Tavneos Liver Warning: The Lab Timeline Families Should Save
Tavneos Liver Warning: The Lab Timeline Families Should Save
Last reviewed: September 19, 2026
For many Tavneos patients, the paper trail is going to matter as much as
the headline. The FDA has not made a final decision on whether avacopan
stays on the U.S. market. Amgen is fighting the proposed withdrawal. In
the meantime, families dealing with a liver injury are left with a more
immediate question: what did the liver tests show, and when?
FDA's March 31, 2026 warning was unusually specific. The agency said it
found 76 cases of drug-induced liver injury with reasonable evidence
tying the injury to avacopan. Fifty-four involved hospitalization. Eight
involved death. Seven were biopsy-confirmed cases of vanishing bile duct
syndrome, or VBDS, and three of those patients died.
The timing stood out too. FDA reported a median of 46 days from starting
Tavneos to liver injury onset. That does not make day 46 a magic number.
It does mean the first prescription date, the baseline liver panel, and
the early follow-up labs may become central records in a claim review.
Do not stop Tavneos, or any prescription drug, based on an article.
Anyone currently taking it should talk with the doctor who prescribed
it.
Two sets of monitoring language are now in the record
The current U.S. prescribing information says clinicians should obtain
ALT, AST, ALP, and total bilirubin before treatment starts. It then
calls for liver testing every four weeks for the first six months, and
later as clinically indicated. For patients of Japanese descent, the
label says clinicians should consider testing every two weeks for the
first three months, then every four weeks for the next three months.
FDA's March safety communication used a slightly different schedule. It
told health care professionals to test every two weeks in the first
month, monthly for the next five months, and then as clinically
indicated.
That difference is not just a medical footnote. If someone later
developed jaundice, itching, dark urine, abnormal bilirubin,
hospitalization, VBDS, liver failure, transplant evaluation, or died
after Tavneos use, the record may need to show whether liver monitoring
happened, what the values were, and how quickly the drug was paused or
stopped after warning signs appeared.
FDA's withdrawal proposal is still unresolved
On April 27, 2026, FDA's Center for Drug Evaluation and Research
proposed withdrawing Tavneos approval. CDER said new information raised
two problems: Tavneos had not been shown to be effective for its
approved use, and the application that led to approval contained untrue
statements of material fact.
FDA also said Tavneos would remain on the market unless the company
removed it or the FDA Commissioner ordered withdrawal after the hearing
process.
Amgen takes the opposite view. In a July 24 update, the company said
Tavneos remains available in the United States, that the approved use
has not changed, and that it submitted additional data and analyses to
FDA on July 23 in support of a hearing request. Amgen also points to the
May 2026 label update as added guidance for doctors on liver monitoring.
So the current status is messy but clear enough for patients: FDA is
pursuing withdrawal, Amgen is contesting it, and Tavneos remains
available while the process continues.
Records that may matter in a Tavneos liver injury review
A claim review usually starts with dates. Families do not need to solve
the medical causation question on their own, but they can help preserve
the raw material.
Useful records may include:
- Tavneos start date, dose, refills, and stop date;
- baseline ALT, AST, ALP, and total bilirubin before the first dose;
- liver panels during the first six months of treatment;
- symptoms such as jaundice, itching, unusual fatigue, nausea, vomiting,
dark urine, pale stools, upper-right abdominal pain, bruising, or loss
of appetite; - ER, hospital, hepatology, biopsy, transplant, or death records; and
- notes showing whether Tavneos was paused, stopped, restarted, or ruled
out as a cause.
None of that proves a lawsuit by itself. It gives reviewing attorneys
and medical experts a timeline they can test against the FDA safety
record.
Tavneos claims remain early
Tavneos liver injury claims are still in the investigative stage. There
is no Tavneos MDL, and no Tavneos settlement program has been announced.
The strongest early step is usually preservation: prescription records,
liver labs, hospitalization records, and names of the treating doctors.
Mass Tort America's main Tavneos page tracks the broader investigation
here: Tavneos
Lawsuit. Readers
comparing prescription drug cases can also review the site's
Depo-Provera
meningioma and
Dupixent CTCL
litigation pages.
Plain-English FAQ
Has FDA removed Tavneos from the market?
No. FDA has proposed withdrawal, but Tavneos remains available in the
U.S. while the process continues.
What is VBDS?
Vanishing bile duct syndrome is a serious liver condition involving
destruction and disappearance of bile ducts. FDA described
biopsy-confirmed VBDS cases in its Tavneos safety review.
Why do early liver tests matter?
FDA reported a median 46-day time to liver injury onset in the cases it
reviewed. Early labs can help show whether warning signs appeared during
the first weeks or months of treatment.
Does one abnormal lab result prove a claim?
No. A Tavneos legal review looks at exposure, timing, diagnosis,
severity, other possible causes, warnings, and the full medical record.
Attorney advertising and medical disclaimer
This article is attorney advertising and general information. It is not
medical advice and does not create an attorney-client relationship.
Prior results do not guarantee a similar outcome. If you currently take
Tavneos, speak with your doctor before changing treatment.
Sources
- FDA Drug Safety Communication, March 31, 2026: https://www.fda.gov/drugs/drug-safety-communications/fda-identifies-cases-serious-liver-injury-patients-taking-tavneos-avacopan-severe-active-anti
- FDA CDER proposal to withdraw approval of Tavneos, April 27, 2026: https://www.fda.gov/drugs/drug-alerts-and-statements/cder-proposes-withdraw-approval-tavneos
- DailyMed Tavneos prescribing information, revised 2026: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c93cbc0b-29a3-46a5-9c85-41815ea5cf4a
- Amgen Tavneos update, last updated July 24, 2026: https://www.amgen.com/tavneos-update
- Vasculitis Foundation Tavneos update, last updated July 24, 2026: https://vasculitisfoundation.org/tavneos-update/
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 →