Simvastatin During Pregnancy & Breastfeeding

by on May 23, 2012

Can Pregnant Women Take Simvastatin?

Pregnant women should not take simvastatin throughout their pregnancy. The U.S. Food and Drug Administration (FDA) classifies simvastatin as a Category X medication which means that it could potentially cause harm on the unborn child and therefore is contraindicated. If you become pregnant or plan to become pregnant while on simvastatin treatment, be sure to consult your healthcare provider immediately.


Animal studies suggest that exposure simvastatin can lead to unwanted effects on the unborn child. On the other hand, limited case reports of pregnant women who have taken simvastatin during pregnancy do not show any significant risk to the fetus. However, since interrupting the cholesterol-lowering therapy does not have apparent effect on the long-term treatment goal, it is recommended that this medication be avoided during pregnancy. Usually, patients on simvastatin are advised to stop taking the medication before becoming pregnant or upon knowledge of conception. It appears, though, that accidental use of simvastatin during pregnancy does not cause notable increase in congenital anomalies as well as problems in pregnancy.

In rare cases, cholesterol-lowering drugs may be used during pregnancy only if the perceived benefits far outweigh the risks.

Studies have shown that the effects of dyslipidemia (abnormal cholesterol levels) do not lead into unwanted consequences for many years. Therefore, even if simvastatin is withheld throughout the pregnancy, it is not likely to have any significant impact on long-term risks. The manufacturers of simvastatin do not recommend prescribing this medication during pregnancy.

Can Breastfeeding Women Take Simvastatin?

There are no well-controlled studies conducted to determine whether simvastatin is excreted into the breast milk and passed to the nursing infant, although studies conducted on other medication in this category show that these medications may be found in the human milk.

Milk Production

There are no specific studies that explore the potential effects of simvastatin on the breastfed child. However, since simvastatin can cause a disruption in fat metabolism, it may affect breast milk production. In addition, relevant studies conducted on medications in this class indicate that children exposed to such medications through breastfeeding may experience serious adverse reactions.

Because of the potential risk on the child and breast milk production, breastfeeding patients are not advised to take simvastatin. If you are breastfeeding or plan to breastfeed, be sure to talk with your healthcare provider before starting with this medication. You and your healthcare provider should evaluate your medical condition and decide whether to continue or discontinue the medication while breastfeeding.

The consensus is that withholding cholesterol-lowering medication throughout breastfeeding will not result in any long-term adverse effects. Healthcare providers, practically, recommend stopping the medication while breastfeeding.