20 Deaths Linked to US Vasculitis Drug in Japan Raise Safety Concerns

Tabneos Sold by Kissei Pharmaceutical Co.

A Total of 22 Cases of Vanishing Bile Duct Syndrome Reported

In Japan, the deaths of 20 patients who had taken a vasculitis treatment have sparked growing concerns over the drug's safety.

According to local media outlets including the Tokyo Shimbun on the 17th, 20 patients who received Tabneos, a vasculitis treatment sold by Kissei Pharmaceutical Co., have reportedly died. Among these, there are cases where the causal relationship between the drug and the deaths has not yet been clearly established. Additionally, there have been 22 reported cases of vanishing bile duct syndrome—where the bile ducts in the liver disappear—among patients who took Tabneos, including 13 cases that resulted in death.

Tabneoth Image. Screenshot from the official website

Tabneos is a drug developed by ChemoCentryx, a subsidiary of the major U.S. pharmaceutical company Amgen. Kissei Pharmaceutical Co. obtained exclusive distribution rights in 2017 and has been selling the drug in Japan since then. It is estimated that approximately 8,500 people in Japan have been administered Tabneos from June 2022 to the present.

The Tokyo Shimbun and other media outlets have reported allegations that false information was included in the efficacy data during the U.S. Food and Drug Administration (FDA) approval process for this drug. In response, Amgen has stated that it does not agree with the FDA's assessment and asserts that the efficacy of the drug is supported by evidence. The Nihon Keizai Shimbun (Nikkei) reported that the FDA's Center for Drug Evaluation and Research (CDER) proposed withdrawing approval for Tabneos from the U.S. market, but approval continues in Japan.

This content was produced with the assistance of AI translation services.