{"id":985,"date":"2026-03-31T23:12:09","date_gmt":"2026-04-01T06:12:09","guid":{"rendered":"https:\/\/www.getasecondopinion.ai\/blog\/?p=985"},"modified":"2026-03-31T23:12:10","modified_gmt":"2026-04-01T06:12:10","slug":"fda-flags-serious-liver-injury-linked-to-tavneos-avacopan","status":"publish","type":"post","link":"https:\/\/www.getasecondopinion.ai\/blog\/policy-alerts\/fda-updates\/fda-flags-serious-liver-injury-linked-to-tavneos-avacopan\/","title":{"rendered":"FDA Flags Serious Liver Injury Linked to Tavneos (Avacopan)"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.getasecondopinion.ai\/medication\/tavneos\">Tavneos<\/a> (<a href=\"https:\/\/www.getasecondopinion.ai\/medication\/avacopan\">avacopan<\/a>) is a prescription medication approved in 2021 to help treat severe active anti\u2011neutrophil cytoplasmic autoantibody (ANCA)\u2011associated vasculitis, a rare autoimmune disease that causes inflammation of small blood vessels. For many patients, <a href=\"https:\/\/www.getasecondopinion.ai\/medication\/tavneos\">Tavneos<\/a> offered a new option to control a difficult and potentially life\u2011threatening condition.<\/p>\n\n\n\n<p>Now, the U.S. Food and Drug Administration (FDA) says new safety data has raised serious concerns about the drug\u2019s impact on the liver.<\/p>\n\n\n\n<p>In a recent safety bulletin, the FDA reported 76 cases of drug\u2011induced liver injury in people taking <a href=\"https:\/\/www.getasecondopinion.ai\/medication\/tavneos\">Tavneos<\/a>. Of those cases, 74 were considered serious, and eight patients died. The agency says the pattern and severity of these cases go beyond what was previously known about the drug\u2019s risks.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What the FDA Found<\/strong><\/h3>\n\n\n\n<p>The FDA\u2019s review looked at post\u2011marketing safety reports submitted through October 9, 2024. These reports came from healthcare providers and regulators around the world after <a href=\"https:\/\/www.getasecondopinion.ai\/medication\/tavneos\">Tavneos<\/a> was already on the market.<\/p>\n\n\n\n<p>Key findings from the FDA include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>76 total cases of liver injury<\/strong> linked to Tavneos<\/li>\n\n\n\n<li><strong>8 deaths<\/strong> associated with liver failure or complications<\/li>\n\n\n\n<li><strong>Median time to onset: 46 days<\/strong>, meaning liver problems often appeared within the first two months of treatment<\/li>\n\n\n\n<li><strong>7 cases of biopsy\u2011confirmed vanishing bile duct syndrome (VBDS)<\/strong>, a rare and severe condition that can lead to permanent liver damage or death<\/li>\n<\/ul>\n\n\n\n<p>Three of the VBDS cases were fatal, underscoring how serious these injuries can be.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why Vanishing Bile Duct Syndrome Matters<\/strong><\/h3>\n\n\n\n<p>Vanishing bile duct syndrome is not a routine liver side effect. It occurs when the small bile ducts inside the liver are progressively destroyed, preventing bile from flowing properly. Over time, this can cause chronic liver failure<strong>,<\/strong> the need for a transplant, or death.<\/p>\n\n\n\n<p>The FDA says the appearance of VBDS in multiple Tavneos cases represents a new and particularly concerning safety signal that was not fully understood at the time of the drug\u2019s approval.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Where the Reports Came From<\/strong><\/h3>\n\n\n\n<p>Most of the reported cases, 66 out of 76 came from Japan, with additional cases reported in the United States, Europe, and Canada. The FDA notes that geographic clustering does not rule out risk elsewhere and may reflect differences in reporting practices rather than differences in safety.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Symptoms Patients Should Watch For<\/strong><\/h3>\n\n\n\n<p>The FDA urges patients taking Tavneos to seek medical care immediately if they notice signs of liver trouble, including:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Yellowing of the skin or eyes<\/li>\n\n\n\n<li>Dark urine or pale stools<\/li>\n\n\n\n<li>Persistent itching<\/li>\n\n\n\n<li>Severe fatigue<\/li>\n\n\n\n<li>Nausea, vomiting, or abdominal pain<\/li>\n<\/ul>\n\n\n\n<p>These symptoms can signal liver injury and should never be ignored.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What the FDA Is Recommending Now<\/strong><\/h3>\n\n\n\n<p>To reduce risk, the FDA recommends:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Frequent liver blood tests, especially early in treatment<\/li>\n\n\n\n<li>Immediate discontinuation of Tavneos if liver injury is suspected<\/li>\n\n\n\n<li>Careful weighing of benefits versus risks before starting therapy<\/li>\n<\/ul>\n\n\n\n<p>The agency also asked the drug\u2019s manufacturer to voluntarily withdraw Tavneos from the U.S. market. As of the bulletin\u2019s release, the company had not agreed to withdraw the drug.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why This Matters for Patients<\/strong><\/h3>\n\n\n\n<p>ANCA\u2011associated vasculitis is a serious disease, and treatment decisions are often complex. The FDA\u2019s findings do not mean Tavneos is unsafe for everyone &#8211; but they do mean the risks are higher and more severe than previously understood.<\/p>\n\n\n\n<p>For patients currently taking Tavneos, the message is not panic, but awareness and vigilance. For those considering it, the decision should involve a careful discussion with a healthcare provider about alternatives, monitoring, and individual risk factors.<\/p>\n\n\n\n<div class=\"wp-block-group is-style-default has-accent-4-background-color has-background has-global-padding is-layout-constrained wp-container-core-group-is-layout-384690f3 wp-block-group-is-layout-constrained\" style=\"padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--20);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--20)\">\n<figure class=\"wp-block-image aligncenter size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"789\" height=\"354\" src=\"https:\/\/www.getasecondopinion.ai\/blog\/wp-content\/uploads\/2026\/02\/directory-membership-benefits-2.webp\" alt=\"\" class=\"wp-image-810\" style=\"object-fit:cover\" srcset=\"https:\/\/www.getasecondopinion.ai\/blog\/wp-content\/uploads\/2026\/02\/directory-membership-benefits-2.webp 789w, https:\/\/www.getasecondopinion.ai\/blog\/wp-content\/uploads\/2026\/02\/directory-membership-benefits-2-300x135.webp 300w, https:\/\/www.getasecondopinion.ai\/blog\/wp-content\/uploads\/2026\/02\/directory-membership-benefits-2-768x345.webp 768w\" sizes=\"auto, (max-width: 789px) 100vw, 789px\" \/><\/figure>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button pattern-info discover_button_pattern is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-base-color has-text-color has-link-color wp-element-button\" href=\"https:\/\/www.getasecondopinion.ai\/signup\" style=\"border-style:none;border-width:0px;padding-top:var(--wp--preset--spacing--20);padding-right:55px;padding-bottom:var(--wp--preset--spacing--20);padding-left:55px;font-style:normal;font-weight:500\" target=\"_blank\" rel=\"noreferrer noopener\">Quickly Understand Treatment Risks<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Source<\/strong><\/h2>\n\n\n\n<p>FDA Drug Safety Communication:<br><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-identifies-cases-serious-liver-injury-patients-taking-tavneos-avacopan-severe-active-anti\">https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-identifies-cases-serious-liver-injury-patients-taking-tavneos-avacopan-severe-active-anti<\/a>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tavneos (avacopan) is a prescription medication approved in 2021 to help treat severe active anti\u2011neutrophil cytoplasmic autoantibody (ANCA)\u2011associated vasculitis, a rare autoimmune disease that causes inflammation of small blood vessels. For many patients, Tavneos offered a new option to control a difficult and potentially life\u2011threatening condition. Now, the U.S. Food and Drug Administration (FDA) says [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":986,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[752,751,750,748,755,754,747,753,749,746],"class_list":["post-985","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda-updates","tag-anca-vasculitis-treatment","tag-avacopan-liver-risk","tag-avacopan-side-effects","tag-fda-drug-safety","tag-fda-tavneos-bulletin","tag-fda-tavneos-deaths","tag-fda-tavneos-warning","tag-tavneos-liver-failure","tag-tavneos-liver-injury","tag-vanishing-bile-duct-syndrome"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Flags Serious Liver Injury Linked to Tavneos (Avacopan) - Get a Second Opinion<\/title>\n<meta name=\"description\" content=\"FDA warns of serious liver injury and deaths linked to Tavneos (avacopan) in ANCA vasculitis patients. 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