{"id":28988,"date":"2020-09-30T09:00:00","date_gmt":"2020-09-30T13:00:00","guid":{"rendered":"https:\/\/wfh.org\/recommandation-de-la-fmh-disponibilite-de-la-desmopressine-dans-lattente-de-la-reprise-de-la-fabrication-de-la-desmopressine-par-voie-intranasale\/"},"modified":"2024-07-11T11:39:33","modified_gmt":"2024-07-11T15:39:33","slug":"recommandation-de-la-fmh-disponibilite-de-la-desmopressine-dans-lattente-de-la-reprise-de-la-fabrication-de-la-desmopressine-par-voie-intranasale","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/recommandation-de-la-fmh-disponibilite-de-la-desmopressine-dans-lattente-de-la-reprise-de-la-fabrication-de-la-desmopressine-par-voie-intranasale\/","title":{"rendered":"Recommandation de la FMH : disponibilit\u00e9 de la desmopressine dans l\u2019attente de la reprise de la fabrication de la desmopressine par voie intranasale"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"28988\" class=\"elementor elementor-28988 elementor-17836\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-fbceb52 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fbceb52\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-e5419f6\" data-id=\"e5419f6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e8fe9de elementor-widget elementor-widget-text-editor\" data-id=\"e8fe9de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Mise \u00e0 jour de l\u2019<a href=\"https:\/\/news.wfh.org\/fr\/avertissement-de-la-fmh-rappel-dune-solution-de-desmopressine-en-flacons-pulverisateurs-par-ferring-pharmaceuticals\/\" target=\"_blank\" rel=\"noopener noreferrer\">Avertissement de la FMH\u00a0: rappel mondial par Ferring Pharmaceuticals d\u2019Octim<sup>\u00ae<\/sup>\/Octostim<sup>\u00ae<\/sup>\u00a0(desmopressine), solution pour pulv\u00e9risation nasale (1,5\u00a0mg\/ml)<\/a><\/p>\n<p>Compte tenu de l\u2019enqu\u00eate en cours faisant suite au rappel mondial des produits de desmopressine par voie intranasale d\u00e9cid\u00e9 par Ferring Pharmaceuticals \u00e0 la mi-juillet, les perturbations et les ruptures d\u2019approvisionnement devraient se poursuivre au moins jusqu\u2019au milieu ou la fin de l\u2019ann\u00e9e\u00a02021. Suivent une synth\u00e8se et une mise \u00e0 jour du Comit\u00e9 sur la s\u00e9curit\u00e9, l\u2019approvisionnement et l\u2019acc\u00e8s aux m\u00e9dicaments de la FMH concernant la disponibilit\u00e9 d\u2019autres options th\u00e9rapeutiques.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9c33c1c elementor-widget elementor-widget-spacer\" data-id=\"9c33c1c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bcc4201 elementor-widget elementor-widget-heading\" data-id=\"bcc4201\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Contexte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62cd4a8 elementor-widget elementor-widget-text-editor\" data-id=\"62cd4a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n<li>La desmopressine (1-d\u00e9samino-8-D-arginine vasopressine, \u00e9galement connue sous le nom de \u00ab\u00a0DDAVP\u00a0\u00bb) est un analogue synth\u00e9tique de la vasopressine qui accro\u00eet les taux plasmatiques de facteur\u00a0VIII et de facteur Willebrand<sup>1<\/sup><\/li>\n<li>La desmopressine pourrait \u00eatre le traitement de choix pour les patients atteints d\u2019h\u00e9mophilie\u00a0A mineure ou mod\u00e9r\u00e9e, y compris les porteurs, et de nombreux patients ayant la\u00a0<a href=\"https:\/\/www.wfh.org\/en\/our-work-global\/vwd-initiative-program\" target=\"_blank\" rel=\"noopener noreferrer\">maladie de Willebrand (mW)<\/a>, en particulier ceux ayant une mW de type\u00a01<sup>1<\/sup><\/li>\n<li>Bien que la desmopressine puisse \u00eatre administr\u00e9e par voie sous-cutan\u00e9e, elle est essentiellement administr\u00e9e par perfusion intraveineuse ou pulv\u00e9risation nasale<sup>1<\/sup><\/li>\n<li>\u00c0 la mi-juillet\u00a02020, par mesure de pr\u00e9caution, Ferring Pharmaceuticals a proc\u00e9d\u00e9 \u00e0 un rappel mondial volontaire de ses flacons pulv\u00e9risateurs de desmopressine, y compris de la formulation utilis\u00e9e dans le traitement de l\u2019h\u00e9mophilie mineure\/mod\u00e9r\u00e9e et de la mW (Octostim\u00ae, Octim\u00ae, Stimate\u00ae de CSL Behring et autres appellations commerciales dans le monde)<\/li>\n<li>Les formulations retir\u00e9es du march\u00e9 comportaient des concentrations de desmopressine plus \u00e9lev\u00e9es que celles sp\u00e9cifi\u00e9es<\/li>\n<li>Le rappel a \u00e9t\u00e9 annonc\u00e9 \u00e0 l\u2019\u00e9chelle mondiale entre le 10\u00a0juillet et le 5\u00a0ao\u00fbt par diff\u00e9rentes parties\u00a0: Ferring Pharmaceuticals, les autorit\u00e9s r\u00e9glementaires nationales, les minist\u00e8res de la Sant\u00e9 et les distributeurs<\/li>\n<li>Le niveau de rappel (\u00e0 savoir au niveau des pharmacies ou des patients) et les formulations retir\u00e9es dans chaque pays varient en fonction des d\u00e9cisions et des exigences r\u00e9glementaires locales<\/li>\n<li>Bien que la majorit\u00e9 des pays aient publi\u00e9 des rappels au niveau des pharmacies, les patients peuvent envisager de rapporter le produit inutilis\u00e9 \u00e0 la pharmacie apr\u00e8s consultation de leurs centres de traitement<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c1fd203 elementor-widget elementor-widget-spacer\" data-id=\"c1fd203\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c2ac55 elementor-widget elementor-widget-heading\" data-id=\"0c2ac55\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Risques<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-85a0629 elementor-widget elementor-widget-text-editor\" data-id=\"85a0629\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\r\n \t<li>Les cons\u00e9quences potentielles pour la sant\u00e9 d\u2019une exposition \u00e0 une quantit\u00e9 accrue de desmopressine sont notamment la r\u00e9tention d\u2019eau, l\u2019hypotension et l\u2019hyponatr\u00e9mie (faible concentration de sodium dans le sang),1 ce qui pourrait, dans des cas extr\u00eames, entra\u00eener des crises, un coma et la mort2<\/li>\r\n \t<li>Aucun signalement d\u2019\u00e9v\u00e9nement ind\u00e9sirable li\u00e9 \u00e0 l\u2019utilisation de lots non conformes aux sp\u00e9cifications n\u2019a \u00e9t\u00e9 port\u00e9 \u00e0 notre connaissance \u00e0 ce stade<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c78a3a9 elementor-widget elementor-widget-spacer\" data-id=\"c78a3a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2e628cd elementor-widget elementor-widget-heading\" data-id=\"2e628cd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Disponibilit\u00e9 d\u2019autres options<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-37d011b elementor-widget elementor-widget-text-editor\" data-id=\"37d011b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n<li>L\u2019enqu\u00eate sur les causes des formulations d\u00e9fectueuses est toujours en cours<\/li>\n<li>\u00c0 ce stade, l\u2019on ne sait pas quand la fabrication des formulations de desmopressine par voie intranasale reprendra. \u00c9tant donn\u00e9 que l\u2019enqu\u00eate se poursuit et que les mesures et actions correctives pourraient prendre un certain temps, la fabrication ne reprendra pas de si t\u00f4t et il est probable que ces produits ne seront pas disponibles au moins jusqu\u2019au milieu ou la fin de l\u2019ann\u00e9e 2021.<\/li>\n<li>Dans l\u2019attente de la reprise de la fabrication, des formulations injectables (par voie intraveineuse ou sous-cutan\u00e9e) de desmopressine (4\u00a0microgrammes\/mL et 15\u00a0microgrammes\/mL) sont disponibles et doivent \u00eatre consid\u00e9r\u00e9es comme des options th\u00e9rapeutiques pour les patients concern\u00e9s<\/li>\n<li>L\u2019\u00e9ducation et la formation des patients\/aidants sur l\u2019administration du traitement par voie sous-cutan\u00e9e ou intraveineuse sont, le cas \u00e9ch\u00e9ant, recommand\u00e9es<\/li>\n<li>La coordination avec les professionnels de sant\u00e9 est recommand\u00e9e pour tous les patients concern\u00e9s par le rappel afin de discuter des autres options th\u00e9rapeutiques (p.\u00a0ex., concentr\u00e9s de facteur de coagulation, acide tranexamique ou autres formes de desmopressine) qui pourraient \u00eatre n\u00e9cessaires, en particulier pour la prise en charge des \u00e9v\u00e9nements h\u00e9morragiques et les soins p\u00e9ri-op\u00e9ratoires<\/li>\n<li>En collaboration avec les professionnels de sant\u00e9 et les autorit\u00e9s nationales, il est conseill\u00e9 aux ONM d\u2019informer leurs communaut\u00e9s sur la situation dans leur pays respectif<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aa15196 elementor-widget elementor-widget-spacer\" data-id=\"aa15196\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89273a2 elementor-widget elementor-widget-text-editor\" data-id=\"89273a2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><sup>1<\/sup>\u00a0Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition.\u00a0<em>Haemophilia<\/em>. 2020:26(Suppl 6):1-158.\u00a0<a href=\"https:\/\/doi.org\/10.1111\/hae.14046\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/doi.org\/10.1111\/hae.14046<\/a><\/p>\n<p><sup>2<\/sup>\u00a0U.S. Food and Drug Administration. Ferring US Issues Voluntary Nationwide Recall of DDAVP\u00ae Nasal Spray 10 mcg\/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg\/0.1mL, STIMATE\u00ae Nasal Spray 1.5 mg\/mL Due to Superpotency. Site Web de la FDA. Silver Spring, MD: U.S. Food and Drug Administration.\u00a0<a href=\"http:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate<\/a>\u00a0Derni\u00e8re consultation : 5 ao\u00fbt 2020.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Mise \u00e0 jour de l\u2019Avertissement de la FMH : rappel mondial par Ferring Pharmaceuticals d\u2019Octim\u00ae\/Octostim\u00ae (desmopressine), solution pour pulv\u00e9risation nasale (1,5 mg\/ml)<\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[197],"tags":[],"search-category":[],"class_list":["post-28988","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-declarations-publiques-et-recommandations-de-la-fmh"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - 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