Use in pregnancy: Safety and efficacy of edoxaban have not been established in pregnant women. Studies in animals have shown reproductive toxicity. Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that edoxaban passes the placenta, Edoxaban (Lixiana) is contraindicated during pregnancy.
Use in lactation: Safety and efficacy of edoxaban have not been established in breast-feeding women. Data from animals indicate that edoxaban is secreted into breast milk. Therefore Edoxaban (Lixiana) is contraindicated during breast-feeding. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy.