From the Guidelines
Lipitor (atorvastatin) should not be given to pregnant women unless they are at very high risk of heart attack or stroke, such as those with homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD). The potential risk to the developing baby outweighs the benefits of cholesterol-lowering during pregnancy, as cholesterol and products formed from cholesterol are important for fetal development 1. Statins like Lipitor work by inhibiting an enzyme involved in cholesterol production, but this same pathway is necessary for fetal development, particularly for cell membrane formation and hormone synthesis.
Some studies suggest that the risk of teratogenicity with statins appears to be low, but data are limited 1. However, hydrophilic statins, such as pravastatin, may be associated with less fetal harm than lipophilic statins like atorvastatin 1. Recent guidelines recommend that individuals of childbearing potential use a form of contraception when also using lipid-lowering medications with unknown risks, limited evidence on safety, or known risks during pregnancy, regardless of intention to become pregnant 1.
In general, pregnant women should discontinue Lipitor before or as soon as pregnancy is detected, and alternative approaches to managing cholesterol during pregnancy may include diet, exercise, and in some cases, pregnancy-safe medications if absolutely necessary. Women taking Lipitor who are planning pregnancy should consult their healthcare provider to discuss stopping the medication before conception and exploring alternative management strategies during pregnancy. However, for high-risk individuals, consideration of initiating or continuing statin therapy during pregnancy should occur on a case-by-case basis, taking into account the potential benefits and risks 1.
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
- Pregnancy Risk: Atorvastatin may cause fetal harm when administered to pregnant patients.
- Recommendation: Discontinue atorvastatin calcium when pregnancy is recognized.
- Key Point: Treatment of hyperlipidemia is not generally necessary during pregnancy. Based on the information provided in the drug label 2, Lipitor (Atorvastatin) should not be given to pregnant women.
From the Research
Lipitor (Atorvastatin) Use in Pregnant Women
- Lipitor (Atorvastatin) is a statin, a group of lipid-lowering drugs that are generally contraindicated during pregnancy due to results from animal studies and human case series 3.
- However, recent systematic reviews and meta-analyses suggest that statin use during pregnancy may not be detrimental and could be beneficial in selected cases, such as pregnant patients with very high cardiovascular risk 3.
- A retrospective review of 39 pregnancies in women with homozygous familial hypercholesterolemia found that statin therapy during pregnancy appeared to be safe for both mother and fetus, particularly in resource-poor settings where alternative treatments are not available 4.
- Another study found that maternal statin use during pregnancy was associated with an increased risk of low birth weight and preterm labor, but not with congenital anomalies 5.
- Animal studies have shown that statin treatment in hypercholesterolemic pregnant mice can reduce cardiovascular risk factors in their offspring 6.
Considerations for Use
- The decision to use lipid-lowering therapy, including statins, during pregnancy should be individualized and weigh the potential risks and benefits 3.
- In some cases, the benefits of statin therapy may outweigh the potential risks, such as in pregnant patients with very high cardiovascular risk or those with homozygous familial hypercholesterolemia 3, 4.
- Further research is needed to fully understand the effects of statin use during pregnancy and to determine the safest and most effective treatment options for pregnant women with dyslipidemia 3, 7.