Rosufen Use In Pregnancy & Lactation

Pregnancy: Rosuvastatin is contraindicated in pregnancy and lactation.
Women of child bearing potential should use appropriate contraceptive measures.
Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity. If a patient becomes pregnant during use of this product, treatment should be discontinued immediately.
There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. Embryotoxic effects have been shown at doses in the range of maternal toxicity. The potential risk for humans is unknown. Therefore, fenofibrate 160 mg tablets should only be used after a careful benefit/risk assessment.
Lactation: Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion in milk in humans.
There are no data on the excretion of fenofibrate and/or its metabolites into breast milk. Consequently, fenofibrate 160mg tablets should not be used in nursing mothers.