FDA Identifies Serious Liver Injury Cases and Deaths with Tavneos

Drug Safety Communication (PDF - 244 KB)

03-31-2026 FDA Drug Safety Communication

What Is FDA Doing?

FDA is alerting patients and health care professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos (avacopan). Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver. This condition can slow or stop the flow of bile and may lead to permanent liver damage. VBDS is often accompanied by the yellowing of skin or eyes (jaundice), itchiness, and tiredness.

Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, VBDS and DILI cases with fatal outcomes represent new safety concerns. FDA is continuing to monitor postmarketing cases of DILI, including VBDS, involving Tavneos and will provide updates as appropriate.

What Is Tavneos (avacopan)?

Tavneos was approved on October 7, 2021, and is used together with glucocorticoids and other standard-of-care medications to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), a group of rare diseases that cause inflammation in small-to-medium-sized blood vessels. Tavneos does not eliminate glucocorticoid use.

What Should Patients Do?

Patients should contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury, such as: feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of skin or eyes; dark urine; swelling in the stomach or abdomen; or pain in the right upper abdomen. Patients should talk to their health care professional about the safety risks associated with Tavneos and whether to continue therapy or switch to alternative treatments.

What Should Health Care Professionals Do?

When treating patients who take Tavneos, health care professionals should:

• Conduct liver panel testing every 2 weeks in the first month of treatment, monthly for the next 5 months, and then as clinically indicated.
• Promptly discontinue Tavneos treatment, evaluate patients, and consider alternative treatments for patients with severe active ANCA-associated vasculitis if:
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is >3 times the upper limit of normal (ULN) or alkaline phosphatase (ALP) is >2 times the ULN;
  • A patient presents with evidence of symptomatic cholestasis such as jaundice or pruritus.
• If liver test abnormalities or symptoms of liver injury do not improve, patients should be referred to a hepatologist for further evaluation. Professionals should consult the American College of Rheumatology treatment guidelines for more information.

What Did FDA Find?

After reviewing postmarketing data from the applicant's submission (cases from their global safety database), the literature, and the FDA Adverse Event Reporting System (FAERS) database, which has been incorporated into the FDA Adverse Event Monitoring System (AEMS) database, through October 9, 2024, FDA identified 76 cases of DILI with reasonable evidence of a causal association with avacopan use. A total of 74 cases reported a serious outcome, including hospitalization (n=54) and death (n=8). A total of 60 cases provided laboratory information to determine the initial pattern of liver injury; the majority (n=38) had a cholestatic or mixed pattern often marked by substantial elevations in ALP and total bilirubin. A total of 73 cases provided time from avacopan initiation to DILI onset, and the median time-to-onset was 46 days (range 22 to 140 days). Most cases (n=66) were reported from Japan, followed by the United States (n=5), Europe (n=4), and Canada (n=1).

Of the 76 cases, 7 reported biopsy-confirmed VBDS as a complication of DILI with reasonable evidence of a causal association with avacopan use. All cases reported hospitalization (n=7), of which 3 had a fatal outcome. The initial pattern of liver injury was cholestatic or mixed in 4 cases and hepatocellular in 3 cases. The median time from avacopan initiation to DILI onset among the 7 cases was 46 days (range 33 to 59 days). Cases were reported from Japan (n=6) and Canada (n=1).

FDA is continuing to monitor postmarketing cases of DILI, including VBDS, involving avacopan and will provide updates as appropriate.

How Do I Report Side Effects from Tavneos?

To help FDA monitor safety issues with medicines, we urge patients and health care professionals to report side effects involving Tavneos or other medicines to the FDA MedWatch program using the information in the "Contact FDA" box at the bottom of this page.

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03/31/2026

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