FDA warns of serious liver injury with Tavneos, including fatal cases

On March 31, 2026 the FDA issued a drug safety communication on serious drug-induced liver injury linked to TAVNEOS, including cases of vanishing bile duct syndrome and fatal outcomes. The FDA said these are new safety concerns beyond the hepatotoxicity already described in the labeling. The warning came three weeks before the FDA formally proposed withdrawing the drug's approval.

• FDA drug safety communication dated March 31, 2026
• Cases of serious drug-induced liver injury, some with vanishing bile duct syndrome
• FDA says fatal liver injury cases represent new safety concerns
• TAVNEOS (avacopan) was approved in October 2021