Statins and Pregnancy: What You Need to Know About Risks and Planning

For years, doctors told women to stop statins the moment they found out they were pregnant. It wasn’t just a suggestion-it was a hard rule. The fear? That these cholesterol-lowering drugs could cause serious birth defects. But in 2021, the FDA changed its stance. After reviewing data from over a million pregnancies, they removed the strongest warning against statins in pregnancy. This wasn’t a small tweak. It was a full rethink. And it’s changed how doctors talk to women who need these drugs.

Why Were Statins Banned in Pregnancy?

Statins work by blocking HMG-CoA reductase, an enzyme your body uses to make cholesterol. Since cholesterol is critical for building cell membranes-and especially for fetal brain and organ development-scientists worried that lowering it too much might harm the baby. Early animal studies showed birth defects at very high doses. That was enough for regulators to label statins as "Pregnancy Category X"-meaning the risks clearly outweighed any benefits.

But animals aren’t people. And the doses used in those animal studies? Way higher than what humans take. Still, the warning stuck for decades. Even when women accidentally took statins in early pregnancy, they were often told to panic. Many ended up terminating pregnancies out of fear, even though no solid evidence showed harm.

The Data That Changed Everything

In 2015, a massive study looked at 1,152 women who took statins during pregnancy and compared them to nearly 900,000 who didn’t. The results? No meaningful increase in birth defects. The relative risk was 1.07-so close to 1 that it could easily be due to chance. Even after adjusting for things like diabetes, obesity, and smoking, the numbers didn’t budge.

Then came the 2021 JAMA study of over 1.4 million pregnancies. Among the 469 women exposed to statins, there was no rise in congenital anomalies. Same with a 2025 Norwegian study of 805,000 pregnancies. No link to heart defects, limb problems, or neural tube issues. The biggest concern now isn’t birth defects-it’s preterm birth and low birth weight. Even those risks are small and likely tied more to the mother’s underlying heart disease than the statin itself.

And here’s the kicker: the normal background risk of major birth defects in any pregnancy is 3% to 5%. Statins don’t push that number higher. Not meaningfully. Not in humans.

Who Should Still Take Statins During Pregnancy?

For most women, stopping statins is still the right call. Cholesterol naturally rises during pregnancy-it’s normal. And unless you have a serious condition, you don’t need to treat high cholesterol while pregnant. The real exception? Women with familial hypercholesterolemia (FH) or established cardiovascular disease.

FH affects 1 in 250 women. Their LDL cholesterol can be over 190 mg/dL from birth. Without treatment, they face a 50% chance of a heart attack before age 50. During pregnancy, the added strain on the heart can be dangerous. One woman in a BabyCenter forum shared: "My LDL was 320 before I got pregnant. My doctor said the risk of a heart attack was worse than any risk from the statin. So I stayed on 10mg of atorvastatin the whole time. My baby is healthy."

For these women, the risk of a heart attack, stroke, or plaque rupture during pregnancy can be life-threatening. In those cases, continuing statins may be the safer choice.

What Do Experts Recommend Now?

There’s no universal answer. The FDA says doctors can consider continuing statins for women at "very high risk" for heart events. The American College of Cardiology agrees. But the European Society of Cardiology still advises stopping statins at pregnancy recognition-except in "exceptional circumstances."

Dr. Cynthia Maxwell from the University of Toronto puts it simply: "It’s not about whether statins cause birth defects. It’s about whether stopping them puts the mother at greater risk."

For women with FH or ASCVD, the decision isn’t made by one doctor. It’s a team effort: cardiologist, maternal-fetal medicine specialist, and the patient. Shared decision-making is key. You need to know your numbers, your history, and your risks. No one-size-fits-all answer exists.

When and How to Stop (or Keep) Statins

If you’re planning pregnancy and take statins, talk to your doctor at least 3 months before trying to conceive. That’s when you can switch to safer options if needed-like bile acid sequestrants or lifestyle changes. But if you’re already pregnant and taking statins, don’t panic.

Most exposures happen before a woman knows she’s pregnant. That’s common. And if it happens? The data says: don’t terminate the pregnancy. The risk of birth defects isn’t increased. Your baby is likely fine.

For women who continue statins during pregnancy, monitoring is critical. Monthly liver tests. Fetal growth scans starting at 20 weeks. Close tracking of blood pressure and cholesterol. Some clinics now have formal protocols. Others are still catching up. A 2022 survey found only 17% of community practices had clear guidelines-compared to 42% at academic centers.

What About the Baby Later On?

So far, there’s no evidence that statin exposure in utero affects long-term child development. No studies show learning delays, behavioral issues, or heart problems later in life. But long-term data is still limited. That’s why the NIH is launching the PRESTO study in 2025, tracking 5,000 pregnancies exposed to statins to see how these kids develop into adolescence.

For now, the message is simple: if you took statins early in pregnancy and your baby is growing normally, there’s no reason to assume harm. Don’t wait for a perfect study to feel safe. The evidence we have is strong enough to reassure.

What’s Next? New Uses, New Hope

Statins might not just be safe in pregnancy-they could be helpful. The StAmP trial is testing pravastatin to prevent preeclampsia in high-risk women. Early results showed a 47% drop in preeclampsia. That’s huge. Preeclampsia kills mothers and babies. If statins can reduce that risk, it could change prenatal care forever.

The FDA is now actively encouraging research into drugs like statins for use during pregnancy. This isn’t just about safety anymore. It’s about finding treatments for conditions that currently have none.

What Should You Do Right Now?

• If you’re planning pregnancy and take statins: Talk to your doctor. Don’t stop on your own. There are safer alternatives for most women.
• If you’re pregnant and taking statins: Don’t panic. Most exposures are harmless. Call your OB or a pregnancy exposure hotline like MotherToBaby.
• If you have FH or heart disease: Get a team involved. Cardiologist + MFM specialist + you. Make a plan before you get pregnant.
• If you took statins before knowing you were pregnant: Your baby is likely fine. No need for extra scans or tests unless your doctor recommends them for other reasons.

The old fear-that statins cause birth defects-isn’t supported by the science. The new reality? For some women, continuing statins might save their lives. The shift isn’t just about drugs. It’s about trusting data over fear. And that’s a change worth celebrating.