The U.S. Food and Drug Administration (FDA) has issued a significant safety communication regarding Tavneos, a specialty drug for rare vasculitis. According to the FDA Adverse Event Reporting System (FAERS), the agency identified 76 cases of drug-induced liver injury (DILI) with “reasonable evidence” of a causal link to Tavneos between 2021 and October 2024.
Key findings from the safety report include:
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Severe Outcomes: Among the reported cases, 54 patients required hospitalization and 8 deaths were recorded. The majority of these reports originated from Japan (66 cases), with additional cases in the U.S., Europe, and Canada.
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New Safety Concerns: The FDA has flagged two new concerns: Vanishing Bile Duct Syndrome (VBDS) — a rare condition causing progressive destruction of bile ducts resulting in jaundice and fatigue — and drug-induced liver injury (DILI).
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Onset Timeline: The median time from the initiation of Tavneos treatment to the onset of liver injury was found to be 46 days.
Currently, the FDA is requesting Amgen to voluntarily withdraw Tavneos from the market following a re-evaluation of its risk-benefit profile and concerns over clinical trial data integrity. Amgen has resisted this request, stating confidence in the drug’s real-world effectiveness and favorable safety profile. Regulatory authorities advise healthcare providers to conduct regular liver panel testing and discontinue treatment immediately if symptoms of hepatotoxicity are detected.