Rosuvastatin, pravastatin and atorvastatin are preferred; simvastatin and ezetimibe can also be used. Recommendations apply to full term and healthy infants.
This article includes the most commonly used medicines for lipid management. Many other lipid-lowering medicines are available and may need to be added in various combinations for more specialist situations. Contact our specialist service (SPS page) for further advice.
Recommendations
Some lipid-lowering medicines can be used during breastfeeding with caution. However, if possible, the preferred option would be to postpone lipid-lowering therapy until after the exclusive breastfeeding period.
If statin (HMG CoA reductase inhibitor) therapy is required, rosuvastatin, pravastatin and atorvastatin are preferred, since some evidence is available to support their use.
Simvastatin or ezetimibe can also be used with caution.
If lipid-lowering therapy is taken whilst breastfeeding, precautionary monitoring of infant growth and weight gain is recommended.
Effect on cholesterol
There are concerns that lipid-lowering medicines could affect the essential cholesterols and lipids needed for infant development. However, this is not proven.
Although there is very limited evidence for the use of lipid-lowering medicines while breastfeeding, the reduction in cholesterol in the breast milk is only likely to be to near-normal levels.
There is no evidence that this reduction has any adverse effects on the growth and development of breastfed infants. The infant’s cholesterol intake from breast milk would still be higher than with standard formula milks, which do not contain any cholesterol.
There is also concern that the amounts of lipid-lowering medicines found in breast milk could affect lipid metabolism in the infant. Again, there is no evidence to prove this, and a case report showed no effects on serum cholesterol and triglyceride levels measured in one breastfed infant.
Low infant exposure expected
The pharmacokinetic properties of statins and ezetimibe are favourable. High protein binding, large volume of distribution, or relatively high molecular weight would make significant transfer into breast milk unlikely.
In addition, statins and ezetimibe have very poor oral bioavailability, so small amounts that might pass into breast milk are unlikely to be absorbed by the infant in any significant amount.
Side-effects, or clinical effects on the infant’s cholesterol level, are therefore not anticipated.
Clinical considerations
The preferred option is to postpone treatment for a short time until after the exclusive breastfeeding period. This is unlikely to have a negative impact on the management of hypercholesterolaemia in the long-term.
In some cases, it may not be appropriate to postpone treatment, especially if it has already been withheld during previous pregnancies or breastfeeding periods. Consideration should also be given to the cardiovascular risks of untreated high cholesterol.
If immediate treatment is necessary, the choice of medicine should primarily focus on effectively reducing cholesterol, and associated cardiovascular risks. Suitability in breastfeeding is a secondary consideration.
Specific recommendations
Use with caution
Atorvastatin can be used with caution while breastfeeding, but infant monitoring is still required.
Infant monitoring
As a precaution, monitor that the infant is feeding well, and growing and gaining weight as expected. Also monitor the infant for potential side effects including diarrhoea, constipation, and irritability.
Monitoring the infant should quickly identify potential issues. However, further investigation is usually required before a cause can be attributed to the medicine.
Further Information
Very limited published evidence shows negligible levels in breast milk (0.05% to 0.09% of the weight-adjusted maternal dose) with doses up to 80mg daily. There are no data on infant serum levels, but minimal absorption by the infant is expected based on the medicine’s properties.
Eleven breast fed infants whose mothers were taking atorvastatin (40mg or 80mg daily) or other unspecified statins, were followed up to school age and showed no adverse effects on learning and development.
No side effects or developmental concerns were reported in two partially breastfed infants whose mothers were taking atorvastatin (20mg and 40mg daily).
Use with caution
Pravastatin can be used with caution while breastfeeding, but infant monitoring is still required.
Infant monitoring
As a precaution, monitor that the infant is feeding well, and growing and gaining weight as expected.
Monitoring the infant should quickly identify potential issues. However, further investigation is usually required before a cause can be attributed to the medicine.
Further Information
Very limited published evidence shows negligible (0.13% to 0.21% of the weight-adjusted maternal dose) or undetectable levels in breast milk with doses up to 40mg daily. There are no data on infant serum levels, but minimal absorption by the infant is expected based on the medicine’s properties.
There is no specific published evidence looking at infant side effects with pravastatin exposure via breast milk.
Use with caution
Rosuvastatin can be used with caution while breastfeeding, but infant monitoring is still required.
Infant monitoring
As a precaution, monitor that the infant is feeding well, and growing and gaining weight as expected. Also monitor the infant for potential side effects including constipation, lethargy, and irritability.
Monitoring the infant should quickly identify potential issues. However, further investigation is usually required before a cause can be attributed to the medicine.
Further Information
Very limited published evidence shows that levels in breast milk are very small (0.6% to 1.5% of the weight-adjusted maternal dose) with doses up to 40mg daily. There are no data on infant serum levels, but minimal absorption by the infant is expected based on the medicine’s properties.
No effects on cholesterol levels or development were observed in a 13 month old infant who was followed up for 5 months after his mother started taking rosuvastatin 10mg daily while breastfeeding.
Use with caution
Simvastatin can be used with caution and infant monitoring during breastfeeding, but other statins are preferred.
Infant monitoring
As a precaution, monitor that the infant is feeding well, and growing and gaining weight as expected.
Monitoring the infant should quickly identify potential issues. However, further investigation is usually required before a cause can be attributed to the medicine.
Further Information
There is no published evidence about the use of simvastatin in breastfeeding, or its transfer into breast milk. Theoretically, low milk levels and minimal absorption by the infant are expected, due to the medicine’s properties.
There is no specific published evidence looking at infant side effects with simvastatin exposure via breast milk.
Use with caution
Ezetimibe can be used with caution and infant monitoring during breastfeeding, but statins are preferred.
Infant monitoring
As a precaution, monitor that the infant is feeding well, and growing and gaining weight as expected. Also monitor the infant for potential side effects including diarrhoea, abdominal pain, flatulence, lethargy and irritability.
Monitoring the infant should quickly identify potential issues. However, further investigation is usually required before a cause can be attributed to the medicine.
Further Information
Very limited published evidence shows that levels in breast milk are negligible (less than 0.3% of the weight adjusted maternal dose), and infant serum levels were predicted to be low by a pharmacokinetic simulated model. Minimal absorption by the infant is also expected based on the medicine’s properties.
There is no published evidence looking at infant side effects with ezetimibe exposure via breast milk.
the medicine in question is not included in our advice
the infant is unwell or premature
multiple medicines are being taken
About our recommendations
Recommendations are based on published evidence where available. However, evidence is generally very poor and limited, and can require professional interpretation. Assessments are often based on reviewing case reports which can be conflicting and lack detail.
If there is no published clinical evidence, assessments are based on: pharmacodynamic and pharmacokinetic principles, extrapolation from similar drugs, risk assessment of normal clinical use, expert advice, and unpublished data. Simulated data is now increasingly being used due to the ethical difficulties around gathering good quality evidence in this area.