Ezetimibe Pregnancy and Breastfeeding Warnings

Brand names: Zetia

Ezetimibe Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: Concomitant therapy with a statin is contraindicated during pregnancy.
-Refer to the manufacturer product information for any statin, fenofibrate, or other LDL-C lowering therapy used in combination with this drug for additional recommendations on use during pregnancy.

Animal studies have failed to reveal evidence of direct or indirect harmful effects on pregnancy, embryofetal development, or on birth/postnatal development. Administration of this drug to pregnant animals during the period of organogenesis at doses ranging from 10 to 150 times the human exposure at the maximum recommended human dose (MRHD) resulted in an increased incidence of common fetal skeletal findings (e.g., extra thoracic ribs). Placental drug transfer was demonstrated in animal studies.

Administration of this drug in combination with a statin during animal studies resulted in higher exposures to this drug and/or the statin as compared to monotherapy; fetal abnormalities were observed. There were no adverse fetal effects observed when this drug was given concomitantly with fenofibrate at doses corresponding to 5 times (total ezetimibe) and 38 times (fenofibric acid) the anticipated MRHD. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Ezetimibe Breastfeeding Warnings

Use is considered acceptable; benefit to mother should outweigh risk to the infant.
-According to some authorities: Use is not recommended during lactation.

Excreted into human milk: Yes (in very low amounts)

Comments:
-If this drug is used in combination with a statin, treatment should be avoided (or may be contraindicated) in patients who are breastfeeding; consult the manufacturer product information.
-There are no data on the effects of this drug on the breastfed infant or on milk production.
-Case reports and pharmacokinetic models predict that serum levels in infants exposed to this drug during breastfeeding are considerably lower than in adults.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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