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Using oral anticoagulants during breastfeeding

Last updated See all updates
Topics: ApixabanDabigatran etexilateEdoxaban · Haematological disordersRivaroxabanSafety in BreastfeedingWarfarin ·

Warfarin is the preferred choice during breastfeeding; rivaroxaban or dabigatran may also be used. Recommendations apply to full term and healthy infants.

Contents

  1. General considerations
  2. Recommendations
  3. Specific recommendations
  4. Warfarin
  5. Direct Oral Anticoagulants (DOACs)
    1. Dabigatran etexilate
    2. Rivaroxaban
    3. Apixaban
    4. Edoxaban
  7. Patient Information
  8. Contact us
  9. About our recommendations
  10. Bibliography
  11. Update history

General considerations

It is important to complete an individual risk assessment for your patient and to apply the principles of prescribing in breastfeeding when looking at the available information and making treatment decisions.

Recommendations

Warfarin is the preferred oral anticoagulant to use during breastfeeding due to wider experience and no reported infant side effects.

There is less published evidence for direct oral anticoagulants (DOACs).  Dabigatran or rivaroxaban can be used if clinically indicated based on passage into breast milk, the amount likely to be absorbed by the infant and the availability of published evidence.

Treatment choice should primarily be directed at controlling symptoms, with safety in breastfeeding a secondary consideration.

See also our guidance on heparins in breastfeeding.

Specific recommendations

Warfarin

Preferred choice

Warfarin can be used during breastfeeding, although infant monitoring is required.

Infant monitoring

As a precaution, monitor the infant for bruising on the skin, blood in urine, vomit, or stools.

Monitoring the infant will quickly pick up any potential issues but usually further investigation is required before the cause can be attributed to the medicine.

Further information

There is a moderate amount of published evidence of use during breastfeeding. Warfarin is highly protein bound and negligible amounts pass into breast milk (0.01% of the weight-adjusted maternal dose). Plasma levels of warfarin were undetectable in infants exposed to warfarin via breast milk.

No side effects have been reported in breastfed infants who have been exposed. Even in a case of accidental maternal overdosing, the breastfed infant did not show any clinical problems and coagulation tests were not altered.

Direct Oral Anticoagulants (DOACs)

Dabigatran etexilate can be used during breastfeeding, although infant monitoring is required.

Infant monitoring

As a precaution, monitor the infant for bruising on the skin, blood in urine, vomit, or stools.

Monitoring the infant will quickly pick up any potential issues but usually further investigation is required before the cause can be attributed to the medicine.

Further information

There is very limited published evidence of use during breastfeeding. Dabigatran etexilate is a large molecule and has a large volume of distribution, therefore it would be expected to pass into breast milk in negligible amounts.

The active compound, dabigatran, has very low oral bioavailability.  Therefore any dabigatran that is excreted into breast milk is unlikely to be absorbed in clinically significant amounts by the infant.

Dabigatran levels were measured in breastmilk from two breastfeeding women who took dabigatran etexilate 220mg as a single dose. The weight-adjusted maternal dose was calculated to be between 0.05 and 0.32%. The infants did not receive any breast milk during this time.

There is no published evidence of infants being exposed to dabigatran though breastmilk, however infant side effects are not expected.

Rivaroxaban can be used during breastfeeding, although infant monitoring is required.

Infant monitoring

As a precaution, monitor the infant for bruising on the skin, blood in urine, vomit, or stools.

Monitoring the infant will quickly pick up any potential issues but usually further investigation is required before the cause can be attributed to the medicine.

Further information

There is limited published evidence of use during breastfeeding.

Although rivaroxaban has a high oral bioavailability, very low levels are expected in milk due to its other pharmacokinetic properties, so infant exposure should still be minimal.

Limited evidence from maternal doses between 15 and 30mg rivaroxaban daily have reported very small amounts in breast milk, (weight-adjusted maternal dose 1.3% to 5%).

Blood samples from three new-born breastfed infants, whose mothers were taking rivaroxaban 15mg daily, showed undetectable levels of rivaroxaban.

From the limited published evidence, no side effects have been observed in infants after exposure to rivaroxaban through breast milk.

Not recommended for use

Apixaban is not recommended for use during breastfeeding.  Dabigatran or rivaroxaban are preferred.

Further information

Due to its pharmacokinetic properties, clinically significant amounts of apixaban may pass into breast milk. Limited evidence from four women taking apixaban 5mg twice daily indicates that levels in breast milk are moderate to significant, with weight-adjusted maternal dose between 12.8 and 21%.

None of the infants was breastfed, so it is unknown how much the infant will absorb, and whether this will be clinically significant.

Until further published evidence is available, apixaban is not recommended during breastfeeding.

Not recommended for use

Edoxaban is not recommended for use during breastfeeding.  Dabigatran or rivaroxaban are preferred.

Further information

Only small amounts of edoxaban are expected to pass into breastmilk based on its pharmacokinetic properties.

However, since there is no published evidence available, edoxaban is not recommended during breastfeeding.

Patient Information

The NHS website provides advice for patients on the use of specific medicines in breastfeeding.

Contact us

Get in touch with the UK Drugs In Lactation Advisory Service (UKDILAS), our specialist breastfeeding medicines advice service if you need support in the following situations:

  • you need further advice
  • the medicine in question is not included here
  • the infant is unwell or premature
  • multiple medicines are being taken

About our recommendations

Recommendations are based on published evidence where available. However, evidence is generally very poor and limited, and can require professional interpretation. Assessments are often based on reviewing case reports which can be conflicting and lack detail.

If there is no published clinical evidence, assessments are based on: pharmacodynamic and pharmacokinetic principles, extrapolation from similar drugs, risk assessment of normal clinical use, expert advice, and unpublished data. Simulated data is now increasingly being used due to the ethical difficulties around gathering good quality evidence in this area.

Bibliography

Full referencing is available on request.

Update history

  1. Republished
  2. Full clinical update and rewrite
  1. Minor title amendment
  1. Published