Japan pharma company warns against rare disease drug after 20 deaths

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Tokyo: The Japanese pharmaceutical company Kissei Pharmaceutical has advised doctors not to prescribe its rare disease medicine Tavneos to new patients following reports of twenty deaths and multiple cases of severe liver damage linked to the treatment.

The company says that the medication, which is meant to treat rare autoimmune illnesses that result in inflammation of blood vessels, carries a risk of ‘severe liver dysfunction.’ Kissei asked doctors to reconsider their present patients' treatment and stop writing new prescriptions.

Amgen's Tavneos has been administered to about 8,500 patients in Japan since its launch in 2022. Most cases of serious liver damage were reported within three months of treatment, according to the safety alert.

Both companies say that not all recorded deaths have been officially linked to the drug. However, US regulators have also voiced concern after finding dozens of liver damage cases linked to Tavneos, including multiple deaths.