Is Dabigatran safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Dabigatran. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
In adults, less than 7% of dabigatran is absorbed orally in its prodrug form of dabigatran etexilate mesylate; dabigatran itself is not absorbed orally. Preliminary data indicate that dabigatran is poorly excreted into breastmilk and undetectable in breastfed infant plasma. If the mother requires dabigatran, it is not a reason to discontinue breastfeeding. Because data are limited, monitor preterm or newborn infants for signs of bleeding.[1,2]
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: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Dabigatran” (LM1170). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.