Dabigatran Pregnancy and Breastfeeding Warnings

Dabigatran is also known as: Pradaxa

Dabigatran Pregnancy Warnings

AU: Use should be avoided. UK: Use is not recommended unless clearly needed. US: Safety has not been established during pregnancy. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: Safety and effectiveness of this drug during labor and delivery have not been study in clinical trials. Consider the risks of bleeding and stroke in using this drug in this setting. Women of childbearing potential should avoid pregnancy during treatment with dabigatran.

Small amounts of dabigatran and/or its metabolites have been shown to cross the placenta in animal studies, and 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. Studies in rats have shown that small amounts of dabigatran and/or its metabolites cross the placenta. 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. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Dabigatran Breastfeeding Warnings

AU, UK: Use is not recommended. US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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