Vytorin Use In Pregnancy & Lactation

Pregnancy: Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering drugs during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia.
VYTORIN: VYTORIN is contraindicated during pregnancy.
Simvastatin: The safety of simvastatin in pregnant women has not been established. No controlled clinical trials with simvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. However, in an analysis of approximately 200 prospectively followed pregnancies exposed during the first trimester to simvastatin or another closely related HMG-CoA reductase inhibitor, the incidence of congenital anomalies was comparable to that seen in the general population. This number of pregnancies was statistically sufficient to exclude a 2.5-fold or greater increase in congenital anomalies over the background incidence.
Although there is no evidence that the incidence of congenital anomalies in offspring of patients taking simvastatin or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, maternal treatment with simvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. For this reason, VYTORIN should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with VYTORIN should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant (see Contraindications).
Ezetimibe: No clinical data on exposed pregnancies are available for ezetimibe.
When ezetimibe was given with simvastatin, no teratogenic effects were observed in embryo-fetal development studies in pregnant rats. In pregnant rabbits, a low incidence of skeletal malformations was observed.
Nursing Mothers: Studies in rats have shown that ezetimibe is excreted in milk. It is not known whether the active components of VYTORIN are excreted into human breast milk; therefore, women who are nursing should not take VYTORIN.