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FDA Safety Alert: Serious Liver Injury With Tavneos (avacopan) In March 2026, t…
FDA Safety Alert: Serious Liver Injury With Tavneos (avacopan)
In March 2026, the FDA alerted prescribers to reports of serious drug-induced liver injury in patients taking Tavneos (avacopan), used for ANCA-associated vasculitis. Roughly 76 cases of liver injury were identified, including some deaths.
What this means for prescribers:
Baseline liver function tests should be obtained before starting avacopan, with ongoing monitoring during treatment per the updated label.
Patients should be counselled to report symptoms such as jaundice, dark urine, right upper quadrant pain, unusual fatigue or itching promptly.
Treatment interruption or discontinuation should be considered for significant liver enzyme elevation or clinical signs of hepatotoxicity, with hepatology input where appropriate.
This is a reminder that even targeted, relatively novel therapies for complex autoimmune conditions warrant close post-marketing vigilance, not just at initiation.
Source: FDA Drug Safety Communication, March 2026.