What statin (HMG-CoA reductase inhibitor) is safe during pregnancy?

From the Guidelines

No statin is considered safe for pregnancy, but pravastatin may be considered in rare cases where the benefits outweigh the risks, under close medical supervision. Statins, including medications like atorvastatin, simvastatin, rosuvastatin, are contraindicated during pregnancy and should be discontinued before conception when possible 1. These medications cross the placenta and may interfere with fetal cholesterol synthesis, which is essential for normal fetal development. There is concern about potential teratogenic effects, with some animal studies and human case reports suggesting possible birth defects. If you're taking a statin and planning pregnancy, you should discuss this with your healthcare provider to discontinue the medication ideally 1-3 months before attempting conception. For women who require lipid management during pregnancy, lifestyle modifications including diet and appropriate physical activity are the preferred approach. In rare cases where treatment of severe hyperlipidemia is absolutely necessary during pregnancy, bile acid sequestrants (such as cholestyramine) may be considered as they are not absorbed systemically, though these alternatives should only be used under close medical supervision 2, 3, 4.

Some key points to consider:

• The FDA has removed the contraindication against the use of statins in all pregnant patients, allowing for individual decisions about benefit and risk 1.
• Pravastatin, a hydrophilic statin, has been studied for the prevention of pre-eclampsia in high-risk pregnant women and may have pleiotropic effects that diminish inflammation and oxidative stress 1.
• Women with homozygous familial hypercholesterolemia or clinical ASCVD may require ongoing statin therapy during pregnancy, but this should be decided on a case-by-case basis with close medical supervision 1.
• Lifestyle modifications, including diet and physical activity, are the preferred approach for managing lipid levels during pregnancy 2, 3, 4.

It's essential to weigh the potential benefits and risks of statin therapy during pregnancy and to consider alternative treatments, such as bile acid sequestrants, when necessary. Ultimately, the decision to use a statin during pregnancy should be made in consultation with a healthcare provider, taking into account the individual patient's needs and circumstances.

From the FDA Drug Label

8. 1 Pregnancy

Risk Summary Discontinue pravastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient Pravastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action

The FDA drug label does not answer the question of a safe statin during pregnancy, as it recommends discontinuing pravastatin when pregnancy is recognized due to potential fetal harm.

From the Research

Statin Safety During Pregnancy

• The safety of statin use during pregnancy has been questioned, but some studies suggest that certain statins may be safe [ 5, 6 ].
• A retrospective cohort study found that statin exposure during pregnancy was not associated with congenital anomalies, but was associated with an increased risk of low birth weight and preterm labor [ 5 ].
• A retrospective review of 39 pregnancies in women with homozygous familial hypercholesterolaemia found that statin therapy during pregnancy appeared to be safe for both mother and fetus 6.
• Pravastatin has been suggested as a potential safe option for use during pregnancy, due to its limited cholesterol-lowering properties 7.
• A systematic review and meta-analysis found that most available data suggests that statins are unlikely to be teratogenic 8.

Specific Statins and Pregnancy

• Pravastatin may be a safe option for use during pregnancy, but more research is needed to fully understand its effects 7.
• Other statins, such as those used in the study by 6, may also be safe, but more research is needed to confirm this.

Guidelines and Recommendations

• The NICE guidelines recommend that women stop statins three months before conception to avoid teratogenicity 9.
• Contraception during statin treatment is also recommended, and women should not take lipid-lowering drugs until the end of lactation 9.