Can I take simvastatin while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Category X [See Contraindications (4). ] Simvastatin is contraindicated in women who are or may become pregnant. Lipid lowering drugs offer no benefit during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. 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. There are no adequate and well-controlled studies of use with simvastatin during pregnancy; however, there are rare reports of congenital anomalies in infants exposed to statins in utero . Animal reproduction studies of simvastatin in rats and rabbits showed no evidence of teratogenicity. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Because statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, simvastatin may cause fetal harm when administered to a pregnant woman.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Simvastatin (oral), NuCare Pharmaceuticals,Inc. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

No relevant published information exists on the use of simvastatin during breastfeeding. Because of a concern with disruption of infant lipid metabolism, the consensus is that simvastatin should not be used during breastfeeding. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

“Summary of Use during Lactation”, LactMed record “Simvastatin” (LM484), quoted verbatim. Everything LactMed reports about Simvastatin while breastfeeding.

Nursing Mothers It is not known whether simvastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not nurse their infants. A decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother [see Contraindications (4) ] .

Prescribing label, section “Nursing Mothers”: Simvastatin (oral), NuCare Pharmaceuticals,Inc. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.