Can statins (HMG-CoA reductase inhibitors) be given to a breastfeeding mother?

Statins and Breastfeeding

No, statins should not be given to a breastfeeding mother. The European Society of Cardiology explicitly states that statins should not be prescribed during breastfeeding since their harmlessness is not proven, and no disadvantages to the mother are expected by temporary interruption of therapy 1.

Guideline-Based Recommendation

All major cardiovascular societies recommend avoiding statins during lactation:

• The European Society of Cardiology guidelines clearly state that statins should not be prescribed during breastfeeding because safety has not been established, and temporary therapy interruption poses no significant maternal risk 1
• The International Atherosclerosis Society recommends that statins and other systemically absorbed cholesterol-lowering drugs should ideally be discontinued during lactation 2
• The American College of Cardiology advises that lipid-lowering therapy may be resumed after completion of breastfeeding, allowing mothers to breastfeed for the desired duration 2

Rationale for Avoidance

The concern is based on mechanism of action, not proven harm:

• 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
• Limited data from case reports indicate that rosuvastatin is present in human milk 3
• The FDA drug label for rosuvastatin explicitly advises that breastfeeding is not recommended during treatment based on the mechanism of action and potential for serious adverse reactions 3

Safe Alternative: Bile Acid Sequestrants

If cholesterol management is absolutely necessary during breastfeeding:

• Bile acid sequestrants are the only lipid-lowering medications considered safe during breastfeeding because they are not systemically absorbed 2
• Both the European Society of Cardiology and International Atherosclerosis Society suggest these agents can be used during lactation if cholesterol management is necessary 2
• Monitor for vitamin K deficiency when using bile acid sequestrants during breastfeeding, as well as malabsorption of other fat-soluble vitamins and folate 2

Other Cholesterol-Lowering Medications to Avoid

All systemically absorbed lipid-lowering agents should be avoided:

• Ezetimibe, PCSK9 inhibitors, bempedoic acid, fibrates, and niacin should all be avoided during breastfeeding due to insufficient safety data 2

Emerging Research Context

Recent data on atorvastatin transfer is reassuring but does not change guideline recommendations:

• A 2024 case series found minimal transfer of atorvastatin into human milk, with the highest weight-adjusted relative infant dose of 0.09%, far below established safety thresholds 4
• Despite this reassuring pharmacokinetic data, guidelines still recommend avoidance because the impact on milk composition in hyperlipidemia states (treated or untreated) is not well understood 4
• This research represents only three cases and does not override the consensus guideline recommendations from major cardiovascular societies 4

Clinical Decision Algorithm

For a breastfeeding mother requiring lipid management:

1. Discontinue the statin immediately upon initiation of breastfeeding 1
2. Assess the urgency of lipid-lowering therapy:
   • For primary prevention: therapy can safely be deferred until after breastfeeding completion 2
   • For extremely high-risk patients (homozygous familial hypercholesterolemia with established ASCVD): individual risk-benefit assessment with lipid specialist referral 2
3. If lipid management is deemed necessary: switch to bile acid sequestrants with monitoring for vitamin K deficiency 2
4. Resume statin therapy after completion of breastfeeding 2

Common Pitfalls to Avoid

• Failing to counsel women of childbearing age on reliable contraception while taking statins, and not planning the switch 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 the rare patient requiring lipid management 2
• Continuing statins for primary prevention during breastfeeding when the cardiovascular benefit during this period is negligible compared to theoretical infant risks 2