Can I take Lipitor (atorvastatin) during pregnancy?

Atorvastatin (Lipitor) Should Not Be Taken During Pregnancy

Atorvastatin (Lipitor) should be discontinued during pregnancy as it may cause fetal harm. 1

Risk Assessment for Statins in Pregnancy

• The FDA drug label for atorvastatin clearly states that it "may cause fetal harm" and should be discontinued during pregnancy 1
• Atorvastatin's patient information explicitly instructs: "If you become pregnant, stop taking atorvastatin calcium tablets and call your healthcare provider right away" 1
• Statins are generally not recommended during pregnancy for most women, particularly those taking them for primary prevention of cardiovascular disease 2

Special Considerations for High-Risk Patients

• In July 2021, the FDA revised information regarding statins in pregnancy, removing the absolute contraindication for all pregnant patients 2
• For a small subset of very high-risk pregnant patients, the benefits of statin therapy may outweigh risks in specific situations:
  • Women with homozygous familial hypercholesterolemia (HoFH) 2, 3
  • Women with established clinical atherosclerotic cardiovascular disease (ASCVD) at very high risk for heart attack or stroke 2
  • In these rare cases, healthcare professionals and patients should make individual decisions about benefit and risk 2

Recommendations Based on Risk Category

For Primary Prevention (Most Cases):

• Women taking statins for primary prevention of ASCVD should discontinue therapy:
  • At least 1 month and preferably 3 months before attempted conception, or
  • Immediately if already pregnant 2
• Alternative therapies during pregnancy:
  • Bile acid sequestrants are the only lipid-lowering drugs approved during pregnancy 4
  • Pregnant patients managed with bile acid sequestrants should be monitored for vitamin K deficiency 2

For Very High-Risk Patients Only:

• Patients with established clinical ASCVD identified as very high risk should:
  • Consult with their healthcare provider to consider ongoing therapeutic needs 2
  • Be referred to a lipid specialist 2
  • Receive intensive lifestyle modification counseling 2

Safety Evidence and Concerns

• Recent large observational studies have not demonstrated evidence of major congenital malformations with statin exposure 2, 5
• However, a 2021 study found statin exposure during pregnancy was associated with:
  • Higher risk of low birth weight (RR 1.51)
  • Greater chance of preterm birth (RR 1.99)
  • Lower 1-minute Apgar scores (RR 1.83) 5
• Pravastatin may have a better safety profile than other statins if treatment is absolutely necessary during pregnancy 6

Post-Pregnancy Considerations

• Lipid-lowering therapy may be resumed after completion of breastfeeding 2
• Breastfeeding is not recommended during treatment with atorvastatin calcium tablets 1

Clinical Decision Algorithm

1. Determine if patient is pregnant or planning pregnancy
2. Assess cardiovascular risk category:
   • Primary prevention → Discontinue atorvastatin immediately
   • Very high-risk (ASCVD or HoFH) → Consult specialist for risk-benefit assessment
3. If discontinuation is indicated:
   • Monitor for significant elevations in LDL-C and triglycerides during pregnancy
   • Counsel on lifestyle modifications
   • Consider bile acid sequestrants if absolutely necessary
4. Resume statin therapy after completion of breastfeeding