Tavneos FDA Hearing Request: What the Public Docket Means for Liver Injury Claims

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Last reviewed: October 2, 2026

The Tavneos story did not end with FDA's spring safety warning. It has turned
into a public fight over what FDA should do next, and patients are now part of
that record.

On September 24, 2026, the Vasculitis Foundation asked FDA leaders to hold a
public hearing before the agency makes a final decision on whether to withdraw
Tavneos (avacopan). The group is not saying the liver reports should be ignored.
Its point is narrower: people with ANCA-associated vasculitis, their caregivers,
and the doctors treating them should be able to speak directly about what
withdrawal would mean in real life.

For a family looking at a possible Tavneos liver injury claim, that matters in a
practical way. The paper trail is getting fuller. There is the March FDA safety
communication. There is the April withdrawal notice. There is the Federal
Register docket. There are patient comments, Amgen materials, and now a renewed
push for a public hearing.

Do not wait for the FDA process to finish before gathering records. Hospitals
merge portals. Pharmacies close. A specialist's note that feels easy to get in
October can be a chore six months later. If Tavneos use and liver injury are in
the same medical story, save the documents now.

The September hearing request

The Vasculitis Foundation's September 24 letter asks FDA to convene a public
hearing on Docket No. FDA-2026-N-1321 before reaching a final decision. The
foundation says FDA should hear from patients and clinicians about the benefit
and risk of Tavneos, the limits of other treatment options, and possible risk
controls such as updated labeling, stronger liver monitoring, or prescribing
restrictions.

That is a patient-access argument. It is not the same thing as a personal injury
claim. Still, it belongs in the same timeline because it shows how unsettled the
Tavneos decision remains in the United States.

The foundation also says the uncertainty itself is affecting care. Some patients
are anxious about losing access to a medicine they believe has helped them. Some
clinicians are unsure how to advise current Tavneos users while FDA and Amgen
continue the process. Those concerns do not cancel out the liver-injury evidence,
but they explain why FDA is under pressure to make the process more public.

The docket is bigger than one agency notice

The Federal Register page for the Tavneos withdrawal proposal reported 120
public comments on the document page. The Vasculitis Foundation later wrote that
FDA had received 143 public comments from patients, caregivers, and health care
professionals. Docket counts can change depending on timing and display rules,
so the exact number should be checked in the live docket. The important part is
that the comments are now part of the public record.

For claim review, public comments usually are not a substitute for medical
records. A personal story in a docket does not prove what happened to another
patient. But dockets can show what regulators, companies, physicians, and
patients were saying at a specific point in time. In a drug case, that timeline
can become important.

FDA's liver findings are still the main safety record

FDA's March 31, 2026 Drug Safety Communication remains the starting point for
serious Tavneos liver injury reviews. FDA said it found 76 postmarketing cases
of drug-induced liver injury with reasonable evidence of a causal association
with avacopan. Seventy-four had a serious outcome. Fifty-four involved
hospitalization. Eight involved death.

FDA also identified 7 biopsy-confirmed cases of vanishing bile duct syndrome, or
VBDS. Three of those cases had a fatal outcome. FDA described VBDS as the
progressive destruction and disappearance of bile ducts in the liver, a condition
that can interfere with bile flow and may lead to permanent liver damage.

The agency told patients to contact a health care professional right away if
they develop possible liver injury symptoms, including unusual fatigue, nausea,
vomiting, itching, light-colored stools, yellowing of the skin or eyes, dark
urine, abdominal swelling, or pain in the upper right abdomen.

That symptom list is not a legal checklist. It is a medical warning. If someone
is reviewing a claim, the stronger records usually involve a diagnosed liver
injury, abnormal liver labs, hospitalization, hepatology care, biopsy findings,
transplant evaluation, transplant, or death after Tavneos use.

The withdrawal proposal adds a separate issue

FDA's April 27 statement and April 30 Federal Register notice raised a different
problem: the reliability of the evidence used to approve the drug. CDER said it
proposed withdrawal because new information showed a lack of substantial
evidence of effectiveness and because the Tavneos application contained untrue
statements of material fact.

FDA alleged that unblinded study personnel manipulated endpoint results in the
ADVOCATE study, the pivotal trial used for approval. FDA also said the original
analysis was not submitted to the agency.

That does not decide any lawsuit. It does mean a Tavneos review may involve two
separate sets of questions. One is medical: what happened to the patient's
liver? The other is regulatory: what did the company and FDA know, and when did
they know it?

Records to pull now

Families do not need a perfect binder before asking for a case review, but the
basics help. Start with the records that show dates and severity. A lawyer can
work around missing pieces; it is much harder to work around a timeline that no
one can pin down.

If Tavneos was followed by serious liver problems, try to save or request:

Tavneos prescription records, pharmacy fill dates, and dose instructions.
The date Tavneos started and, if it was stopped, the stop date.
Liver panel results from before Tavneos and during the first months of use.
Emergency room records, hospital records, hepatology notes, and discharge
summaries.
Imaging, biopsy reports, or notes that mention cholestasis, bile duct loss,
DILI, VBDS, liver failure, transplant evaluation, or transplant.
Death certificate and autopsy records, if the review involves a loved one's
death.
Written instructions from the prescriber about monitoring, stopping, or
changing treatment.

If you are taking Tavneos now, do not stop because of a lawsuit article. Talk to
your doctor. FDA's own communications point patients back to their treating
health care professionals for individual decisions.

How this connects to the Tavneos investigation

Mass Tort America is tracking Tavneos as an early investigation, not an MDL. The
main case page explains the injuries and claim criteria we are watching:
Tavneos Lawsuit.

For related background, see our notes on the
new U.S. registry liver-injury study
and the EU and UK withdrawal actions.

FAQ

Has FDA removed Tavneos from the U.S. market?

No. FDA has proposed withdrawal, but its April statement says Tavneos remains on
the market until the applicant removes it or the FDA Commissioner orders
withdrawal after the required process.

Does the hearing request mean Tavneos is safe?

No. It means patients and clinicians are asking FDA for a public forum before a
final decision. FDA's March safety communication still identifies serious and
sometimes fatal liver injury reports associated with Tavneos.

What Tavneos injuries are being reviewed?

The most serious reviews usually involve drug-induced liver injury, VBDS, liver
failure, hospitalization, transplant, or death after Tavneos use. Prescription
records and liver-related medical records are the starting point.

Sources

Attorney advertising. This article is for general information only and is not
medical advice or legal advice. Past results do not guarantee a similar outcome.
Submitting information for a case review does not create an attorney-client
relationship.

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 →