Statins and Anti-Cholesterol Drugs During Breastfeeding
Statins and other systemically absorbed cholesterol-lowering drugs should be avoided during breastfeeding and discontinued until breastfeeding is complete. 1
Primary Recommendation
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. 1 The International Atherosclerosis Society reinforces this, recommending that statins and other systemically absorbed cholesterol-lowering drugs should ideally be discontinued during lactation. 1
Rationale for Avoidance
- Statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, which may cause harm to the breastfed infant based on their mechanism of action. 2, 3
- The FDA drug labels for both rosuvastatin and pravastatin explicitly advise that breastfeeding is not recommended during treatment with these medications. 2, 3
- While recent research shows minimal transfer of atorvastatin into breast milk (relative infant dose of only 0.09%), this does not change the guideline-based recommendation to avoid statins during lactation. 4
Safe Alternative: Bile Acid Sequestrants
Bile acid sequestrants are the only lipid-lowering medications considered safe during breastfeeding because they are not systemically absorbed. 5
- These agents can be used during lactation if cholesterol management is necessary. 1, 5
- Monitor for vitamin K deficiency when using bile acid sequestrants during breastfeeding. 1, 5
- Also monitor for malabsorption of other fat-soluble vitamins and folate. 1
Other Cholesterol-Lowering Medications
Ezetimibe, PCSK9 inhibitors, bempedoic acid, fibrates, and niacin should all be avoided during breastfeeding due to insufficient safety data. 1, 5
- There is no available information on the presence of these drugs in human milk or their effects on breastfed infants. 1
- The recommendation is to discontinue these medications during lactation. 1
When to Resume Therapy
Lipid-lowering therapy may be resumed after completion of breastfeeding. 1, 5
- This allows mothers to breastfeed for the desired duration while managing their cardiovascular risk appropriately afterward. 5
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. 1, 5
- These patients should be counseled on intensive lifestyle modifications and referred to a lipid specialist. 1, 5
- Even in these exceptional cases, the default recommendation remains to avoid statins during breastfeeding unless the maternal risk is truly life-threatening. 1
Common Pitfalls to Avoid
- Failing to counsel women of childbearing age on reliable contraception while taking statins. 5
- Not switching to bile acid sequestrants before conception in women who require ongoing lipid management. 1, 5
- Overlooking vitamin K monitoring when bile acid sequestrants are used during lactation. 1, 5
- Unnecessarily discontinuing breastfeeding when bile acid sequestrants would be an appropriate alternative. 5