Are statins teratogenic in humans? Addressing the safety of statins in light of potential benefits during pregnancy

HMG-CoA reductase inhibitors (statins) are increasingly being prescribed. Their safety during pregnancy has not been determined. Statins are contraindicated during pregnancy based on the overarching concept that their benefits do not outweigh potential fetal risks of exposure. The role of cholesterol during gestation, combined with teratogenic effects seen in animal testing of lovastatin has supported this contraindication. However, statins have become exceedingly popular, women are delaying pregnancy, and obesity and subsequent cardiovascular risk has increased. The time off of therapy may have detrimental effects to both the fetus and mother. Additionally, statins have been shown to have benefits not related to cholesterol lowering effects, known as pleiotropic effects. These indications may support use during pregnancy for obstetrical complications. This article will systematically review statin safety during pregnancy. Included, we present a meta-analysis of controlled studies in an attempt to provide objective assessment regarding the effects of statins in pregnancy.