Rezulin Online, Description, Chemistry, Ingredients - Troglitazone (removed from the US market 3/21/00)

Hepatic

Rare cases of severe idiosyncratic hepatocellular injury have been reported during marketed use (see ADVERSE REACTIONS). The hepatic injury is usually reversible, but very rare cases of hepatic failure, leading to death or liver transplant, have been reported. Injury has occurred after both short- and long- term troglitazone treatment.

During all clinical studies in North America, a total of 48 of 2510 (1.9%) Rezulin-treated patients and 3 of 475 (0.6%) placebo-treated patients had ALT levels greater than 3 times the upper limit of normal. Twenty of the Rezulin-treated and one of the placebo-treated patients were withdrawn from treatment. Two of the 20 Rezulin-treated patients developed reversible jaundice; one of these patients had a liver biopsy which was consistent with an idiosyncratic drug reaction. An additional Rezulin-treated patient had a liver biospy which was also consistent with an idiosyncratic drug reaction. (See ADVERSE REACTIONS, Laboratory Abnormalities)

It is recommended that serum transaminase levels be checked at the start of therapy, monthly for the first six months of therapy, every two months for the remainder of the first year of troglitazone therapy, and periodically thereafter. Liver function tests also should be obtained for patients at the first symptoms suggestive of hepatic dysfunction, e.g., nausea, vomiting, abdominal pain, fatigue. anorexia, dark urine. Rezulin therapy should not be initiated if the patient exhibits clinical or laboratory evidence of active liver disease (e.g., ALT> 3 times the upper limit of normal) and should be discontinued if the patient has jaundice or laboratory measurements suggest liver injury (e.g., ALT> 3 times the upper limit of normal).