The FDA has issued a safety alert regarding serious cases of drug-induced liver injury (DILI), including fatal outcomes, associated with Tavneos (avacopan), used to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Several cases involved vanishing bile duct syndrome (VBDS), a rare condition that causes progressive destruction of bile ducts, leading to cholestasis and potentially permanent liver damage.
Although liver toxicity was previously noted in Tavneos’ labeling, the FDA said VBDS and fatal DILI cases represent new safety concerns. The agency identified 76 postmarketing DILI cases deemed reasonably linked to avacopan use, including 74 serious outcomes, 54 hospitalizations, and eight deaths. Seven biopsy-confirmed cases of VBDS were reported, three of which were fatal. The median time to liver injury onset was 46 days after treatment initiation.
Most reports originated from Japan, with additional cases documented in the U.S., Europe, and Canada. The FDA urged clinicians to perform regular liver panel testing—every two weeks during the first month, monthly for the next five months, and as clinically indicated thereafter—and to discontinue treatment if patients show significant abnormalities or symptoms such as jaundice or pruritus.
Patients are advised to contact their healthcare professional immediately if they experience fatigue, nausea, jaundice, dark urine, abdominal pain, or other signs of liver injury. The FDA continues to monitor DILI and VBDS cases linked to avacopan and will update the public as new information becomes available.
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