Is Ezetimibe safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Ezetimibe. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Data from 2 mothers indicate that levels of ezetimibe and its active metabolite appear in very low amounts in milk and serum levels in infants predicted by a pharmacokinetic model are considerably lower than in adults. Ezetimibe appears to be acceptable during breastfeeding. Ezetimibe in combination with a statin (e.g., atorvastatin, simvastatin) should be avoided in nursing mothers.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Two nursing mothers taking ezetimibe 10 mg daily donated a total of 15 milk samples for analysis of ezetimibe and ezetimibe glucuronide. In one mother, the highest drug concentrations were found in hindmilk at 2.08 hours after a dose. The ezetimibe concentration was 0.95 mcg/L, and the glucuronide concentration was 1.39 mcg/L. In the second mother, the highest ezetimibe concentration of 0.98 mcg/L occurred 5.22 hours after a dose between feedings and the highest ezetimibe glucuronide concentration of 2.65 mcg/L occurred 8.47 hours after a dose just after feeding. These values result in a total ezetimibe plus ezetimibe glucuronide relative infant dosages of about 0.16% and 0.25%, respectively. A computer model of ezetimibe during nursing was consistent with the observed levels and indicated that predicted serum levels in infants were considerably lower than in adults.[1]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Ezetimibe in pregnancy
LactMed covers breastfeeding only. For what the NHS and the US prescribing label say about pregnancy, see:
“No published information” means the studies do not exist yet — not that Ezetimibe is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Ezetimibe” (LM736). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.