Are statins safe before trying to conceive?

What does the evidence say about statins before trying to conceive while trying to conceive?

1. Statins were historically avoided in pregnancy and even during preconception planning because they block cholesterol production in all cells, and cholesterol plays a role in fetal development, a concern reinforced by early case reports and high-dose animal studies. 1
2. In July 2021, the FDA removed its long-standing contraindication against statin use during preconception planning and pregnancy, based on more than three decades of accumulated human data that did not confirm the original concern. 1
3. In a study that adjusted for other maternal factors, statin exposure wasn't linked to a significantly higher rate of birth defects, and women who had used a statin for more than 3 months before conceiving and continued it into pregnancy had comparable outcomes, including birth defects, low birth weight, and preterm birth, to those who stopped. 2
4. For some women, the benefit of staying on a statin through some or all of pregnancy may outweigh the medication's potential risk to the fetus, which is why current guidance favors an individualized conversation with a provider rather than a blanket stop-before-conceiving rule. 3
5. Experts generally still recommend avoiding statins while breastfeeding, mainly because there isn't enough data on effects in a nursing infant, though some now frame this as a personalized decision between patient and provider rather than an absolute rule. 4

What to know about statins before trying to conceive while trying to conceive

• For most people planning ahead, this is when the old blanket advice to stop was routinely given. That contraindication was removed by the FDA in 2021, so today's approach is a conversation with your provider about your specific cardiovascular risk and cholesterol levels rather than an automatic stop.
• If you conceive while still taking a statin, decades of accumulated data, including accidental use right around conception, haven't confirmed the original birth-defect concern. Let your provider know as soon as you have a positive test so they can weigh your specific situation rather than assuming the medication needs to stop immediately.
• For some people, especially those with a condition like familial hypercholesterolemia or an established history of cardiovascular disease, the benefit of staying on a statin through some or all of pregnancy may outweigh the medication's potential risk, since stopping it has its own downsides for cardiovascular risk. That's an individualized call with your provider, not a one-size-fits-all rule.