The US Food and Drug Administration (FDA) has reported cases of liver injury in patients treated with Amgen’s drug Tavneos (avacopan), used for ANCA-associated vasculitis.

The agency identified 76 cases of drug-induced liver injury, including seven cases of vanishing bile duct syndrome (VBDS). Eight deaths were reported among these cases.

The FDA has advised healthcare providers to discontinue treatment if liver injury is suspected.

The findings are based on post-marketing data.

Tavneos is indicated for the treatment of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, a rare autoimmune condition.

The FDA had earlier asked Amgen to voluntarily withdraw the drug, but the company declined.

Warnings related to VBDS are included in labels in Europe and Australia, while the US prescribing information does not currently include this warning.

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