Lescol and Pregnancy
The U.S. Food and Drug Administration has classified Lescol as a pregnancy Category X medicine, which means that the drug can potentially cause harm to an unborn child. Because of this classification, Lescol is not recommended for use in women who are pregnant. If you are pregnant or thinking about becoming pregnant and are taking Lescol, be sure to contact your healthcare provider.
Lescol® (fluvastatin sodium) is a pregnancy Category X medicine, meaning that the medicine could potentially cause harm to your unborn child. Therefore, Lescol is not recommended in women who are pregnant. If you are pregnant or thinking about becoming pregnant, talk to your healthcare provider immediately.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in pregnant animal studies or in humans who have taken the medicine during pregnancy. The use of a Category X medicine during pregnancy is not recommended.
Giving Lescol to pregnant rats and rabbits produced delays in skeletal development. In rats, misalignment of the vertebrae was also seen. There have been occasional reports of problems such as miscarriages or birth defects in humans that take statins (such as Lescol), 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).
Theoretically, statins (such as Zocor) could cause problems, since cholesterol is necessary for normal fetal development. Because Lescol provides no significant benefit during pregnancy and because there are theoretical risks, it is not recommended for use in pregnant women.