Statins in pregnancy: Are they safe for the baby?

A nationwide registry study of over 800,000 pregnancies shows no association between statin exposure in the first trimester and congenital malformations in the offspring, underpinning the safety of statin use in pregnancy for the growing foetus.

The incidences of congenital malformations were 6.7, 4.3, and 5.9 percent in the statin-exposed, non-statin-exposed, and statin-discontinuer groups, respectively.

In the comparison between exposed and non-exposed pregnancies, the adjusted odds ratios (aORs) for any, major, and minor malformations were attenuated and not significant (1.30, 1.15, and 1.47, respectively). Between the exposed and discontinuer groups, the corresponding aORs were 1.01, 1.08, and 0.94. [Eur Heart J 2026;47:318-327]

Major malformations were defined as ‘structural changes in any organ system that have significant medical, social, or cosmetic consequences, and typically require medical intervention’, while minor malformations referred to ‘structural changes that pose no significant health problem in the neonatal period and tend to have limited social or cosmetic consequences for the affected individual’. [https://www.who.int/publications/i/item/9789241548724, accessed March 2, 2026]

There was also no association between exposure to any lipid-modifying agent (LMA) and heart malformations (aOR, 1.22). Heart malformations were defined as severe congenital heart defects but not benign conditions (eg, related to premature birth).

Insufficient human studies

Statins have been contraindicated during pregnancy and lactation due to their potential foetal risks; however, their effects on human pregnancies have remained uncertain. [Eur Heart J 2020;41:111-188; J Clin Lipidol 2016;10:1081-1090]

“Early animal studies suggested teratogenic effects of statins at high doses, yet human data have been scarce. Therefore, guidelines recommend discontinuation of statin therapy in most women planning pregnancy,” the researchers noted.

The investigators used data from four* Norwegian national health registries from 2005 until 2018. This included 805,368 pregnancies for 495,754 unique women. There were 803,830 non-statin-exposed pregnancies, 1,255 statin-discontinuer pregnancies, and 283 statin-exposed pregnancies.

The non-exposed group included pregnancies with no prescription fills during the first trimester or in the year before conception. The discontinuer group included pregnancies with prescription fills up to 1 year before conception but not during the first trimester. The exposed group comprised pregnancies with prescription fills during the first trimester. “The main exposure window was first-trimester prescription fills because organogenesis and most major malformations occur in gestational weeks 3–8,” the researchers noted.

Indications for statin therapy were established atherosclerotic cardiovascular disease (ASCVD), high ASCVD risk, familial hypercholesterolaemia, or other dyslipidaemias. The most commonly used statins were simvastatin and atorvastatin.

Implications

This large nationwide study showed no significant association between first-trimester exposure to statins or other LMAs and congenital malformations, the researchers noted. “Although limited power may have prevented the detection of weak but clinically relevant associations, the findings do not support a strong or independent association between statin exposure in pregnancy and congenital malformations.”

“Our results add to the growing body of evidence suggesting that statins and other LMAs are unlikely to be major teratogens,” they added.

Given evidence showing no increased risk of major birth defects following statin use in pregnancy, the FDA has requested the removal of the strongest warning against statin use in pregnancy, but they still advise most pregnant women to stop using statins. [https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy, accessed March 2, 2026]

Conversely, the EMA continues to uphold stringent protocols on statin use in pregnancy. [https://www.ema.europa.eu/en/medicines/human/referrals/Lipitor, accessed March 2, 2026]

“[Our data suggest] that EMA and other regulatory bodies should reconsider the strongest warning against statin use during pregnancy, in alignment with recent FDA recommendations. Additionally, off-treatment periods around pregnancy should be kept as short as possible,” the investigators said.