Hepatitis C Drug Leads to 3 Deaths in Japan

Sovriad found to have caused significant increase in blood bilirubin levels in deceased patients.

Sovriad found to have caused significant increase in blood bilirubin levels in deceased patients.

Three people in Japan have died following treatment with the hepatitis C drug Sovriad (simeprevir sodium), which was launched in Japan late last year.

As a result, the health ministry in Japan ordered distributor Janssen Pharmaceutical to revise drug packaging to indicate that people should stop usage when abnormalities are detected by a blood test. Janssen was also ordered to notify health care professionals of the change in writing. Approximately 18,900 patients in Japan are estimated to have taken the HCV medication through October 2014.

The deceased patients ranged in age from their 40s to 60s. The health ministry said the deaths were attributed to hepatic and/or renal impairment that resulted from a spike in blood bilirubin levels.

All patients on the medication should have their blood bilirubin levels closely monitored during the treatment course of Sovriad, the health ministry noted.