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Enoxaparin Pregnancy and Breastfeeding Warnings

Enoxaparin is also known as: Clexane, Clexane Forte, Lovenox, Lovenox HP

Medically reviewed on Apr 5, 2018

Enoxaparin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity. Reduced pup weights and increased postimplantation loss have been noted in rats and rabbits, respectively. In humans, hemorrhagic events and neonatal hemorrhage have occurred, but major congenital anomalies in live births occurred at rates similar to background rates. There have been postmarketing reports of fetal death, but causality has not been determined. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed.

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

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus and the mother. Preservative-free formulations are recommended if used during pregnancy.
-Pregnant women with thromboembolic disease, including those with mechanical prosthetic heart valves and those with inherited or acquired thrombophilia, have an increased risk of maternal complications and fetal loss.

See references

Enoxaparin Breastfeeding Warnings

Due to its relatively large molecular weight, this drug is not expected to undergo excretion into breast milk or to be absorbed from breast milk by the infant.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: This drug has been used without apparent harmful effects in the nursing infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Lovenox (enoxaparin)." Rhone-Poulenc Rorer, Collegeville, PA.

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Lovenox (enoxaparin)." Rhone-Poulenc Rorer, Collegeville, PA.

Further information

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

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