HMG-CoA reductase inhibitors are contraindicated during pregnancy and in nursing mothers, because of cholesterol and other products of cholesterol biosynthesis are essential components of fetal development. HMG-CoA reductase inhibitors by decreasing cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol may cause fetal harm when administered to pregnant women. Rare reports of congenital abnormalities have been received while following intrauterine exposure to HMG-CoA reductase inhibitors. An interval of 1 month should be allowed from stopping atorvastatin to conception in the event of planning pregnancy. If a woman becomes pregnant while taking atorvastatin; the drug should be discontinued and the patient advised again as to potential hazards to the fetus. It is not known whether this drug or its active metabolites are excreted in human milk.
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.