In April 2026, the U.S. Food and Drug Administration proposed withdrawing its approval of Tavneos, citing new cases of serious liver injury, including fatal cases of vanishing bile duct syndrome, and concerns about the data used to support the drug's approval. At Cory Watson Attorneys, we are investigating claims on behalf of patients who developed serious liver injury after taking Tavneos, and families who lost a loved one.
Call (877) 562-0000 today or complete our free online case evaluation to learn more.
What Is Tavneos?
Tavneos (avacopan) is a prescription capsule approved by the FDA on October 7, 2021, as an add-on treatment for adults with severe, active ANCA-associated vasculitis, a rare autoimmune disease that inflames small blood vessels and can damage the kidneys, lungs, and other organs. It is taken twice daily alongside other standard treatments and was marketed as a way to reduce reliance on steroids. Tavneos is made by Amgen Inc. and its subsidiary ChemoCentryx, Inc., which Amgen acquired in 2022.
Why Is the FDA Trying to Pull Tavneos Off the Market?
On April 27, 2026, the FDA's Center for Drug Evaluation and Research proposed withdrawing approval of Tavneos. According to the FDA:
- Results of the drug's pivotal clinical trial were allegedly manipulated by unblinded personnel, and the original analysis was not disclosed to the agency.
- New cases of serious liver injury were identified, including vanishing bile duct syndrome with fatal outcomes.
- In a March 2026 safety communication, the FDA identified 76 cases of drug-induced liver injury with reasonable evidence of a causal association to Tavneos, including 54 hospitalizations and 8 deaths.
The FDA had earlier asked Amgen to withdraw the drug voluntarily, and Amgen declined. Amgen has requested a hearing, and Tavneos remains on the U.S. market while the process continues.
What Is Vanishing Bile Duct Syndrome?
Vanishing bile duct syndrome (VBDS) is a rare and serious condition in which the small bile ducts inside the liver are destroyed. Because bile can no longer drain properly, it builds up and damages the liver. VBDS can continue to progress even after the medication that caused it is stopped, and in severe cases it can lead to liver failure, the need for a liver transplant, or death.
Common symptoms of Tavneos-related liver injury may include:
- Yellowing of the skin or eyes (jaundice)
- Severe itching
- Dark urine
- Pale stools
- Fatigue
- Nausea or vomiting
- Pain or swelling in the upper right abdomen
According to the FDA, liver injury from Tavneos typically appears within the first few months of treatment. If you are taking Tavneos and have any of these symptoms, contact your doctor right away. Do not stop taking any prescribed medication without speaking to your healthcare provider.
Who May Qualify for a Tavneos Lawsuit?
You may be eligible to pursue a Tavneos lawsuit if:
- You took Tavneos (avacopan) in the United States, and
- You developed serious liver injury, such as jaundice, hospitalization, vanishing bile duct syndrome, liver failure, or a liver transplant, or
- You lost a loved one to liver injury after they took Tavneos
Strict time limits apply to filing a lawsuit, and they vary by state. An experienced attorney can review your situation and help determine whether you qualify.
What Are the Allegations Against Amgen and ChemoCentryx?
Lawsuits over Tavneos are expected to allege that the manufacturers:
- Failed to adequately warn patients and doctors about the risk of vanishing bile duct syndrome and other serious liver injury
- Failed to use liver monitoring and guidance cutoffs that prevent patient harm
- Delayed strengthening the drug's warnings after liver injury reports emerged
- Promoted the drug's benefits based on trial results the FDA now says cannot be relied upon
Why Choose Cory Watson Attorneys?
Cory Watson Attorneys is a nationally recognized personal injury law firm with offices in Birmingham, Alabama, and Memphis and Nashville, Tennessee. The firm has recovered more than $4 billion for clients across the country and is frequently at the forefront of major pharmaceutical and product liability litigation, often in leadership roles in national cases.
When you contact our firm, we will:
- Review your case at no cost
- Help determine whether your injury may be linked to Tavneos
- Obtain medical and pharmacy records when appropriate
- Explain your legal options
- Fight for the compensation you deserve
You pay nothing unless we recover compensation for you.
Frequently Asked Questions
Is there a Tavneos lawsuit?
Attorneys are investigating claims involving serious liver injury after Tavneos use. The FDA has proposed withdrawing the drug's approval, and Cory Watson Attorneys is evaluating cases for individuals who were injured.
Is Tavneos still on the market?
Yes. As of the FDA's most recent public update, Tavneos remains available while Amgen contests the proposed withdrawal. Talk to your doctor before making any changes to your treatment.
What injuries qualify?
We are evaluating cases involving serious liver injury, including hospitalization with jaundice, vanishing bile duct syndrome, liver failure, liver transplant, or death, after taking Tavneos.
How can I prove I took Tavneos?
Tavneos is dispensed through specialty pharmacies, so pharmacy and insurance records typically document use. Our team can help you gather them.
How much does it cost to hire Cory Watson Attorneys?
Nothing upfront. We handle these cases on a contingency fee basis, meaning you pay no attorney fees unless we recover compensation for you.
About Cory Watson Attorneys
Cory Watson Attorneys is a nationally recognized personal injury law firm with offices in Birmingham, Memphis, and Nashville. The firm has recovered more than $4 billion for clients nationwide and has extensive experience handling complex product liability and mass tort litigation.