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Ezetimibe Pregnancy and Breastfeeding Warnings

Ezetimibe is also known as: Zetia

Medically reviewed on November 27, 2017

Ezetimibe Pregnancy Warnings

Animal studies have revealed evidence of increased incidences of abnormal skeletal findings at higher doses. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

AU TGA pregnancy category: B3
US FDA pregnancy category: C

See references

Ezetimibe Breastfeeding Warnings

Use should be avoided; according to some experts, this drug may be used only if the potential benefit justifies the potential risk to the nursing infant.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

Due to concern over disruption of infant lipid metabolism, other agents are preferred, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. "Product Information. Zetia (ezetimibe)." Schering-Plough Corporation, Kenilworth, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Zetia (ezetimibe)." Schering-Plough Corporation, Kenilworth, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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