The safety of direct oral anticoagulants use during lactation: A systematic review.

INTRODUCTION

Direct Oral Anticoagulants (DOACs) are generally not recommended during breastfeeding due to limited data on milk transfer and potential effects on the infant. The main advantages of DOACs over the other anticoagulants are absence of a need for regular laboratory monitoring, rapid onset of action, fewer drug and food interactions, fixed dosing and short half-life. We conducted a systematic review of published evidence aiming to understand the effects of DOACs in breast milk and the consequences for the breastfed infant.

METHODS

This systematic review was conducted in adherence to the PRISMA. PubMed, Cochrane, and Embase were systematically searched up to June 2025. Data was descriptively synthesized.

RESULTS

Of the 301 citations identified, 21 full-text articles were assessed for eligibility and 5 studies met our inclusion criteria. The studies enrolled 12 lactating women and 3 breastfed infants, with infants evaluated only in one case series. For apixaban, a Relative Infant Dose (RID) of 18% and of 12.78% and a milk-to-plasma ratio of 2.61 was observed. Rivaroxaban does transfer into breast milk, but the RIDs in the women were all below 10%. Plasma rivaroxaban concentrations in the infants, measured 2 h after breastfeeding, were below the lower limit of quantification. Dabigatran did not produce a significant impact on neonatal TT, FIIa, or plasma Clauss-fibrinogen levels.

CONCLUSION

Available evidence on the use of DOACs during lactation is extremely limited and of low certainty. Consequently, no definitive conclusions regarding safety or clinical use during breastfeeding can be drawn.