The U.S. Food and Drug Administration (FDA) is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant.
As per FDA, Patients should not breastfeed when taking a statin because the medicine may pass into breast milk and pose a risk to the baby. Many can stop statins temporarily until breastfeeding ends. However, patients requiring ongoing statin treatment should not breastfeed and instead use infant formula or other alternatives.
Highlights from FDA data summary:
FDA reviewed data from case series and prospective and retrospective observational cohort studies over decades of use of statins in pregnant women. Multiple larger, well-designed, and controlled observational studies did not find an increase in major birth defects associated with use of statins during pregnancy.
The most recent 2015 Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders.
Propensity score-based methods were used to control for maternal age, diabetes, hypertension, obesity, and alcohol and tobacco use. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval (CI) 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes.
Published data from prospective and retrospective observational cohort studies with statin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage. Many older studies did not report or discuss the rate of miscarriage; however, three studies included miscarriage in their analyses and did not find an increased risk once adjustments were made for confounders.
In a meta-analysis of six small observational studies of statin exposure in pregnant women, Zarek et al.reported a risk ratio of miscarriage of 1.35 (95% CI 1.04-1.75).
In 2017, McGrogan et al. published a retrospective cohort study specifically looking at fetal loss as a primary outcome. The authors compared 281 statin-exposed pregnant women versus 2,643 controls. The cohorts were matched for maternal age, diabetes mellitus, hypertension and body mass index, and free text was used to help identify type of loss (i.e., miscarriage vs. elective termination). They found a miscarriage rate of 25% in statin-exposed versus 21% for controls. The adjusted hazard ratio was 1.64 (95% CI 1.1-2.46). Although there was an attempt to control for the presence of diabetes, the authors acknowledged there might still be some confounding because the study was not controlled for the type or severity of diabetes, which can influence rate of miscarriage. They also acknowledged the possibility of residual misclassification regarding smoking and alcohol use based on changed behavior patterns during pregnancy.
FDA also re-reviewed nonclinical data from statin development programs. The totality of the data suggests a limited potential for statins to cause malformations or embryofetal lethality, and limited potential to affect nervous system development during human embryofetal development and during the pre- and post-natal period.
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