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Perspective

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

, , , &
Pages 513-524 | Published online: 10 Jan 2014
 

Abstract

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.

Financial & competing interests disclosure

This article is supported by the Canadian Institutes for Health Research and the Research Leadership for Better Pharmacotherapy During Pregnancy and Lactation (Sickkids Hospital). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

  • • Statins are being widely used by men and women at risk for cardiovascular events, increasing the chance that women who find themselves pregnancy will be taking a statin.

  • • Statin therapy is not believed to outweigh potential risks of exposure to the fetus, supporting their contraindication.

  • • Observational controlled studies published to date have not identified an increase in birth defects after statin exposure.

  • • The perceived risks of statin exposure during pregnancy appear to increase the risk of therapeutic abortions in a desired pregnancy.

  • • Additional effects of statin therapy may warrant reconsideration of their contraindication for obstetrical complications.

  • • Detrimental effects of hypercholesterolemia during pregnancy may warrant continuation of statin therapy in certain cases.

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