The risks of statin use in pregnancy: A systematic review

J Clin Lipidol. 2016 Sep-Oct;10(5):1081-90. doi: 10.1016/j.jacl.2016.07.002. Epub 2016 Jul 20.


Statins are contraindicated in pregnancy; however, as women delay pregnancy and statin use increases the risk of statin exposure in pregnancy is likely to rise. In contrast to some early reports that statins are teratogenic, more recent observational studies have called into question the teratogenic risk of statins. Therefore, whether statins are associated with congenital anomalies or other pregnancy complications remains an important clinical question. This article provides an up-to-date systematic review on the risks of statins in pregnancy. We conducted a literature search to identify relevant English language studies related to statin exposure and pregnancy. Single case reports, animal studies, studies only published in abstract form, and non-English language studies were excluded. A total of 16 clinical studies were included in this systematic review. Although early uncontrolled case series reported congenital anomalies associated with statin use, more recent observational studies did not report an increased risk of congenital anomalies with statin exposure in pregnancy when compared to control groups or the prevalence of congenital anomalies in the general population. Our findings show no clear relationship of congenital anomalies with statin use in pregnancy, and our study supports the findings that statins are probably not teratogenic. However, until more information is available, statins should still be avoided in pregnancy.

Keywords: Congenital anomalies; Pregnancy; Pregnancy complications; Statins.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Clinical Trials as Topic
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hyperlipidemias / drug therapy*
  • Hyperlipidemias / genetics
  • Pre-Eclampsia / etiology
  • Pregnancy
  • Pregnancy Complications
  • Risk


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors