The Food and Drug Administration (FDA) has revised the labeling of all statins to remove the contraindication for use during pregnancy. Removing this contraindication allows the small number of pregnant women who are at high risk for myocardial infarction or stroke to continue to use statins to prevent cardiovascular events. Statins approved for use in the United States include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).

Statins, which are used to lower cholesterol levels, were initially contraindicated during pregnancy based on animal studies indicating potential fetal malformation or alteration of the fetus's developing nervous system. In an FDA review of data from case reports and observational studies published since statins' original approval, an increase in birth defects was not identified, although a risk of miscarriage may still exist.

Although the contraindication has been removed, most women should still be advised to stop statin use during pregnancy. Statin use prior to pregnancy or during the period before confirmation of pregnancy is not considered a significant risk to the fetus. Since infants can be exposed to the medications during breastfeeding, however, statin use while breastfeeding is not recommended.

To read the FDA Drug Safety Communication regarding the change to statins' labeling, go to http://www.fda.gov/media/150774/download.