Pradaxa and Pregnancy

In animal studies of Pradaxa (dabigatran), the drug was shown to increase the risk of death for both the mother and the baby when very high doses were given to pregnant rats. Because of the potentially serious risks, the U.S. Food and Drug Administration has classified Pradaxa as a pregnancy Category C medication, meaning it may not be safe for women who are expecting.

Can Pregnant Women Take Pradaxa?

Pradaxa® (dabigatran etexilate mesylate) is a prescription anticoagulant ("blood thinner") medication. Based on the results of animal studies, Pradaxa may not be safe for use during pregnancy, although the full risks are currently unknown.
 

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. A pregnancy Category C classification is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies.
 
Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to rats at high doses, Pradaxa decreased the number of implantations. This implies that the medication could possibly contribute to infertility. When the drug was given to pregnant rats, high doses of Pradaxa increased the risk of death (for both the mother and baby rats) during labor, due to excessive vaginal and uterine bleeding.
 
It is important to remember that Pradaxa can be a life-saving drug and is used in serious situations. In some cases, the benefits to the mother might outweigh the risks to the fetus. These issues should be discussed with your healthcare provider.
 
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