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Electron microscopy studies have demonstrated peroxisomal proliferation following fenofibrate administration to the ratAn adequate study to test for peroxisome proliferation in humans has not been donebut changes in peroxisome morphology and numbers have been observed in humans after treatment with other members of the fibrate class when liver biopsies were compared before and . after treatment in the same individual.
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Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment with the maximum recommended dose of 145 mg once daily.
Fenofibrate has been demonstrated to be devoid of mutagenic potential in the following testsAmesmouse lymphomachromosomal aberration and unscheduled DNA synthesis in primary rat hepatocytes.
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