Skip to Main Content
The first stop for professional medicines advice

Using lipid-lowering medicines during breastfeeding

Published
Topics: AtorvastatinCardiovascular system disordersEzetimibe · PravastatinRosuvastatinSafety in BreastfeedingSimvastatin ·

Rosuvastatin, pravastatin and atorvastatin are preferred; simvastatin and ezetimibe can also be used. Recommendations apply to full term and healthy infants.

Contents

  1. General considerations
  2. Recommendations
    1. Effect on cholesterol
    2. Side-effects are not expected
  4. Clinical considerations
  5. Specific recommendations
    1. Atorvastatin
    2. Pravastatin
    3. Rosuvastatin
    4. Simvastatin
    5. Ezetimibe
  7. Patient Information
  8. Contact us
  9. About our recommendations
  10. Bibliography

General considerations

It is important to complete an individual risk assessment (SPS page) for your patient and to apply the principles of prescribing in breastfeeding (SPS page) when looking at the available information and making treatment decisions.

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, the safest option would always be to postpone lipid-lowering therapy until after the exclusive breastfeeding period has finished.

If statin (HMG CoA reductase inhibitor) therapy is required, rosuvastatin, pravastatin and atorvastatin are preferred, since some evidence is available to support their use.

There is no published evidence for the use of simvastatin or ezetimibe during breastfeeding, but they 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 required 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.

Side-effects are not expected

The pharmacokinetic properties of statins 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 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.

Low levels of ezetimibe in milk are also expected, based on the pharmacokinetic properties.

Clinical considerations

Due to the lack of evidence in breastfeeding, and theoretical risks, use of lipid-lowering therapy should be considered on a case-by case basis.

Postponing treatment during the exclusive breastfeeding period is the preferred option, and 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 pregnancy. Consideration should also be given to the cardiovascular risks of untreated high cholesterol.

Treatment choice should primarily focus on effectively reducing cholesterol, and associated cardiovascular risks. Safety 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 for gastrointestinal disturbances, lethargy and irritability.

Further information

There is very limited published evidence about the use of atorvastatin in breastfeeding, and no published evidence about its transfer into breast milk. Theoretically, low milk levels and minimal absorption by the infant are expected, due to 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.

Use with caution

Pravastatin can be used with caution while breastfeeding, but infant monitoring is still required.

Infant monitoring

As a precaution, monitor that infants are feeding well, and growing and gaining weight as expected. Also monitor for gastrointestinal disturbances, lethargy and irritability.

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.

Preferred choice

Rosuvastatin can be used with caution while breastfeeding, but infant monitoring is still required.

Infant monitoring

As a precaution, monitor that infants are feeding well, and growing and gaining weight as expected. Also monitor for gastrointestinal disturbances, lethargy and irritability.

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.

There is no specific published evidence looking at infant side-effects with rosuvastatin exposure via breast milk.

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 infants are feeding well, and growing and gaining weight as expected. Also monitor for gastrointestinal disturbances, lethargy and irritability.

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 infants are feeding well, and growing and gaining weight as expected. Also monitor for gastrointestinal disturbances and lethargy.

Further information

There is no published evidence about the use of ezetimibe in breastfeeding, or its transfer into breast milk. Low milk levels are expected due to its large protein binding capacity. In addition it has poor oral bioavailability; therefore minimal absorption by the infant from breast milk would be expected.

There is no published evidence looking at infant side effects with ezetimibe exposure via breast milk.

Patient Information

The NHS website provides advice for patients on the use of specific medicines in breastfeeding.

Contact us

Get in touch with the UK Drugs In Lactation Advisory Service (UKDILAS) (SPS page), our specialist breastfeeding medicines advice service if you need support in the following situations:

  • you need further advice
  • 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.

Bibliography

Full referencing is available on request.