Just 2 Months Earlier, Amgen Refused an FDA Request to Withdraw Tavneos; Will There Be a Tavneos Recall Soon?

(Posted by Tom Lamb at Drug Injury Watch)

On March 31, 2026, the FDA issued a Tavneos liver injury Drug Safety Communication to alert doctors and patients about reports it received for cases of drug-induced liver injury (DILI) associated with Tavneos (avacopan), some of which resulted in deaths. The FDA also pointed out Tavneos side-effect cases of vanishing bile duct syndrome (VBDS); this involves progressive destruction and disappearance of the bile ducts in the liver, which may lead to permanent liver damage.

Tavneos (avacopan), approved by the FDA in October 2021, is used as a part of a treatment regimen for adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Tavneos is typically used together with glucocorticoids and other standard-of-care medications.

This March 2026 Drug Safety Communication, “FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitis,” included background about its purpose:

Although hepatotoxicity is a serious adverse reaction for Tavneos identified in premarket clinical trials and described in product labeling, [vanishing bile duct syndrome (VBDS)] and [drug-induced liver injury (DILI)] cases with fatal outcomes represent new safety concerns. FDA is continuing to monitor postmarketing cases of DILI, including VBDS, involving Tavneos and will provide updates as appropriate.

That FDA safety alert concerning Tavneos had some information on drug-induced liver injury symptoms in a section titled “What Should Patients Do?”

Patients should contact their health care professional immediately if they develop any signs or symptoms that may indicate liver injury, such as: feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of skin or eyes; dark urine; swelling in the stomach or abdomen; or pain in the right upper abdomen. Patients should talk to their health care professional about the safety risks associated with Tavneos and whether to continue therapy or switch to alternative treatments. [Emphasis added.]

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And more so for doctors, in that same document, the FDA set forth detailed medical findings that resulted in this Tavneos liver injury Drug Safety Communication:

After reviewing postmarketing data from the applicant’s submission (cases from their global safety database), the literature, and the FDA Adverse Event Reporting System (FAERS) database, which has been incorporated into the FDA Adverse Event Monitoring System (AEMS) database, through October 9, 2024, FDA identified 76 cases of DILI with reasonable evidence of a causal association with [Tavneos (avacopan)] use. A total of 74 cases reported a serious outcome, including hospitalization (n=54) and death (n=8). A total of 60 cases provided laboratory information to determine the initial pattern of liver injury; the majority (n=38) had a cholestatic or mixed pattern often marked by substantial elevations in ALP and total bilirubin. A total of 73 cases provided time from [Tavneos (avacopan)] initiation to [drug-induced liver injury (DILI)] onset, and the median time-to-onset was 46 days (range 22 to 140 days). Most cases (n=66) were reported from Japan, followed by the United States (n=5), Europe (n=4), and Canada (n=1).

Of the 76 cases, 7 reported biopsy-confirmed [vanishing bile duct syndrome (VBDS)] as a complication of DILI with reasonable evidence of a causal association with [Tavneos (avacopan)] use. All cases reported hospitalization (n=7), of which 3 had a fatal outcome. The initial pattern of liver injury was cholestatic or mixed in 4 cases and hepatocellular in 3 cases. The median time from [Tavneos (avacopan)] initiation to DILI onset among the 7 cases was 46 days (range 33 to 59 days). Cases were reported from Japan (n=6) and Canada (n=1). [Emphasis added.]

What makes the timing of this March 2026 FDA action more interesting is that only two months earlier, the risk-benefit aspect of Tavneos was the subject of a “disagreement” between the drug manufacturer Amgen and the FDA, as can be seen by these February 2026 news report headlines:

— “Amgen says it doesn’t plan to pull its rare disease drug Tavneos, despite FDA request” – EndPoints News, 2/3/26

— “Amgen Will Not Heed FDA Request To Withdraw Rare Disease Drug Tavneos” – BioSpace, 2/4/26

— “Amgen Defends Tavneos Benefit-Risk Profile Following FDA Withdrawal Request” – Medical Professionals Reference (MPR), 2/4/26

We will watch for developments related to this Tavneos liver injury Drug Safety Communication, including whether, despite Amgen’s earlier rejection of the FDA request to withdraw Tavneos, these DILI and VBDS side-effect cases lead to a Tavneos recall in the near future.

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