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In a separate 92-week carcinogenicity study in mice at doses up to 25 mg/kg/day, no evidence of a tumorigenic effect was observed mean plasma drug levels were 1 times higher than humans given 80 mg simvastatin as measured by AUC In a two-year study in rats at 25 mg/kg/day, there was a statistically significant increase in the incidence of thyroid follicular adenomas in female rats exposed to approximately 11 times higher impax vytorin of simvastatin than in humans given 80 impax vytorin simvastatin as measured by AUC A second two-year rat carcinogenicity impax vytorin with doses of 50 and 100 mg/kg/day produced hepatocellular adenomas and carcinomas in female rats at both doses and in males at 100 mg/kg/day Thyroid follicular cell adenomas were increased in males and females at both doses; thyroid follicular cell carcinomas were increased in females at 100 mg/kg/day.
The increased incidence of thyroid neoplasms appears to be consistent with findings from other HMG-CoA reductase inhibitors.The following serious adverse reactions are discussed in greater detail in other sections of the label: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the impax vytorin studies of another drug and may not reflect the rates observed in practice.
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