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Fondaparinux Pregnancy and Breastfeeding Warnings

Fondaparinux is also known as: Arixtra, Arixtra 10 mg/dose, Arixtra 5 mg/dose, Arixtra 7.5 mg/dose

Fondaparinux Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: B

Animal studies did not show fetal harm. This drug crossed the placenta in animal models. There are no adequate or well-controlled studies in pregnant women. 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.

See references

Fondaparinux Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Lagrange F, Brun JL, Vergnes MC, et al. "Fondaparinux sodium does not cross the placental barrier: study using the in-vitro human dually perfused cotyledon model." Clin Pharmacokinet 41 Suppl 2 (2002): 47-9
  4. "Product Information. Arixtra (fondaparinux)." Organon, West Orange, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Arixtra (fondaparinux)." Organon, West Orange, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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