Kissei reports 20 deaths linked to Amgen drug Tavneos
Kissei Pharmaceutical has advised Japanese doctors to stop new prescriptions of Tavneos following reports of 20 deaths and serious liver dysfunction. The drug faces increasing global regulatory scrutiny as the FDA moves toward formal withdrawal proceedings due to similar safety concerns.
KISSEI PHARMACEUTICAL CO LTD issued a safety notice on Friday reporting 20 deaths in Japan linked to AMGEN INC's rare disease drug Tavneos. The partner firm halted new prescriptions after patients developed serious liver dysfunction and bile duct damage. The safety crisis threatens a key asset from Amgen's $3.7 billion acquisition of ChemoCentryx.
### Liver Scrutiny Intensifies in Japan Kissei reported that some deaths as of April 27 involved a severe condition destroying bile ducts. While a direct link to Tavneos is not confirmed in every case, most severe injuries occurred within three months of starting treatment. Approximately 8,503 patients in Japan have used the drug since its 2022 launch.
