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 hypercholesterolaemia.
VYTORIN: VYTORIN is contraindicated during pregnancy. No clinical data are available on the use of VYTORIN during pregnancy. Animal studies on combination therapy have demonstrated reproduction toxicity. (See Pharmacology: Toxicology: Preclinical safety data under Actions.)
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 foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. For this reason, VYTORIN must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with VYTORIN must 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 are available on the use of ezetimibe during pregnancy.
Breast-feeding: VYTORIN is contraindicated during lactation. Studies on rats have shown that ezetimibe is excreted into breast milk. It is not known if the active components of VYTORIN are secreted into human breast milk. (See Contraindications.)
Fertility: Ezetimibe: No clinical trial data are available on the effects of ezetimibe on human fertility. Ezetimibe had no effect on the fertility of male or female rats (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Simvastatin: No clinical trial data are available on the effects of simvastatin on human fertility. Simvastatin had no effect on the fertility of rats male and female (see Pharmacology: Toxicology: Preclinical safety data under Actions).