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The FDA requests removal of pregnancy contraindication from statin prescribing information based on comprehensive reviews that found no evidence of an increase in birth defects.
The US Food and Drug Administration (FDA) requested this week in a Drug Safety Communication dated 7-20-21 that manufacturers of statin medications remove from their labels the contraindication against use during pregnancy.
The request to discontinue the agency’s strongest warning was made after a comprehensive review of all available data related to statin exposure in pregnant patients. The review determined that across multiple large, well designed and controlled observational studies, there were no increases observed in major birth defects with the use of statins during pregnancy.
According to the Safety Communication, results reported from the most recent 2015 Medicaid cohort linkage study—a comparison of 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). Further, there were no statistically significant increases in any organ-specific malformations were observed. In the majority of pregnancies included, statin therapy was initiated before pregnancy and was typically discontinued during the first trimester when pregnancy was confirmed.
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). Breastfeeding, however, is not recommended in patients who require stains.
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.