﻿{"id":4191,"date":"2019-03-10T00:17:58","date_gmt":"2019-03-09T17:17:58","guid":{"rendered":"https:\/\/www.vnras.com\/drug\/?p=4191"},"modified":"2019-03-10T00:17:58","modified_gmt":"2019-03-09T17:17:58","slug":"fda-us-canh-bao-nguy-co-khi-su-dung-silicone-dang-tiem-va-nguy-co-tu-vong-lien-quan-tim-mach-cua-febuxostat","status":"publish","type":"post","link":"https:\/\/vnras.com\/drug\/fda-us-canh-bao-nguy-co-khi-su-dung-silicone-dang-tiem-va-nguy-co-tu-vong-lien-quan-tim-mach-cua-febuxostat\/","title":{"rendered":"FDA-US: c\u1ea3nh b\u00e1o nguy c\u01a1 khi s\u1eed d\u1ee5ng silicone d\u1ea1ng ti\u00eam v\u00e0 nguy c\u01a1 t\u1eed vong li\u00ean quan tim m\u1ea1ch c\u1ee7a febuxostat"},"content":{"rendered":"<h2>C\u1ea3nh b\u00e1o ch\u1ed1ng l\u1ea1i vi\u1ec7c ti\u00eam silicone trong n\u00e2ng \u0111\u1ee1 ho\u1eb7c l\u00e0m t\u0103ng k\u00edch th\u01b0\u1edbc c\u00e1c v\u00f9ng c\u01a1 th\u1ec3<\/h2>\n<p>FDA \u0111\u00e3 \u0111\u01b0a ra c\u1ea3nh b\u00e1o v\u1edbi c\u1ed9ng \u0111\u1ed3ng v\u00e0 c\u00e1c nh\u00e2n vi\u00ean y t\u1ebf v\u1ec1 vi\u1ec7c kh\u00f4ng c\u1ea5p ph\u00e9p <strong>silicone<\/strong> d\u1ea1ng ti\u00eam cho n\u00e2ng \u0111\u1ee1 hay l\u00e0m t\u0103ng k\u00edch th\u01b0\u1edbc c\u00e1c v\u00f9ng c\u01a1 th\u1ec3. C\u00e1ch d\u00f9ng silicone nh\u01b0 v\u1eady c\u00f3 th\u1ec3 g\u00e2y ra \u0111au \u0111\u1edbn li\u00ean t\u1ee5c, nhi\u1ec5m tr\u00f9ng, v\u00e0 c\u00e1c v\u1ebft th\u01b0\u01a1ng nghi\u00eam tr\u1ecdng, nh\u01b0 s\u1eb9o h\u00f3a v\u00e0 bi\u1ebfn d\u1ea1ng v\u0129nh vi\u1ec5n, t\u1eafc m\u1ea1ch, \u0111\u1ed9t qu\u1ecb v\u00e0 t\u1eed vong.<\/p>\n<p>FDA nh\u1eadn th\u1ea5y nhi\u1ec1u tr\u01b0\u1eddng h\u1ee3p b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng silicone d\u1ea1ng ti\u00eam nh\u1eb1m m\u1ee5c \u0111\u00edch n\u00e2ng c\u00e1c v\u00f2ng c\u01a1 th\u1ec3, nh\u01b0 v\u00f2ng m\u00f4ng hay ng\u1ef1c, t\u1eeb c\u00e1c nh\u00e0 cung c\u1ea5p kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn l\u00e0 b\u00e1c s\u0129 hay k\u0129 thu\u1eadt vi\u00ean y t\u1ebf \u1edf c\u00e1c c\u01a1 s\u1edf phi l\u00e2m s\u00e0ng nh\u01b0 nh\u00e0 ri\u00eang hay kh\u00e1ch s\u1ea1n. FDA nh\u1eadn th\u1ea5y m\u1ed9t s\u1ed1 ng\u01b0\u1eddi th\u1eadm ch\u00ed \u0111\u00e3 n\u00f3i d\u1ed1i kh\u00e1ch h\u00e0ng r\u1eb1ng h\u1ecd \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng dung d\u1ecbch l\u00e0m \u0111\u1ea7y \u0111\u01b0\u1ee3c FDA c\u1ea5p ph\u00e9p, nh\u01b0ng th\u1ef1c t\u1ebf l\u1ea1i \u0111\u01b0\u1ee3c ti\u00eam silicone.<\/p>\n<p>Silicone ti\u00eam t\u1ed3n t\u1ea1i v\u0129nh vi\u1ec5n, v\u1edbi t\u00e1c d\u1ee5ng kh\u00f4ng mong mu\u1ed1n c\u00f3 th\u1ec3 x\u1ea3y ra ngay sau khi ti\u00eam v\u00e0 nhi\u1ec1u n\u0103m sau khi ti\u00eam. Silicone lan r\u1ed9ng v\u00e0 di chuy\u1ec3n d\u1ec5 d\u00e0ng trong c\u01a1 th\u1ec3, \u0111i\u1ec1u n\u00e0y c\u00f3 th\u1ec3 l\u00e0m n\u1eb7ng th\u00eam c\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i v\u00e0 khi\u1ebfn cho vi\u1ec7c ph\u1eabu thu\u1eadt lo\u1ea1i b\u1ecf d\u1ea7u silicone tr\u1edf n\u00ean kh\u00f3 kh\u0103n h\u01a1n, th\u1eadm ch\u00ed l\u00e0 b\u1ea5t kh\u1ea3 thi. M\u1ed9t khi silicone \u0111\u01b0\u1ee3c ti\u00eam v\u00e0o c\u00e1c v\u00f9ng gi\u00e0u m\u1ea1ch m\u00e1u nh\u01b0 m\u00f4ng, ch\u1ea5t n\u00e0y c\u00f3 th\u1ec3 di chuy\u1ec3n d\u1ec5 d\u00e0ng t\u1edbi c\u00e1c ph\u1ea7n c\u01a1 th\u1ec3 kh\u00e1c v\u00e0 g\u00e2y t\u1eafc m\u1ea1ch ph\u1ed5i, tim ho\u1eb7c n\u00e3o. \u0110i\u1ec1u n\u00e0y d\u1eabn t\u1edbi t\u1ed5n th\u01b0\u01a1ng v\u0129nh vi\u1ec5n c\u00e1c m\u00f4 n\u00f3i tr\u00ean v\u00e0 g\u00e2y \u0111\u1ed9t qu\u1ecb ho\u1eb7c t\u1eed vong.<\/p>\n<p>K\u1ec3 c\u1ea3 khi ph\u1eabu thu\u1eadt nh\u1eb1m lo\u1ea1i b\u1ecf l\u01b0\u1ee3ng silicone \u0111\u00e3 ti\u00eam \u1edf qui m\u00f4 l\u1edbn, v\u1eabn c\u00f3 th\u1ec3 xu\u1ea5t hi\u1ec7n th\u00eam c\u00e1c nguy c\u01a1 v\u00e0 bi\u1ebfn ch\u1ee9ng n\u1eb7ng n\u1ec1, v\u00e0 c\u00f3 th\u1ec3 v\u1eabn kh\u00f4ng lo\u1ea1i b\u1ecf h\u1ebft \u0111\u01b0\u1ee3c silicone kh\u1ecfi c\u01a1 th\u1ec3. \u0110\u00f4i khi ng\u01b0\u1eddi ta c\u00f2n c\u1ea7n ph\u1eabu thu\u1eadt v\u00e0 \u0111i\u1ec1u tr\u1ecb b\u1eb1ng thu\u1ed1c th\u00eam nhi\u1ec1u l\u1ea7n n\u1eefa nh\u1eb1m x\u1eed l\u00ed c\u00e1c tri\u1ec7u ch\u1ee9ng xu\u1ea5t hi\u1ec7n nhi\u1ec1u n\u0103m sau l\u1ea7n ti\u00eam silicone \u0111\u1ea7u ti\u00ean; v\u00e0 k\u1ec3 c\u1ea3 khi \u0111\u00f3, b\u1ec7nh nh\u00e2n v\u1eabn ti\u1ebfp t\u1ee5c ph\u1ea3i ch\u1ecbu \u0111\u1ef1ng c\u00e1c c\u01a1n \u0111au li\u00ean t\u1ee5c, nhi\u1ec5m tr\u00f9ng, s\u1eb9o v\u00e0 c\u00e1c bi\u1ebfn d\u1ea1ng v\u0129nh vi\u1ec5n \u0111\u00f2i h\u1ecfi ph\u1ea3i ti\u1ebfp t\u1ee5c \u0111i\u1ec1u tr\u1ecb.<br \/>\nFDA v\u1eabn \u0111ang theo d\u00f5i c\u00e1c b\u00e1o c\u00e1o v\u1ec1 bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i c\u00f3 li\u00ean quan \u0111\u1ebfn silicone \u0111\u01b0\u1eddng ti\u00eam v\u00e0 c\u00e1c b\u00e0i vi\u1ebft ch\u01b0a \u0111\u01b0\u1ee3c ch\u1ea5p thu\u1eadn \u0111\u0103ng t\u1ea3i kh\u00e1c v\u00e0 s\u1ebd c\u1eadp nh\u1eadt cho c\u00f4ng ch\u00fang n\u1ebfu c\u00f3 th\u00eam c\u00e1c th\u00f4ng tin m\u1edbi quan tr\u1ecdng.<br \/>\nFDA ti\u1ebfp t\u1ee5c khuy\u1ebfn c\u00e1o kh\u00f4ng ti\u00eam silicone \u0111\u1ec3 n\u00e2ng ng\u1ef1c, m\u00f4ng hay t\u0103ng k\u00edch th\u01b0\u1edbc c\u01a1.<\/p>\n<h2>\u0110\u00e1nh gi\u00e1 nguy c\u01a1 cao g\u00e2y t\u1eed vong li\u00ean quan tim m\u1ea1ch c\u1ee7a febuxostat<\/h2>\n<p>FDA s\u1ebd \u0111\u01b0a ra c\u1ea3nh b\u00e1o cho c\u1ed9ng \u0111\u1ed3ng v\u1ec1 c\u00e1c k\u1ebft qu\u1ea3 nghi\u00ean c\u1ee9u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng s\u01a1 b\u1ed9 cho th\u1ea5y nguy c\u01a1 cao g\u00e2y t\u1eed vong li\u00ean quan \u0111\u1ebfn tim m\u1ea1ch c\u1ee7a febuxostat (Uloric) khi so s\u00e1nh v\u1edbi allopurinol, m\u1ed9t thu\u1ed1c kh\u00e1c trong \u0111i\u1ec1u tr\u1ecb b\u1ec7nh gout. FDA y\u00eau c\u1ea7u nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ee7a Uloric l\u00e0 h\u00e3ng Takeda Pharmaceuticals ph\u1ea3i ti\u1ebfn h\u00e0nh nghi\u00ean c\u1ee9u t\u00ednh an to\u00e0n c\u1ee7a thu\u1ed1c khi \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p v\u00e0o n\u0103m 2009. Ngay khi nh\u1eadn \u0111\u01b0\u1ee3c k\u1ebft qu\u1ea3 cu\u1ed1i c\u00f9ng t\u1eeb nh\u00e0 s\u1ea3n xu\u1ea5t, FDA s\u1ebd ti\u1ebfn h\u00e0nh r\u00e0 so\u00e1t to\u00e0n di\u1ec7n v\u00e0 s\u1ebd c\u1eadp nh\u1eadt b\u1ea5t c\u1ee9 th\u00f4ng tin n\u00e0o m\u1edbi cho c\u1ed9ng \u0111\u1ed3ng.<\/p>\n<p>Tr\u00ean nh\u00e3n thu\u1ed1c c\u1ee7a febuxostat \u0111\u00e3 c\u00f3 th\u00f4ng tin C\u1ea3nh b\u00e1o v\u00e0 Th\u1eadn tr\u1ecdng v\u1ec1 bi\u1ebfn c\u1ed1 tim m\u1ea1ch, v\u00ec c\u00e1c th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh tr\u01b0\u1edbc khi c\u1ea5p ph\u00e9p \u0111\u00e3 cho th\u1ea5y t\u1ec9 l\u1ec7 xu\u1ea5t hi\u1ec7n bi\u1ebfn c\u1ed1 tim m\u1ea1ch \u1edf b\u1ec7nh nh\u00e2n s\u1eed d\u1ee5ng febuxostat cao h\u01a1n so v\u1edbi allopurinol. C\u00e1c bi\u1ebfn c\u1ed1 n\u00e0y bao g\u1ed3m \u0111au ng\u1ef1c, \u0111\u1ed9t qu\u1ecb v\u00e0 t\u1eed vong li\u00ean quan \u0111\u1ebfn tim m\u1ea1ch. Do \u0111\u00f3, FDA \u0111\u00e3 y\u00eau c\u1ea7u ti\u1ebfn h\u00e0nh th\u00eam th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng v\u1ec1 an to\u00e0n c\u1ee7a thu\u1ed1c sau khi \u0111\u01b0\u1ee3c c\u1ea5p ph\u00e9p v\u00e0 l\u01b0u h\u00e0nh tr\u00ean th\u1ecb tr\u01b0\u1eddng \u0111\u1ec3 n\u1eafm r\u00f5 h\u01a1n s\u1ef1 kh\u00e1c bi\u1ec7t n\u00f3i tr\u00ean gi\u1eefa 2 nh\u00f3m, v\u00e0 m\u1edbi \u0111\u00e2y th\u1eed nghi\u1ec7m \u0111\u00f3 \u0111\u00e3 k\u1ebft th\u00fac.<\/p>\n<p>Th\u1eed nghi\u1ec7m \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh \u1edf h\u01a1n 6.000 b\u1ec7nh nh\u00e2n gout \u0111\u01b0\u1ee3c \u0111i\u1ec1u tr\u1ecb b\u1eb1ng febuxostat ho\u1eb7c allopurinol. Ch\u1ec9 s\u1ed1 \u0111\u1ea7u ra ch\u00ednh l\u00e0 ch\u1ec9 s\u1ed1 k\u1ebft h\u1ee3p gi\u1eefa t\u1eed vong li\u00ean quan \u0111\u1ebfn tim m\u1ea1ch, \u0111au ng\u1ef1c kh\u00f4ng g\u00e2y t\u1eed vong, \u0111\u1ed9t qu\u1ecb kh\u00f4ng g\u00e2y t\u1eed vong v\u00e0 t\u00ecnh tr\u1ea1ng t\u01b0\u1edbi m\u00e1u \u0111\u1ebfn tim kh\u00f4ng ph\u00f9 h\u1ee3p \u0111\u00f2i h\u1ecfi ph\u1eabu thu\u1eadt c\u1ea5p c\u1ee9u. C\u00e1c k\u1ebft qu\u1ea3 s\u01a1 b\u1ed9 cho th\u1ea5y n\u00f3i chung, febuxostat kh\u00f4ng l\u00e0m t\u0103ng nguy c\u01a1 ph\u1ed1i h\u1ee3p c\u00e1c bi\u1ebfn c\u1ed1 n\u00e0y khi so s\u00e1nh v\u1edbi allopurinol. Tuy nhi\u00ean, ph\u00e2n t\u00edch ri\u00eang r\u1ebd c\u00e1c ch\u1ec9 s\u1ed1 cho th\u1ea5y febuxostat l\u00e0m t\u0103ng nguy c\u01a1 t\u1eed vong li\u00ean quan \u0111\u1ebfn tim m\u1ea1ch v\u00e0 t\u1eed vong do m\u1ecdi nguy\u00ean nh\u00e2n.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u1ea3nh b\u00e1o ch\u1ed1ng l\u1ea1i vi\u1ec7c ti\u00eam silicone trong n\u00e2ng \u0111\u1ee1 ho\u1eb7c l\u00e0m t\u0103ng k\u00edch th\u01b0\u1edbc c\u00e1c v\u00f9ng c\u01a1 th\u1ec3 FDA \u0111\u00e3 \u0111\u01b0a ra c\u1ea3nh b\u00e1o v\u1edbi c\u1ed9ng \u0111\u1ed3ng v\u00e0 c\u00e1c nh\u00e2n vi\u00ean y t\u1ebf v\u1ec1 vi\u1ec7c kh\u00f4ng c\u1ea5p ph\u00e9p silicone d\u1ea1ng ti\u00eam cho n\u00e2ng \u0111\u1ee1 hay l\u00e0m t\u0103ng k\u00edch th\u01b0\u1edbc c\u00e1c v\u00f9ng c\u01a1 th\u1ec3. C\u00e1ch [&#8230;]\n","protected":false},"author":1,"featured_media":4192,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4191","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\/4191","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=4191"}],"version-history":[{"count":0,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/posts\/4191\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media\/4192"}],"wp:attachment":[{"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/media?parent=4191"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/categories?post=4191"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vnras.com\/drug\/wp-json\/wp\/v2\/tags?post=4191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}