Tavneos FDA hearing request: what liver injury families should save now
Tavneos FDA hearing request: what liver injury families should save now
Last reviewed: October 3, 2026
The newest Tavneos development is a hearing
request, not a lawsuit filing.
On September 24, 2026, the Vasculitis
Foundation asked the FDA to hold a public
hearing before the agency decides whether to
withdraw Tavneos (avacopan). That is worth
watching, but it needs a careful read. A
hearing request does not prove a claim. It
also does not mean FDA has softened the liver
safety warning it issued earlier this year.
For families, the practical point is much
smaller and more urgent: if Tavneos was
followed by liver failure, vanishing bile
duct syndrome, transplant evaluation, or
death, save the records now. Hospital portals
close. Doctors change systems. Dates blur
after a medical emergency.
We keep the broader case overview on our
Tavneos
lawsuit
page. Our current mass torts
page
lists the other investigations we are
reviewing.
What the September request adds
The Vasculitis Foundation letter is tied to
FDA docket FDA-2026-N-1321. The group wants
patients, caregivers, and clinicians to have
a public forum before FDA makes a final
decision.
The letter is not a blanket defense of the
drug. It asks FDA to consider the risks of
Tavneos alongside the limits of other
treatments for severe GPA and MPA, possible
liver monitoring, restricted prescribing, and
what some patients may lose if Tavneos is
removed from the U.S. market.
The same update says FDA had received 143
public comments about the proposed
withdrawal. For a rare disease drug, that is
not just background noise. It shows the
dispute is about both patient access and
liver safety.
That still leaves the claim question where it
always lands: in the chart. Public comments
can explain what patients and doctors are
worried about. They cannot show what happened
to one person after one prescription.
The source language is worth saving, too. FDA
says Tavneos "will remain on the market"
unless the applicant removes it or the FDA
Commissioner mandates removal after the
process runs. Amgen says there is "no change
to TAVNEOS approval status, use or
availability" in the United States. The
Vasculitis Foundation says a public hearing
would let patients and clinicians discuss
risk, treatment alternatives, and possible
liver-monitoring approaches before a final
decision.
Why FDA proposed withdrawal
FDA's April 27 notice gives two reasons for
the proposed withdrawal. FDA says new
information showed Tavneos had not been
proven effective for its approved use. FDA
also says the approval application contained
untrue statements of material fact.
The trial language is unusually direct. FDA
says unblinded study personnel manipulated
results after the original analysis did not
support effectiveness, and that the original
analysis was not disclosed.
The liver risk is a separate piece, but it
matters to the same decision. FDA had already
warned that postmarketing reports included
serious drug-induced liver injury and
vanishing bile duct syndrome. If the benefit
proof is in doubt, the safety side of the
scale looks different.
Amgen disagrees with FDA. Its July 24 update
says Tavneos remains available in the United
States while the company works through the
FDA process. Amgen also says patients should
not stop or change Tavneos without talking
with the clinician who prescribed it.
The liver injury facts FDA published
FDA's March 31 Drug Safety Communication
identified 76 drug-induced liver injury cases
with reasonable evidence of a causal
association with avacopan use.
Seventy-four had serious outcomes. FDA
counted 54 hospitalizations and 8 deaths. The
agency also described 7 biopsy-confirmed
vanishing bile duct syndrome cases. All 7
involved hospitalization. Three were fatal.
FDA reported a median time to liver injury
onset of 46 days after starting Tavneos. That
number is useful for screening. It is not a
rule that ends the discussion. Some patients
have other medications, infections,
autoimmune flares, or liver history in the
record. That is why the actual timeline
matters so much.
FDA told patients to contact a health care
professional right away for possible liver
injury symptoms, including unusual fatigue,
nausea, vomiting, itching, light-colored
stools, yellowing skin or eyes, dark urine,
abdominal swelling, or pain in the right
upper abdomen.
Records we would save first
For a Tavneos review, we would start with the
timeline: first dose, first symptom, first
abnormal liver test, hospitalization,
diagnosis, stopping Tavneos, and the outcome.
The records that usually answer those
questions are the pharmacy fill history, the
rheumatology or nephrology notes, liver labs
from before and after the first dose, ER and
hospital records, hepatology notes, ICU
records, transplant-center records, imaging,
liver biopsy or pathology reports, discharge
summaries, and any death certificate or
autopsy report in a fatal case.
We would also save the medication list.
Antibiotics, immunosuppressants, supplements,
alcohol history if it appears in the chart,
and other possible liver stressors may all
show up in the doctor's differential. Do not
throw those pages away because they seem
unhelpful. A clean review needs the whole
record, not just the pages that sound
favorable.
What we are watching next
FDA may grant a hearing, deny it, ask for
more material, or move toward a final
withdrawal decision. The docket may also show
how FDA, Amgen, clinicians, and patient
groups talk about liver monitoring and access
limits.
For claim screening, the strongest fact
patterns remain severe and documented:
drug-induced liver injury requiring
hospitalization, vanishing bile duct
syndrome, acute liver failure, transplant
evaluation, liver transplant, or death after
Tavneos exposure.
There is no Tavneos MDL right now. We are not
aware of a public settlement program. Any
promise of a set payout or fast timeline is
ahead of the record.
Plain-English FAQ
Is Tavneos still available in the United States?
Yes. Amgen says Tavneos remains available in
the U.S. while it engages with FDA. Patients
should speak with their prescribing health
care professional before changing treatment.
Did FDA already withdraw Tavneos?
No. FDA proposed withdrawal and issued a
notice of opportunity for a hearing. Tavneos
remains on the market unless the applicant
removes it or FDA orders withdrawal after the
required process.
Why does the hearing request matter to families?
It may create a public forum about Tavneos
safety, liver monitoring, patient access, and
possible restrictions. It does not prove an
individual claim. Medical records still do
that work.
What injuries are being reviewed most closely?
The closest reviews usually involve
hospitalization for drug-induced liver
injury, vanishing bile duct syndrome, acute
liver failure, transplant evaluation, liver
transplant, or death after Tavneos use.
Sources
- FDA: CDER proposes to withdraw approval of TAVNEOS
- FDA: Drug Safety Communication on serious liver injury with Tavneos
- Federal Register: ChemoCentryx proposal to withdraw Tavneos approval; opportunity for hearing
- Vasculitis Foundation: Tavneos update and request for public hearing
- Amgen: Tavneos update and patient FAQ
Attorney advertising and informational notice
This article is attorney advertising and
general information. It is not medical advice
and does not create an attorney-client
relationship. If you are taking Tavneos, talk
with your prescribing health care
professional before making treatment
decisions.
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 →