Tavneos liver injury claims: the 2026 FDA warning, in plain English

If Tavneos is in your medicine cabinet, or if it was prescribed to
someone in your family, the news this year has probably been
confusing.

The drug has not simply disappeared from pharmacies. Amgen says
Tavneos remains available in the United States. At the same time,
the FDA has taken two major public steps in 2026: first a
liver-injury safety warning, then a proposal to withdraw approval of
the drug.

That is a lot for any patient to sort through, especially when the
patient was already dealing with ANCA-associated vasculitis, a
serious illness on its own. This update is meant to slow the story
down and separate what is known from what still has to be proved in
an individual case.

The short version

Tavneos is the brand name for avacopan. It was approved in 2021 as
an add-on treatment for adults with severe active ANCA-associated
vasculitis, including granulomatosis with polyangiitis and
microscopic polyangiitis. The FDA says it is used with standard
therapy, including glucocorticoids, and that it does not eliminate
glucocorticoid use.

On March 31, 2026, FDA warned that it had identified serious
postmarketing cases of drug-induced liver injury associated with
Tavneos. Some cases involved vanishing bile duct syndrome, often
shortened to VBDS. FDA described VBDS as destruction and
disappearance of bile ducts in the liver, a problem that can slow or
stop bile flow and may lead to permanent liver damage. Some reported
cases were fatal.

Less than a month later, on April 27, 2026, FDA’s Center for Drug
Evaluation and Research proposed that Tavneos be withdrawn from the
market. The proposal was not just about liver safety. CDER also said
new information raised concerns about whether Tavneos had been shown
to be effective for its approved use, and whether the application
that led to approval contained untrue statements of material fact.

For families, the headline is this: a Tavneos claim is going to turn
on records. Dates. Lab work. Hospital notes. Biopsy findings.
Medication history. Not guesses.

What FDA reported about liver injuries

FDA said it reviewed postmarketing data from the applicant’s global
safety database, medical literature, and FDA adverse event reports
through October 9, 2024.

The agency identified 76 cases of drug-induced liver injury with
reasonable evidence of a causal association with avacopan use.
Seventy-four of those cases had a serious outcome. FDA listed 54
hospitalizations and 8 deaths. Among the cases with timing
information, the median time from starting Tavneos to liver-injury
onset was 46 days, with a range of 22 to 140 days.

FDA also reported 7 biopsy-confirmed VBDS cases as a complication of
drug-induced liver injury. All 7 involved hospitalization. Three had
fatal outcomes.

Most of the 76 cases were reported from Japan. Five were reported
from the United States. Amgen has said that, to date, it knows of no
U.S. deaths linked to serious liver injury, including VBDS, among
more than 8,000 U.S. patients treated with Tavneos. That statement
is part of Amgen’s public position, and it should be read alongside
the FDA warning, not instead of it.

Why VBDS gets special attention

Many medicines can cause liver enzyme changes. Some are mild and go
away after a drug is stopped. VBDS is different.

The current Tavneos prescribing information, revised in May 2026,
says that in the postmarketing setting, VBDS as a consequence of
liver injury has been reported, including fatal cases. It also says
these events were reported predominantly in Japan in patients 65 and
older, but can affect patients of any age or ethnicity who are
receiving Tavneos.

The medication guide tells patients to call a healthcare provider
right away for symptoms such as yellowing of the skin or eyes,
itching, upper-right abdominal pain, unusual tiredness, dark or
tea-colored urine, easy bleeding or bruising, or loss of appetite.

A person reading that list after the fact may recognize things that
seemed scattered at the time: a new itch, darker urine, a hospital
visit, a sudden referral to a liver specialist. That is why the
paper trail matters.

What changed in the label

The May 2026 label update added more detailed liver monitoring and
stopping guidance. DailyMed’s Tavneos label says liver tests should
be obtained before starting Tavneos, every 4 weeks after starting
therapy for the first 6 months, and as clinically indicated after
that. It also says patients of Japanese descent may need more
frequent testing in the first 6 months.

The label says Tavneos should be discontinued while Tavneos-induced
liver injury is ruled out if certain liver test thresholds are met
or if clinical symptoms such as jaundice or itching appear. It also
says Tavneos should be immediately and permanently discontinued if
VBDS is suspected.

Those details may matter in a legal review. They can help frame
questions like: Were liver tests done before and during treatment?
Were symptoms documented? Was the drug stopped promptly? Did the
patient keep taking Tavneos after abnormal labs or liver-injury
symptoms appeared?

The withdrawal proposal is a separate issue, but it matters

The April 2026 withdrawal proposal is unusual. In the Federal
Register notice for docket FDA-2026-N-1321, CDER said it proposed
withdrawal because, based on new information, there was a lack of
substantial evidence of effectiveness and because the application
contained untrue statements of material fact.

FDA’s public summary said new information became known more than
three years after approval and involved alleged manipulation of
pivotal study results so the drug appeared effective when the
original analysis did not support that conclusion. FDA said the
applicant did not disclose the original analysis.

Amgen strongly disagrees with FDA’s proposal. Amgen says Tavneos
remains approved and available in the United States, and says it
submitted additional data and analyses to FDA on July 23, 2026, in
support of its request for a hearing.

So the regulatory process is not finished. Patients should not stop
Tavneos because of something they read online. They should talk with
the doctor who knows their vasculitis history, kidney status,
medications, and liver labs.

What a potential Tavneos claim may involve

Mass tort attorneys are reviewing whether Tavneos users were
adequately warned about serious liver injury risks, including VBDS,
liver failure, transplant, and death. These investigations are
early. There is no Tavneos MDL as of this writing. No settlement
amount should be assumed.

A stronger fact pattern may include:

• Confirmed Tavneos or avacopan use
• Liver symptoms or abnormal liver tests within weeks or months of starting
• Hospitalization for cholestasis, jaundice, hepatitis, liver failure, or suspected drug-induced liver injury
• A biopsy report mentioning VBDS or bile duct loss
• Liver transplant evaluation, liver transplant, or death
• Medical notes linking the liver injury to Tavneos or stopping Tavneos because of liver concerns

A weaker fact pattern may involve a brief exposure, mild lab changes
that resolved quickly, a long time gap, no clear proof the drug was
taken, or another strong medical explanation.

That does not mean a family should decide the case alone. It means
the review has to be careful.

Records to gather before you call

If you are trying to understand what happened, start with the
documents closest to the event.

Ask the pharmacy for a fill history. Save the Tavneos bottle if you
still have it. Request hospital records, discharge summaries, liver
panels, imaging reports, biopsy reports, and specialist notes. If
the case involved death, families may also need the death
certificate, autopsy records if there was an autopsy, and estate or
probate information.

It is also worth writing down a simple timeline while memories are
fresh: when Tavneos started, when symptoms appeared, when labs
changed, when the drug was stopped, and what doctors said.

You can report suspected side effects to FDA MedWatch. That report
does not file a lawsuit. It helps regulators track possible safety
problems.

Bottom line for patients and families

Tavneos cases will not be one-size-fits-all. The underlying disease
is serious. The medication history may be complicated. But FDA’s
2026 warning and withdrawal proposal are important developments, and
people who suffered severe liver injury after Tavneos deserve a real
review.

Mass Tort America is reviewing potential Tavneos liver injury claims
involving avacopan use followed by serious liver injury, VBDS, liver
failure, transplant, or death. A review is not a promise that a
claim qualifies, and no attorney can guarantee compensation or a
particular result.

Sources checked for this update include the FDA Drug Safety
Communication dated March 31, 2026; the FDA CDER April 27, 2026
proposal to withdraw Tavneos; the Federal Register notice for docket
FDA-2026-N-1321; the May 2026 DailyMed/Tavneos prescribing
information; and Amgen’s Tavneos update last updated July 24, 2026.

Attorney advertising. This page is for general information only. It
is not medical advice and it is not legal advice. If you have
symptoms of liver injury, contact a medical professional
immediately. Contacting Mass Tort America does not create an
attorney-client relationship unless and until a written agreement is
signed.