Japan’s health ministry notified clinicians on October 21 to restrict starting Tavneos in new vasculitis patients and consider discontinuation or alternative treatment for existing patients. Twenty-three deaths following severe liver injury were reported after treatment, although drug causation has not been established in every case. Concerns about the reliability of clinical data also prompted consideration of administrative action, including approval withdrawal, by year-end. This is a Japanese action, not a withdrawal of Korean approval. Patients taking the medicine should ask their prescriber about safety assessment and treatment alternatives rather than stop it on their own.