Pravachol and Pregnancy

Pravachol is considered a pregnancy Category X medicine, which means it could potentially cause harm to the fetus. Healthcare providers will generally not recommend Pravachol during pregnancy. The effects of high cholesterol do not cause problems for many years (or even decades), and temporarily putting off treatment will have little impact on any long-term risks to the mother.

Is Pravachol Safe During Pregnancy?

Pravachol® (pravastatin sodium) is a pregnancy Category X medicine, meaning that it could potentially cause harm to your unborn child. Therefore, the medication is not recommended in women who are pregnant. If you are pregnant or thinking about becoming pregnant, talk to your healthcare provider right away.

Pravachol 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.
Animal studies do not indicate that Pravachol increases the risk of birth defects. There have been occasional reports of problems (such as miscarriages or birth defects) possibly due to statin medications in humans, but it does not appear that statins actually increase the risks of such problems (a certain number of miscarriages and birth defects will occur during pregnancies even if no medications are taken). For Pravachol specifically, there are two reports of use in pregnant women; one case ended in fetal death and the other ended with a normal, healthy baby.
Theoretically, statins such as Pravachol could cause problems during pregnancy, since cholesterol is necessary for normal fetal development. However, because the drug 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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