Statins, Breastfeeding, and Familal Hypercholesterolemia in 2024

by Katie Black

The information in this article is purely for educational purposes and should not be taken as medical advice. Always consult your doctor before starting or stopping medications.

Chances are if you’re reading an article about statins you already know more than you’d like about high cholesterol and all the diseases that come with it. Scroll down for the breastfeeding part if you don’t need a refresher.

But for those who don’t know, cholesterol is a waxy lipid found in all the cells of your body. Your body needs it to build cell membranes, make hormones, vitamin D, and things that help you digest food.

There are different kinds of cholesterol including low-density lipoprotein (LDL), which is often called "bad" cholesterol, and high-density lipoprotein (HDL), or "good" cholesterol. HDL helps take out other forms of cholesterol from the bloodstream and carries it back to the liver, where it can be processed and taken out of the body. Higher levels of HDL are associated with a lower risk of heart disease.

High levels of LDL cholesterol can lead to fat building up in your blood vessels, making it harder for enough blood to flow through. This can cause coronary artery disease (arteries can’t deliver enough oxygenated blood to the heart), heart attack (flow of blood to the heart is blocked), or stroke (blood to the brain is blocked).

What are statins?

Statins, also known as HMG-CoA reductase inhibitors, are a class of drugs used to lower cholesterol levels in the blood, particularly LDL.

They work by stopping the enzyme HMG-CoA reductase. This enzyme is crucial for making cholesterol in the liver and blocking it lowers the liver's ability to do so.

While the liver makes less cholesterol, it ups the number of LDL receptors on its surface. More receptors mean more LDL is pulled from the bloodstream, lowering cholesterol levels in the blood.

Statins can also have anti-inflammatory effects on the blood vessel walls, which can help to stabilize plaques and prevent them from bursting. They also lower oxidative stress, balancing free radicals and antioxidants which can help the overall health of blood vessels.

The most common sides effects are:

Headache
Dizziness
Nausea
Abdominal pain
Diarrhea
Changes in liver function
Muscle pain

Statins include the medications:

Atorvastatin (Lipitor).
Fluvastin (Lescol XL).
Lovastatin (Altoprev).
Pitavastatin (Livalo).
Pravastatin (Pravachol).
Rosuvastatin (Crestor).
Simvastatin (Zocor).

Risks of breastfeeding on statins

Before 2021, the FDA advised against taking statins during pregnancy with the strongest warning label, clearly stating the risks outweigh any possible benefits. But in 2021 the FDA revised their category and statins are no longer contraindicated. It’s still recommended that most women stop taking statins during pregnancy, but the FDA now recognizes there are cases where statins are needed during pregnancy, like with patients with familial hypercholesterolemia, or who’ve had a heart attack or stroke.

But while breastfeeding, the FDA still doesn’t recommend anyone take statins. They say moms who want to breastfeed should pause treatment and “patients requiring ongoing statin treatment should not breastfeed and instead use infant formula or other alternatives.”

This is because of risks that can come with statins passing through breast milk and into an infant’s body:

developmental issues since babies have immature livers and kidneys that can’t always safely get rid of drugs.
statins can remove too much cholesterol from a mom’s milk. cholesterol is important for things like developing the brain and cell membranes of babies.
impaired ability for an infant to synthesize cholesterol.

There’s unfortunately a huge lack of studies to confirm if these potential risks are worth not breastfeeding. But since there’s so much unknown, doctors, patients, and policy makers have to err on the side of caution.

Familial hypercholesterolemia

Here’s where it gets interesting. Researchers have recently put forward that it might be time for a paradigm shift in how statins for pregnant women are handled. Similarly, there are researchers looking at whether the guideline that breastfeeding while taking statins is always a bad idea should be rethought for women with familial hypercholesterolaemia (FH).

FH is a genetic disorder that causes very high levels of LDL cholesterol. It’s passed down from parents to children. If a mom has FH, her children each have a 50% chance of inheriting the condition. FH increases the risk of getting atherosclerosis (narrowing and hardening of the arteries), which can cause heart attacks, strokes, and other cardiovascular diseases at a young age.

Possible benefits of breastfeeding while on statins

This 2017 article from the Journal of the Norwegian Medical Association put out some interesting points on the statin, FH, and breastfeeding discussion. The researchers wonder if it could actually be a bigger health risk for both moms and babies to not breastfeed.

For starters, they point to some animal studies showing that statins may protect the heart not just for pregnant and lactating mice, but for their babies too, which could be super important since babies of women with FH have such a high chance of getting the disease.

Secondly, women with FH have shown to have up to three times as much cholesterol as that of healthy women. If statins normalize cholesterol levels, the researchers reason that the lipids in breast milk will also go down to normal levels. And even if the amount of lipids goes down by a lot, they hypothesize there’s still a whole lot more than formula, which generally has very little in comparison.

While the researchers acknowledge that all drugs pass into breast milk, it’s usually only in small amounts since a mom’s body dilutes them a lot. How a mom’s body reacts to a drug and vice versa affects how much of it gets into breast milk. They point out that statins are large molecules that latch onto proteins strongly, and have shown they don’t move much from blood into breast milk. Statins are mostly broken down by the liver and aren’t easily absorbed when taken by mouth, so the risk to the baby may be low even if they pass through milk.

Keep in mind there are no clinical trials on statin use during breastfeeding, but there’s also no evidence at the moment that shows it causes harm from things like observational studies. Plus, high-dose statins are approved for some children with FH as young as a year old.

Hydrophilic statins (those that can dissolve in water) like rosuvastatin and pravastatin are less likely to move into breast milk compared to lipophilic statins (which dissolve in fats).

Rosuvastatin binds to protein more, has a higher molecular weight, and leaves blood quicker, maybe making it the best option. The researchers mention a case report of a breastfeeding woman taking rosuvastatin that showed low drug levels in her breast milk, similar to those in her blood. Her child's dose was 0.59%, which is well below the threshold considered low risk for side effects. The mom’s 40 mg/day dose lead to about 0.01 mg max in her breast milk daily, making it unlikely to affect her baby because so little of the drug was there to absorb.

Breastfeeding also has a bunch of health benefits for women with FH. It may lower the risk of heart attack, hypertension, and type 2 diabetes, while bettering blood glucose control and lipid profile.

For infants, breast milk helps with growth and development, protects against childhood obesity, and lowers the risk of type 1 and type 2 diabetes. For children of women with FH, who have a 50% chance of inheriting the condition, breastfeeding is especially important. Weaning too soon could be disadvantageous for these children. In the researchers’ opinion, the benefits of breastfeeding while taking statins outweigh the risks.

Conclusion

The question is then: is it better to stop taking a statin if you want to breastfeed, better to take the statin and not breastfeed, or can you safely do both? Unfortunately, there’s not a clear answer. The best thing you can do is talk to your doctors and healthcare team to make an informed decision together for you and your family’s unique needs.