{"id":2703,"date":"2019-06-26T09:28:24","date_gmt":"2019-06-26T13:28:24","guid":{"rendered":"https:\/\/natural-womanhood.local\/?p=2703"},"modified":"2024-05-18T12:55:44","modified_gmt":"2024-05-18T17:55:44","slug":"fda-petition-contraceptifs-hormonaux-birth-control-side-effects-2019","status":"publish","type":"post","link":"https:\/\/naturalwomanhood.org\/fr\/fda-petition-hormonal-contraceptives-birth-control-side-effects-2019\/","title":{"rendered":"Analyse de la r\u00e9cente p\u00e9tition citoyenne de la FDA concernant les contraceptifs hormonaux"},"content":{"rendered":"<p>Vous savez peut-\u00eatre d\u00e9j\u00e0 qu'un <a href=\"https:\/\/www.regulations.gov\/document?D=FDA-2019-P-2289-0001\">P\u00e9tition citoyenne<\/a> a r\u00e9cemment \u00e9t\u00e9 d\u00e9pos\u00e9e aupr\u00e8s de la FDA (Food and Drug Administration) pour demander plus de transparence et d'avertissements aux patients concernant les effets secondaires potentiels des diff\u00e9rentes formes de contraceptifs hormonaux. Nous en parlons depuis quelques semaines et, comme le dit G\u00e9rard Migeon, PDG de Natural Womanhood <a href=\"https:\/\/naturalwomanhood.org\/fr\/effets-secondaires-du-controle-des-naissances-petition-de-la-fda-2019\/\">invit\u00e9s<\/a> Il y a quelques semaines, nous avons encourag\u00e9 toutes les personnes ayant souffert des effets secondaires d'un contraceptif \u00e0 partager leur histoire. <a href=\"https:\/\/www.regulations.gov\/document?D=FDA-2019-P-2289-0001\">faire un commentaire sur la p\u00e9tition<\/a>Des dizaines de personnes ont d\u00e9j\u00e0 fait part de leurs commentaires \u00e0 ce sujet.<\/p>\n<p>Mais que contient exactement cette p\u00e9tition ? <a href=\"https:\/\/www.regulations.gov\/document\/FDA-2019-P-2289-0001\" target=\"_blank\" rel=\"noopener\">Avec pr\u00e8s de 100 pages, ce document volumineux<\/a> peut sembler un peu intimidant \u00e0 premi\u00e8re vue. C'est pourquoi nous sommes heureux de pr\u00e9senter le contenu sous la forme d'une FAQ digeste.<\/p>\n<h2 id=\"what-is-the-goal-of-the-petition\">Quel est l'objectif de la p\u00e9tition ?<\/h2>\n<p>En bref, le <a href=\"https:\/\/www.regulations.gov\/document?D=FDA-2019-P-2289-0001\">P\u00e9tition citoyenne<\/a> vise \u00e0 sensibiliser tous les prestataires de soins de sant\u00e9 et les consommateurs de contraceptifs hormonaux \u00e0 leurs effets secondaires possibles et av\u00e9r\u00e9s. Pour ce faire, elle demande \u00e0 la FDA d'ajouter des avertissements de type \"bo\u00eete noire\" \u00e0 certaines informations de prescription, ainsi que d'autres informations relatives \u00e0 la s\u00e9curit\u00e9, et de retirer compl\u00e8tement du march\u00e9 l'un des pires coupables.<\/p>\n<p>A <a href=\"https:\/\/www.fda.gov\/media\/74382\/download\">avertissement de la bo\u00eete noire<\/a> est une \u00e9tiquette appos\u00e9e sur un m\u00e9dicament d\u00e9livr\u00e9 sur ordonnance qui avertit les prestataires de soins et les consommateurs des graves probl\u00e8mes de s\u00e9curit\u00e9 li\u00e9s \u00e0 ce m\u00e9dicament, g\u00e9n\u00e9ralement des effets secondaires ind\u00e9sirables (pouvant mettre la vie en danger). La FDA peut d\u00e9cider d'exiger du fabricant qu'il ajoute une bo\u00eete noire sur l'emballage d'un m\u00e9dicament \u00e0 tout moment apr\u00e8s l'approbation de sa mise sur le march\u00e9.<\/p>\n<h2 id=\"what-exactly-would-these-potential-changes-be\">Quels seraient exactement ces changements potentiels ?<\/h2>\n<p>Si elle \u00e9tait accept\u00e9e, cette p\u00e9tition permettrait tout d'abord de retirer compl\u00e8tement un m\u00e9dicament du march\u00e9, le contraceptif injectable Depo Provera, connu sous le nom m\u00e9dical d'ac\u00e9tate de m\u00e9droxyprogest\u00e9rone (DMPA). Il est prouv\u00e9 qu'il est responsable d'une augmentation de la transmission du VIH de l'homme \u00e0 la femme (un effet secondaire qui n'est actuellement m\u00eame pas signal\u00e9 dans les sources d'information en ligne sur les contraceptifs, telles que le <a href=\"https:\/\/www.plannedparenthood.org\/learn\/birth-control\/birth-control-shot\/what-are-the-disadvantages-of-the-birth-control-shot\">Planning familial<\/a>). Comme l'indique la p\u00e9tition de la FDA <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=FDA-2019-P-2289-0001&amp;attachmentNumber=1&amp;contentType=pdf\">documents<\/a>:<\/p>\n<blockquote><p>\"Quatre m\u00e9ta-analyses (3 rapports) ont \u00e9t\u00e9 publi\u00e9es en 2015. Chacune a utilis\u00e9 des crit\u00e8res d'inclusion diff\u00e9rents et a compil\u00e9 les donn\u00e9es sur un nombre diff\u00e9rent d'\u00e9tudes, mais toutes les quatre ont abouti essentiellement au m\u00eame r\u00e9sultat, \u00e0 savoir un risque significativement accru de transmission du VIH de l'homme \u00e0 la femme chez les femmes utilisant le DMPA. . . . Il est important de noter qu'aucune association coh\u00e9rente n'est apparue en ce qui concerne les contraceptifs oraux ou d'autres contraceptifs injectables ou implantables et la facilitation de la transmission du VIH\".<\/p><\/blockquote>\n<p>Outre la demande de retrait du Depo Provera du march\u00e9, l'impact de cette p\u00e9tition serait principalement d'affecter la publicit\u00e9 de nombreux contraceptifs, ce qui affecterait ensuite les destinataires de la publicit\u00e9, c'est-\u00e0-dire les consommateurs ordinaires. La p\u00e9tition demande \u00e0 la FDA d'ajouter des avertissements dans la bo\u00eete noire concernant les effets secondaires ind\u00e9sirables prouv\u00e9s et signal\u00e9s du cancer du sein, du cancer du col de l'ut\u00e9rus, des maladies inflammatoires de l'intestin, du lupus \u00e9ryth\u00e9mateux diss\u00e9min\u00e9 (LED), de la d\u00e9pression et du suicide, de la thrombose veineuse (caillots sanguins) et des \u00e9v\u00e9nements cardiovasculaires.<\/p>\n<p>Les informations de s\u00e9curit\u00e9 suppl\u00e9mentaires que la p\u00e9tition demande d'ajouter aux \u00e9tiquettes des contraceptifs comprennent : le risque accru de d\u00e9velopper une scl\u00e9rose en plaques (SEP), un risque accru de fractures osseuses, une augmentation significative du pourcentage de masse grasse (qui peut conduire \u00e0 d'autres conditions graves telles que le diab\u00e8te et les probl\u00e8mes cardiovasculaires), et un risque accru de probl\u00e8mes urog\u00e9nitaux. Les probl\u00e8mes urog\u00e9nitaux potentiels comprennent un risque significativement plus \u00e9lev\u00e9 de d\u00e9velopper une cystite interstitielle, un risque accru d'infections des voies urinaires, une s\u00e9cheresse vaginale, une dysfonction sexuelle f\u00e9minine (DSF) caus\u00e9e par une dyspareunie induite par les CO, une r\u00e9duction du d\u00e9sir sexuel et de la libido, ainsi que d'autres probl\u00e8mes. (Visitez le site <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=FDA-2019-P-2289-0001&amp;attachmentNumber=1&amp;contentType=pdf\">Document de la FDA<\/a> pour toutes les recherches cit\u00e9es).<\/p>\n<p>\u00c0 l'heure actuelle, ces risques et effets secondaires potentiels ne figurent pas dans les avertissements de la bo\u00eete noire de la plupart des contraceptifs hormonaux, ou ils sont minimis\u00e9s ou, au mieux, trompeurs. Tout comme il a fallu des ann\u00e9es pour que les cigarettes soient accompagn\u00e9es d'avertissements sanitaires appropri\u00e9s sur leurs paquets, il semble que la FDA mette un temps inacceptable \u00e0 ajouter des avertissements suffisants sur les paquets de contraceptifs hormonaux.<\/p>\n<p>M\u00eame avec <a href=\"https:\/\/www.seegerweiss.com\/drug-injury\/yaz-birth-control\/fda-warnings\/\">quelques avertissements actuels<\/a> sur l'emballage des pilules contraceptives, l'implication est que certains risques - comme les caillots sanguins (qui ont co\u00fbt\u00e9 la vie \u00e0 une jeune femme de 20 ans) - peuvent \u00eatre \u00e9vit\u00e9s. <a href=\"https:\/\/naturalwomanhood.org\/fr\/pilules-contraceptives-caillots-de-sang-et-mort-prematuree-lhistoire-de-notre-famille\/\">Alexandra Williams<\/a>) - ne se produisent que lorsqu'ils sont associ\u00e9s \u00e0 la cigarette, et augmentent avec un \"tabagisme intensif\" et l'\u00e2ge. Cela induit les utilisateurs en erreur en leur faisant croire que leur risque est nul s'ils ne fument pas de cigarettes et\/ou s'ils n'ont pas plus de 35 ans. Cela sugg\u00e8re \u00e9galement que ce n'est pas le\u00a0<i>contraceptif <\/i>qui cause le caillot sanguin, mais la cigarette. Si la FDA tient compte de cette p\u00e9tition, elle suivra la demande de modification de ces \u00e9tiquettes pour qu'elles indiquent : \"AVERTISSEMENT : RISQUE ACCRU D'\u00c9V\u00c9NEMENTS CARDIOVASCULAIRES GRAVES, Y COMPRIS DE CAILLOTS SANGUINS\".<\/p>\n<h2 id=\"what-forms-of-contraception-does-the-petition-cover\">Quelles sont les formes de contraception couvertes par la p\u00e9tition ?<\/h2>\n<p>Comme l'explique la d\u00e9claration pr\u00e9liminaire, les contraceptifs hormonaux existent depuis 50 ans. Lorsque la plupart des gens pensent au contr\u00f4le des naissances, ils pensent \u00e0 la \"pilule\", mais on ne se rend pas toujours compte qu'il y a eu de nombreuses formulations diff\u00e9rentes de celle-ci au fil des ans. En outre, d'autres m\u00e9thodes de contraception hormonale que les pilules orales gagnent de plus en plus en popularit\u00e9, comme les anneaux intravaginaux, les timbres transdermiques, les implants et le SIU\/SIU.<\/p>\n<p>La p\u00e9tition citoyenne \u00e9tablit une distinction entre les formules contraceptives combin\u00e9es \u0153stroprogestatives (COC) et les formules contraceptives progestatives (POC), en \u00e9num\u00e9rant les nombreux \"agents\" contraceptifs diff\u00e9rents, c'est-\u00e0-dire les noms pharmaceutiques des diff\u00e9rents types de contraceptifs hormonaux. L'\u00e9crasante majorit\u00e9 d'entre eux sont regroup\u00e9s sous la banni\u00e8re \"COC\" en tant que pilules combin\u00e9es \u0153stroprogestatives (EE-P) - de Natazia \u00e0 Ortho-Novum en passant par Yasmin. Il existe deux types de patchs COC et un anneau vaginal (le populaire Nuvaring). Le nombre de pilules progestatives \"POC\" est beaucoup plus faible, bien qu'il existe plusieurs produits injectables POC, des implants (<a href=\"https:\/\/naturalwomanhood.org\/fr\/limplant-contraceptif-peut-ne-pas-rester-dans-le-bras-effets-secondaires-du-nexplanon-1-2019\/\">Nexplanon<\/a> a \u00e9t\u00e9 sur la sellette cette ann\u00e9e), et les st\u00e9rilets (le <a href=\"https:\/\/naturalwomanhood.org\/fr\/le-lien-troublant-entre-votre-contraception-et-vos-problemes-de-vue-031319\/\">DIU Mirena<\/a> a \u00e9galement eu son lot de connexions malheureuses).<\/p>\n<h2 id=\"what-is-the-research-behind-this-petition\">Quelles sont les recherches \u00e0 l'origine de cette p\u00e9tition ?<\/h2>\n<p>La cr\u00e9ation de cette p\u00e9tition a n\u00e9cessit\u00e9 beaucoup de travail, sous l'impulsion du Dr. William V. Williams, r\u00e9dacteur en chef \u00e9m\u00e9rite de la revue <i>Linacre Quarterly<\/i>. Un \"groupe d'\u00e9tude sur les contraceptifs\" compos\u00e9 de professionnels de la sant\u00e9 et d'experts (dont le PDG de Natural Womanhood, G\u00e9rard Migeon) a compil\u00e9 toutes les informations et les recherches approfondies n\u00e9cessaires \u00e0 la FDA pour prendre sa d\u00e9cision concernant les changements propos\u00e9s.<\/p>\n<p>La p\u00e9tition d\u00e9crit en d\u00e9tail chaque effet secondaire ind\u00e9sirable pour lequel elle demande une bo\u00eete noire, en citant des recherches issues de diverses \u00e9tudes r\u00e9alis\u00e9es au cours des derni\u00e8res d\u00e9cennies, ainsi qu'une s\u00e9rie d'\u00e9tudes documentaires compl\u00e8tes et bien document\u00e9es. Dans le cas du Depo Provera (DMPA), le seul m\u00e9dicament contraceptif qui, selon la p\u00e9tition, devrait \u00eatre imm\u00e9diatement retir\u00e9 du march\u00e9, la p\u00e9tition fournit des preuves \u00e9pid\u00e9miologiques issues de diverses \u00e9tudes et rapports, ainsi que des preuves m\u00e9canistes et exp\u00e9rimentales, notamment <i>in vitro<\/i> la preuve d'une augmentation de la r\u00e9plication du VIH au niveau cellulaire. Comme la p\u00e9tition <a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=FDA-2019-P-2289-0001&amp;attachmentNumber=1&amp;contentType=pdf\">conclut<\/a>: \"Aux \u00c9tats-Unis, o\u00f9 la disponibilit\u00e9 d'une large gamme de m\u00e9dicaments et de dispositifs contraceptifs est pratiquement universelle, et o\u00f9, parmi ces choix contraceptifs, une et une seule m\u00e9thode particuli\u00e8re - le DMPA - est maintenant connue pour augmenter la transmission d'une infection virale souvent mortelle (VIH\/SIDA), il ne peut y avoir aucune justification pour la disponibilit\u00e9 continue d'un tel m\u00e9dicament sur le march\u00e9.\"<\/p>\n<p>Des recherches et des statistiques approfondies sont fournies concernant la relation de cause \u00e0 effet entre les contraceptifs hormonaux et le cancer - du sein et du col de l'ut\u00e9rus - y compris des tableaux d'\u00e9tudes de contr\u00f4le de cas. Des analyses bibliographiques de PubMed confirment les all\u00e9gations de liens de causalit\u00e9 avec la maladie de Crohn, la colite ulc\u00e9reuse, la scl\u00e9rose en plaques et le lupus \u00e9ryth\u00e9mateux diss\u00e9min\u00e9. Diverses \u00e9tudes sur les contraceptifs et la d\u00e9pression, les troubles de l'humeur et le suicide sont fournies, ainsi que des \u00e9tudes sur tous les autres effets secondaires av\u00e9r\u00e9s des agents hormonaux. (Encore une fois, toutes ces r<a href=\"https:\/\/www.regulations.gov\/contentStreamer?documentId=FDA-2019-P-2289-0001&amp;attachmentNumber=1&amp;contentType=pdf\">La recherche est cit\u00e9e dans les documents \u00e0 l'appui de la demande de la FDA.<\/a>.)<\/p>\n<h2 id=\"the-economic-impact-of-contraception\">L'impact \u00e9conomique de la contraception<\/h2>\n<p>La conclusion explique comment l'ensemble des donn\u00e9es examin\u00e9es ci-dessus refl\u00e8tent un grand nombre d'\u00e9l\u00e9ments de la politique de l'UE en mati\u00e8re d'environnement. <i>connu<\/i> des effets secondaires qui ne sont pas correctement repr\u00e9sent\u00e9s dans les informations de prescription actuelles (en effet, comme elle l'explique, les informations d'avertissement sont souvent pr\u00e9sent\u00e9es de mani\u00e8re trompeuse). La conclusion supplie \u00e9galement la FDA de prendre en consid\u00e9ration les nombreux impacts environnementaux et \u00e9conomiques du contr\u00f4le hormonal des naissances :<\/p>\n<blockquote><p>\"Des millions de femmes re\u00e7oivent actuellement des COC et des POC. Des millions d'autres ont \u00e9t\u00e9 expos\u00e9es \u00e0 ces agents \u00e0 un moment ou \u00e0 un autre de leur vie. Elles devraient recevoir des informations actualis\u00e9es sur les risques qui n'ont pas \u00e9t\u00e9 communiqu\u00e9s, ou pas de mani\u00e8re ad\u00e9quate, dans le pass\u00e9. Toutes les femmes qui ont \u00e9t\u00e9 expos\u00e9es \u00e0 des COC ou \u00e0 des POC doivent \u00eatre inform\u00e9es afin qu'elles puissent tenir compte de ces informations, car elles risquent de rencontrer certains de ces effets ind\u00e9sirables, parfois de nombreuses ann\u00e9es apr\u00e8s l'arr\u00eat de l'utilisation.<\/p><\/blockquote>\n<p>Cette d\u00e9claration est imm\u00e9diatement suivie de nombreuses \u00e9tudes documentant les divers impacts environnementaux des agents hormonaux, soulignant par exemple les effets des hormones synth\u00e9tiques sur les populations de poissons et d'autres esp\u00e8ces. Elle calcule l'impact \u00e9conomique estim\u00e9 en tenant compte \u00e0 la fois des femmes qui utilisent actuellement des COC et de celles qui les ont d\u00e9j\u00e0 utilis\u00e9s. Il cite des rapports et des \u00e9tudes qui donnent une estimation du co\u00fbt des contraceptifs hormonaux pour notre soci\u00e9t\u00e9, en prenant en compte diff\u00e9rents cas de cancers, de maladies et de troubles de l'humeur.<\/p>\n<p>En r\u00e9sum\u00e9, la conclusion r\u00e9v\u00e8le qu'il existe <i>encore plus <\/i>raisons de s'opposer aux contraceptifs hormonaux que les nombreux probl\u00e8mes de sant\u00e9 \u00e9vidents (et graves).<\/p>\n<h2 id=\"so-what-can-i-do-to-help\">Que puis-je faire pour vous aider ?<\/h2>\n<p>La FDA sollicite des commentaires de la part de prestataires m\u00e9dicaux qui ont \u00e9t\u00e9 les t\u00e9moins directs d'effets secondaires ind\u00e9sirables de la contraception, ou de patients qui les ont subis. Si vous ou une personne de votre entourage avez souffert des effets secondaires d'une contraception hormonale, le moment est venu de faire entendre votre voix.<\/p>\n<p>S'il vous pla\u00eet <a href=\"https:\/\/www.regulations.gov\/document?D=FDA-2019-P-2289-0001\">commenter directement la p\u00e9tition<\/a> (en cliquant sur le bouton \"Commentez maintenant !\" dans le coin droit), ou le partager avec quelqu'un qui, selon vous, aimerait en savoir plus. Avec votre aide, nous pouvons avoir un impact \u00e9norme et sensibiliser davantage le public aux nombreux risques av\u00e9r\u00e9s li\u00e9s aux diff\u00e9rentes formes de contr\u00f4le des naissances. Des vies pourraient \u00eatre sauv\u00e9es ! Votre aide est tr\u00e8s appr\u00e9ci\u00e9e.<\/p>\n<p>Trop de femmes re\u00e7oivent une ordonnance sans explication. Trop de femmes sont mal inform\u00e9es et induites en erreur sur les effets dangereux (voire potentiellement mortels) de la contraception hormonale. L'objectif global de cette p\u00e9tition est de modifier ce cycle de d\u00e9sinformation. En retour, nous esp\u00e9rons que les m\u00e9decins commenceront \u00e0 r\u00e9fl\u00e9chir \u00e0 deux fois avant de prescrire certains de ces contraceptifs \u00e0 leurs patientes et qu'ils proposeront des alternatives naturelles efficaces dans leurs cabinets (comme les <a href=\"https:\/\/naturalwomanhood.org\/fr\/lobservation-des-effets-secondaires-de-la-contraception-a-pousse-un-gynecologue-a-proposer-une-sensibilisation-a-la-fertilite-032719\/\">certains m\u00e9decins nous ont d\u00e9j\u00e0 dit<\/a> qu'ils font). Nous vivons actuellement dans un monde o\u00f9 une femme dispose de beaucoup plus d'informations sur les effets secondaires possibles de son ibuprof\u00e8ne que sur son contraceptif - et cela doit changer.<\/p>","protected":false},"excerpt":{"rendered":"Vous savez peut-\u00eatre d\u00e9j\u00e0 qu'une p\u00e9tition citoyenne a \u00e9t\u00e9 r\u00e9cemment d\u00e9pos\u00e9e aupr\u00e8s de la FDA (Food and Drug Administration)...","protected":false},"author":54,"featured_media":2704,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","csco_singular_sidebar":"","csco_page_header_type":"","csco_page_load_nextpost":"","csco_post_video_location":[],"csco_post_video_url":"","csco_post_video_bg_start_time":0,"csco_post_video_bg_end_time":0,"footnotes":""},"categories":[5183,5266],"tags":[1163,5409,5437],"class_list":{"0":"post-2703","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-birth-control-issues","8":"category-in-the-news","9":"tag-birth-control-side-effects","10":"tag-blood-clots","11":"tag-hiv-transmission","12":"cs-entry","13":"cs-video-wrap"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - 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