This drug crosses the rat placenta and reaches levels in the fetal liver equivalent to that of maternal plasma. Animal studies have failed to reveal evidence of embryofetal toxicity or congenital malformations. Rats administered doses 6 times the maximum recommended human dose from gestation day 7 through day 21 of weaning showed decreased postnatal growth and development. Limited published data have not shown an increased risk of major congenital malformations or miscarriages. Rare cases of congenital anomalies following intrauterine exposure to other 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. Since atherosclerosis is a chronic process, discontinuation of lipid-lowering drugs during pregnancy should have little impact on 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Contraindicated

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Limited data on the use of HMG-CoA reductase inhibitors (statins) are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage; this drug may cause fetal harm during pregnancy because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol.

Comments:
-This drug is contraindicated in pregnant women since the safety in pregnant women has not been established and there is no apparent benefit.
-If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient should be apprised of the potential harm to the fetus.
-Women of reproductive potential should use effective contraception during therapy.

See references

Use is contraindicated.

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

Comments:
-A similar drug of this class has been detected in human milk.
-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.

See references