Xarelto and Pregnancy

Although Xarelto (rivaroxaban) has not been adequately studied in pregnant women, animal studies have shown that using high doses of this drug may cause miscarriages, low fetal weights, or bleeding in the mothers. Due to the potential risks, the FDA has classified Xarelto as a pregnancy Category C medicine, meaning it should only be used by pregnant women if the benefits clearly outweigh the risks.

Can Pregnant Women Take Xarelto?

Xarelto® (rivaroxaban) is a prescription medication approved to prevent blood clots after a surgery to replace a hip or a knee. It also prevents blood clots and strokes in people with an irregular heart rhythm known as atrial fibrillation. Most recently, it was also approved for the treatment of blood clots (as well as to prevent such clots from recurring). Based on the results of animal studies, Xarelto may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Xarelto is classified as a pregnancy Category C drug. The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is used during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Xarelto has not been adequately studied in pregnant humans. However, when given to pregnant rabbits at extremely high doses (equivalent to 11 times the usual dose in humans), Xarelto increased the risk for miscarriages. When extremely high doses were given to pregnant rats, it increased the risk for low fetal weights and caused bleeding in the mother rats. The drug did not cause any birth defects.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including Xarelto, may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
There is little experience with the use of this medication during pregnancy. Heparin or low-molecular-weight heparin medications are usually the preferred anticoagulants for pregnant women. However, there may be rare cases in which a pregnant woman may not be able to take heparin or a low-molecular-weight heparin, usually due to an allergy or severe reaction. In such cases, Xarelto might be an acceptable alternative, at least theoretically.
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