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Simvastatin / sitagliptin Pregnancy and Breastfeeding Warnings

Simvastatin / sitagliptin is also known as: Juvisync

Simvastatin / sitagliptin Pregnancy Warnings

Simvastatin-sitagliptin 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-sitagliptin is considered contraindicated in women who are or may become pregnant.

Simvastatin / sitagliptin Breastfeeding Warnings

There are no data on the excretion of simvastatin or sitagliptin into human milk. A small amount of another drug in the same class as simvastatin is excreted in human milk. Simvastatin-sitagliptin is considered to be contraindicated by the manufacturer.

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