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Dabigatran Pregnancy and Breastfeeding Warnings

Dabigatran is also known as: Pradaxa

Dabigatran Pregnancy Warnings

Dabigatran has been assigned to pregnancy category C by the FDA. Dabigatran is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Animal studies have revealed evidence of decreased implantations when females and males were treated at doses about 2.5 to 3.0 times the human exposure. In addition, animals treated after implantation experienced an increase in the death of offspring and vaginal/uterine bleeding resulting in maternal death. Although treatment of animals caused an increased incidence of delayed or irregular ossification of fetal skull bones and vertebrae, it did not cause major malformations. There are no controlled data in human pregnancy.

Dabigatran Breastfeeding Warnings

There are no data on the excretion of dabigatran into human milk. The manufacturer recommends that caution be used when administering dabigatran to nursing women.

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