Animal studies have failed to reveal evidence of teratogenicity or embryotoxicity. However, animal studies with other HMG-CoA reductase inhibitors revealed an increased incidence of skeletal malformations at higher doses. Rare cases of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development. Administration of this drug to pregnant women may cause fetal harm. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on the long-term outcomes of primary hypercholesterolemia therapy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: 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.

Use in women who are or may become pregnant is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-This drug should only be used in women of childbearing potential who are highly unlikely to conceive and who have been informed of the potential hazards.
-If the patient becomes pregnant while taking this drug, therapy should be immediately discontinued and the patient should be apprised of the potential hazard to the fetus.
-Use of adequate methods of contraception should be encouraged.

See references

Based on animal data, the breast milk to plasma ratio of this drug is 2:1. Perinatal/postnatal studies in rats demonstrated mortality associated with an increase in sensitivity to cardiotoxic effects of this drug at higher doses. This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

See references