Which hypolipidemic (lipid-lowering) agents are safe to use during pregnancy?

Hypolipidemic Medications in Pregnancy

Bile acid sequestrants are the only lipid-lowering medications considered safe for use during pregnancy. 1, 2 All other hypolipidemic agents should generally be discontinued before conception or immediately upon pregnancy confirmation.

Safe Hypolipidemic Options During Pregnancy

• Bile Acid Sequestrants (First-Line)

  • Only class of lipid-lowering medications considered safe during pregnancy 1, 2
  • Should be initiated ideally 3 months before planned pregnancy 2
  • Require monitoring for vitamin K deficiency and other fat-soluble vitamin deficiencies during pregnancy 1, 2
  • May cause gastrointestinal side effects

• Lifestyle Modifications

  • Heart-healthy diet, appropriate physical activity, and weight management 2
  • Primary approach for most pregnant women with hyperlipidemia

Medications to Avoid During Pregnancy

• Statins

  • Generally contraindicated during pregnancy 1, 2
  • Should be discontinued at least 1 month (preferably 3 months) before conception 1
  • Recent evidence suggests teratogenicity risk may be lower than previously thought 1
  • Pravastatin (hydrophilic statin) may have less fetal harm than lipophilic statins 1

• Ezetimibe

  • Should be discontinued when pregnancy is recognized 1
  • Insufficient data on safety during pregnancy 1

• Bempedoic Acid

  • Should be discontinued when pregnancy is recognized 1
  • No adequate data on use in pregnant women 1

• PCSK9 Inhibitors (evolocumab, alirocumab)

  • Should be discontinued prior to pregnancy 1, 2
  • No available safety data for use during pregnancy 1

• Inclisiran

  • Recommended to discontinue when pregnancy is recognized 1
  • May cause fetal harm based on mechanism of action 1

• Fibrates

  • Should be discontinued prior to pregnancy 2
  • Limited safety data during pregnancy 3

• Lomitapide

  • Not recommended in pregnancy due to concerns for fetal harm 1

Special Considerations

High-Risk Patients

For women with homozygous familial hypercholesterolemia (HoFH) or established atherosclerotic cardiovascular disease (ASCVD), special considerations apply:

• Lipoprotein Apheresis

  • Recommended for pregnant women with HoFH 1, 2, 4
  • Can be considered for severe heterozygous FH with LDL-C ≥300 mg/dL 1, 2
  • Shown to be effective and safe throughout pregnancy 4

• Statin Continuation (Rare Cases)

  • May be considered in a shared decision-making process for women with:
    • History of ASCVD
    • HoFH
    • Severe heterozygous FH 1
  • Hydrophilic statins like pravastatin may be preferred if absolutely necessary 1

Monitoring During Pregnancy

• Monitor for significant elevations in lipid levels during pregnancy, especially in third trimester 1, 2
• Close monitoring of triglyceride levels is essential for women with pre-pregnancy triglycerides ≥500 mg/dL 2
• Referral to a lipid specialist is strongly recommended for high-risk patients 1, 2

Post-Pregnancy Considerations

• Lipid-lowering medications may be resumed after completion of breastfeeding 1, 2
• Women of childbearing potential taking lipid-lowering medications should use effective contraception 2

Clinical Pitfalls

• Physiologic increases in lipid levels during pregnancy (LDL-C and triglycerides) should not be confused with pathologic hyperlipidemia 1, 5
• Severe hypertriglyceridemia during pregnancy increases risk of acute pancreatitis, pre-eclampsia, and other complications 5, 6
• Discontinuation of statins in very high-risk patients may pose greater risk than continuation in select cases 1, 2
• Routine monitoring of lipid levels during pregnancy is not recommended unless results would change management 2