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Tavneos After the EU and UK Actions: Liver Monitoring Records to Save Now

Last reviewed: September 12, 2026

Tavneos is no longer just a U.S. safety-watch story. The FDA has
proposed pulling Tavneos approval in the United States, European
regulators have moved from recommendation to a final EU revocation, and
the UK has started a managed withdrawal plan for new and current
avacopan patients.

For U.S. families looking at a possible Tavneos liver injury claim, the
practical point is narrow: save the records that show when the drug
started, what liver tests showed before and after treatment, and how
doctors responded when symptoms or abnormal labs appeared.

Our Tavneos lawsuit hub covers the broader
investigation. This update focuses on what changed after the European
and UK actions, and why those actions make the medical timeline more
important than ever.

What changed after the FDA's March and April actions

On March 31, 2026, the FDA warned patients and clinicians about serious
postmarketing cases of drug-induced liver injury, including fatal cases,
associated with Tavneos. The agency said it had identified 76 cases with
reasonable evidence of a causal association with avacopan use.
Seventy-four of those cases involved a serious outcome, including 54
hospitalizations and 8 deaths.

The FDA also described seven biopsy-confirmed cases of vanishing bile
duct syndrome, or VBDS. All seven involved hospitalization, and three
had a fatal outcome. The median time from starting Tavneos to liver
injury onset was 46 days in both the larger DILI group and the VBDS
group.

On April 27, 2026, CDER proposed withdrawing Tavneos approval. The
agency said new information showed a lack of substantial evidence of
effectiveness and untrue statements of material fact in the application.
The FDA letter also said the pivotal ADVOCATE study data could not be
reliably interpreted because endpoint results were manipulated after
database lock and unblinding.

That is not the same as a settlement, a court ruling, or proof that
Tavneos caused any one person's liver injury. It is a regulatory record
that attorneys and medical experts will read closely when evaluating
claims.

The EU decision is now final, and the UK has its own withdrawal plan

EMA's human medicines committee recommended revoking Tavneos's EU
marketing authorization on June 25, 2026. EMA said the ADVOCATE study
was conducted in breach of good clinical practice principles, that
submitted study data were incorrect and misleading, and that the data
could no longer be relied on to show Tavneos's effectiveness.

The important August update is that the European Commission issued a
final legally binding decision on August 4, 2026. Tavneos is no longer
authorized across EU member states under that decision.

The UK followed with a separate action. According to Vasculitis UK's
September 1, 2026 summary of the MHRA decision, no new UK patients may
be started on Avacopan Vifor from September 1, 2026, existing patients
may continue during a six-month managed withdrawal period, and the MHRA
intends to revoke the UK marketing authorization on March 1, 2027.

For patients, the key safety message is consistent across these sources:
do not stop or change Tavneos without specialist medical advice.
Regulators and patient groups are discussing transitions because
ANCA-associated vasculitis is a serious disease and treatment changes
need a doctor.

Why the monitoring timeline matters in a Tavneos liver injury review

The FDA did not tell patients to build a lawsuit file. It told
clinicians to monitor liver panels every two weeks in the first month,
monthly for the next five months, and then as clinically indicated. The
same FDA communication said Tavneos should be promptly discontinued and
patients evaluated if ALT or AST rises above three times the upper limit
of normal, ALP rises above two times the upper limit of normal, or the
patient has signs of symptomatic cholestasis such as jaundice or
pruritus.

That is why a careful Tavneos case review usually starts with a
calendar, not a conclusion.

Useful records may include:

The first Tavneos prescription date and every pharmacy fill.
The prescribing rheumatologist's notes and the diagnosis being treated.
Baseline liver labs before Tavneos, including ALT, AST, ALP, bilirubin, and INR if available.
Follow-up liver panels during the first weeks and months of treatment.
Notes describing itching, jaundice, dark urine, light-colored stools, nausea, fatigue, abdominal swelling, or right-upper-abdominal pain.
Emergency room, hospital, hepatology, transplant-center, imaging, and biopsy records.
A list of other medicines taken around the same time, including immune medicines, antibiotics, antifungals, supplements, and over-the-counter products.
Any MedWatch report number, if the patient or clinician reported the event to FDA.

Those records help answer basic causation questions: Was there a normal
or stable liver picture before Tavneos? How soon did abnormal labs or
symptoms appear? Did the pattern look cholestatic, mixed, or
hepatocellular? Did liver tests improve after stopping the drug? Were
there other plausible causes doctors considered?

Severe injury tiers attorneys are likely to examine first

Every medical event deserves careful treatment, but not every abnormal
liver lab becomes a strong product-liability claim. The current Tavneos
investigation is most likely to focus first on severe outcomes that are
clear in the medical records.

Those may include drug-induced liver injury requiring hospitalization,
vanishing bile duct syndrome, acute liver failure, transplant
evaluation, liver transplant, and death after Tavneos exposure. Less
severe liver enzyme changes can still matter medically, but a legal
review usually needs a documented injury, a treatment timeline, and a
reason other causes are less likely.

There is still no Tavneos MDL listed for this investigation. That means
families should be wary of anyone describing bellwether trials,
settlement values, or a national Tavneos court schedule as if those
already exist. Mass Tort America's current mass tort
list is a better place to track whether the investigation
remains pre-MDL or later becomes centralized.

What to do now if your family is worried about Tavneos

First, talk with the treating doctor before changing any prescription.
Second, request the records while dates are still easy to reconstruct.
Third, write down a plain timeline: when Tavneos started, when symptoms
began, when labs changed, when the drug was stopped, and what diagnosis
doctors gave.

If there was a hospitalization, transplant evaluation, liver transplant,
VBDS diagnosis, or death, keep the discharge summary and specialist
records together. If your family is also comparing other
prescription-drug investigations, our pages on Depo-Provera meningioma
claims and Dupixent CTCL
claims show the same basic theme: prescription
records and diagnosis records matter more than memory.

Mass Tort America can review Tavneos liver injury information and
connect potential claimants with counsel when the facts appear to fit. A
review is not a promise of a lawsuit, compensation, or any outcome.

FAQ

Is Tavneos still available in the United States?

Yes. Amgen says Tavneos remains available in the U.S. while it engages
with the FDA, and patients should not change treatment without
consulting their healthcare provider.

What symptoms did FDA tell Tavneos patients to report right away?

The FDA listed symptoms such as unusual fatigue, nausea, vomiting,
unusual itching, light-colored stools, yellowing skin or eyes, dark
urine, abdominal swelling, and right-upper-abdominal pain.

Does the EU or UK action prove my liver injury was caused by Tavneos?

No. Those actions are important regulatory evidence, but an individual
case still needs medical records, timing, diagnosis details, and review
of other possible causes.

Sources

Attorney Advertising. This page is general information, not medical advice and not legal advice. Talking with Mass Tort America or submitting a form does not create an attorney-client relationship. Prior results do not guarantee a similar outcome.

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 →