Tavneos Liver Injury Update: FDA Withdrawal Push and What Patients Should Know
I checked the FDA pages again before writing this. Tavneos is in a
strange spot right now. It is still the drug many vasculitis patients
remember by name, but FDA's Center for Drug Evaluation and Research says
it proposed withdrawing approval on April 27, 2026. The FDA page for
that proposal was updated July 13, 2026.
The liver warning came first.
On March 31, 2026, FDA said it had identified serious drug-induced liver
injury reports in people taking Tavneos, also called avacopan. The
agency's notice said some reports involved hospitalization and death.
Search results checked today also point to the FDA proposal letter and
to summaries noting vanishing bile duct syndrome in some reported cases.
That does not mean every bad liver outcome in a Tavneos patient was
caused by the drug. ANCA-associated vasculitis is a serious disease, and
patients may be taking steroids, immune medicines, antibiotics, or other
drugs. The medical review has to be careful. Timing is usually the
starting point.
Records worth saving now include the Tavneos
prescription history, pharmacy fills, baseline liver tests, later ALT,
AST, bilirubin, alkaline phosphatase and INR results, hospital records,
hepatology notes, imaging, biopsy reports, transplant center records,
and discharge summaries. Families should also keep a list of other
medicines taken in the same months.
I also checked the JPML pending MDL
list for July 1, 2026. Tavneos does not appear to have its own federal
MDL listed there. For now, these look like pre-MDL liver injury
investigations tied to a fresh FDA safety action, not a centralized
litigation with a judge and bellwether schedule.
The injuries likely to
get the closest review are the severe ones: acute liver failure,
vanishing bile duct syndrome, transplant evaluation, liver transplant,
and death after Tavneos exposure. Lesser liver lab changes may still
matter medically, but a legal claim usually needs a clear injury and a
clear timeline.
If your family is dealing with this, do the boring
paperwork first. Get the records. Write down dates. Do not rely on
memory for when Tavneos started or when the liver numbers changed. And
do not stop or change any prescription without your doctor.
This
article is attorney advertising and general information only. It is not
medical advice and does not create an attorney-client relationship. A
case review does not guarantee compensation or any legal outcome.
Sources checked: FDA March 31, 2026 Tavneos drug safety communication;
FDA CDER Tavneos withdrawal proposal page updated July 13, 2026;
Drugs@FDA application 214487; JPML pending MDL list as of July 1, 2026;
current DuckDuckGo search results for Tavneos avacopan liver injury
updates.