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Simvastatin Pregnancy and Breastfeeding Warnings

Simvastatin is also known as: Zocor

Simvastatin Pregnancy Warnings

Simvastatin has been assigned to pregnancy category X by the FDA. While animal studies with simvastatin failed to reveal evidence of teratogenicity, animal studies with other HMG-CoA reductase inhibitors revealed an increase in the incidence of skeletal malformations. There are no controlled data in human pregnancy. However, HMG-CoA reductase inhibitors are known to inhibit biosynthetic processes necessary in fetal development. 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. Simvastatin use is considered contraindicated during pregnancy.

Simvastatin Breastfeeding Warnings

There are no data on the excretion of simvastatin into 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 simvastatin, taking into account the importance of the drug to the mother.

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