L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) signale en 2025 la survenue d\u2019un nouveau cas \u00e9vitable de toxicit\u00e9 s\u00e9v\u00e8re li\u00e9 \u00e0 une chimioth\u00e9rapie \u00e0 base de fluoropyrimidines, malgr\u00e9 l\u2019existence de mesures de pr\u00e9vention. Elle rappelle l\u2019obligation r\u00e9glementaire de r\u00e9aliser un test de d\u00e9pistage du d\u00e9ficit en dihydropyrimidine d\u00e9shydrog\u00e9nase (DPD) avant toute initiation de traitement par 5-fluorouracile (5-FU) ou cap\u00e9citabine, afin de v\u00e9rifier la capacit\u00e9 de l\u2019organisme \u00e0 \u00e9liminer ces m\u00e9dicaments.<\/p>\n
Les r\u00e9sultats 2025 de l\u2019enqu\u00eate nationale de pharmacovigilance, mise en place par l\u2019ANSM depuis 2018, montrent que peu de cas graves de toxicit\u00e9 ont \u00e9t\u00e9 d\u00e9clar\u00e9s. Cette enqu\u00eate suit annuellement les effets ind\u00e9sirables graves (pronostic vital engag\u00e9, d\u00e9c\u00e8s) qui auraient pu \u00eatre \u00e9vit\u00e9s si les recommandations avaient \u00e9t\u00e9 respect\u00e9es, \u00e0 partir des d\u00e9clarations des patients et des professionnels de sant\u00e9 via le portail de signalement et le r\u00e9seau des centres r\u00e9gionaux de pharmacovigilance (CRPV).<\/p>\n
En 2025, un cas d\u2019erreur m\u00e9dicamenteuse \u00e9vitable avec la cap\u00e9citabine a \u00e9t\u00e9 signal\u00e9 chez une patiente pr\u00e9sentant un d\u00e9ficit partiel en DPD d\u00e9j\u00e0 connu, sans adaptation de la dose prescrite. Cet \u00e9v\u00e9nement a conduit l\u2019\u00e9tablissement de sant\u00e9 concern\u00e9 \u00e0 mettre en place des mesures internes pour s\u00e9curiser les futures prescriptions et d\u00e9livrances de cap\u00e9citabine. L\u2019ANSM souligne que ce type de signalement illustre la n\u00e9cessit\u00e9 de maintenir une vigilance constante de l\u2019ensemble des acteurs de la cha\u00eene de soins.<\/p>\n
\u00c0 la demande de la Direction g\u00e9n\u00e9rale de la sant\u00e9 (France), l\u2019ANSM et l\u2019Institut national du cancer (INCa) ont coordonn\u00e9 un groupe pluridisciplinaire d\u2019experts qui a rendu un avis national visant \u00e0 guider l\u2019adaptation de la dose initiale de fluoropyrimidines chez les patients pr\u00e9sentant un d\u00e9ficit partiel en DPD. Ces recommandations portent notamment sur l\u2019ajustement posologique en fonction du niveau d\u2019uracile dans le sang. Un rapport d\u00e9taill\u00e9 de l\u2019enqu\u00eate nationale de pharmacovigilance sur les toxicit\u00e9s graves li\u00e9es au 5-FU ou \u00e0 la cap\u00e9citabine en lien avec un d\u00e9ficit en DPD a \u00e9t\u00e9 mis \u00e0 disposition le 9 septembre 2026.\u00a0(contenu r\u00e9sum\u00e9 par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) signale en 2025 la survenue d\u2019un nouveau cas \u00e9vitable de toxicit\u00e9 s\u00e9v\u00e8re li\u00e9 \u00e0 une chimioth\u00e9rapie \u00e0 base […]<\/p>\n","protected":false},"author":1,"featured_media":3852,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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