Official Statement
Important Information for the Vasculitis Community Regarding TAVNEOS® (avacopan)
Updated Drug Safety Communication
March 31, 2026
On Tuesday, March 31, 2026, the FDA released a drug safety communication regarding Tavneos.
FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis
What is the 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.
To read the complete drug safety communication, please click here. The communication includes guidance for patients and health care professionals to follow as well as information on what the FDA learned from their review of the data.
To download a PDF of the communication, please click here.
For the most current information, patients and clinicians are encouraged to review Amgen’s official updates:
- Patient information: www.amgen.com/tavneos-update (Updated April 1, 2026)
- Healthcare provider information: www.amgen.com/tavneos-prescribers (Updated April 1, 2026)
The VF will continue to monitor developments closely and share updates as appropriate.
February 4, 2026
The Vasculitis Foundation (VF) is aware of recent announcements regarding TAVNEOS (avacopan), a medication approved for the treatment of adults with severe active ANCA-associated vasculitis, including granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). On January 16, 2026, the U.S. Food and Drug Administration requested a voluntary withdrawal of TAVNEOS from the U.S. market
At this time, TAVNEOS remains available in the United States. Amgen, the current manufacturer and distributor of this medication, has indicated that it is engaged in ongoing discussions with the US Food and Drug Administration following recent regulatory communications. No final determination has been issued by the FDA, and no changes to patient access have been announced.
“For patients living with vasculitis, treatment decisions are deeply personal and often lifesaving,” said Joyce Kullman, Executive Director of the VF. “We know that uncertainty around a medication you rely on can be concerning. Patients should not make changes to their treatment without guidance from their healthcare provider, and we remain focused on ensuring the community has clear, accurate information as this situation continues to evolve.”
The VF does not provide medical advice. Patients and caregivers with questions about their individual care should consult their healthcare provider.
For the most current information, patients and clinicians are encouraged to review Amgen’s official updates:
- Patient information: www.amgen.com/tavneos-update
- Healthcare provider information: www.amgen.com/tavneos-prescribers
The VF will continue to monitor developments closely and share updates as appropriate.
More For You
Explore helpful resources, personal stories, and supportive tools to guide you through every step of living with vasculitis.
From Our Blog
Stay informed with voices from the vasculitis community, expert commentary, and updates on research, treatment breakthroughs, and quality-of-life topics.
»
Video Library
Access our growing collection of videos and webinars featuring patient experiences, clinician discussions, treatment explanations, and practical tips for managing life with vasculitis.
»
Treatment & Care
Find clear, patient-centered information about treatment options, care planning, medication guidance, and tools to help you talk with your healthcare team.
»