Japan - Following reports of eight cases of fulminant hepatitis related to use of benzbromarone, the Ministry of Health and Welfare in Japan has requested all manufacturers to revise the labelling to include a warning of hepatic dysfunction and to circulate a letter to health professionals.
Benzbromarone, which is indicated for gout, is marketed as 13 products by 10 companies. As reflected in the revised labelling, liver function tests should now be performed periodically and for at least six months after the start of administration. Patients should receive an explanation of the risk of hepatic dysfunction and should consult the physician immediately in the event of anorexia or general malaise. Contraindications for this condition have also been added.
Reference: Pharma Japan, Number 1689, 20 March 2000.