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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Dabigatran

Last Revision: November 16, 2020.

Estimated reading time: 1 minute

CASRN: 211914-51-1

image 135134764 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

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 from 2 individuals indicate that dabigatran is poorly excreted into breastmilk and unlikely to affect the breastfed infant. However, because no information is available on the effect in breastfed infants, some expert opinion (prior to the study on the drug excretion into milk) suggests that an alternate drug is preferred while nursing a newborn or preterm infant.[1,2]

Drug Levels

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). Dabigratin 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.[3]

Infant Levels. Measurements of dabigatran in infant plasma after breastfeeding have not been made. However, based on data from 2 infants and assuming complete dabigatran absorption by the infant, investigators estimated that infant plasma levels would be less than 0.1 ng/L on days 1, 3 and 5 postpartum with a maternal dosage of 220 mg of dabigatran etexilate mesylate.[3]

Effects in Breastfed Infants

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.[3]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1.
Vanassche T, Vandenbriele C, Peerlinck K, et al. Pharmacotherapy with oral Xa inhibitors for venous thromboembolism. Expert Opin Pharmacother. 2015;16:645–58. [PubMed: 25554350]
2.
Cohen H, Arachchillage DR, Beyer-Westendorf J, et al. Direct oral anticoagulants and women. Semin Thromb Hemost. 2016;42:789–97. [PubMed: 27706531]
3.
Ayuk P, Kampouraki E, Truemann A, et al. Investigation of dabigatran secretion into breast milk: Implications for oral thromboprophylaxis in post-partum women. Am J Hematol. 2020;95:E10–E3. [PubMed: 31599003]

Substance Identification

Substance Name

Dabigatran

CAS Registry Number

211914-51-1

Drug Class

Breast Feeding

Lactation

Anticoagulants

Antithrombins

Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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