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Liver Injury Warning for Amgen's Rare Disease Drug
1 Apr
Summary
- FDA found 76 liver injury cases linked to Tavneos.
- Seven cases of vanishing bile duct syndrome reported.
- Eight deaths occurred among patients taking the drug.
The U.S. Food and Drug Administration (FDA) has issued a safety alert regarding Amgen's drug, Tavneos, used for rare autoimmune diseases. The agency reported 76 cases of drug-induced liver injury, including seven instances of vanishing bile duct syndrome, a condition that can cause permanent liver damage. Eight deaths were associated with these cases.
The FDA is advising healthcare providers to promptly discontinue Tavneos if liver damage is suspected. This warning follows recent regulatory scrutiny. Last month, the FDA requested Amgen voluntarily withdraw the drug due to concerns identified during a re-evaluation of trial data. Amgen has stated confidence in Tavneos's efficacy and safety profile.
In January, the European Medicines Agency also initiated a review of Tavneos concerning data integrity questions. While European and Australian labels mention vanishing bile duct syndrome, it is not currently included in the U.S. prescribing information. Amgen has a pending request submitted in 2024 to update the U.S. label with this warning.
