Contraindicated

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; because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, this drug may cause fetal harm during pregnancy.

Comments:
-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.
-Use of adequate methods of contraception should be encouraged.

In rats and rabbits, neither embryo-fetal toxicity or congenital malformations were observed when administered 22 and 4-times the maximum recommended human dose, respectively, during organogenesis. In rats administered doses up to 30 mg/kg/day from organogenesis through weaning, maternal toxicity was observed at doses of 0.3 mg/kg/day and impaired lactation at all doses which contributed to decreased survival of neonates in all doses (0.1 mg/kg/day represents approximately 1-time human systemic exposure at 4 mg/day). In humans, rare reports of congenital anomalies have been received following intrauterine exposure to HMG-CoA reductase inhibitors, although the incidences do not exceed the rate expected in the general population. 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 hyperlipidemia therapy.

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.

See references

Contraindicated

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

Comments:
-A similar drug of this class has been detected in small amounts 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