Use 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 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.

Animal studies have failed to reveal evidence of teratogenicity, however, oral gavage doses of 4, 20, 100, 500, and 1000 mg/kg/day given to rats from gestation day 7 through 17 increased mortality of offspring and skeletal anomalies and developmental delays were observed at 100 mg/kg/day (10 times the human exposure of 80 mg/day). 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 (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. Atherosclerosis is a chronic process and 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 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.

See references

Use is contraindicated.

Excreted into human milk: Yes (in small amounts)

Comments:
-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.

The excretion of this drug into breast milk was evaluated in 11 women following oral administration of 20 mg orally twice a day for a total of 5 doses. The maximum concentrations of this drug and its major metabolite in milk following the last dose averaged 3.9 mcg/L and 2.1 mcg/L, respectively. Using these peak levels, a fully breastfed infant would receive a maximum of 900 mcg/kg per day or about 1.4% of the maternal weight adjusted dose.

See references