Is atorvastatin (Lipitor) safe during pregnancy?

From the Guidelines

Atorvastatin should be avoided in pregnancy, except in rare cases where the benefits outweigh the risks, such as in patients with homozygous familial hypercholesterolemia or those at very high risk of heart attack or stroke. The use of statins, including atorvastatin, during pregnancy is a complex issue, and the decision to continue or discontinue therapy should be made on a case-by-case basis, considering the individual patient's risk factors and medical history 1. According to recent guidelines, statins may be considered in pregnant women with a history of atherosclerotic cardiovascular disease or familial hypercholesterolemia, but the risks and benefits should be carefully weighed 1.

Key Considerations

• The FDA has removed the contraindication against the use of statins in all pregnant patients, allowing for individualized decision-making about benefit and risk 1.
• Recent large observational studies have not demonstrated evidence of harm to mother or fetus with statin use, but the data are limited 1.
• Hydrophilic statins, such as pravastatin, may be associated with less fetal harm than lipophilic statins, like atorvastatin 1.
• Lifestyle modifications, including diet and exercise, are the preferred approach for lipid management during pregnancy, and medication should only be considered in high-risk cases 1.

Clinical Implications

• Women taking atorvastatin and planning to become pregnant should discuss alternative treatments with their healthcare provider before conception.
• If a woman becomes pregnant while taking atorvastatin, she should stop the medication immediately and contact her doctor, unless the benefits of continuing therapy outweigh the risks.
• After delivery, atorvastatin should be avoided during breastfeeding, as it may pass into breast milk.

From the FDA Drug Label

8 USE IN SPECIFIC POPULATIONS 8. 1 Pregnancy Risk Summary Discontinue atorvastatin calcium when pregnancy is recognized.

Atorvastatin calcium decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium may cause fetal harm when administered to pregnant patients based on the mechanism of action Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations

• Atorvastatin is not recommended in pregnancy due to the potential risk of fetal harm based on its mechanism of action.
• The available data from observational studies have not identified a significant risk of major congenital malformations, but the drug should be discontinued when pregnancy is recognized.
• Treatment of hyperlipidemia is not generally necessary during pregnancy, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients 2.

From the Research

Safety of Atorvastatin in Pregnancy

• The safety of atorvastatin, a type of statin, during pregnancy has been a topic of discussion due to its potential teratogenic effects 3, 4, 5, 6, 7.
• A systematic review from 2007 found that although statins have been identified as potential teratogens, the available evidence is far from conclusive, and epidemiological data suggest that statins are not major teratogens 3.
• A 2021 study published in The American Journal of Nursing reported that the labeling of statins has been revised to remove the contraindication for use during pregnancy, but most women should still avoid statins during pregnancy unless they are at high risk for cardiovascular events 4.
• Another study from 2022 evaluated the potential benefits of statin therapy in reproductive-aged women and found that while statins have several potential benefits, the effects of long-term statin use on fetal and neonatal health remain unknown 5.
• A retrospective cohort study from 2021 examined perinatal outcomes after statin exposure during pregnancy and found that statin use was associated with an increased risk of low birth weight and preterm labor, but not with congenital anomalies 6.
• A systematic review and meta-analysis from 2012 found that most available data suggest that statins are unlikely to be teratogenic, and animal studies show conflicting results, but excessive doses were used in reports of congenital anomalies 7.

Key Findings

• Statins may not be major teratogens, but the available evidence is limited 3, 7.
• Atorvastatin may be safe to use during pregnancy in women at high risk for cardiovascular events, but caution is needed due to the potential risks of low birth weight and preterm labor 4, 6.
• The effects of long-term statin use on fetal and neonatal health remain unknown, and more research is needed to assess the risks and benefits of statin use during pregnancy 5.