Overview
- - The FDA’s safety alert, released March 31, details 76 postmarketing cases of drug‑induced liver injury tied to avacopan, including 74 serious outcomes and eight deaths.
- - The agency tells clinicians to check liver panels every two weeks in month one, then monthly for five months, and to stop the drug for ALT or AST above three times normal, ALP above twice normal, or signs of cholestasis such as jaundice or itching.
- - Seven patients had biopsy‑confirmed vanishing bile duct syndrome, a rare condition that can cause permanent liver damage, and three of those patients died.
- - Reports show a median onset of liver injury at 46 days after starting treatment, with many cases showing a cholestatic or mixed pattern marked by high alkaline phosphatase and bilirubin.
- - Scrutiny of Tavneos has intensified since January, when the FDA asked for a voluntary withdrawal and the European Medicines Agency opened a review of trial data integrity, even as most injury reports to date have come from Japan.