The FDA issued a safety alert on March 31, 2026, regarding Tavneos (avacopan), a medication used to treat a rare autoimmune disease.
Recent reports have linked the drug to serious and, in some cases, fatal liver injuries.
What Is the Concern?
While Tavneos was already known to potentially affect the liver, the FDA has identified new, more severe safety concerns through post-marketing reports. Specifically, officials have found cases of drug-induced liver injury (DILI), some of which involved vanishing bile duct syndrome (VBDS).
VBDS is a rare but dangerous condition in which the bile ducts in the liver are destroyed. This can lead to permanent liver damage because bile can no longer flow properly.
Recent findings
The FDA identified 76 cases of liver injury likely caused by the drug. Of these 76 cases, 74 resulted in serious outcomes, including 54 hospitalizations and eight deaths. Symptoms typically emerged quickly, with a median onset of 46 days after treatment began.
In early 2026, the FDA requested that the drugmaker voluntarily withdraw Tavneos from the U.S. market. But the drugmaker has declined to do so, stating they stand by the drug’s effectiveness and benefit-risk profile.
What Is Tavneos?
Approved in 2021, Tavneos is used with other medications to treat adults with severe active ANCA-associated vasculitis. This rare condition causes inflammation of small to medium blood vessels.
Signs and Symptoms to Watch For
If you are taking Tavneos, contact your doctor right away if you notice any of the following symptoms:
- Yellowing of the skin or the whites of the eyes (jaundice)
- Unusual tiredness or fatigue
- Severe itching or dark-colored urine
- Pain or swelling in the stomach or the upper right side of the abdomen (belly area)
- Nausea, vomiting, or light-colored stools
Important Advice for Patients
- Do not stop treatment suddenly. Talk to your health care provider before making any changes to your medication.
- Get regular bloodwork. Your doctor should perform liver tests every two weeks during your first month of treatment, and then monthly for the following five months.
- Discuss alternatives. Because of these new findings, the FDA urges patients to talk to their doctors about whether to continue therapy or switch to a different treatment.
Reporting side effects
If you have a side effect, you or your doctor can report it to the FDA’s MedWatch program online or by calling 800-332-1088.
