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FDA Reports 76 Tavneos Liver Injuries, Urges Withdrawal

4/1/2026

Summary

Story summary

The U.S. Food and Drug Administration reports 76 Tavneos-related drug-induced liver injuries, including eight fatalities.
The FDA urges healthcare providers to discontinue Tavneos if liver damage is suspected.
The FDA has asked Amgen to withdraw Tavneos due to trial data concerns; Amgen refused.
The European Medicines Agency is reviewing Tavneos for data integrity issues.
U.S. labeling does not warn about vanishing bile duct syndrome, though Amgen has proposed an update.

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Story summary

The U.S. Food and Drug Administration reports 76 Tavneos-related drug-induced liver injuries, including eight fatalities.
The FDA urges healthcare providers to discontinue Tavneos if liver damage is suspected.
The FDA has asked Amgen to withdraw Tavneos due to trial data concerns; Amgen refused.
The European Medicines Agency is reviewing Tavneos for data integrity issues.
U.S. labeling does not warn about vanishing bile duct syndrome, though Amgen has proposed an update.