Tavneos label change: liver monitoring records that may matter

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Last reviewed: October 9, 2026

People usually do
not call about
Tavneos with a neat
file. They call with
pieces of a story: a
new vasculitis drug,
a bad liver panel,
itching that would
not stop, yellow
eyes, a hospital
stay, or a doctor
mentioning vanishing
bile duct syndrome
for the first time.

The May 2026 Tavneos
label update helps
put those pieces in
order.

Tavneos is avacopan.
Doctors use it with
other medicines for
adults with severe
active ANCA-
associated
vasculitis. It is
still available in
the United States
while FDA considers
a proposed
withdrawal of
approval. If you are
taking it now, do
not stop on your
own. Talk with the
doctor who
prescribed it.

For the full
investigation page,
see our [Tavneos
lawsuit hub](https:/
/masstortamerica.com
/mass-
torts/tavneos/).
This article stays
with one practical
question: after the
label changed, what
records matter in a
serious liver injury
review?

Start with the label, not the headlines

DailyMed lists a May
2026 major change to
Tavneos's
hepatotoxicity
warning. The current
label says serious
liver injury has
been observed in
Tavneos patients,
including life-
threatening events.
It also says
vanishing bile duct
syndrome, or VBDS,
has been reported
after marketing as a
consequence of liver
injury, including
cases with a fatal
outcome.

That is the language
a reviewer will care
about. News
headlines fade. The
label is the
document doctors,
drug companies,
experts, and lawyers
come back to.

The updated label
tells doctors to get
a liver test panel
before Tavneos
starts. After that,
it calls for testing
every four weeks for
the first six
months, then as
clinically
indicated. For
patients of Japanese
descent, it says
doctors should
consider testing
every two weeks for
the first three
months, then every
four weeks for the
next three months.

If a patient later
had liver failure,
suspected VBDS, a
transplant
evaluation, or
death, the first
question is simple:
what did the early
testing show, and
when?

The numbers that can change the review

A family does not
need to decode every
liver value before
asking for help.
Still, the actual
lab report is better
than a summary.

The Tavneos label
says the drug should
be discontinued
until Tavneos-
induced liver injury
is ruled out if AST
or ALT is more than
five times the upper
limit of normal. It
says the same if ALT
or AST is more than
three times the
upper limit of
normal with total
bilirubin more than
two times the upper
limit of normal. It
also points to
alkaline phosphatase
at or above two
times the upper
limit of normal, or
symptoms such as
jaundice or
pruritus.

Pruritus means
itching. Jaundice
means yellowing of
the skin or eyes.
Those words may show
up in the chart
before anyone writes
"drug-induced liver
injury."

The label is even
stronger on VBDS. It
says Tavneos should
be stopped
immediately and
permanently if VBDS
is suspected.

Why the first two months deserve attention

FDA's March 31, 2026
Drug Safety
Communication
identified 76 drug-
induced liver injury
cases with
reasonable evidence
of a causal
association with
avacopan. FDA said
74 had a serious
outcome. Fifty-four
involved
hospitalization.
Eight involved
death.

FDA also described
seven biopsy-
confirmed VBDS
cases. All seven
involved
hospitalization, and
three had a fatal
outcome. In those
VBDS cases, the
median time from
starting avacopan to
liver injury onset
was 46 days. The
range was 33 to 59
days.

That does not prove
any one case. It
does make the first
several weeks
important. A claim
review may turn on a
handful of dates:
first prescription,
first fill, first
abnormal lab, first
symptom, first ER
visit, first
hepatology consult,
the day Tavneos was
stopped, and what
happened after that.

The FDA approval dispute is related, but not the whole case

On April 27, 2026,
FDA's Center for
Drug Evaluation and
Research proposed
withdrawing Tavneos
approval. FDA said
new information
raised concerns
about whether
Tavneos had been
shown to be
effective for its
approved use and
whether the
application
contained untrue
statements of
material fact. The
Federal Register
notice also
discussed serious
and sometimes fatal
hepatotoxicity.

Amgen disagrees. In
a July 2026 update,
the company said
Tavneos remains
available in the
United States,
defended the drug's
benefit-risk
profile, and said it
submitted more data
and analyses to FDA
in support of a
hearing request.

For an injured
patient, that
regulatory fight is
background. The
personal medical
timeline still
carries the weight.
Did Tavneos come
before the liver
injury? Were the
warning signs
documented? Were
there other likely
causes? How severe
was the outcome?
Which state's filing
deadline applies?

Records worth saving now

Do not wait for a
perfect file. Start
with what you have.

Useful records
include Tavneos
prescription and
pharmacy fill
records;
rheumatology notes;
baseline liver labs;
follow-up ALT, AST,
alkaline
phosphatase,
bilirubin, and INR
results; ER records;
hospital records;
hepatology notes;
imaging; biopsy
reports; transplant
center records; and
a medication list
from the same
period. If the
patient died, the
death certificate
and final hospital
records are
important too.

Mass Tort America is
reviewing Tavneos
cases involving
serious drug-induced
liver injury,
suspected or
confirmed VBDS,
liver failure,
transplant
evaluation, liver
transplant, or
death. Our [Tavneos
registry-study artic
le](https://masstort
america.com/mass-
torts/tavneos-us-
registry-liver-
injury-study-2026/)
covers another piece
of the evidence. Our
[current mass tort d
ocket](https://masst
ortamerica.com/mass-
torts/) lists other
active
investigations.

FAQ

Does the label update mean every abnormal liver test is a claim?

No. A claim review
depends on timing,
severity, diagnosis,
other possible
causes, and state
law.

Which Tavneos liver injuries should be reviewed closely?

Hospitalization for
drug-induced liver
injury, suspected or
confirmed VBDS,
acute liver failure,
transplant
evaluation, liver
transplant, or death
should be reviewed
closely.

Should a patient stop Tavneos because of the FDA warning?

No. Patients should
not stop or change
Tavneos without
medical advice. FDA
tells patients to
contact a healthcare
professional right
away if possible
liver injury
symptoms appear.

Sources

Informational and attorney advertising disclaimer

This article is for
general information
and attorney
advertising. It is
not medical advice
and does not create
an attorney-client
relationship. Prior
results do not
guarantee a similar
outcome. If you are
taking Tavneos now,
talk with your
prescribing doctor
before making any
medication change.

Robert B. Baker, Board-Certified Civil Trial Attorney

Claims reviewed by Baker Legal Team
Robert B. Baker, Esq., B.C.S. — Board-Certified Civil Trial Lawyer. 30+ years of trial experience, more than $400 million recovered for clients. About Robert Baker →