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

Statins and Pregnancy: The Real Risks and How to Plan

If you’re taking statins and just found out you’re pregnant-or you’re trying to conceive-your mind is probably racing. Is your baby at risk? Should you stop the medication? Was it safe to take it in the first few weeks? These aren’t hypothetical questions. Around 12,000 to 15,000 pregnancies in the U.S. each year involve women who were on statins when they conceived. And for the first time in decades, the science is changing how doctors think about this.

Just a few years ago, the answer was simple: stop statins immediately. The FDA labeled them as Pregnancy Category X, meaning the risks clearly outweighed any benefit. But in July 2021, the FDA quietly reversed that stance. After reviewing data from over a million pregnancies, they concluded that statins are unlikely to cause major birth defects. That doesn’t mean they’re risk-free. But it does mean the old fear of severe fetal harm was based on theory, not solid evidence.

Why Were Statins Thought to Be Dangerous?

Statins work by blocking HMG-CoA reductase, an enzyme your body needs to make cholesterol. Cholesterol isn’t just a villain in heart disease-it’s essential for building cell membranes, hormones, and even the developing brain of a fetus. Early animal studies showed that very high doses of statins could cause birth defects in rats and rabbits. That led to the assumption: if it harms animals at high doses, it might harm human babies too.

But humans aren’t rats. And the doses used in those animal studies were many times higher than what any human would ever take. The real question wasn’t whether cholesterol matters-it’s whether statins lower it enough in the fetus to cause harm. And that’s where the data now tells a different story.

What Does the Evidence Actually Show?

Large human studies have now looked at thousands of pregnancies where women took statins, mostly during the first trimester. The most convincing one, published in 2015 and analyzed by the FDA, tracked over 1,100 women who took statins while pregnant and compared them to nearly 900,000 who didn’t. After adjusting for age, diabetes, obesity, smoking, and other factors, the risk of major birth defects was almost identical: 1.07 times higher-a difference so small it could be due to chance.

A 2021 study of over 1.4 million pregnancies found no increase in heart defects, cleft lip, or neural tube defects among babies exposed to statins. Another study in Norway, published in early 2025, followed over 800,000 pregnancies and found the same: no link to congenital malformations.

So what’s the catch? Two things keep popping up: preterm birth and low birth weight. Some studies show a slightly higher chance of babies being born early or under 2,500 grams. But here’s the key: these outcomes are also common in women with high cholesterol, diabetes, or high blood pressure-all conditions that often lead to statin use in the first place. It’s hard to tell if the statin is causing the issue, or if it’s the underlying heart disease.

Who Should Still Stop Statins?

For most women, the answer is still yes-stop statins as soon as you know you’re pregnant. Why? Because if you don’t have a serious heart condition, you don’t need statins during pregnancy. Cholesterol naturally rises in pregnancy to support hormone production and fetal growth. Trying to lower it with medication isn’t helpful, and the risks, even if small, aren’t worth it.

But for a small group of women, stopping statins could be more dangerous than continuing them. That’s the group doctors are now starting to talk about: women with familial hypercholesterolemia (FH) or established atherosclerotic cardiovascular disease (ASCVD).

FH affects about 1 in 250 women. These women have LDL cholesterol levels that can hit 300 or higher from birth. Without treatment, they have a 50% chance of having a heart attack before age 50. During pregnancy, their risk of heart attack or stroke can spike. One woman in a BabyCenter forum shared: “My LDL was 320 before pregnancy. My doctor said the risk of a cardiac event outweighed the fetal risks.” She stayed on atorvastatin 10mg throughout.

For these women, the danger isn’t from statins-it’s from uncontrolled cholesterol. A heart attack during pregnancy can be fatal for both mother and baby. That’s why experts now say: if you’re in this high-risk group, don’t panic. Talk to your cardiologist and OB-GYN. A shared decision is the only right answer.

What About Planning Ahead?

If you’re thinking about getting pregnant and you’re on statins, don’t wait until you miss your period. Start planning at least three months in advance.

• Get your cholesterol levels checked. Know where you stand.
• Ask your doctor: Do I have FH or ASCVD? Or is my high cholesterol manageable with diet and exercise?
• If you’re high risk, bring your cardiologist into the conversation. A team approach-cardiology, maternal-fetal medicine, and your OB-GYN-is critical.
• Discuss alternatives. For most women, switching to safe, non-drug strategies like a low-saturated-fat diet, daily walking, and omega-3s is enough. For those with FH, some doctors may consider bile acid sequestrants (like cholestyramine), which don’t cross the placenta.
• Once you stop statins, give your body time to clear them. Most are out of your system in a week or two.

And if you accidentally took statins in the first few weeks before you knew you were pregnant? Don’t panic. The data shows your baby’s risk of a major defect is still around 3-5%-the same as any other pregnancy. Most doctors now reassure women in this situation: you didn’t harm your baby.

What’s Changing in 2025?

The conversation around statins and pregnancy is no longer just about avoiding harm-it’s about finding benefit. The StAmP trial, currently enrolling 500 women across 15 U.S. hospitals, is testing whether pravastatin can actually prevent preeclampsia in high-risk women. Early results showed a 47% drop in preeclampsia cases. If confirmed, this could turn statins from a medication to avoid into one that protects.

Meanwhile, the NIH is launching the PRESTO study in 2025, tracking 5,000 pregnancies where statins were taken. This will give us the clearest picture yet of risks by trimester, by drug type, and by dose.

And attitudes are shifting. In 2019, only 32% of obstetricians told patients that accidental statin exposure in early pregnancy was unlikely to cause birth defects. By 2023, that number jumped to 68%. That’s not just data changing-it’s culture changing.

What Do the Guidelines Say Now?

There’s no global agreement. The FDA says: “Consider continuing in high-risk cases.” The European Society of Cardiology says: “Stop unless it’s an extreme exception.” ACOG recommends a team-based decision for women with FH or ASCVD.

Here’s what you can expect in a good clinic today:

• If you’re low risk: Stop statins immediately. Focus on diet, movement, and monitoring.
• If you’re high risk: You’ll be referred to a maternal-fetal medicine specialist and a cardiologist. You may continue a low dose (like 10mg atorvastatin or 20mg pravastatin) with monthly liver tests and growth ultrasounds starting at 20 weeks.
• Documentation is key. Your chart should note why you’re continuing, what risks were discussed, and what alternatives were considered.

And if your doctor still says, “Just stop and never go back,” ask why. Are they following the 2021 FDA update? Or are they stuck in old guidelines? You deserve a conversation based on today’s science.

What About Breastfeeding?

Statins don’t pass into breast milk in significant amounts. The American Academy of Pediatrics considers them compatible with breastfeeding. If you’re planning to nurse, you can restart statins after delivery. There’s no need to wait.

Final Thoughts: It’s Not Black and White

Statins aren’t a safe choice for every pregnant woman. But they’re not the danger they were once thought to be. The real issue isn’t the drug-it’s the condition it’s treating. For most women, stopping statins is the right move. For a small but critical group, continuing them could save lives.

There’s no one-size-fits-all answer. But there is a better way: plan ahead, get expert advice, and don’t let fear make your decisions for you. The data is clearer than ever. Now, the challenge is making sure every woman who needs it gets the right care.