A spike in the blood bilirubin levels resulting in hepatic dysfunction and/or renal impairment was determined as the cause of death.
Sovriad (simeprevir sodium) was launched in Japan in December 2013. Of an estimated 18,900 patients taking the medication for hepatitis C infection, 3 deaths have been reported till October 2014. Hepatic and or renal impairement resulting from a significant increase in blood bilirubin levels was identified as the cause of death. The Pharmaceutical and Medical Devices Agency in Japan subsequently issued a "Dear Healthcare Professional Letter" and also asked Janssen to update the Warnings Subsection in the Precautions Section within the label.
Link to the letter issued by PMDA: http://bit.ly/1waEwBf