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Apixaban Pregnancy and Breastfeeding Warnings

Apixaban is also known as: Eliquis

Medically reviewed on January 16, 2017.

Apixaban Pregnancy Warnings

Animal studies did not show an increased risk of fetal malformations or toxicity, and no maternal or fetal deaths were attributed to bleeding. Increased maternal bleeding was seen at concentrations higher than the usual human exposure. 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.

Use is not recommended. (AU, UK)
This drug should be used during pregnancy only if the benefit outweighs the risk to the mother and fetus. (US)

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

Comments:
-Treatment can cause placental hemorrhage and subsequent fetal loss.
-Treatment increases the risk of hemorrhage during pregnancy and delivery.

See references

Apixaban Breastfeeding Warnings

Animal studies in lactation did not result in death of offspring. The drug was excreted in the milk of the animal model at a high milk to plasma ratio, possibly due to active transport.

A decision should be made to discontinue breast-feeding 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

The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Eliquis (apixaban)." Bristol-Myers Squibb Canada Inc, Montreal, IN.
  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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Eliquis (apixaban)." Bristol-Myers Squibb Canada Inc, Montreal, IN.

Further information

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

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