Le comit\u00e9 de pharmacovigilance de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (PRAC, EMA) a engag\u00e9 une proc\u00e9dure de r\u00e9examen des m\u00e9dicaments injectables contenant du fer, en raison d\u2019un risque de baisse du phosphate sanguin (hypophosphat\u00e9mie) et de probl\u00e8mes osseux associ\u00e9s, notamment l\u2019ost\u00e9omalacie (ramollissement des os pouvant entra\u00eener des douleurs osseuses et des fractures). Ces m\u00e9dicaments sont utilis\u00e9s pour traiter la carence martiale et l\u2019an\u00e9mie ferriprive lorsque les formes orales sont inefficaces, impossibles \u00e0 utiliser ou lorsqu\u2019un r\u00e9tablissement rapide des taux de fer est n\u00e9cessaire.<\/p>\n
L\u2019hypophosphat\u00e9mie et l\u2019ost\u00e9omalacie hypophosphat\u00e9mique sont d\u00e9j\u00e0 des effets ind\u00e9sirables connus des m\u00e9dicaments \u00e0 base de carboxymaltose ferrique. L\u2019hypophosphat\u00e9mie figure comme effet ind\u00e9sirable fr\u00e9quent dans les informations sur le produit (jusqu\u2019\u00e0 1 patient sur 10), mais la fr\u00e9quence de l\u2019ost\u00e9omalacie hypophosphat\u00e9mique n\u2019est pas connue, faute de donn\u00e9es suffisantes. Les r\u00e9sum\u00e9s des caract\u00e9ristiques du produit pr\u00e9voient d\u00e9j\u00e0 des mesures de r\u00e9duction du risque, en particulier la surveillance de la phosphat\u00e9mie chez les patients recevant des doses \u00e9lev\u00e9es, des traitements prolong\u00e9s ou pr\u00e9sentant des facteurs de risque connus.<\/p>\n
La r\u00e9vision a \u00e9t\u00e9 d\u00e9clench\u00e9e par des signalements mettant en doute l\u2019efficacit\u00e9 de ces mesures pour les sp\u00e9cialit\u00e9s contenant du carboxymaltose ferrique. Des cas graves d\u2019hypophosphat\u00e9mie ont \u00e9t\u00e9 rapport\u00e9s, certains compliqu\u00e9s d\u2019ost\u00e9omalacie, y compris chez des patients n\u2019ayant re\u00e7u qu\u2019une ou deux doses et sans facteur de risque identifi\u00e9. Dans plusieurs situations, le diagnostic d\u2019hypophosphat\u00e9mie a \u00e9t\u00e9 retard\u00e9, les sympt\u00f4mes (fatigue, douleurs musculaires et osseuses) pouvant \u00eatre confondus avec ceux de la carence en fer, et certains troubles osseux, comme l\u2019ost\u00e9omalacie, n\u2019\u00e9tant pas toujours visibles \u00e0 la radiographie. Des cas similaires ayant \u00e9t\u00e9 signal\u00e9s avec d\u2019autres sp\u00e9cialit\u00e9s injectables \u00e0 base de fer, le champ de la r\u00e9vision porte sur l\u2019ensemble de ces m\u00e9dicaments, et non plus uniquement sur ceux contenant du carboxymaltose ferrique.<\/p>\n
Les m\u00e9dicaments contenant du fer administr\u00e9s par voie orale ne sont pas concern\u00e9s par cette r\u00e9vision, car ils d\u00e9livrent des quantit\u00e9s de fer nettement inf\u00e9rieures sur la dur\u00e9e et sont jug\u00e9s moins susceptibles d\u2019induire une hypophosphat\u00e9mie. Le PRAC va examiner le risque d\u2019hypophosphat\u00e9mie et de troubles osseux associ\u00e9s pour tous les m\u00e9dicaments injectables \u00e0 base de fer, ainsi que l\u2019efficacit\u00e9 des mesures de minimisation du risque actuellement en place, afin d\u2019\u00e9valuer leur impact sur le rapport b\u00e9n\u00e9fice\u2011risque global de ces traitements. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le comit\u00e9 de pharmacovigilance de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (PRAC, EMA) a engag\u00e9 une proc\u00e9dure de r\u00e9examen des m\u00e9dicaments injectables contenant du fer, en raison d\u2019un risque de baisse du […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[31,2],"tags":[257,227,226],"class_list":["post-17713","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-politiques-europeennes-sante-social-travail","category-sante-publique-et-systeme-de-soins","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17713","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17713"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17713\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17713"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17713"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17713"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}