Statin Use During Pregnancy Does Not Increase Congenital Anomalies

Pregnancy and Congenital Heart Disease
Pregnancy and Congenital Heart Disease
Researchers sought to determine the effect of statin use during pregnancy on multiple neonatal outcomes, including congenital anomalies.

Statins may be used during pregnancy with no increased risk for congenital anomalies, even in women with dyslipidemia or at high risk for cardiovascular disease (CVD), according to a study published in JAMA Network Open.

Researchers selected women diagnosed with hyperlipidemia who gave birth to their first child between January 1, 2004, and December 31, 2014, and who received statins during their pregnancy. An age-matched group of women who gave birth but were not exposed to statins during pregnancy served as the control group. Researchers compared neonatal outcomes.

Compared with mothers in the control group, multivariate analysis showed that the statin-exposed mothers had significantly greater risk of developing preeclampsia or eclampsia (risk ratio [RR], 2.78; 95% CI, 1.66-4.65); their offspring also had significantly greater risk for preterm birth (RR 1.99; 95% CI, 1.46-2.71) and low birth weight (RR 1.51; 95% CI, 1.05-2.16). Congenital anomaly was not associated with statin exposure when considering the factors associated with congenital anomalies (RR, 1.24 [95% CI, 0.81-1.90]) and was only associated with pregestational diabetes (RR, 2.29; 95% CI, 1.38-3.80) after adjusting for maternal age and comorbidities.

This study may be limited by its cohort study design and lack of a randomized controlled trial. Potential confounding maternal conditions, such as smoking status, body mass index (BMI), and previous birth histories, were not recorded. The database utilized included information only on live births. Outcomes cannot be applied to cases of miscarriage or intrauterine fetal death.

“Our findings suggested that statins may be used during pregnancy with no increase in the rate of congenital anomalies,” researchers noted. “For pregnant women at low risk, statins should be used carefully after assessing the risks [for] [low birth weight] and [preterm birth]. For women with dyslipidemia or [at high risk for CVD], as well as those who use statins before conception, statins may be continuously used with no increased risks [for] neonatal adverse effects.”


Chang JC, Chen YJ, Chen IC, Lin WS, Chen YM, Lin CH. Perinatal outcomes after statin exposure during pregnancy. JAMA Netw Open. Published online December 30, 2021. doi:10.1001/jamanetworkopen.2021.41321