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Liver Injury, Vanishing Bile Duct Syndrome, and Death
Tavneos lawsuits involve claims that Tavneos® (avacopan), a prescription drug used with standard therapy for severe active ANCA-associated vasculitis, is linked to serious liver injuries, including drug-induced liver injury, vanishing bile duct syndrome, liver failure, hospitalization, and death.
Our law firm is currently investigating Tavneos injury lawsuits nationwide, including claims involving serious liver injury, vanishing bile duct syndrome, liver transplant, hospitalization, and wrongful death after Tavneos use.
For a free case evaluation, fill out our form here.
Tavneos, also known as avacopan, is an oral medication approved by the FDA on October 7, 2021. It is used with glucocorticoids and other standard-of-care medications to treat adults with severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis. The FDA notes that Tavneos does not eliminate the need for glucocorticoids.
April 2026
In April 2026, the FDA took the significant step of proposing to withdraw approval of Tavneos, citing concerns that there is no substantial evidence the drug is effective and alleging that material facts in the approval application were untrue. The agency also raised concerns that clinical trial data may have been manipulated to achieve a statistically significant result.
March 2026
Just weeks earlier, on March 31, 2026, the FDA issued a public safety alert warning of serious drug-induced liver injury (DILI) and cases of vanishing bile duct syndrome (VBDS), including fatal outcomes. The agency specifically identified VBDS as a new safety concern emerging in postmarketing reports.
The FDA identified 76 Tavneos-related drug-induced liver injury cases with reasonable evidence of a causal association, including 54 hospitalizations and 8 deaths.
January 2026
Earlier in 2026, the regulatory conflict between the FDA and Amgen escalated. On January 16, 2026, the FDA formally requested that Amgen voluntarily withdraw Tavneos from the market due to concerns about the integrity of the pivotal clinical trial data and the drug’s overall benefit-risk profile, particularly in light of hepatotoxicity risks. However, on January 28, 2026, Amgen declined to withdraw the drug and indicated it would continue to defend Tavneos.
2023-2025
These actions followed years of growing safety signals after the drug entered the market. Between 2023 and 2025, postmarketing surveillance identified increasing reports of serious liver injury, including drug-induced liver injury and vanishing bile duct syndrome, with some cases resulting in hospitalization and death.
November 2022
Notably, the first known case of vanishing bile duct syndrome associated with Tavneos was reported to the FDA on November 1, 2022, shortly after the drug’s approval.
October 2021
Tavneos was originally approved by the FDA on October 7, 2021, as an adjunct treatment for adults with severe active ANCA-associated vasculitis. At the time of approval, the label did not identify vanishing bile duct syndrome as a risk with the use of the drug.
You may qualify for a Tavneos lawsuit if you took Tavneos and suffered serious liver-related injuries or complications, including hospitalization, liver failure, vanishing bile duct syndrome, or death.
Potential Tavneos claims may involve patients who:
Patients who took Tavneos should seek medical attention if they experience symptoms of liver injury, including:
The FDA has advised healthcare professionals to conduct liver panel testing frequently during the first months of Tavneos treatment and to discontinue Tavneos when certain liver abnormalities or symptoms occur.
Tavneos liver injury lawsuits allege that patients and doctors were not adequately warned about serious postmarketing risks, including vanishing bile duct syndrome and fatal drug-induced liver injury. Further, the lawsuits allege the manufacturer’s manipulation of clinical trial data and failure to establish substantial evidence of the effectiveness of Tavenos rendered the drug inherently defective in that its risks greatly outweighed its purported benefits.
If you or a loved one suffered liver injury, vanishing bile duct syndrome, or other serious complications after taking Tavneos, you may have a legal claim.
Recent FDA actions, including safety warnings about fatal liver injuries and a proposal to withdraw approval of Tavneos, raise serious concerns about the drug’s safety and effectiveness. These developments may be important to your case.
Our attorneys are actively investigating Tavneos lawsuits nationwide and are available to evaluate your claim.
There are time limits for filing a claim. It is important to act promptly to protect your rights.
Call us today at 800.277.1193, or complete our online form to speak with a member of our Tavneos team.
Tavneos lawsuits involve claims that Tavneos may cause serious liver injuries, including drug-induced liver injury, vanishing bile duct syndrome, liver failure, hospitalization, and death.
The FDA has proposed withdrawing approval of Tavneos, but Amgen had not voluntarily withdrawn the drug as of the cited April 2026 reports.
Vanishing bile duct syndrome is a serious liver condition involving progressive destruction and disappearance of bile ducts.
Family members may be able to pursue a wrongful death claim if a loved one died after Tavneos-related liver injury or serious infection. A free case review can help determine eligibility.
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