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

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

If you’re taking statins and just found out you’re pregnant-or you’re planning to get pregnant-your mind is probably racing. Statins have long been labeled dangerous in pregnancy. But the story isn’t that simple anymore.

In 2021, the U.S. Food and Drug Administration (FDA) made a major shift. They removed the strongest warning against statins in pregnancy. That warning, called ‘Pregnancy Category X,’ had told doctors and patients to avoid statins at all costs because they were thought to cause birth defects. Now, after reviewing data from over a million pregnancies, the FDA says the risk of major birth defects from statins is likely no higher than the normal background risk of 3-5%.

This doesn’t mean statins are safe for everyone during pregnancy. But it does mean the old fear-that statins are automatic fetal poison-is outdated. The real question isn’t whether statins cause birth defects. It’s: Who should keep taking them, and who should stop?

Why Were Statins Thought to Be Dangerous?

Statins work by blocking an enzyme called HMG-CoA reductase. That enzyme helps your body make cholesterol. Cholesterol isn’t just a ‘bad guy’ in your blood-it’s essential for building cell membranes, hormones, and even your baby’s developing brain and nerves.

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 humans too. So for decades, doctors told women to stop statins before getting pregnant.

But animals don’t always react like humans. And those high doses? They were far beyond what people ever take. Human studies tell a different story.

The Real Data: What Do Large Human Studies Show?

Since 2015, multiple large, well-designed studies have looked at what happens when women take statins during early pregnancy.

• A 2015 study of over 1,150 women who took statins during pregnancy found no increase in birth defects, even after adjusting for age, diabetes, obesity, and smoking.
• A 2021 study of nearly 1.5 million pregnancies-including 469 with statin exposure-found no link to major birth defects.
• A 2025 study in Norway, tracking over 800,000 pregnancies, found no increased risk of congenital malformations after first-trimester statin use.

The biggest concern isn’t birth defects-it’s preterm birth and low birth weight. Some studies show a slightly higher chance of these outcomes. But it’s unclear if statins cause them, or if they’re linked to the underlying health problems that made women need statins in the first place-like severe high cholesterol, diabetes, or heart disease.

Stillbirth, miscarriage, and elective abortion rates didn’t go up in any of the major studies. The risk of stillbirth, for example, was no different than in women who didn’t take statins.

Who Should Keep Taking Statins During Pregnancy?

This is the critical part. Most women can and should stop statins when they get pregnant. But not everyone.

If you have one of these conditions, the risks of stopping statins may be greater than the risks of continuing them:

• Familial hypercholesterolemia (FH): A genetic condition where LDL (‘bad’) cholesterol is sky-high from birth. Some people have levels over 300 mg/dL. Without treatment, heart attacks can happen in their 20s or 30s.
• Established atherosclerotic cardiovascular disease (ASCVD): You’ve had a heart attack, stroke, or have blocked arteries. Your risk of another event is high.

For these women, stopping statins can be dangerous. Pregnancy puts extra strain on the heart. Blood volume increases. Blood pressure changes. Cholesterol naturally rises. If your cholesterol is already dangerously high, you’re at risk for a heart event during pregnancy.

A woman in Manchester, age 34, with FH and an LDL of 320 before pregnancy, was told by her cardiologist: ‘The chance of a heart attack while pregnant is real. The chance of a birth defect from atorvastatin is not.’ She stayed on a low dose throughout her pregnancy. Her baby was born healthy at 38 weeks.

For women without these conditions-say, you’re on statins for mild high cholesterol or as a preventive measure-you should stop. The benefits of statins in healthy women during pregnancy are minimal. The risks, even if small, aren’t worth it.

What Should You Do Before Getting Pregnant?

If you’re planning a pregnancy and take statins, don’t wait until you miss your period.

Start planning at least 3 months ahead. Talk to your doctor-ideally, both your cardiologist and your OB-GYN. Here’s what you need to cover:

1. Why are you on statins? Is it for FH? ASCVD? Or just borderline cholesterol?
2. What are your cholesterol levels? If your LDL is over 190 mg/dL and you have no other risk factors, statins may not be necessary.
3. Can you manage without statins? For many, diet, exercise, and plant sterols can help lower cholesterol enough during pregnancy.
4. What’s your heart disease risk? If you’ve had a heart attack or have a strong family history, stopping statins could be dangerous.

For women with FH or ASCVD, continuing statins may be the safest choice. But it’s not a decision you make alone. Shared decision-making is key. You need to understand the risks, the benefits, and your own values.

What If You Took Statins Before You Knew You Were Pregnant?

This happens more than you think. About 18% of calls to MotherToBaby’s pregnancy helpline in 2022 were from women who were taking statins when they got pregnant-often because they didn’t realize they were pregnant yet.

Here’s the good news: if you took statins in the first 4-6 weeks of pregnancy, your baby is very likely fine. That’s when organs are forming, and the data shows no increase in birth defects.

Don’t panic. Don’t assume the worst. Call your doctor or a pregnancy exposure hotline. They’ll review your specific medication, dose, and timing. Most of the time, the answer is: ‘No need for extra testing. Your baby’s risk is no higher than any other pregnancy.’

What About Other Cholesterol Medications?

Statins aren’t the only option. But other drugs have even less safety data.

• Fibrates and niacin: Almost no large studies in pregnancy. Avoid unless absolutely necessary.
• Bile acid sequestrants (like cholestyramine): These aren’t absorbed into the bloodstream, so they’re considered low risk. But they can cause nausea and interfere with vitamin absorption.
• PCSK9 inhibitors (like evolocumab): Too new. No pregnancy data yet.

For most women, lifestyle changes are the best first step: more fiber, less saturated fat, daily movement. But for women with severe genetic cholesterol disorders, these changes aren’t enough.

What’s Changing in 2025?

Guidelines are shifting fast. The European Society of Cardiology still says: stop statins as soon as you know you’re pregnant-unless it’s a life-threatening situation. The American College of Cardiology says: if you have FH or ASCVD, it’s okay to continue with careful monitoring.

And there’s new research on the horizon:

• The StAmP trial is testing whether pravastatin can prevent preeclampsia in high-risk women. Early results show a 47% reduction.
• The PRESTO study, launching in 2025, will track 5,000 pregnancies with statin exposure to give us detailed data by trimester.

By 2030, experts predict 15-20% of women with severe cholesterol disorders will continue statins during pregnancy. That’s up from less than 5% today.

What You Need to Do Right Now

Whether you’re planning a pregnancy or already pregnant, here’s your action plan:

1. Don’t stop statins on your own. Talk to your doctor. Stopping suddenly could be risky if you have heart disease.
2. Know your reason for taking statins. Is it for genetics? Heart disease? Or just borderline numbers?
3. Get your cholesterol checked. If your LDL is below 160 mg/dL and you have no heart disease, stopping is likely safe.
4. Use a pregnancy registry. If you’re continuing statins, ask your doctor to enroll you in a safety registry. Your data helps future moms.
5. Get extra monitoring. If you continue statins, you’ll need monthly liver tests and growth ultrasounds starting at 20 weeks.

There’s no one-size-fits-all answer. But the old rule-‘never take statins in pregnancy’-is gone. The new rule? Know your risk. Talk to your team. Make a plan.

Final Thoughts

The message isn’t ‘statins are safe in pregnancy.’ It’s: ‘The fear of statins in pregnancy was based on outdated science. Now we have real data-and it’s changing how we care for women with serious heart conditions.’

If you have high cholesterol but no heart disease, stop your statin and focus on diet and lifestyle. But if you’ve had a heart attack, or you have familial hypercholesterolemia, your health matters too. Stopping statins might put you at greater risk than continuing them.

There’s no perfect answer. But there’s a better way: talk to your team. Know your numbers. Make a plan. And don’t let old warnings scare you away from the care you need.