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Rivaroxaban Pregnancy and Breastfeeding Warnings

Rivaroxaban is also known as: Xarelto

Rivaroxaban Pregnancy Warnings

Animal studies have shown marked maternal hemorrhagic complication and an increased post-implantation pregnancy loss. In addition, increased fetal toxicity (at doses about 4 times the human exposure); decreased fetal body weights (at doses about 14 times the human exposure); and maternal bleeding and maternal and fetal death (at doses about 6 times the human exposure) were reported. No increased risk of structural malformation or impairment of fertility was observed. There are no controlled data in human pregnancy. 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.

FDA pregnancy category: C Potential benefit should outweigh the potential risk to mother and fetus. Comments: A discussion of pregnancy planning is warranted in women with reproductive potential.

Rivaroxaban Breastfeeding Warnings

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.

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