L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) met \u00e0 jour, \u00e0 la suite de l\u2019\u00e9valuation de l\u2019\u00e9tude EPI-PHARE, les notices et les r\u00e9sum\u00e9s des caract\u00e9ristiques du produit (RCP) des contraceptifs contenant du d\u00e9sogestrel ou de l\u2019\u00e9tonogestrel afin d\u2019y inscrire un risque de m\u00e9ningiome. Cette d\u00e9cision intervient apr\u00e8s l\u2019analyse par le comit\u00e9 de pharmacovigilance (PRAC) de l\u2019EMA des r\u00e9sultats de l\u2019\u00e9tude EPI-PHARE publi\u00e9s en juin 2025 dans le BMJ, \u00e0 la demande de l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM). En juillet 2026, l\u2019EMA a recommand\u00e9 l\u2019ajout de ce risque dans les documents d\u2019information des produits. \u00c0 la demande de l\u2019EMA et en accord avec l\u2019ANSM, les laboratoires concern\u00e9s adressent un courrier de type DHPC aux professionnels de sant\u00e9 pour les informer de ces nouvelles recommandations. Un premier courrier d\u2019information avait d\u00e9j\u00e0 \u00e9t\u00e9 diffus\u00e9 par l\u2019ANSM en juin 2025, d\u00e9taillant les conduites \u00e0 tenir.<\/p>\n
L\u2019\u00e9tude EPI-PHARE met en \u00e9vidence une augmentation tr\u00e8s faible mais r\u00e9elle du risque de m\u00e9ningiome associ\u00e9 \u00e0 l\u2019utilisation en cours et prolong\u00e9e (au moins un an) de contraceptifs \u00e0 base de d\u00e9sogestrel ou d\u2019\u00e9tonogestrel, utilis\u00e9s seuls ou en association avec un \u0153strog\u00e8ne. Le m\u00e9ningiome est d\u00e9crit comme une tumeur en g\u00e9n\u00e9ral non canc\u00e9reuse des membranes entourant le cerveau. Le risque demeure rare et est quantifi\u00e9 pour le d\u00e9sogestrel \u00e0 un cas suppl\u00e9mentaire de m\u00e9ningiome pour 67 300 femmes utilisatrices. Le m\u00e9ningiome est d\u00e9sormais mentionn\u00e9 comme effet ind\u00e9sirable de ces contraceptifs, et l\u2019utilisation de m\u00e9dicaments contenant du d\u00e9sogestrel ou de l\u2019\u00e9tonogestrel est contre-indiqu\u00e9e chez les patientes atteintes de m\u00e9ningiome ou ayant des ant\u00e9c\u00e9dents de m\u00e9ningiome.<\/p>\n
Les professionnels de sant\u00e9 sont appel\u00e9s \u00e0 \u00eatre attentifs \u00e0 des sympt\u00f4mes pouvant \u00e9voquer un m\u00e9ningiome (troubles de la vue, baisse de l\u2019audition ou acouph\u00e8nes, perte de l\u2019odorat, aggravation des maux de t\u00eate, troubles de la m\u00e9moire, convulsions, faiblesse des bras ou des jambes) et \u00e0 se r\u00e9f\u00e9rer aux recommandations diffus\u00e9es en 2025. L\u2019ANSM poursuit ses travaux en lien avec les professionnels de sant\u00e9 pour d\u00e9finir les modalit\u00e9s d\u2019information personnalis\u00e9e des femmes concern\u00e9es, afin de leur permettre d\u2019\u00e9changer avec leur m\u00e9decin, gyn\u00e9cologue ou sage-femme sur leur contraception. Des courriers d\u2019information ciblant patients et prescripteurs doivent \u00eatre envoy\u00e9s \u00e0 partir de septembre. Ces mesures s\u2019inscrivent dans un dispositif de pharmacovigilance et d\u2019information visant \u00e0 adapter la prescription contraceptive en tenant compte d\u2019un risque rare mais identifi\u00e9 de m\u00e9ningiome, et \u00e0 renforcer le dialogue m\u00e9decin-patiente sur le choix de la m\u00e9thode contraceptive.\u00a0(contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)Lire la Suite<\/a>\u200b<\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA) met \u00e0 jour, \u00e0 la suite de l\u2019\u00e9valuation de l\u2019\u00e9tude EPI-PHARE, les notices et les r\u00e9sum\u00e9s des caract\u00e9ristiques du produit (RCP) des contraceptifs contenant du 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