{"id":4146,"date":"2019-03-09T22:54:48","date_gmt":"2019-03-09T15:54:48","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4146"},"modified":"2021-11-30T10:00:28","modified_gmt":"2021-11-30T03:00:28","slug":"prac-ema-khuyen-cao-moi-doi-voi-valproate-flupirtine-retinoid-va-khuyen-cao-tam-thoi-doi-voi-esmya-ulipristal","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/prac-ema-khuyen-cao-moi-doi-voi-valproate-flupirtine-retinoid-va-khuyen-cao-tam-thoi-doi-voi-esmya-ulipristal\/","title":{"rendered":"PRAC (EMA): khuy\u1ebfn c\u00e1o m\u1edbi \u0111\u1ed1i v\u1edbi valproate, flupirtine, retinoid v\u00e0 khuy\u1ebfn c\u00e1o t\u1ea1m th\u1eddi \u0111\u1ed1i v\u1edbi Esmya (ulipristal)"},"content":{"rendered":"<h2>Valproate v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p m\u1edbi gi\u00fap tr\u00e1nh ti\u1ebfp x\u00fac v\u1edbi valproate trong th\u1eddi k\u00ec mang thai<\/h2>\n<p>C\u00e1c thu\u1ed1c ch\u1ee9a <strong>valproate<\/strong> \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh \u1edf qui m\u00f4 qu\u1ed1c gia tr\u00ean to\u00e0n Li\u00ean minh ch\u00e2u \u00c2u cho c\u00e1c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb \u0111\u1ed9ng kinh, r\u1ed1i lo\u1ea1n c\u1ea3m x\u00fac l\u01b0\u1ee1ng c\u1ef1c, v\u00e0 \u1edf m\u1ed9t s\u1ed1 qu\u1ed1c gia c\u00f2n cho ch\u1ec9 \u0111\u1ecbnh d\u1ef1 ph\u00f2ng \u0111au n\u1eeda \u0111\u1ea7u. Do thu\u1ed1c g\u00e2y nguy c\u01a1 d\u1ecb t\u1eadt b\u1ea9m sinh v\u00e0 r\u1ed1i lo\u1ea1n ph\u00e1t tri\u1ec3n sau n\u00e0y, \u1ee6y ban \u0110\u00e1nh gi\u00e1 nguy c\u01a1 C\u1ea3nh gi\u00e1c d\u01b0\u1ee3c ch\u00e2u \u00c2u (PRAC) \u0111\u00e3 khuy\u1ebfn c\u00e1o c\u00e1c bi\u1ec7n ph\u00e1p m\u1edbi nh\u1eb1m tr\u00e1nh cho tr\u1ebb s\u01a1 sinh kh\u1ecfi ti\u1ebfp x\u00fac v\u1edbi c\u00e1c thu\u1ed1c valproate t\u1eeb khi c\u00f2n trong b\u1ee5ng m\u1eb9.<\/p>\n<p>PRAC \u0111\u00e3 nghi\u00ean c\u1ee9u c\u00e1c b\u1eb1ng ch\u1ee9ng hi\u1ec7n c\u00f3 v\u00e0 h\u1ecfi \u00fd ki\u1ebfn r\u1ed9ng r\u00e3i c\u00e1c chuy\u00ean gia y t\u1ebf v\u00e0 b\u1ec7nh nh\u00e2n, bao g\u1ed3m c\u00e1c ph\u1ee5 n\u1eef v\u00e0 tr\u1ebb em b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi vi\u1ec7c s\u1eed d\u1ee5ng valproate trong th\u1eddi k\u00ec mang thai, b\u1eb1ng c\u00e1c h\u00ecnh th\u1ee9c n\u1ed9p b\u00e1o c\u00e1o vi\u1ebft tay, g\u1eb7p g\u1ee1 chuy\u00ean gia, g\u1eb7p g\u1ee1 c\u00e1c c\u00f4ng ty \u0111\u0103ng k\u00ed thu\u1ed1c v\u00e0 th\u00f4ng qua th\u00f4ng tin c\u1ed9ng \u0111\u1ed3ng. PRAC nh\u1eadn th\u1ea5y c\u00e1c ph\u1ee5 n\u1eef v\u1eabn c\u00f2n ch\u01b0a \u0111\u01b0\u1ee3c th\u00f4ng tin ch\u00ednh x\u00e1c \u0111\u00fang l\u00fac v\u00e0 c\u1ea7n c\u00f3 th\u00eam c\u00e1c bi\u1ec7n ph\u00e1p \u0111\u1ec3 l\u00e0m gi\u1ea3m vi\u1ec7c s\u1eed d\u1ee5ng valproate trong thai k\u00ec. Tuy nhi\u00ean, r\u00f5 r\u00e0ng l\u00e0 \u0111\u1ed1i v\u1edbi m\u1ed9t s\u1ed1 ph\u1ee5 n\u1eef, v\u00ed d\u1ee5 nh\u1eefng ng\u01b0\u1eddi c\u00f3 c\u00e1c th\u1ec3 \u0111\u1ed9ng kinh \u0111\u1eb7c bi\u1ec7t, valproate l\u00e0 thu\u1ed1c \u0111i\u1ec1u tr\u1ecb ph\u00f9 h\u1ee3p duy nh\u1ea5t v\u00e0 th\u1eadm ch\u00ed c\u00f3 th\u1ec3 l\u00e0 thu\u1ed1c c\u1ee9u m\u1ea1ng.<\/p>\n<p>Do \u0111\u00f3, PRAC khuy\u1ebfn c\u00e1o n\u00ean thay \u0111\u1ed5i vi\u1ec7c s\u1eed d\u1ee5ng valproate theo c\u00e1ch gi\u1edbi h\u1ea1n ch\u1eb7t ch\u1ebd h\u01a1n n\u1eefa v\u00e0 \u0111\u01b0a ra m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh d\u1ef1 ph\u00f2ng trong thai k\u00ec bao g\u1ed3m c\u00e1c bi\u1ec7n ph\u00e1p m\u1edbi nh\u1eb1m d\u1ef1 ph\u00f2ng ti\u1ebfp x\u00fac v\u1edbi valproate trong thai k\u00ec.<\/p>\n<p>Chi ti\u1ebft xem t\u1ea1i:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/valproate-article-31-referral-prac-recommends-new-measures-avoid-valproate-exposure-pregnancy_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/valproate-article-31-referral-prac-recommends-new-measures-avoid-valproate-exposure-pregnancy_en.pdf<\/a><\/p>\n<h2>Esmya: c\u00e1c ph\u1ee5 n\u1eef \u0111i\u1ec1u tr\u1ecb u x\u01a1 t\u1eed cung b\u1eb1ng Esmya c\u1ea7n \u0111\u01b0\u1ee3c ki\u1ec3m tra ch\u1ee9c n\u0103ng gan th\u01b0\u1eddng xuy\u00ean trong khi ch\u1edd \u0111\u1ee3i t\u1ed5ng h\u1ee3p t\u1eeb EMA<\/h2>\n<p>PRAC khuy\u1ebfn c\u00e1o ti\u1ebfn h\u00e0nh theo d\u00f5i ch\u1ee9c n\u0103ng th\u01b0\u1eddng xuy\u00ean cho ph\u1ee5 n\u1eef \u0111i\u1ec1u tr\u1ecb u x\u01a1 t\u1eed cung b\u1eb1ng Esmya (ulipristal acetat), sau khi nh\u1eadn \u0111\u01b0\u1ee3c c\u00e1c b\u00e1o c\u00e1o v\u1ec1 t\u1ed5n th\u01b0\u01a1ng gan nghi\u00eam tr\u1ecdng, k\u1ec3 c\u1ea3 suy gan d\u1eabn t\u1edbi ph\u1ea3i gh\u00e9p gan.<\/p>\n<p>\u1ee6y ban n\u00e0y c\u0169ng khuy\u1ebfn c\u00e1o kh\u00f4ng \u0111i\u1ec1u tr\u1ecb th\u00eam Esmya cho b\u1ec7nh nh\u00e2n m\u1edbi n\u00e0o c\u0169ng nh\u01b0 b\u1ec7nh nh\u00e2n \u0111\u00e3 ho\u00e0n th\u00e0nh \u0111\u1ee3t \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c n\u00e0y tr\u01b0\u1edbc \u0111\u00f3.<\/p>\n<p>\u0110\u00e2y l\u00e0 c\u00e1c khuy\u1ebfn c\u00e1o t\u1ea1m th\u1eddi trong khi ch\u1edd \u0111\u1ee3i EMA t\u1ed5ng h\u1ee3p l\u1ee3i \u00edch v\u00e0 nguy c\u01a1 c\u1ee7a thu\u1ed1c.<\/p>\n<p>Chi ti\u1ebft xem t\u1ea1i:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/esmya-article-20-procedure-women-taking-esmya-uterine-fibroids-have-regular-liver-tests-while-ema_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/esmya-article-20-procedure-women-taking-esmya-uterine-fibroids-have-regular-liver-tests-while-ema_en.pdf<\/a><\/p>\n<h2>R\u00fat c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh c\u1ee7a thu\u1ed1c gi\u1ea3m \u0111au flupirtine<\/h2>\n<p>PRAC \u0111\u1ec1 ngh\u1ecb r\u00fat gi\u1ea5y ph\u00e9p l\u01b0u h\u00e0nh c\u1ee7a thu\u1ed1c gi\u1ea3m \u0111au flupirtine, do l\u1ee3i \u00edch kh\u00f4ng c\u00f2n v\u01b0\u1ee3t tr\u1ed9i so v\u1edbi nguy c\u01a1 thu\u1ed1c n\u00e0y mang l\u1ea1i, nh\u1ea5t l\u00e0 nguy c\u01a1 t\u1ed5n th\u01b0\u01a1ng gan.<\/p>\n<p>T\u1ed5ng h\u1ee3p v\u1ec1 flupirtine \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh ngay sau t\u1ed5ng h\u1ee3p tr\u01b0\u1edbc \u0111\u00f3 c\u1ee7a EMA n\u0103m 2013, t\u1ed5ng h\u1ee3p n\u00e0y \u0111\u01b0a ra c\u00e1c bi\u1ec7n ph\u00e1p nh\u1eb1m h\u1ea1n ch\u1ebf vi\u1ec7c s\u1eed d\u1ee5ng flupirtine do ghi nh\u1eadn c\u00e1c tr\u01b0\u1eddng h\u1ee3p t\u1ed5n th\u01b0\u01a1ng gan nghi\u00eam tr\u1ecdng.<\/p>\n<p>Gi\u1edd \u0111\u00e2y PRAC \u0111\u00e3 t\u1ed5ng h\u1ee3p c\u00e1c d\u1eef li\u1ec7u hi\u1ec7n c\u00f3 v\u1ec1 l\u1ee3i \u00edch v\u00e0 nguy c\u01a1 c\u1ee7a thu\u1ed1c t\u1eeb c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng v\u00e0 b\u00e1o c\u00e1o ca b\u1ec7nh, k\u1ec3 c\u1ea3 c\u00e1c tr\u01b0\u1eddng h\u1ee3p t\u1ed5n th\u01b0\u01a1ng gan nghi\u00eam tr\u1ecdng \u0111\u01b0\u1ee3c ghi nh\u1eadn trong t\u1ed5ng h\u1ee3p n\u0103m 2013 v\u00e0 c\u00e1c nghi\u00ean c\u1ee9u m\u1edbi v\u1ec1 c\u00e1ch m\u00e0 c\u00e1c thu\u1ed1c ch\u1ee9a flupirtine \u0111ang \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng.<\/p>\n<p>Chi ti\u1ebft xem t\u1ea1i:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/prac-recommends-marketing-authorisation-painkiller-flupirtine-be-withdrawn_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/prac-recommends-marketing-authorisation-painkiller-flupirtine-be-withdrawn_en.pdf<\/a><\/p>\n<h2>Retinoid v\u00e0 c\u1eadp nh\u1eadt c\u00e1c bi\u1ec7n ph\u00e1p d\u1ef1 ph\u00f2ng khi s\u1eed d\u1ee5ng thu\u1ed1c n\u00e0y trong thai k\u00ec<\/h2>\n<p>PRAC \u0111\u00e3 \u0111\u01b0a ra khuy\u1ebfn c\u00e1o c\u1eadp nh\u1eadt c\u00e1c bi\u1ec7n ph\u00e1p d\u1ef1 ph\u00f2ng trong thai k\u00ec v\u00e0 \u0111\u01b0a ra c\u1ea3nh b\u00e1o v\u1ec1 nguy c\u01a1 cao g\u00e2y r\u1ed1i lo\u1ea1n th\u1ea7n kinh \u2013 t\u00e2m th\u1ea7n (nh\u01b0 tr\u1ea7m c\u1ea3m, lo \u00e2u v\u00e0 thay \u0111\u1ed5i kh\u00ed s\u1eafc) \u0111\u1ed1i v\u1edbi c\u00e1c thu\u1ed1c <a href=\"https:\/\/nhathuocngocanh.com\/hoat-chat\/retinoids\/\" rel=\"noopener\">retinoid<\/a>, d\u1ea1ng \u0111\u01b0\u1eddng u\u1ed1ng hay kem ho\u1eb7c gel b\u00f4i trong \u0111i\u1ec1u tr\u1ecb c\u00e1c t\u00ecnh tr\u1ea1ng t\u1ed5n th\u01b0\u01a1ng da.<\/p>\n<p>PRAC kh\u1eb3ng \u0111\u1ecbnh r\u1eb1ng t\u1ea5t c\u1ea3 c\u00e1c thu\u1ed1c retinoid \u0111\u01b0\u1eddng u\u1ed1ng \u0111\u1ec1u g\u00e2y \u1ea3nh h\u01b0\u1edfng b\u1ea5t l\u1ee3i \u0111\u1ebfn thai nhi v\u00e0 do \u0111\u00f3 kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong thai k\u00ec. Ngo\u00e0i ra, c\u00e1c retinoid \u0111\u01b0\u1eddng u\u1ed1ng nh\u01b0 acitretin, alitretinoin v\u00e0 isotretinoin kh\u00f4ng \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng \u1edf ph\u1ee5 n\u1eef c\u00f3 kh\u1ea3 n\u0103ng sinh s\u1ea3n tr\u1eeb khi \u0111\u00e1p \u1ee9ng \u0111\u1ee7 \u0111i\u1ec1u ki\u1ec7n c\u1ee7a ch\u01b0\u01a1ng tr\u00ecnh d\u1ef1 ph\u00f2ng ti\u1ebfp x\u00fac trong thai k\u00ec.<\/p>\n<p>Trong qu\u00e1 tr\u00ecnh t\u1ed5ng h\u1ee3p, PRAC \u0111\u00e3 \u0111\u00e1nh gi\u00e1 c\u00e1c d\u1eef li\u1ec7u hi\u1ec7n c\u00f3 bao g\u1ed3m c\u00e1c y v\u0103n c\u0169ng nh\u01b0 c\u00e1c b\u00e1o c\u00e1o h\u1eadu m\u00e3i v\u1ec1 t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n, v\u00e0 h\u1ecfi \u00fd ki\u1ebfn b\u1ec7nh nh\u00e2n c\u0169ng nh\u01b0 chuy\u00ean gia y t\u1ebf khi g\u1eb7p g\u1ee1 c\u00e1c doanh nghi\u1ec7p \u0111\u0103ng k\u00ed thu\u1ed1c v\u00e0 h\u1ecfi \u00fd ki\u1ebfn li\u00ean t\u1ee5c b\u1eb1ng v\u0103n b\u1ea3n.<\/p>\n<p>Chi ti\u1ebft xem t\u1ea1i:\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/referral\/retinoid-article-31-referral-prac-recommends-updating-measures-pregnancy-prevention-during-retinoid_en.pdf\" rel=\"noopener\">https:\/\/www.ema.europa.eu\/en\/documents\/referral\/retinoid-article-31-referral-prac-recommends-updating-measures-pregnancy-prevention-during-retinoid_en.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Valproate v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p m\u1edbi gi\u00fap tr\u00e1nh ti\u1ebfp x\u00fac v\u1edbi valproate trong th\u1eddi k\u00ec mang thai C\u00e1c thu\u1ed1c ch\u1ee9a valproate \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p l\u01b0u h\u00e0nh \u1edf qui m\u00f4 qu\u1ed1c gia tr\u00ean to\u00e0n Li\u00ean minh ch\u00e2u \u00c2u cho c\u00e1c ch\u1ec9 \u0111\u1ecbnh \u0111i\u1ec1u tr\u1ecb \u0111\u1ed9ng kinh, r\u1ed1i lo\u1ea1n c\u1ea3m x\u00fac l\u01b0\u1ee1ng c\u1ef1c, v\u00e0 \u1edf m\u1ed9t s\u1ed1 [&#8230;]\n","protected":false},"author":1,"featured_media":4147,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4146","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-y-te-suc-khoe"],"acf":[],"_links":{"self":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4146","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/comments?post=4146"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4146\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4147"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}