Vytorin and Pregnancy

Taking Vytorin, a medicine used to lower cholesterol, during pregnancy could harm the unborn child. According to the FDA, this medication has been classified as a pregnancy Category X medicine, which means it can potentially cause harm to the fetus. If you are taking Vytorin and pregnancy occurs, your healthcare provider will likely tell you to stop taking the drug.

Vytorin and Pregnancy: An Overview

Vytorin® (ezetimibe/simvastatin) is a pregnancy Category X medicine, meaning that the drug could potentially cause harm to your unborn child. Therefore, Vytorin is not recommended in women who are pregnant. If you are pregnant or thinking about becoming pregnant and are taking this drug, talk to your healthcare provider.

Vytorin and Pregnancy Category X

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in humans who have taken the medicine. The use of a Category X medicine during pregnancy is not recommended.
Vytorin is a combination medication, containing ezetimibe (Zetia®) and simvastatin (Zocor®). When large doses of ezetimibe were given to pregnant rats and rabbits, increases in the number of skeletal variations (such as extra ribs) occurred. Ezetimibe did not increase the risk of miscarriage or stillbirth. It has not been adequately studied in any pregnant women.
Animal studies do not indicate that simvastatin increases the risk of birth defects. There have been occasional reports of problems in humans, such as miscarriages or birth defects, but it does not appear that simvastatin actually increases the risks of such problems (a certain number of miscarriages and birth defects will occur during pregnancies, even if no medications are taken).
Theoretically, statins such as simvastatin could cause problems, since cholesterol is necessary for normal fetal development. Because Vytorin provides no significant benefit during pregnancy and because there are theoretical risks, it is not recommended for use in pregnant women.
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Vytorin Information

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