Evidence Shows that Xarelto is Passed From Mother to Fetus

There is now documented evidence that Xarelto (rivaroxaban), the controversial anticoagulant used to reduce blood clots in patients with atrial fibrillation, transfers rapidly back and forth across the placenta between mother and fetus when ingested during pregnancy.

A research team with The Motherisk Program at the Hospital for Sick Children in Toronto was tasked with studying the degree of transfer of the anticoagulant across the placenta from the mother to the fetus, potentially causing side effects. The findings, published last week in the American Journal of Obstetrics & Gynecology, are said to be the first clear evidence of the back and forth transfer of Xarelto between mother and the unborn fetus.

“This is the first direct evidence of rivaroxaban transfer across the term human placenta from both the mother to the fetus and fetus to mother,” the researchers concluded. “Additional studies will need to explore its safety before administering rivaroxaban to a pregnant woman.”

A history of troubling Xarelto side effects

Xarelto has had a troubled history to date because of reported adverse events involving uncontrolled bleeding among users. The problem is made more frightening because when a bleeding event occurs, there is no antidote available to stop the blood flow. These findings are disturbing because anticoagulant therapy is often required in cases of high-risk pregnancy. The anticoagulant thins the blood and helps prevent venous thromboembolism following surgery, atrial fibrillation, and congestive heart failure. If a bleeding event occurs in the fetus in the presence of rivaroxaban (Xarelto), the fetus will be at risk.

Coumadin, also known as warfarin, had been the industry standard among anticoagulants, until the introduction of the new generation of blood thinners. Xarelto, introduced in 2011, was marketed as a more convenient medication because, unlike warfarin, there is no regular blood monitoring, no dietary restrictions, and no need for frequent dosage adjustment.

The most serious downside is that, unlike warfarin, there is no known antidote for a bleeding event with Xarelto. Researchers did not draw any conclusions about the potential link between Xarelto and birth defects when the medication is used during pregnancy, but indicated that further studies are needed to explore the potential Xarelto pregnancy risks.

Are uncontrolled bleeding and other potential Xarelto side effects worth the risk?

Hundreds of Xarelto lawsuits are now being pursued in state and federal courts with the common claim that users were not provided sufficient warning of the risks of uncontrolled bleeding, possibly leading to severe injury or death. They also claim that testing was insufficient to establish how serious Xarelto side effects could be before introducing it to the market.

All Xarelto bleeding lawsuits filed in federal court have now been centralized in a multidistrict litigation (MDL) before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana for coordinated pretrial proceedings.

The first federal bellwether Xarelto trials are expected to begin in August 2016 so plaintiffs and the defense can see how evidence and testimony may play out before a jury.

Resources Resources