Overview
- U.S. regulators issued a safety communication identifying 76 drug-induced liver injury cases tied to Tavneos, including seven biopsy-confirmed vanishing bile duct syndrome cases and eight deaths, and urged prompt discontinuation if liver damage is suspected.
- Tavneos, approved in 2021 to treat ANCA‑associated vasculitis that inflames small and medium blood vessels, was linked to liver injury with a median onset of 46 days and patterns that were often cholestatic or mixed based on lab reports.
- The FDA advised clinicians to check liver panels every two weeks during the first month, then monthly for five months, and to stop the drug if ALT or AST exceed three times the upper limit of normal or if ALP exceeds twice that limit or if jaundice or itching occurs.
- Regulatory scrutiny has intensified after the FDA asked for a voluntary withdrawal in January based on a re‑evaluation of trial data, which Amgen declined as it defended the drug’s benefit‑risk profile, and the European Medicines Agency opened a data‑integrity review.
- Labels in Europe and Australia note post‑marketing cases of vanishing bile duct syndrome, the U.S. label does not yet include that warning, and the FDA said it will keep reviewing reports and may update guidance as more data emerge.