Can statins (HMG-CoA reductase inhibitors) be used to treat dyslipidemia in breastfeeding women?

Statins in Breastfeeding for Dyslipidemia

Statins should not be used during breastfeeding and must be discontinued until breastfeeding is completed. 1, 2

Primary Recommendation

All lipid-lowering drugs, including statins, should be avoided during breastfeeding. 1 The European Society of Cardiology explicitly states that statins should not be prescribed during breastfeeding since their harmlessness is not proven, and disadvantages to the mother are not expected by temporary interruption of therapy. 2 The International Atherosclerosis Society recommends that statins and other systemically absorbed cholesterol-lowering drugs should ideally be discontinued during lactation. 2

The mechanism-based concern is that statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, which may cause harm to the breastfed infant. 3, 4 While limited case reports show minimal transfer of atorvastatin into human milk (relative infant dose of 0.09%, far below safety thresholds), 5 the lack of comprehensive safety data across all statins and the theoretical developmental concerns justify the guideline recommendations to avoid these medications. 2

Safe Alternative: Bile Acid Sequestrants

If lipid-lowering therapy is absolutely necessary during breastfeeding, bile acid sequestrants are the only safe option. 2, 6 These agents (cholestyramine, colestipol, colesevelam) are not systemically absorbed and therefore do not enter breast milk. 2

Important Monitoring Requirements:

• Monitor for vitamin K deficiency when using bile acid sequestrants during breastfeeding 2, 7
• Also monitor for malabsorption of other fat-soluble vitamins (A, D, E) and folate 2

Other Lipid-Lowering Medications to Avoid

All other lipid-lowering medications should be avoided during breastfeeding: 2

• Ezetimibe - insufficient safety data 2
• PCSK9 inhibitors (alirocumab, evolocumab) - insufficient safety data 2
• Bempedoic acid - insufficient safety data 2
• Fibrates - insufficient safety data 2
• Niacin - insufficient safety data 2

When to Resume Statin Therapy

Lipid-lowering therapy may be resumed after completion of breastfeeding. 1, 2 This allows mothers to breastfeed for their desired duration while managing cardiovascular risk appropriately afterward. 2 The American College of Cardiology explicitly supports this approach to balance infant nutrition with maternal cardiovascular health. 1

Extremely High-Risk Patients

For the rare patient with homozygous familial hypercholesterolemia (HoFH) and established atherosclerotic cardiovascular disease at very high risk for heart attack or stroke, individual risk-benefit assessment may be considered. 2 These patients should:

• Receive intensive lifestyle modification counseling 2
• Be referred to a lipid specialist 2
• Have individualized discussions about the risks of continuing versus discontinuing therapy 1

The FDA has removed the absolute contraindication against statin use in pregnancy for such extreme cases, 1 though this does not extend to a blanket approval for breastfeeding use.

Clinical Algorithm for Management

For women requiring lipid management during breastfeeding:

1. Discontinue all statins and systemically absorbed lipid-lowering drugs 1, 2

2. Implement intensive lifestyle interventions: 2, 6

   • Heart-healthy diet (Mediterranean diet pattern) 1
   • Regular exercise and physical activity 1
   • Weight management 1

3. If pharmacologic therapy is essential: 2

   • Use bile acid sequestrants only 2
   • Monitor for vitamin K and fat-soluble vitamin deficiencies 2, 7

4. Resume statin therapy after breastfeeding completion 1, 2

Common Pitfalls to Avoid

• Failing to counsel women of childbearing age on reliable contraception while taking statins before pregnancy occurs 2
• Not switching to bile acid sequestrants before conception in women who require ongoing lipid management 2
• Unnecessarily discontinuing breastfeeding when bile acid sequestrants would be an appropriate alternative for essential lipid management 2
• Not monitoring for vitamin K deficiency when bile acid sequestrants are used during lactation 2, 7

Duration of Treatment Interruption

Women with familial hypercholesterolemia lose a median of 2.3 years of statin treatment due to pregnancy-related off-statin periods, representing 18% of treatment time lost by age 31. 8 This underscores the importance of resuming therapy promptly after breastfeeding completion to minimize cumulative cardiovascular risk. 8