Ezetimibe / simvastatin Pregnancy and Breastfeeding Warnings

Ezetimibe / simvastatin is also known as: Vytorin

Ezetimibe / simvastatin Pregnancy Warnings

Ezetimibe-simvastatin has been assigned to pregnancy category X by the FDA. Animal studies with ezetimibe have revealed evidence of increased incidences of common fetal skeletal findings. Ezetimibe crossed the placenta in animal studies. 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. Ezetimibe-simvastatin use is considered contraindicated during pregnancy.

Ezetimibe / simvastatin Breastfeeding Warnings

There are no data on the excretion of ezetimibe-simvastatin into human milk. Because a small amount of another drug in the same class as simvastatin 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 ezetimibe-simvastatin, taking into account the importance of the drug to the mother.

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