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Ezetimibe is a reducer of intestinal absorption of cholesterol and phytosterols (AEMPS 2016, Merck 2007). Oral administration in a daily dose.
Its pharmacokinetic data (high binding to plasma proteins and very high volume of distribution) explain the very low excretion in breast milk found. (Yeung 2024)
Milk cholesterol levels are very stable, even in hypercholesterolemic women, and are not severely affected by diet or maternal nutritional status, suggesting that milk cholesterol is synthesized, at least in part, in the mammary gland (Lawrence 2016, p 289-90). It is therefore unlikely that ezetimibe is able to alter the lipid composition of milk.
Infants need to ingest high amounts of cholesterol as it is essential for the proper development of the nervous system and cell membranes and is a precursor of several hormones and vitamins.
Until more data is known regarding lactation, it may be prudent to avoid its use at least while breastfeeding is exclusive.
Discontinuing drug treatment of non-severe hyperlipidemias during the period of exclusive breastfeeding is not likely to alter the long-term outcome of the disease, especially when breastfeeding can be considered therapeutic (Lawrence 2016, p. 393). It is appropriate to follow a lipid-lowering diet and to practice regular exercise.
For considerations on the appropriateness of lipid-lowering treatment during lactation see Maternal hyperlipidemia, hypercholesterolemia, hypertriglyceridemia.
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