{"id":16435,"date":"2023-08-29T08:13:00","date_gmt":"2023-08-29T12:13:00","guid":{"rendered":"https:\/\/www.napolilaw.com\/?p=16435"},"modified":"2023-08-23T10:14:43","modified_gmt":"2023-08-23T14:14:43","slug":"horizon-adds-hearing-loss-warning-label-to-tepezza","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/ja\/article\/horizon-adds-hearing-loss-warning-label-to-tepezza\/","title":{"rendered":"Horizon \u304c Tepezza \u306b\u96e3\u8074\u306e\u8b66\u544a\u30e9\u30d9\u30eb\u3092\u8ffd\u52a0"},"content":{"rendered":"<p>\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u304b\u3089\u306e\u5727\u529b\u3092\u53d7\u3051\u3066\u3001\u30db\u30e9\u30a4\u30ba\u30f3\u306f\u540c\u793e\u306e\u30d9\u30b9\u30c8\u30bb\u30e9\u30fc\u85ac\u306e 1 \u3064\u306b\u3001\u3088\u308a\u5f37\u529b\u306a\u96e3\u8074\u306e\u8b66\u544a\u30e9\u30d9\u30eb\u3092\u8ffd\u52a0\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u8b66\u544a\u306f\u3001Horizon Therapeutics \u306e Tepezza (\u30c6\u30d7\u30ed\u30c4\u30e0\u30de\u30d6) \u306b\u95a2\u9023\u3059\u308b\u96e3\u8074\u3092\u542b\u3080\u91cd\u5ea6\u306e\u8074\u899a\u969c\u5bb3\u306e\u53ef\u80fd\u6027\u306b\u3064\u3044\u3066\u8cfc\u5165\u8005\u306b\u8b66\u544a\u3057\u3066\u3044\u307e\u3059\u3002\u65b0\u3057\u3044\u30e9\u30d9\u30eb\u306f\u3001\u96e3\u8074\u306e\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/seekingalpha.com\/news\/3989316-horizon-tepezza-hearing-loss-warning-added-labeling\" target=\"_blank\" rel=\"noopener\">\u6c38\u7d9a<\/a>\u3002\u3055\u3089\u306b\u3001\u30c6\u30da\u30c3\u30c4\u30a1\u6cbb\u7642\u524d\u3001\u6cbb\u7642\u4e2d\u3001\u6cbb\u7642\u5f8c\u306b\u60a3\u8005\u306e\u8074\u529b\u691c\u67fb\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068\u4ed8\u3051\u52a0\u3048\u305f\u3002<\/p>\n\n\n\n<p><strong>\u30c6\u30da\u30c3\u30c4\u30a1\u306e\u554f\u984c<\/strong><\/p>\n\n\n\n<p>Tepezza \u3092\u670d\u7528\u3059\u308b\u4eba\u306f\u3001\u6df1\u523b\u306a\u8074\u899a\u969c\u5bb3\u3092\u5f15\u304d\u8d77\u3053\u3059\u30ea\u30b9\u30af\u304c\u9ad8\u304f\u306a\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u305d\u3057\u3066\u304a\u305d\u3089\u304f\u3082\u3063\u3068\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u30db\u30e9\u30a4\u30be\u30f3\u793e\u306f\u305d\u306e\u30ea\u30b9\u30af\u3092\u77e5\u3063\u3066\u3044\u3066\u3001\u305d\u306e\u60c5\u5831\u3092\u60a3\u8005\u306b\u4f1d\u3048\u306a\u304b\u3063\u305f\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u4e8b\u5b9f\u304c\u6839\u62e0\u3068\u306a\u3063\u3066\u3044\u308b\u306e\u304c\u3001 <a href=\"https:\/\/napolilaw.lemonadestand.org\/ja\/%e3%82%af%e3%83%a9%e3%83%88%e3%83%a0%e3%82%b5%e3%83%97%e3%83%aa%e3%83%a1%e3%83%b3%e3%83%88-2\/\">\u30c6\u30da\u30b6\u8a34\u8a1f<\/a>.<\/p>\n\n\n\n<p>2010 \u5e74\u4ee3\u5f8c\u534a\u306e Tepezza \u306e\u958b\u767a\u4e2d\u306b\u3001\u7814\u7a76\u8005\u3089\u306f\u3001\u7532\u72b6\u817a\u773c\u75be\u60a3 (\u30d0\u30bb\u30c9\u30a6\u75c5) \u3068\u547c\u3070\u308c\u308b\u7a00\u306a\u75c7\u72b6\u3092\u6cbb\u7642\u3059\u308b\u85ac\u3067\u3042\u308b\u30c6\u30d7\u30ed\u30c4\u30e0\u30de\u30d6\u304c\u3001\u6b21\u306e\u3088\u3046\u306a\u6df1\u523b\u306a\u8074\u899a\u969c\u5bb3\u306e\u554f\u984c\u3092\u5f15\u304d\u8d77\u3053\u3059\u3053\u3068\u3092\u767a\u898b\u3057\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8033\u9cf4\u308a\uff08\u8033\u9cf4\u308a\uff09<\/li>\n\n\n\n<li>\u30aa\u30fc\u30c8\u30d5\u30a9\u30cb\u30fc\uff08\u8033\u306b\u97ff\u304f\uff09\u3001<\/li>\n\n\n\n<li>\u8074\u899a\u969c\u5bb3\uff08\u97f3\u75f4\uff09\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u30db\u30e9\u30a4\u30be\u30f3\u6c0f\u306fFDA\u5f53\u5c40\u306b\u5bfe\u3057\u3001\u305d\u306e\u3088\u3046\u306a\u526f\u4f5c\u7528\u306f\u9060\u9694\u5730\u3067\u6563\u767a\u7684\u306a\u3082\u306e\u3067\u3042\u308b\u3068\u8a9e\u3063\u305f\u3002\u5f8c\u306e\u5206\u6790\u306b\u3088\u308b\u3068\u3001\u96e3\u8074\u306e\u526f\u4f5c\u7528\u767a\u751f\u7387\u306f <a href=\"https:\/\/endocrinenews.endocrine.org\/new-data-show-promise-for-novel-thyroid-eye-disease-drug\/\" target=\"_blank\" rel=\"noopener\">80\u30d1\u30fc\u30bb\u30f3\u30c8\u4ee5\u4e0a<\/a>\u3001\u30db\u30e9\u30a4\u30be\u30f3\u306f\u614e\u91cd\u306b\u96a0\u853d\u3057\u305f\u4e8b\u5b9f\u3002<\/p>\n\n\n\n<p>\u8981\u7d04\u3059\u308b\u3068\u3001\u30db\u30e9\u30a4\u30be\u30f3\u793e\u306f\u91cd\u7be4\u306a\u526f\u4f5c\u7528\u306b\u3064\u3044\u3066\u77e5\u3063\u3066\u3044\u3066\u305d\u306e\u60c5\u5831\u3092\u96a0\u3057\u305f\u304c\u3001FDA\u306f\u8cea\u554f\u3057\u306a\u304b\u3063\u305f\u3002\u88fd\u85ac\u4f1a\u793e\u3084\u653f\u5e9c\u306e\u76e3\u8996\u6a5f\u95a2\u304c\u4eba\u3005\u3092\u4fdd\u8b77\u3057\u306a\u3044\u5834\u5408\u3001\u719f\u7df4\u3057\u305f\u6b20\u9665\u306e\u3042\u308b\u9ebb\u85ac\u5f01\u8b77\u58eb\u304c\u4ecb\u5165\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n\n\n\n<p>\u5f01\u8b77\u58eb\u306f\u6cd5\u7684\u8a34\u8a1f\u3092\u8d77\u3053\u3057\u3001\u602a\u6211\u306e\u88ab\u5bb3\u8005\u306b\u516c\u6b63\u306a\u8ce0\u511f\u3092\u5f97\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u3053\u308c\u3089\u306e\u63aa\u7f6e\u306b\u3088\u308a\u3001\u30db\u30e9\u30a4\u30be\u30f3\u306e\u3088\u3046\u306a\u4f01\u696d\u306f\u30d3\u30b8\u30cd\u30b9\u306e\u3084\u308a\u65b9\u3092\u5909\u66f4\u3057\u3001\u516c\u8846\u885b\u751f\u3068\u5b89\u5168\u3092\u4f55\u3088\u308a\u3082\u512a\u5148\u3059\u308b\u5fc5\u8981\u304c\u51fa\u3066\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>FDA\u306e\u5bfe\u5fdc<\/strong><\/p>\n\n\n\n<p>\u4e00\u822c\u7684\u306a\u901a\u8aac\u306b\u53cd\u3057\u3066\u3001FDA \u306f\u5371\u967a\u30c9\u30e9\u30c3\u30b0\u3092\u4e00\u65b9\u7684\u306b\u56de\u53ce\u3057\u305f\u308a\u3001\u88fd\u9020\u696d\u8005\u306b\u8b66\u544a\u30e9\u30d9\u30eb\u306e\u8ffd\u52a0\u3092\u4e00\u65b9\u7684\u306b\u5f37\u5236\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u3053\u306e\u653f\u5e9c\u6a5f\u95a2\u304c\u3067\u304d\u308b\u306e\u306f\u3001\u516c\u7136\u3068\u4f01\u696d\u306b\u3053\u308c\u3089\u306e\u3053\u3068\u3092\u884c\u3046\u3088\u3046\u5727\u529b\u3092\u304b\u3051\u308b\u3053\u3068\u3060\u3051\u3060\u3002<\/p>\n\n\n\n<p><strong>\u640d\u5bb3\u8ce0\u511f\u8acb\u6c42<\/strong><\/p>\n\n\n\n<p>\u88ab\u5bb3\u8005\u3089\u306f\u30b7\u30ab\u30b4\u9023\u90a6\u5730\u65b9\u88c1\u5224\u6240\u306b\u30c6\u30da\u30c3\u30c4\u30a1\u96c6\u56e3\u8a34\u8a1f\u3092\u8d77\u3053\u3057\u305f\u3002 2022\u5e74\u672b\u306e\u6642\u70b9\u3067\u540d\u4e57\u308a\u51fa\u305f\u72a0\u7272\u8005\u306f20\u4eba\u306b\u3082\u6e80\u305f\u306a\u304b\u3063\u305f\u3002 2023 \u5e74\u521d\u982d\u307e\u3067\u306b\u3001\u305d\u306e\u6570\u306f 200 \u3092\u8d85\u3048\u308b\u307e\u3067\u6025\u5897\u3057\u3001\u305d\u306e\u6570\u306f\u6bce\u6708\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3042\u306a\u305f\u307e\u305f\u306f\u611b\u3059\u308b\u4eba\u304c Tepezza \u3092\u670d\u7528\u3057\u3001\u91cd\u5ea6\u306e\u96e3\u8074\u3068\u8a3a\u65ad\u3055\u308c\u305f\u5834\u5408\u306f\u3001\u6b21\u306e\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002 <a href=\"https:\/\/napolilaw.lemonadestand.org\/ja\/%e3%82%af%e3%83%a9%e3%83%88%e3%83%a0%e3%82%b5%e3%83%97%e3%83%aa%e3%83%a1%e3%83%b3%e3%83%88-2\/\">\u884c\u52d5\u3092\u8d77\u3053\u3059<\/a>\u3002\u30c6\u30da\u30b6\u8a34\u8a1f\u304c\u6c7a\u7740\u3059\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u5834\u5408\u3001\u8a34\u8a1f\u3092\u8d77\u3053\u3057\u305f\u88ab\u5bb3\u8005\u306e\u307f\u304c\u6700\u5927\u306e\u8ce0\u511f\u91d1\u3092\u53d7\u3051\u53d6\u308b\u3053\u3068\u306b\u306a\u308b\u3002\u88ab\u5bb3\u8005\u306f\u8a34\u8a1f\u306b\u53c2\u52a0\u3059\u308b\u8cc7\u683c\u304c\u3042\u308b\u304c\u3001\u53d7\u3051\u53d6\u308c\u308b\u91d1\u984d\u306f\u5927\u5e45\u306b\u6e1b\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u85ac\u54c1\u306e\u96c6\u56e3\u8a34\u8a1f\u306f\u975e\u5e38\u306b\u8907\u96d1\u3067\u3059\u304c\u3001\u305d\u306e\u4e3b\u306a\u7406\u7531\u306f\u3001\u8ffd\u52a0\u306e\u624b\u7d9a\u304d\u4e0a\u304a\u3088\u3073\u30ed\u30b8\u30b9\u30c6\u30a3\u30c3\u30af\u4e0a\u306e\u30cf\u30fc\u30c9\u30eb\u304c\u3044\u304f\u3064\u304b\u3042\u308b\u305f\u3081\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u624b\u7d9a\u304d\u7684\u306b\u306f\u3001\u9577\u671f\u306b\u308f\u305f\u308b\u8907\u6570\u5730\u533a\u306e\u8a34\u8a1f\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u3001\u901a\u5e38\u3001\u5148\u5236\u6a29\u3084\u305d\u306e\u4ed6\u306e\u3042\u3044\u307e\u3044\u306a\u539f\u5247\u306b\u57fa\u3065\u304f\u5374\u4e0b\u7533\u3057\u7acb\u3066\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u57fa\u672c\u7684\u306b\u3001\u5148\u5236\u3068\u306f\u3001FDA \u306e\u3088\u3046\u306a\u653f\u5e9c\u6a5f\u95a2\u304c\u533b\u85ac\u54c1\u304c\u5b89\u5168\u3067\u3042\u308b\u3068\u5ba3\u8a00\u3059\u308b\u3068\u3001\u88c1\u5224\u6240\u306f\u305d\u306e\u8a8d\u5b9a\u3092\u518d\u5ea6\u63a8\u6e2c\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3068\u3044\u3046\u8003\u3048\u65b9\u3067\u3059\u3002\u3053\u306e\u8003\u3048\u306f\u3001\u9023\u90a6\u88c1\u5224\u6240\u306e\u72ec\u7acb\u6027\u3068\u3001\u8b66\u544a\u3092\u6020\u3063\u305f\u7d1b\u4e89\u3092\u89e3\u6c7a\u3059\u308b\u6a29\u5229\u3092\u77ed\u7d61\u3059\u308b\u3053\u3068\u306b\u306a\u308b\u3002<\/p>\n\n\n\n<p>\u85ac\u4e8b\u8a34\u8a1f\u7d4c\u9a13\u8c4a\u5bcc\u306a\u5f01\u8b77\u58eb\u306b\u3088\u308b\u7121\u6599\u76f8\u8ac7\u306f\u3001 <a href=\"https:\/\/napolilaw.lemonadestand.org\/ja\/%e3%82%af%e3%83%a9%e3%83%88%e3%83%a0%e3%82%b5%e3%83%97%e3%83%aa%e3%83%a1%e3%83%b3%e3%83%88-2\/\">\u30ca\u30dd\u30ea\u30fb\u30b7\u30e5\u30b3\u30eb\u30cb\u30af\u306b\u9023\u7d61\u3059\u308b<\/a>\u3002\u5f53\u793e\u306f\u5168\u56fd\u3067\u8a34\u8a1f\u3092\u53d7\u3051\u4ed8\u3051\u3066\u304a\u308a\u3001\u8a34\u8a1f\u306b\u52dd\u3064\u307e\u3067\u6599\u91d1\u306f\u56de\u53ce\u3055\u308c\u307e\u305b\u3093\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u304b\u3089\u306e\u5727\u529b\u3092\u53d7\u3051\u3066\u3001\u30db\u30e9\u30a4\u30ba\u30f3\u306f\u540c\u793e\u306e\u30d9\u30b9\u30c8\u30bb\u30e9\u30fc\u85ac\u306e 1 \u3064\u306b\u3001\u3088\u308a\u5f37\u529b\u306a\u96e3\u8074\u306e\u8b66\u544a\u30e9\u30d9\u30eb\u3092\u8ffd\u52a0\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u8b66\u544a\u306f\u3001\u8cfc\u5165\u8005\u306b\u6b21\u306e\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u8b66\u544a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>","protected":false},"author":3,"featured_media":16452,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[926,928,972,816,917,919],"class_list":["post-16435","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-pharmaceutical-law","tag-pharmaceutical-lawsuit-attorney","tag-fda-recall","tag-defective-products","tag-pharmaceutical-lawsuit","tag-pharmaceutical-injuries-lawyer-new-york"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/posts\/16435","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/comments?post=16435"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/posts\/16435\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/media\/16452"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/media?parent=16435"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/categories?post=16435"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/ja\/wp-json\/wp\/v2\/tags?post=16435"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}