Liver Failure: Amgen Continues Marketing Avacopan (Tavneos) in the United States

Dr. Greg Vigna

LOS ANGELES, CA, UNITED STATES, April 7, 2026 /EINPresswire.com/ -- Greg Vigna, MD, JD, a national pharmaceutical injury attorney, states, “Amgen is not removing its drug despite the FDA’s request. Reported complications include acute liver injury and death.”

Dr. Greg Vigna, MD, JD, a national medical malpractice and product liability attorney, states, “The FDA re-adjudicated the data used to support the FDA’s approval of Tavneos to enter the market for the treatment of severe polyangiitis compared with prednisone, which is standard treatment. The FDA has serious safety concerns about the causal relationship of vanishing bile duct syndrome. The result can be progressive liver dysfunction after the drug is discontinued.”

About Vanishing Bile Duct Syndrome:

“Vanishing bile duct syndrome (VBDS) is a rare condition characterized by progressive loss, destruction, and disappearance of the intra-hepatic bile ducts, leading to cholestasis and ductopenia. The exact mechanism of development of VDBS has not been established yet,” according to Dr. Paolo Izzo.

Read more about vanishing bile duct syndrome.

Dr. Vigna continues, “It appears that Amgen believes this drug is reasonably safe for its indication for use, which is severe ANCA-associated vasculitis. Clearly, the FDA says no, and the perceived improvement in outcomes does not justify its use, given that the FDA re-adjudicated the data on remission and sustained remission for symptomatic vasculitis, which underpinned its approval. It seems like there is no reasonable benefit compared to standard treatment, which is steroids, but carries safety concerns, including hepatic toxicity and vanishing bile duct syndrome.”

Dr. Vigna is a California and Washington, D.C., Lawyer who focuses on serious injuries caused by pharmaceutical manufacturers, including midurethral slings, including the Coloplast Altis device, Depo-Provera, and meningiomas. He represents the injured with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas, and will investigate liver injuries caused by Tavneos. The attorneys specialize in product liability and medical malpractice, representing patients nationwide with neurological injuries and the physicians who implant them.

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