The Warnings and Precautions and Adverse Reactions sections of the CCDS were modified to include Hepatitis fulminant and Acute hepatic failure from the System-Organ-Class of Hepatobiliary disorders as rare events based on information received from 11 post-marketing cases (4 Hepatic fulminant and 7 Acute hepatic failure). No cases of Hepatitis fulminant or Acute hepatic failure were reported in clinical studies.The majority of the post-marketing cases (7 of 11 cases) were reported in Japanese pat