The Food and Drug Administration (FDA) is requesting that manufacturers of statin medications remove the contraindication against use during pregnancy from the prescribing information.
The request comes following a comprehensive review of all available data related to statin exposure in pregnant patients. Specifically, in large, well-designed, and controlled observational studies, increases in major birth defects with the use of statins during pregnancy were not observed.
Findings from the most recent 2015 Medicaid cohort linkage study, which compared 1152 statin-exposed pregnant women to 886,996 controls, showed no significant teratogenic effect with the use of statins in the first trimester of pregnancy. After adjusting for confounders, the relative risk of congenital malformations between those who took statins in the first trimester and those who did not was 1.07 (95% CI, 0.85-1.37). Additionally, no statistically significant increases in any organ-specific malformations were observed.
A review of animal data suggests limited potential for statins to cause birth defects or miscarriage or to affect nervous system development in an unborn baby. Overall, data from published observational studies were insufficient to determine a drug-associated risk of miscarriage.
While treatment of hyperlipidemia during pregnancy is generally not necessary, the ongoing therapeutic needs of the individual patient should be considered, especially those at very high risk of cardiovascular events during pregnancy (eg, patients with homozygous familial hypercholesterolemia or those with established cardiovascular disease). In most patients, statins should be discontinued once pregnancy is confirmed. Patients with unintended exposure to statins in early pregnancy should be reassured that the drug is unlikely to cause harm to the developing fetus.
FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins. News release. US Food and Drug Administration. Accessed July 20, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy.