Pregnancy outcome following maternal exposure to statins: a multicentre prospective study

BJOG. 2013 Mar;120(4):463-71. doi: 10.1111/1471-0528.12066. Epub 2012 Nov 30.


Objective: This contribution addresses the risk associated with exposure to statins during pregnancy.

Design: Multicentre observational prospective controlled study.

Setting: European Network of Teratology Information Services.

Population: Pregnant women who contacted one of 11 participating centres, seeking advice about exposure to statins during pregnancy, or to agents known to be nonteratogenic.

Methods: Pregnancies exposed during first trimester to statins were followed up prospectively, and their outcomes were compared with a matched control group.

Main outcome measures: Rates of major birth defects, live births, miscarriages, elective terminations, preterm deliveries and gestational age and birthweight at delivery.

Results: We collected observations from 249 exposed pregnancies and 249 controls. The difference in the rate of major birth defects between the statin-exposed and the control groups was small and statistically nonsignificant (4.1% versus 2.7% odds ratio [OR] 1.5; 95% confidence interval [95% CI] 0.5-4.5, P = 0.43). In an adjusted Cox model, the difference between miscarriage rates was also small and not significant (hazard ratio 1.36, 95% CI 0.63-2.93, P = 0.43). Premature birth was more frequent in exposed pregnancies (16.1% versus 8.5%; OR 2.1, 95% CI 1.1-3.8, P = 0.019). Nonetheless, median gestational age at birth (39 weeks, interquartile range [IQR] 37-40 versus 39 weeks, IQR 38-40, P = 0.27) and birth weight (3280 g, IQR 2835-3590 versus 3250 g, IQR 2880-3630, P = 0.95) did not differ between exposed and non-exposed pregnancies.

Conclusions: This study did not detect a teratogenic effect of statins. Its statistical power remains insufficient to challenge current recommendations of treatment discontinuation during pregnancy.

Publication types

  • Multicenter Study

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abortion, Induced / statistics & numerical data
  • Abortion, Spontaneous / epidemiology
  • Adult
  • Birth Rate
  • Case-Control Studies
  • Europe / epidemiology
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Infant, Newborn
  • Infant, Newborn, Diseases / epidemiology
  • Maternal Age
  • Maternal Exposure / adverse effects*
  • Pregnancy
  • Pregnancy Outcome / epidemiology*
  • Pregnancy Trimester, First
  • Premature Birth / epidemiology
  • Prospective Studies
  • Risk Factors
  • Teratogens*


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Teratogens