3. FDA removes statin’s blanket of ‘contraindicated in pregnancy’

FDA removes statin’s blanket of ‘contraindicated in pregnancy’

      Statins are the most commonly used to treat hyperlipidemia. Recently, they have been used during pregnancy for the prevention or treatment of preeclampsia. However, the safety of statin use during pregnancy has been a topic of controversy and the sample sizes of most studies in this aspect are insufficient to prove its safety.

A study published in ‘JAMA Open Network’ assessed the association between statin use during pregnancy and adverse perinatal outcomes. This retrospective cohort study included 1443657 pregnant women 18 years of age or older with their first infant born during the period from January 1, 2004, to December 31, 2014. Data for this study were taken from the Taiwan National Health Insurance Research Database. Women who have received a diagnosis of hyperlipidemia before pregnancy and who were receiving prescriptions of statins during pregnancy were the statin-exposed group. Data on congenital anomalies, birth weight, gestational age, preterm birth, low birth weight, very low birth weight, fetal distress, and Apgar score were compared between participants with and without statin exposure during pregnancy. Risk ratios (RRs) were calculated by multivariable analyses using Poisson regression models to adjust for potential confounders.

The results showed that after controlling for maternal comorbidities and age, low birth weight was more common among offspring in the statin-exposed group (RR, 1.51 [95% CI, 1.05-2.16]), with a greater chance of preterm birth (RR, 1.99 [95% CI, 1.46-2.71]), and a lower 1-minute Apgar score (RR, 1.83 [95% CI, 1.04-3.20]). No association was found between congenital anomalies and statin exposure during pregnancy. Multivariable analysis showed that there was no association between statin use for periconceptual hyperlipidemia and adverse perinatal outcomes among women who had used statins prior to pregnancy.

The study suggests that statins may be safe when used during pregnancy because there was no association with congenital anomalies, but caution is needed because of an increased risk of low birth weight and preterm labor.

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