General considerations

It is important to complete an individual risk assessment for your patient and to apply the principles of prescribing in breastfeeding 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 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

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), 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.