Statins are safe during pregnancy. However there is a risk of abnormalities in the fetus as well as low birthweight. A large study from Taiwan suggests that there could be a higher risk of preterm labor.
The US Food and Drug Administration (FDA released a warning about statins in the summer of 2003. This resulted in the drug’s blanket contraindication was removed for all pregnant women.
The FDA announced in its announcement that the removal of the contraindication should “enable healthcare personnel and patients to make an personal decisions regarding benefit and risk, particularly for those who are at extremely high risk of heart attack or stroke.”
“Our findings suggested that statins could be used during pregnancy with no increase in the incidence of congenital anomalies,” write Jui-Chun Chou Chang, MD, from Taichung Veterans General Hospital, Taiwan and colleagues who are the authors of the latest study.
“For pregnant women at low risk Statins should be used carefully after assessing the risks of low birth weight and preterm birth,” they advise.
Statins are said to continue to be used for women with high-risk cardiovascular disease or dyslipidemia, as well as women who have used statins prior to conception. There aren’t any increased risk of adverse reactions to neonatology.
The study was published online on December 30, in JAMANet Open.
The study covered more than 1.4 million women who were pregnant 18 and over who gave birth to their first child between 2004 and 2014.
The total number of women who were exposed to statins during pregnancy was compared to 4690 matched controls who weren’t exposed to statins.
After controlling for maternal comorbidities, age and gender, women who took statins during pregnancy were more likely have babies weighing less than 2500g at birth weight (risk ratio [RR1.46 to 1.51-2.16) and to have babies born prematurely (RR: 1.99- 95% 95% CI), 1.46- 2.71).
Statin-exposed infants had a higher 1-minute Apgar score (RR 1.83 95% confidence interval, 1.04- 3.20). Important, however, there was no increased risk for fetal anomalies in the statin-exposed infants, the researchers say.
Additionally to women who took statins for more than 3 months prior to pregnancy, maintaining statin use during pregnancy did not increase the risk of adverse neonatal outcomes, including congenital anomalies and low birth weight preterm birth, extremely low birth weight and low Apgar scores, and distress in the fetus.
Researchers demand more research to confirm their findings.
Taichung Veterans General Hospital provided the study with funds. The authors have not disclosed any relevant financial relationships.
JAMA Netw Open. Published online on December 30, 2021. Full text
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