Japan to Issue Safety Warning on Vasculitis Drug After 20 Deaths

May 21, 2026 | News On Japan

TOKYO - A safety alert is expected to be issued as early as May 21st over Tavneos, a drug used to treat vasculitis, after 20 patients who took the medication died from serious liver dysfunction, according to people familiar with the matter.

Kissei Pharmaceutical sells Tavneos in Japan as a treatment for vasculitis, an intractable disease. The company has announced that 20 patients who took the drug developed severe liver dysfunction and died.

Following instructions from the Ministry of Health, Labor and Welfare, Kissei Pharmaceutical is expected to issue a "Blue Letter," a type of safety bulletin that urges medical institutions to take precautions when using Tavneos.

Because liver dysfunction has in many cases developed within three months of starting the drug, the alert is expected to call for frequent liver function tests. It will also include checks before use, including for new patients.

U.S. drug authorities have disclosed that data showing the effectiveness of Tavneos contained false statements. The health ministry said it will respond while coordinating with overseas regulatory authorities.

Source: TBS

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