Does Eliquis (apixaban) affect breastfeeding?

Eliquis (Apixaban) and Breastfeeding

Eliquis (apixaban) should not be used during breastfeeding due to lack of safety data in humans and evidence of significant drug accumulation in breast milk from animal studies. 1, 2

Primary Recommendation

The FDA drug label explicitly states that breastfeeding is not recommended during treatment with apixaban tablets because there are no data on the presence of apixaban or its metabolites in human milk, and the effects on the breastfed child are unknown. 2

Evidence Supporting This Recommendation

Animal Data Raises Serious Concerns

• In lactating rats, apixaban accumulates in milk at a 30:1 milk-to-plasma ratio, indicating substantial drug concentration in breast milk. 2

• Maximal milk concentrations were observed 6 hours after dosing in animal studies, demonstrating prolonged exposure potential. 2

• While animal milk concentrations don't directly predict human milk levels, the magnitude of accumulation (30-fold) is concerning for potential infant exposure. 2

Human Data is Completely Lacking

• There are zero adequate studies on apixaban excretion into human breast milk or its effects on breastfed infants. 2

• A 2021 systematic review found that apixaban milk excretion data, when available, exceeded the maximum allowed safety range for breastfeeding medications. 3

• The International Society on Thrombosis and Haemostasis (ISTH) guidelines explicitly state that DOAC product labels recommend against use during breastfeeding due to insufficient data. 1

Safe Alternatives for Anticoagulation During Breastfeeding

If anticoagulation is required during breastfeeding, warfarin or low molecular weight heparin (LMWH) are the preferred agents with established safety profiles. 4, 5

Warfarin as First-Line Alternative

• The American Society of Hematology (ASH) 2018 guidelines strongly recommend warfarin as a safe option for breastfeeding women requiring anticoagulation. 4

• Warfarin is highly protein-bound, polar, and nonlipophilic, making it unlikely to be excreted in significant amounts into breast milk. 4

• Studies of 13 women found no detectable warfarin levels in breast milk or infant plasma, with no cases of infant bleeding reported. 4

LMWH as Alternative Option

• LMWH is among the agents with the greatest experience and best evidence for safety in breastfeeding women. 4

• LMWH, along with warfarin and acenocoumarol, represents the preferred anticoagulant choices during lactation. 4

Clinical Decision-Making Algorithm

When a breastfeeding woman requires anticoagulation:

1. Discontinue apixaban immediately 1, 2

2. Switch to warfarin or LMWH based on:

   • Patient ability to attend regular INR monitoring (required for warfarin) 4
   • Patient preference for oral vs. subcutaneous administration 4
   • Clinical indication and efficacy requirements 4

3. Do not attempt to "pump and dump" or time breastfeeding around apixaban doses - the lack of safety data makes any exposure unacceptable 2

Critical Pitfalls to Avoid

• Do not assume that because apixaban is "newer" it is safer - the opposite is true; older agents like warfarin have decades of safety data in breastfeeding. 4

• Do not advise temporary discontinuation of breastfeeding while on apixaban - switch to a proven safe anticoagulant instead to allow continued breastfeeding. 1, 2

• Do not rely on the relative infant dose calculation - without human milk concentration data, this cannot be accurately determined for apixaban. 3

Comparison with Other DOACs

• All direct oral anticoagulants (DOACs) should be avoided during breastfeeding. 4, 5

• Among DOACs studied, dabigatran has the least excretion in human breast milk, while apixaban shows the greatest excretion beyond acceptable ranges. 3

• Rivaroxaban has been detected in human breast milk in small amounts, but safety has not been established. 6

• The ASH guidelines strongly recommend against use of any DOAC in breastfeeding women due to limited data on excretion and potential infant effects. 4