Pradaxa Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should avoid pregnancy during treatment with Pradaxa.
Pregnancy: There is limited amount of data from the use of Pradaxa in pregnant women.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Pradaxa should not be used during pregnancy unless clearly necessary.
Breast-feeding: There are no clinical data of the effect of dabigatran on infants during breast-feeding.
Breast-feeding should be discontinued during treatment with Pradaxa.
Fertility: No human data available.
In animal studies an effect on female fertility was observed in the form of a decrease in implantations and an increase in pre-implantation loss at 70 mg/kg (representing a 5-fold higher plasma exposure level compared to patients). No other effects on female fertility were observed. There was no influence on male fertility. At doses that were toxic to the mothers (representing a 5- to 10-fold higher plasma exposure level to patients), a decrease in foetal body weight and embryofoetal viability along with an increase in foetal variations were observed in rats and rabbits. In the pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams (a dose corresponding to a plasma exposure level 4-fold higher than observed in patients).