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Xarelto (Rivaroxaban) Lawsuit FAQ

What is Xarelto?

Xarelto (known generically as rivaroxaban) is an anticoagulant medication. Xarelto is a blood thinner and is used to prevent blood clots and strokes.

What are the concerns about Xarelto?

The main concern about Xarelto is that it, like other blood thinners, comes with an increased risk of uncontrolled bleeding (hemorrhaging). This uncontrolled bleeding can mean that a patient taking Xarelto could suffer a severe bleeding event due to minor injuries. For example, a minor fall that results in slight internal bleeding could potentially be fatal.

There is currently no antidote to Xarelto.

Xarelto has been shown to be less likely than warfarin to cause a hemorrhagic stroke (a stroke caused by bleeding into the brain).

How does Xarelto compare with similar drugs?

Xarelto is similar to Coumadin (warfarin) and Pradaxa (dabigatran). All three are anticoagulant medications that could result in uncontrolled bleeding events. Warfarin, however, has an antidote in the form of vitamin K. This antidote means that when a patient taking warfarin suffers a serious bleeding event, the patient can be given vitamin K, which might reduce the effects of the bleeding or stop it entirely.

No such antidote to Xarelto is currently approved for use in the US.

What does the FDA say about Xarelto?

The FDA notes that there is a concern about severe, uncontrolled bleeding in patients taking Xarelto, but believes that because Xarelto has less risk of hemorrhagic bleeding, the benefits outweigh the risks. The agency also noted in an article (7/17/14) that most bleeding events linked to anticoagulant medications are not life-threatening and not serious when compared with the risk of stroke.

Have there been lawsuits filed regarding Xarelto?

Yes, a lawsuit has been filed against the maker and marketer of Xarelto, alleging the drug has unreasonable risks and should not have been made and sold. The plaintiff in the lawsuit alleges that she suffered severe internal and gastrointestinal bleeding as a result of taking Xarelto. The lawsuit is Stuntebeck v. Janssen Research & Development LLC et al, Case No. 140201754 in the Court of Common Pleas of Philadelphia County.