Warning from Rezulin package liner
"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 2,510 (1.9%) Rezulin-treated patients and three of 475 (0.6%) placebo-treated patients had alanine transaminase (ALT) levels greater than three 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"Twenty of the Rezulin-treated and one of the placebo-treated patients were withdrawn from treatment.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 irreversible 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 biopsy which was also consistent with an idiosyncratic drug reaction. (See ADVERSE REACTIONS, Laboratory Abnormalities.)
"Serum transaminase levels should be checked at the start of therapy, monthly for the first eight months of therapy, every two months for the remainder of the first year of Rezulin therapy, and periodically thereafter. Rezulin therapy should not be initiated if the patient exhibits clinical evidence of active liver disease or increased serum transaminase levels (ALT> 1.5 times the upper limits of normal).
"Liver function tests should also be obtained for all patients at the first symptoms suggestive of hepatic dysfunction, e.g. nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine.
"If serum transaminase levels are moderately increased (ALT> 1.5 to two times the upper limit of normal), liver function tests should be repeated within a week and then weekly until the levels return to normal. If at any time a patient has jaundice or ALT rises above three times the upper limit of normal, Rezulin should be discontinued."
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