Could Xarelto pose a risk to an unborn child? A newly-published study suggests that the medication is able to cross the human placental barrier when it is used by pregnant women. Whether this poses any danger to a developing fetus is not clear.
The study, which appeared last month in the American Journal of Obstetrics & Gynecology, was conducted by researchers with The Motherisk Program at the Hospital for Sick Children in Toronto, Canada. Using an ex-vivo placenta perfusion model, and adding Xarelto to either the maternal or fetal circulation only, the study team was able to determine that there was “rapid transfer” of Xarelto from the mother to the fetus and from the fetus to the mother. A 69% transfer ratio was observed in both directions after just three hours.
While the study authors were able to conclude that Xarelto does cross the human placental barrier at a rapid rate, they did not draw any conclusions about its potential to actually harm a fetus. Among other things, the researchers noted that Xarelto’s active ingredient is highly bound to plasma protein, which suggests the amount of unbound drug that may reach the fetus is likely much lower. “Additional studies will need to explore its safety before administering rivaroxaban to a pregnant woman,” they wrote.
Xarelto (rivaroxaban) was brought to the U.S. market in 2011. Because the drug’s pregnancy risks have not yet been determined, the U.S. Food & Drug Administration (FDA) has placed Xarelto in Pregnancy Category C. While animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, Xarelto’s label states that its potential benefits may warrant its use in pregnant women.
Like other blood thinners, Xarelto may cause episodes of serious internal bleeding. However, unlike an older anticoagulant called warfarin, no antidote has been approved to reverse Xarelto bleeding. The drug’s label also includes a black box warning that contains information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation.
More than 500 Xarelto lawsuits are currently pending in federal court, all of which were filed on behalf of patients who allegedly suffered serious complications related to uncontrollable internal bleeding. They accuse the drug’s manufacturers of failing to provide patients and doctors with adequate warnings regarding these risks, and of wrongly marketing Xarelto as a superior alternative to warfarin.
Bernstein Liebhard LLP is already representing plaintiffs in Xarelto bleeding claims. If you were harmed by this drug, please call to learn more about your available legal options.