Statins may be safe when used during pregnancy, with no increase in risk for fetal anomalies, although there may be a higher risk for low birth weight and preterm labor, results of a large study from Taiwan suggest.
The US Food and Drug Administration (FDA) relaxed its warning on statins last summer, removing the drug’s blanket contraindication in all pregnant women.
Removal of the broadly worded contraindication should “enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke,” the FDA said in their announcement.
“Our findings suggested that statins may be used during pregnancy with no increase in the rate of congenital anomalies,” write Jui-Chun Chang, MD, from Taichung Veterans General Hospital, Taiwan, and colleagues, authors of the new 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.
“For women with dyslipidemia or high-risk cardiovascular disease, as well as those who use statins before conception, statins may be continuously used with no increased risks of neonatal adverse effects,” they say.
The study was published online December 30 in JAMA Network Open.
The study included more than 1.4 million pregnant women aged 18 years and older who gave birth to their first child between 2004 and 2014.
A total of 469 women (mean age, 32.6 years; mean gestational age, 38.4 weeks) who used statins during pregnancy were compared with 4690 matched controls who had no statin exposure during pregnancy.
After controlling for maternal comorbidities and age, women who used statins during pregnancy were more apt to have low-birth-weight babies weighing less than 2500 g (risk ratio [RR], 1.51; 95% confidence interval [CI], 1.05 – 2.16) and to deliver preterm (RR, 1.99; 95% CI, 1.46 – 2.71).
The statin-exposed babies were also more likely to have a lower 1-minute Apgar score (RR, 1.83; 95% CI, 1.04 – 3.20). Important, however, there was no increase in risk for fetal anomalies in the statin-exposed infants, the researchers say.
In addition, for women who used statins for more than 3 months prior to pregnancy, maintaining statin use during pregnancy did not increase the risk for adverse neonatal outcomes, including congenital anomalies, low birth weight, preterm birth, very low birth weight, low Apgar scores, and fetal distress.
The researchers call for further studies to confirm their observations.
Funding for the study was provided by Taichung Veterans General Hospital. The authors have disclosed no relevant financial relationships.
JAMA Netw Open. Published online December 30, 2021. Full text