FDA
FDA warns of serious liver injury risk with Tavneos (avacopan)
FDA today issued a Drug Safety Communication alerting clinicians and patients to reports of serious drug‑induced liver injury (DILI) associated with Tavneos (avacopan), approved for adults with severe active ANCA‑associated vasculitis. A review of postmarketing data identified 76 cases with reasonable evidence of a causal link, most with serious outcomes, including 54 hospitalizations and 8 deaths. Several reports described vanishing bile duct syndrome (VBDS)—a rare condition that can cause permanent liver damage—representing a new safety concern beyond previously recognized hepatotoxicity.
The median time to onset was ~46 days after treatment initiation. FDA advises baseline and frequent liver function testing (every 2 weeks for the first month, then monthly for several months) and prompt discontinuation if significant abnormalities or symptoms occur. Patients should seek care immediately for signs such as fatigue, nausea, pruritus, jaundice, dark urine, light stools, or right‑upper‑quadrant pain. FDA continues to monitor safety and will provide updates as new information becomes available.