{"id":8404,"date":"2021-03-02T13:45:35","date_gmt":"2021-03-02T18:45:35","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/fda-issues-new-xeljanz-warning\/"},"modified":"2021-03-02T13:45:35","modified_gmt":"2021-03-02T18:45:35","slug":"fda-issues-new-xeljanz-%e8%ad%a6%e5%91%8a","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/zh\/article\/fda-issues-new-xeljanz-%e8%ad%a6%e5%91%8a\/","title":{"rendered":"FDA \u53d1\u5e03\u65b0\u7684 Xeljanz \u8b66\u544a"},"content":{"rendered":"<p>\u4e24\u5e74\u6765\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7b2c\u4e09\u6b21\u5bf9\u8f89\u745e\u5f3a\u5927\u4e14\u53d7\u6b22\u8fce\u7684\u5173\u8282\u708e\/UC \u836f\u7269\u53d1\u51fa\u5b89\u5168\u8b66\u544a\u3002\u6700\u65b0\u7684\u8b66\u544a\u662f <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20210215\/we-need-to-see-the-data-fdas-xeljanz-safety-warning-stirs-concerns-for-jak-inhibitors\" target=\"_blank\" rel=\"noopener\">\u6700\u5f3a\u6700\u5168\u9762<\/a> \u4e00\u4e2a\u3002<\/p>\n<p>\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\u8868\u793a\uff0c\u6bcf\u5929 5 \u6beb\u514b\u7684\u5242\u91cf\u53ef\u80fd\u4f1a\u5bfc\u81f4\u764c\u75c7\u548c\u5fc3\u810f\u95ee\u9898\uff0c\u5c24\u5176\u662f\u5728\u8001\u5e74\u4eba\u4e2d\u3002<\/p>\n<p>\u8fd9\u4e9b\u6700\u65b0\u8b66\u544a\u662f\u5728\u5bf9 FDA \u6536\u96c6\u7684 2012 \u5e74\u4e0a\u5e02\u540e\u5b89\u5168\u7814\u7a76\u6570\u636e\u8fdb\u884c\u66f4\u5e7f\u6cdb\u5ba1\u67e5\u540e\u53d1\u51fa\u7684\u3002<\/p>\n<p>\u8fd9\u4e9b\u8bd5\u9a8c\u76f4\u5230 2020 \u5e74\u624d\u7ed3\u675f\u3002\u5373\u4f7f\u662f\u73b0\u5728\uff0c\u4e5f\u53ea\u6709\u4e3b\u8981\u7ed3\u679c\u6765\u81ea\u8f89\u745e\u548c FDA \u7684\u65b0\u95fb\u7a3f\u3002<\/p>\n<p>\u56e0\u6b64\uff0c\u66f4\u591a\u7684\u574f\u6d88\u606f\u53ef\u80fd\u4f1a\u63a5\u8e35\u800c\u81f3\u3002 \u201c\u4ec5\u9760\u91ca\u653e\u5f88\u96be\u751f\u6d3b\uff0c\u201d\u4fc4\u52d2\u5188\u5927\u5b66\u4f20\u67d3\u75c5\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efb\u51ef\u6587\u6e29\u601d\u7f57\u666e\u535a\u58eb\u8bf4\u3002 \u201c\u8001\u5b9e\u8bf4\uff0c\u5f88\u96be\u77e5\u9053\u8be5\u600e\u4e48\u60f3\u3002\u6211\u4eec\u9700\u8981\u5728\u5206\u6790\u4e2d\u67e5\u770b\u6570\u636e\uff0c\u201d\u4ed6\u8865\u5145\u9053\u3002<\/p>\n<p>\u9886\u5148\u7684\u98ce\u6e7f\u75c5\u5b66\u5bb6\u8868\u793a\uff0c\u6700\u65b0\u7684\u62ab\u9732\u7ed9\u50cf Xeljanz \u8fd9\u6837\u5c1a\u672a\u7ecf\u8fc7\u5e7f\u6cdb\u7814\u7a76\u7684\u5f3a\u6548\u836f\u7269\u7684\u5b89\u5168\u6027\u8499\u4e0a\u4e86\u4e00\u5c42\u4e25\u91cd\u7684\u9634\u5f71\u3002<\/p>\n<h2>Xeljanz \u7684\u526f\u4f5c\u7528<\/h2>\n<p>\u8f89\u745e\u664b\u5347 <a href=\"\/zh\/%e7%bb%83%e4%b9%a0%e5%8c%ba\/%e5%8c%bb%e8%8d%af%e8%af%89%e8%ae%bc\/xeljanz-%e5%92%8c-xeljanz-xr-%e5%be%8b%e5%b8%88\/\">\u8c22\u5c14\u8a79\u5179<\/a>\uff0c\u5b83\u662f\u4e00\u79cd JAK\uff08Janus \u6fc0\u9176\uff09\u6291\u5236\u5242\uff0c\u662f\u5bf9\u80bf\u7624\u574f\u6b7b\u56e0\u5b50 (TNF) \u6291\u5236\u5242\u7684\u5f3a\u5927\u5347\u7ea7\u3002<\/p>\n<p>\u4e8b\u5b9e\u4e0a\uff0cJAK \u4f1a\u963b\u65ad\u67d0\u4e9b\u5f15\u8d77\u708e\u75c7\u7684\u9176\uff0c\u800c TNF \u4f1a\u8fc7\u6ee4\u5b83\u4eec\u3002<\/p>\n<p>\u6b64\u5916\uff0cJAK \u662f\u4e00\u79cd\u53e3\u670d\u836f\u7269\uff0c\u800c TNF \u901a\u5e38\u9700\u8981\u6ce8\u5c04\u3002\u8f89\u745e\u4e5f\u79ef\u6781\u63a8\u9500 Xeljanz \u7684\u8fd9\u4e00\u65b9\u9762\u3002<\/p>\n<p>\u4f46\u4e5f\u6709\u9634\u6697\u9762\u3002<\/p>\n<p>\u56e0\u4e3a\u5b83\u6bd4 TNF \u5f3a\u5f97\u591a\uff0c\u6240\u4ee5 Xeljanz \u7684 JAK \u4e0e <a href=\"https:\/\/www.the-rheumatologist.org\/article\/janus-kinase-vs-tnf-inhibitors-the-context-for-venous-thromboembolism-risk-with-ra-treatments\/\" target=\"_blank\" rel=\"noopener\">\u4e25\u91cd\u7684\u526f\u4f5c\u7528<\/a>\uff0c\u6700\u663e\u7740\u7684\u662f\u8840\u51dd\u5757\u95ee\u9898\uff0c\u5982\u6df1\u9759\u8109\u8840\u6813\u5f62\u6210\u548c\u80ba\u6813\u585e\u3002<\/p>\n<p>\u5982\u679c\u4e0d\u53ca\u65f6\u59a5\u5584\u6cbb\u7597\uff0c\u8fd9\u4e24\u79cd\u60c5\u51b5\u90fd\u4f1a\u5371\u53ca\u751f\u547d\u3002<\/p>\n<p>\u53ef\u6015\u7684\u662f\uff0c\u8bb8\u591a DVT \u60a3\u8005\u76f4\u5230\u75c5\u60c5\u8fbe\u5230\u5371\u6025\u9636\u6bb5\u624d\u610f\u8bc6\u5230\u81ea\u5df1\u751f\u75c5\u4e86\u3002<\/p>\n<p>\u800c\u4e14\uff0cPE \u901a\u5e38\u7a81\u7136\u51fa\u73b0\u5e76\u4e14\u6ca1\u6709\u4efb\u4f55\u8b66\u544a\uff0c\u56e0\u6b64\u5f88\u96be\u5728\u9700\u8981\u65f6\u83b7\u5f97\u6240\u9700\u7684\u5e2e\u52a9\u3002<\/p>\n<p>\u7814\u7a76\u4eba\u5458\u62c5\u5fc3\u4ed6\u4eec\u505a\u7684\u7814\u7a76\u8d8a\u591a\uff0c\u4ed6\u4eec\u53d1\u73b0\u7684\u6d88\u606f\u5c31\u8d8a\u7cdf\u7cd5\u3002<\/p>\n<p>\u54c8\u4f5b\u533b\u5b66\u9662\u7684 Rishi J. Desai \u535a\u58eb\u8b66\u544a\u8bf4\uff0c\u201c\u6211\u4eec\u5bf9 JAK \u6291\u5236\u5242\u5b89\u5168\u6027\u7684\u7406\u89e3\u6b63\u5728\u53d1\u751f\u53d8\u5316\u3002\u201d<\/p>\n<p>\u6b64\u5916\uff0cDVT \u548c PE \u95ee\u9898\u201c\u53ea\u662f\u98ce\u9669\u6536\u76ca\u6982\u51b5\u4e2d\u7684\u4e00\u4e2a\u6f5c\u5728\u4e0d\u5229\u4e8b\u4ef6\uff0c\u201d\u4ed6\u8865\u5145\u8bf4\u3002<\/p>\n<h2>\u6cd5\u5f8b\u95ee\u9898<\/h2>\n<p>\u5373\u4f7f\u51fa\u73b0\u8d1f\u9762\u7814\u7a76\uff0c\u50cf\u8f89\u745e\u8fd9\u6837\u7684\u5236\u836f\u516c\u53f8\u4e5f\u5e38\u5e38\u80fd\u591f\u538b\u5236\u4ed6\u4eec\u7684\u53d1\u73b0\u3002<\/p>\n<p>\u5e7f\u64ad\u548c\u5176\u4ed6\u5a92\u4f53\u6e20\u9053\u7684\u6536\u5165\u4e25\u91cd\u4f9d\u8d56\u836f\u7269\u5e7f\u544a\u3002\u907f\u514d\u54ac\u5582\u517b\u60a8\u7684\u624b\u662f\u4eba\u7c7b\u7684\u5929\u6027\u3002<\/p>\n<p>\u56e0\u6b64\uff0c\u53ea\u9700\u4e00\u70b9\u95f4\u63a5\u538b\u529b\uff0c\u8f89\u745e\u516c\u53f8\u901a\u5e38\u53ef\u4ee5\u5c06\u7b2c 1 \u9875\u7684\u6807\u9898\u4e00\u76f4\u79fb\u56de\u7b2c 8 \u6216 10 \u9875\u3002<\/p>\n<p>\u7ed3\u679c\uff0c\u8bb8\u591a\u53d7\u5bb3\u8005\u4e0d\u77e5\u9053\u4ed6\u4eec\u7684\u75be\u75c5\u4e0e\u7279\u5b9a\u836f\u7269\u6709\u5173\u3002\u5ef6\u8fdf\u53d1\u73b0\u89c4\u5219\u4fdd\u62a4\u4e86\u8fd9\u4e9b\u53d7\u5bb3\u8005\u7684\u5408\u6cd5\u6743\u5229\u3002<\/p>\n<p>\u8be5\u5b66\u8bf4\u6682\u505c\u4e86\u4e24\u5e74\u7684\u8bc9\u8bbc\u65f6\u6548\uff0c\u76f4\u5230\u53d7\u5bb3\u8005\u77e5\u9053\u4ed6\u4eec\u53d7\u4f24\u7684\u5168\u90e8\u7a0b\u5ea6\u5e76\u5c06\u8fd9\u4e9b\u4f24\u5bb3\u4e0e\u88ab\u544a\u7684\u5371\u9669\u4ea7\u54c1\u6216\u4e0d\u6cd5\u884c\u4e3a\u8054\u7cfb\u8d77\u6765\u3002\u4f46\u8fd9\u6761\u89c4\u5219\u5f88\u590d\u6742\u3002<\/p>\n<p>\u5047\u8bbe\u5f7c\u5f97\u5728 2020 \u5e74\u670d\u7528 Xeljanz \u51e0\u4e2a\u6708\u6765\u6cbb\u7597\u6e83\u75a1\u6027\u7ed3\u80a0\u708e\u7684\u53d1\u4f5c\u3002\u8f89\u745e\u76f4\u5230 2021 \u5e74\u624d\u66f4\u6539\u8b66\u544a\u6807\u7b7e\u3002<\/p>\n<p>\u90a3\u65f6\uff0c\u5f7c\u5f97\u4e0d\u518d\u670d\u7528 Xeljanz\uff0c\u56e0\u6b64\u4ed6\u6ca1\u6709\u770b\u5230\u8b66\u544a\u3002 2022 \u5e74\uff0cPeter \u53d1\u5c55\u7f13\u6162\u7684 DVT \u8fbe\u5230\u4e86\u9876\u70b9\uff0c\u4ed6\u5dee\u70b9\u6b7b\u53bb\u3002<\/p>\n<p>\u4e00\u5e74\u540e\uff0c\u4e5f\u5c31\u662f 2023 \u5e74\uff0c\u4ed6\u5076\u7136\u53d1\u73b0\u4e86\u4e00\u7bc7\u5c06 Xeljanz \u4e0e DVT \u53ca\u76f8\u5173\u95ee\u9898\u8054\u7cfb\u8d77\u6765\u7684\u6587\u7ae0\u3002<\/p>\n<p>\u8f89\u745e\u51e0\u4e4e\u80af\u5b9a\u4f1a\u4e89\u8fa9\u8bf4\uff0c\u4e24\u5e74\u7684\u65f6\u6548\u671f\u7981\u6b62\u5f7c\u5f97\u91c7\u53d6\u6cd5\u5f8b\u884c\u52a8\uff0c\u56e0\u4e3a\u4ed6\u670d\u7528\u4e86\u8fd9\u79cd\u836f\u7269\u5e76\u5728 2020 \u5e74\u51fa\u73b0\u4e86\u8840\u6813\u3002<\/p>\n<p>\u4f46\u4ed6\u76f4\u5230 2022 \u5e74\u624d\u77e5\u9053\u81ea\u5df1\u7684\u75c5\uff0c\u76f4\u5230 2023 \u5e74\u624d\u77e5\u9053\u4e0e\u8f89\u745e\u7684\u5173\u8054\u3002<\/p>\n<p>\u56e0\u6b64\uff0c\u7ebd\u7ea6\u4eba\u8eab\u4f24\u5bb3\u5f8b\u5e08\u5fc5\u987b\u5728 2025 \u5e74\u4e4b\u524d\u4ee3\u8868\u5f7c\u5f97\u63d0\u51fa\u635f\u5bb3\u8d54\u507f\u8981\u6c42\u3002<\/p>\n<h2>\u5982\u4f55\u8ba9\u4e8b\u60c5\u53d8\u5f97\u66f4\u597d<\/h2>\n<p>\u4ece\u6839\u672c\u4e0a\u8bf4\uff0c\u5371\u9669\u836f\u7269\u7d22\u8d54\u4e0e\u8d54\u507f\u65e0\u5173\uff0c\u5c3d\u7ba1\u8d54\u507f\u53ef\u80fd\u5f88\u4e30\u539a\uff0c\u800c\u4e14\u5927\u591a\u6570\u53d7\u5bb3\u8005\u90fd\u9700\u8981\u6bcf\u4e00\u5206\u94b1\u3002<\/p>\n<p>\u50cf DVT \u8fd9\u6837\u7684\u7d27\u6025\u60c5\u51b5\u901a\u5e38\u4f1a\u5f15\u53d1\u5065\u5eb7\u4fdd\u9669\u516c\u53f8\u62d2\u7edd\u652f\u4ed8\u7684\u6570\u4e07\u7f8e\u5143\u7684\u533b\u7597\u8d39\u7528\u3002<\/p>\n<p>\u5371\u9669\u836f\u7269\u7d22\u8d54\u4e0d\u4ec5\u4ec5\u5173\u4e4e\u91d1\u94b1\u3002\u5f53\u516c\u53f8\u6545\u610f\u5c06\u5229\u6da6\u6446\u5728\u4eba\u4eec\u9762\u524d\u65f6\uff0c\u8fd9\u4e9b\u58f0\u660e\u8981\u6c42\u516c\u53f8\u627f\u62c5\u8d23\u4efb\u3002<\/p>\n<p>\u4e00\u822c\u6765\u8bf4\uff0c\u8fd9\u4e9b\u516c\u53f8\u77e5\u9053\u98ce\u9669\u5347\u9ad8\uff0c\u4f46\u4ed6\u4eec\u4e0d\u613f\u610f\u5728\u6807\u7b7e\u4e0a\u6dfb\u52a0\u7b80\u5355\u7684\u514d\u8d23\u58f0\u660e\u3002\u4ed6\u4eec\u62c5\u5fc3\u8fd9\u6837\u7684\u8b66\u544a\u4f1a\u51cf\u5c11\u9500\u91cf\u3002<\/p>\n<p>\u5371\u9669\u836f\u7269\u58f0\u660e\u8ba9\u60a8\u6709\u673a\u4f1a\u6210\u4e3a\u89e3\u51b3\u65b9\u6848\u7684\u4e00\u90e8\u5206\uff0c\u5e76\u4f7f\u836f\u7269\u5bf9\u6bcf\u4e2a\u4eba\u90fd\u66f4\u5b89\u5168\u3002<\/p>\n<p>\u7531\u4e8e\u4ed6\u4eec\u7684\u6545\u610f\u4e0d\u5f53\u884c\u4e3a\uff0c\u966a\u5ba1\u56e2\u901a\u5e38\u4f1a\u547d\u4ee4\u8fd9\u4e9b\u516c\u53f8\u652f\u4ed8\u5de8\u989d\u7684\u60e9\u7f5a\u6027\u8d54\u507f\u3002\u91d1\u94b1\u662f\u50cf\u8f89\u745e\u8fd9\u6837\u7684\u516c\u53f8\u552f\u4e00\u4f7f\u7528\u7684\u8bed\u8a00\u3002<\/p>\n<p>\u53ea\u6709\u4ee4\u4eba\u77a0\u76ee\u7ed3\u820c\u7684\u635f\u5931\u6570\u989d\u624d\u80fd\u8bf4\u670d\u4ed6\u4eec\u6539\u53d8\u7ecf\u8425\u65b9\u5f0f\u3002<\/p>\n<p>\u4f7f\u7528 Xeljanz \u53ef\u80fd\u5bfc\u81f4\u4e25\u91cd\u4f24\u5bb3\u3002\u514d\u8d39\u54a8\u8be2 <a href=\"\/zh\/%e8%81%94%e7%b3%bb%e6%88%91%e4%bb%ac\/\">\u7ecf\u9a8c\u4e30\u5bcc\u7684\u4eba\u8eab\u4f24\u5bb3\u5f8b\u5e08<\/a>, contact Napoli Shkolnik, . We do not charge upfront legal fees and handle these cases nationwide.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u4e24\u5e74\u6765\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7b2c\u4e09\u6b21\u5bf9\u8f89\u745e\u5f3a\u5927\u4e14\u53d7\u6b22\u8fce\u7684\u5173\u8282\u708e\/UC \u836f\u7269\u53d1\u51fa\u5b89\u5168\u8b66\u544a\u3002\u6700\u65b0\u7684\u8b66\u544a\u662f\u6700\u5f3a\u70c8\u7684\u2026\u2026<\/p>","protected":false},"author":3,"featured_media":8405,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[815,875,917,918,971,972,978,1026],"class_list":["post-8404","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-general-negligence","tag-bad-drugs","tag-pharmaceutical-lawsuit","tag-pharmaceutical-lawyers","tag-health-and-safety","tag-fda-recall","tag-fda-warning","tag-healthcare"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/8404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/comments?post=8404"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/posts\/8404\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media\/8405"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/media?parent=8404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/categories?post=8404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/zh\/wp-json\/wp\/v2\/tags?post=8404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}