In March 2026, Tavneos FDA warnings about liver side effects and some death cases were issued, just a couple of months after the FDA had requested that Amgen recall Tavneos for drug safety reasons.
According to the FDA, Tavneos (avacopan) is used together with glucocorticoids and other standard-of-care medications to treat adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), a group of rare diseases that cause inflammation in small-to-medium-sized blood vessels.
Tavneos FDA Warnings
We get the following information from this March 31, 2026 Drug Safety Communication, “FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis“:
FDA is alerting patients and health care professionals about serious postmarketing cases, including fatal cases, of drug-induced liver injury (DILI) associated with Tavneos (avacopan). Some cases involved vanishing bile duct syndrome (VBDS), which is characterized by progressive destruction and disappearance of the bile ducts in the liver.
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Patients should contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury, such as: feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of skin or eyes; dark urine; swelling in the stomach or abdomen; or pain in the right upper abdomen.
As mentioned at the start, before these March 2026 Tavneos FDA warnings, the drug manufacturer Amgen rejected an FDA request in February 2026 for a Tavneos recall over concerns about drug-induced liver injury (DILI) and vanishing bile duct syndrome (VBDS) liver side effects, as well as reports made to the FDA about death cases involving Tavneos.
Now, a week after the March 31, 2026 Tavneos FDA warnings about these DILI and VBDS liver side effects, and even with those death cases involving Tavneos, there has been no indication from Amgen that there will be a Tavneos recall.
We are investigating possible personal injury lawsuits to be filed against Amgen on behalf of patients using Tavneos who developed serious liver side effects, including DILI and VBDS, or the families who may have wrongful death cases involving Tavneos to bring against Amgen, as the responsible drug company.
[Read the article in full at Drug Injury Watch]Tavneos
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