Is Dabigatran safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Dabigatran. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Samples of newborn and preterm infant blood spiked with of dabigatran in the concentrations found in breastmilk after a 220 mg dose of dabigatran etexilate indicate that no effect on coagulation would occur.[ 1 ]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. In preliminary results from a study on dabigatran in breastmilk, two patients received oral dabigatran etexilate 220 mg (2.5 and 2.7 mg/kg dabigatran). Dabigatran was first detectable in milk 2 to 3 hours after the dose. Peak milk levels occurred at 7 hours after the dose. Milk concentrations at this time were 8.2 mcg/L and 52.6 mcg/L, respectively. Average maximum estimated daily infant dosages on day 5 postpartum were 0.35 and 2.7 mcg/kg, respectively. These values corresponded to weight-adjusted dosages of 0.01 and 0.07% of the maternal dosage. On days 1 and 3 postpartum, estimated dosages were somewhat less.[ 1 ] A preliminary physiologically based pharmacokinetic model was validated using these patients data predicted a steady-state RID of 0.013% with a daily dose of 220 mg of dabigatran etexilate mesylate.[ 3 ] A postpartum woman was prescribed dabigatran etexilate 220 mg once daily for 7 days for primary VTE prophylaxis. She took her dose for 3 days in the afternoon, then at 7 am on the next day when a milk sample was taken at 9 am. The concentration in milk was below the lower limit of quantification ( 2.3 mcg/L).[ 4 ] Infant Levels. A postpartum woman was prescribed dabigatran etexilate 220 mg once daily for 7 days for primary VTE prophylaxis. She took her dose for 3 days in the afternoon, then at 7 am on the next day when an infant plasma sample was taken at 9 am. The infant plasma concentration of dabigatran was below the detection limit ( 2 mcg/L).[ 4 ]
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.