cette décision avait, pour un temps, fait décliner les ventes. Mais celles-ci rebondissent depuis septembre.
Aucun décès en France
Alors pourquoi ne pas avoir interdit plus tôt purement et simplement ces médicaments ? Les autorités sanitaires françaises expliquaient régulièrement avoir les mains liées par la réglementation européenne qui soumet le retrait d’une autorisation à l’avis de l’Agence européenne du médicament (EMA). Or, celle-ci avait estimé l’an dernier que ces traitements ne présentaient pas de risques suffisants pour les interdire, même si elle a imposé de nouvelles contre-indications. Cet avis s’explique par le fait que les effets secondaires graves restent très rares. Ils sont quelques-uns à être signalés chaque année et, en France, aucun décès n’a été rapporté.
Les autorités françaises ont fini cependant par trancher en estimant que le risque, même faible, était inacceptable au vu du caractère bénin de la maladie traitée : un simple rhume. Cette position va dans le sens des principales sociétés savantes françaises (ORL, médecins généralistes, pharmaciens) qui s’opposent toutes à l’usage de ces médicaments.
Elle risque en revanche de froisser les pharmaciens, dont nombre de représentants estiment qu’une telle restriction réduit injustement l’éventail de médicaments à proposer à leurs clients enrhumés, dans un contexte marqué par une difficulté récurrente à obtenir des rendez-vous médicaux.
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