Zetia and Pregnancy

Because adequate research on pregnancy and Zetia has not been done, the drug has been assigned a pregnancy Category C rating. This means that a healthcare provider may prescribe it if the benefits to the woman outweigh any risks to the fetus. If you are taking Zetia and become pregnant, talk to your healthcare provider about the best choice for your particular situation.

Can I Take Zetia During Pregnancy?

Zetia® (ezetimibe) is a prescription medication most often used to treat high cholesterol. Animal studies indicate that the drug might cause problems when used during pregnancy, although the full risks to humans are not known at this time.

Zetia and Pregnancy Category C

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 C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When large doses of Zetia were given to pregnant rats and rabbits, increases in the number of skeletal variations (such as extra ribs) occurred. The medication did not increase the risk of miscarriage or stillbirth. Zetia has not been adequately studied in any pregnant women.
It is important to understand that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Zetia is often used in combination with statins (a certain group of popular cholesterol medications). However, this combination is not appropriate for pregnant women, since statins should never be used during pregnancy.
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