What are the problems occurring with the use of Trovan?
Following the marketing of Trovan in the United States in February 1998, FDA began receiving reports of patients who experienced serious liver reactions in association with use of the product. In July of 1998, FDA worked with the manufacturer to add further information about this toxicity of the drug to Trovan’s label, or package insert, in order to inform practitioners . Since that time, FDA has received over 100 reports of cases of patients who were ill with symptoms of liver toxicity, in addition to others in which patients were without symptoms. Some of these patients developed serious liver injury leading to liver transplant and/or death. At present, FDA is aware of 14 cases in patients whose livers actually failed to function that are strongly associated with Trovan exposure. • Four patients required liver transplantation (one of whom subsequently died). • Five additional patients died of liver-related disease. • Three patients recovered from their acute liver failure without req
