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Rivaroxaban Pregnancy and Breastfeeding Warnings

Rivaroxaban is also known as: Xarelto

Rivaroxaban Pregnancy Warnings

Animal studies have revealed evidence of reproductive toxicity (e.g., hemorrhagic complications) and embryofetal toxicity (e.g., post-implantation loss). Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. There are no controlled data in human pregnancy. Thrombolytic agents may lead to placental hemorrhage and subsequent prematurity and fetal loss. Use with caution in pregnancy because of the potential for pregnancy-related hemorrhage and/or emergent delivery with an anticoagulant that is not reversible. 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 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.

AU and UK: Use is contraindicated US: This drug should be used during pregnancy only if the benefit outweighs the risk AU TGA pregnancy category: C US FDA pregnancy category: C Comments: Use is only recommended in women of childbearing potential using adequate methods of contraception.

Rivaroxaban Breastfeeding Warnings

AU and UK: Use is contraindicated US: 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: The effects in the nursing infant are unknown.

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