Science to Practice
Latest highlights on drug safety and efficacy

24.8.2026

Statins have traditionally been avoided during pregnancy due to concerns about fetal harm. New evidence from a nationwide Norwegian registry study provides reassurance: first-trimester exposure to statins or other lipid-modifying agents was not significantly associated with congenital malformations. This cohort was added in an updated meta-analysis with nearly 2000 early pregnancy exposures, showing no association with increased risk of major malformations or heart malformations (1).

The 2025 European Society of Cardiology (ESC) Guidelines for cardiovascular disease and pregnancy also reflect this shift. Statins are no longer described as contraindicated throughout pregnancy in all situations; instead, continuation may be considered for women with high cardiovascular risk due to familial hypercholesterolaemia or established atherosclerotic cardiovascular disease. Inadvertent pregnancy exposure to statins does not require pregnancy termination, but close follow-up is recommended (2).

New evidence supports a more individualised approach to statin use during pregnancy. For selected patients at high cardiovascular risk, treatment may be considered based on individual risk–benefit assessment.

The Gravbase recommendation for statins therefore distinguishes between routine lipid-lowering use and selected high-risk indications. Most pregnant patients should still discontinue statins when possible, but individual risk–benefit assessment is warranted. Statins remain contraindicated during lactation according to the ESC Guidelines (2). This means breastfeeding is not allowed when statin treatment is deemed essential for a mother with high cardiovascular risk.

For more comprehensive information, explore Gravbase and Lactbase, our specialised databases providing detailed insights on drug safety and efficacy during pregnancy and lactation.

News produced by Medbase Medical Team

References

1. Christensen JJ, Holven KB, Bogsrud MP, Retterstøl K, Roeters van Lennep JE, Michelsen TM, Veierød MB, Nordeng H. Statin use in pregnancy and risk of congenital malformations: a Norwegian nationwide study. European Heart Journal. 2026;47(3):318–327.
2. De Backer J, Haugaa KH, Hasselberg NE, de Hosson M, et al. 2025 ESC Guidelines for the management of cardiovascular disease and pregnancy. European Heart Journal. 2025;46(43):4462–4568.