Last update April 15, 2024

Ezetimibe

Decreased level of risk

New scientific evidences have driven the Apilam staff to update the level of risk associated to this product.
Former level of risk, which was Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment., is now set to Safe. Compatible. Minimal risk for breastfeeding and infant.

Level of risk reviewed on April 10, 2024

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

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.


See below the information of this related product:

Alternatives

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Ezetimibe in other languages or writings:

Tradenames

Main tradenames from several countries containing Ezetimibe in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 35 - 60 %
Molecular weight 409 daltons
Protein Binding 88 - 100 %
VD 1.54 l/Kg
pKa 9.48 -
Tmax 4 - 12 hours
22 hours
Theoretical Dose 0.0004 mg/Kg/d
Relative Dose 0.06 - 0.24 %

References

  1. Yeung CHT, Autmizguine J, Dalvi P, Denoncourt A, Ito S, Katz P, Rahman M, Theoret Y, Edginton AN. Maternal Ezetimibe Concentrations Measured in Breast Milk and Its Use in Breastfeeding Infant Exposure Predictions. Clin Pharmacokinet. 2024 Jan 26. Consulted on Jan. 31, 2024 Abstract
  2. AEMPS. Ezetimiba. Ficha técnica. 2016 Full text (in our servers)
  3. Lawrence RA, Lawrence RM. Breastfeeding. A guide for the medical profession. Eighth Edition. Philadelphia: Elsevier; 2016
  4. Merck. Ezetimibe Drug Summary. 2007 Full text (in our servers)

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