{"id":117920,"date":"2026-05-05T11:08:08","date_gmt":"2026-05-05T11:08:08","guid":{"rendered":"https:\/\/www.europesays.com\/ch-fr\/117920\/"},"modified":"2026-05-05T11:08:08","modified_gmt":"2026-05-05T11:08:08","slug":"attention-a-tegretol-et-trileptal-chez-les-nouveau-nes","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch-fr\/117920\/","title":{"rendered":"Attention \u00e0 T\u00e9gr\u00e9tol et Trileptal chez les nouveau-n\u00e9s"},"content":{"rendered":"<p>\u00c0 la suite d\u2019un <a href=\"http:\/\/www.lemoniteurdespharmacies.fr\/therapeutique\/vigilances\/tegretol-des-restrictions-dutilisation-chez-les-nouveau-nes\" rel=\"nofollow noopener\" target=\"_blank\">retour d\u2019information<\/a> du comit\u00e9 de pharmacovigilance et d\u2019\u00e9valuation des risques des m\u00e9dicaments (Prac) de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), publi\u00e9 en septembre\u00a02025, puis d\u2019une <a href=\"https:\/\/www.lemoniteurdespharmacies.fr\/therapeutique\/vigilances\/tegretol-suspension-buvable-desormais-a-proscrire-chez-les-nouveau-nes\" rel=\"nofollow noopener\" target=\"_blank\">information de s\u00e9curit\u00e9<\/a> transmise par le laboratoire Novartis en janvier\u00a02026, l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament (ANSM) a actualis\u00e9, le 4\u00a0mai 2026, son alerte sur les solutions buvables de T\u00e9gr\u00e9tol 20\u00a0mg\/ml (carbamaz\u00e9pine). Cette mise \u00e0 jour int\u00e8gre d\u00e9sormais aussi Trileptal 60\u00a0mg\/ml (oxcarbaz\u00e9pine) chez les tr\u00e8s jeunes nourrissons. Utilis\u00e9s dans le traitement de l\u2019\u00e9pilepsie, ces m\u00e9dicaments doivent \u00eatre \u00e9vit\u00e9s chez les nouveau-n\u00e9s de moins de 4 semaines, sauf lorsqu\u2019aucune autre option th\u00e9rapeutique n\u2019est disponible.<\/p>\n<p>Un excipient en cause<\/p>\n<p>Les solutions buvables de <a href=\"https:\/\/www.lemoniteurdespharmacies.fr\/therapeutique\/medicaments\/mieux-delivrer\/medicament-a-dispensation-particuliere-focus-sur-tegretol\" rel=\"nofollow noopener\" target=\"_blank\">T\u00e9gr\u00e9tol<\/a> et de Trileptal contiennent du propyl\u00e8ne glycol, un excipient dos\u00e9 \u00e0 25\u00a0mg\/ml, soit un niveau sup\u00e9rieur au seuil recommand\u00e9 chez les nouveau-n\u00e9s, fix\u00e9 \u00e0 1\u00a0mg\/kg\/jour.<\/p>\n<p>Chez les enfants de moins de 4 semaines, l\u2019organisme ne m\u00e9tabolise ni n\u2019\u00e9limine correctement cette substance, ce qui favorise son accumulation d\u00e8s des doses \u00e9gales ou sup\u00e9rieures \u00e0 1\u00a0mg\/kg\/jour.<\/p>\n<p>Cette accumulation peut entra\u00eener des effets ind\u00e9sirables graves, notamment une acidose m\u00e9tabolique, une n\u00e9crose tubulaire aigu\u00eb, une insuffisance r\u00e9nale aigu\u00eb et des troubles h\u00e9patiques. Le risque augmente encore si l\u2019enfant re\u00e7oit en parall\u00e8le d\u2019autres m\u00e9dicaments contenant du <a href=\"https:\/\/www.lemoniteurdespharmacies.fr\/nouvelles-missions\/prevention\/vapotage-et-sante-que-disent-vraiment-les-etudes-scientifiques\" rel=\"nofollow noopener\" target=\"_blank\">propyl\u00e8ne glycol<\/a> ou tout substrat de l\u2019alcool d\u00e9shydrog\u00e9nase, tel que l\u2019\u00e9thanol.<\/p>\n<p>Surveillance renforc\u00e9e<\/p>\n<p>En cas d\u2019utilisation, l\u2019ANSM demande une surveillance \u00e9troite du fonctionnement des reins et du foie. Elle recommande aussi de mesurer l\u2019osmolarit\u00e9 et\/ou le trou anionique afin de d\u00e9tecter rapidement une \u00e9ventuelle toxicit\u00e9.<\/p>\n","protected":false},"excerpt":{"rendered":"\u00c0 la suite d\u2019un retour d\u2019information du comit\u00e9 de pharmacovigilance et d\u2019\u00e9valuation des risques des m\u00e9dicaments (Prac) de&hellip;\n","protected":false},"author":2,"featured_media":117921,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[3628,7115,83,17561,84,23],"class_list":{"0":"post-117920","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sante","8":"tag-communication","9":"tag-epilepsie","10":"tag-health","11":"tag-iatrogenie","12":"tag-sante","13":"tag-suisse"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch_fr\/116521658151021222","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/posts\/117920","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/comments?post=117920"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/posts\/117920\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/media\/117921"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/media?parent=117920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/categories?post=117920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch-fr\/wp-json\/wp\/v2\/tags?post=117920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}