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In U. S. clinical studies, over 2500 patients with type 2 diabetes received ACTOS. There was no evidence of drug-induced hepatotoxicity or elevation of ALT levels in the clinical studies. During pre-approval placebo-controlled clinical trials in the U. S., a total of 4 of 1526 (0.26%) patients treated with ACTOS and 2 of 793 (0.25%) placebo-treated patients had ALT values 3 times the upper limit of normal. The ALT elevations in patients treated with ACTOS were reversible and were not clearly related to therapy with ACTOS. In postmarketing experience with ACTOS, reports of hepatitis and of hepatic enzyme elevations to 3 or more times the upper limit of normal have been received. Very rarely, these reports have involved hepatic failure with and without fatal outcome, although causality has not been established. Pioglitazone is structurally related to troglitazone, a thiazolidinedione no longer marketed in the United States, which was associated with idiosyncratic hepatotoxicity and rare cases of liver failure, liver transplants and death during postmarketing clinical use. Text Continues Below
Pending the availability of the results of additional large, long-term controlled clinical trials and additional postmarketing safety data, it is recommended that patients treated with ACTOS undergo periodic monitoring of liver enzymes. Serum ALT (alanine aminotransferase) levels should be evaluated prior to the initiation of therapy with ACTOS in all patients, every two months for the first year of therapy, and periodically thereafter. Liver function tests should also be obtained for patients if symptoms suggestive of hepatic dysfunction occur, e. g., nausea, vomiting, abdominal pain, fatigue, anorexia or dark urine. The decision whether to continue the patient on therapy with ACTOS should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed, drug therapy should be discontinued. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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