A Virginia man has filed a lawsuit against the makers of a popular new anticoagulant, saying Xarelto caused severe blood loss that led to his wife’s death.

Marjorie S. took Xarelto from mid-August 2014 through mid-October 2014, but suffered internal bleeding around October 22, 2014.

Introduced in the U.S. in 2011, Xarelto belongs to a class of drugs called New Oral Anticoagulants (NOACs). Pradaxa and Eliquis belong to this class as well.

The NOACs have been promoted as a newer, slicker alternative to warfarin (Coumadin) because the NOACs only have to be taken once a day and no blood monitoring is required.

Uncontrollable bleeding can be a problem with any anticoagulant in the event of accident or injury, but warfarin has an antidote that stops its blood-thinning properties from continuing.

Because warfarin can have its action reversed in an emergency, it has been used as a relatively safe medication to prevent stroke and systemic embolism for the past 60 years.

The lawsuit claims Xarelto caused severe blood loss because there is no antidote for Xarelto.

Why Take Xarelto?

Xarelto is used to reduce the risk of stroke and blood clots in people with atrial fibrillation that is not caused by a heart valve issue.

It is also prescribed to treat deep vein thrombosis, which can lead to blood clots in the lungs, known as pulmonary embolisms.

It also is used to reduce the chance of a blood clot forming in the legs and lungs of people who have recently undergone knee or hip replacement surgery.

Xarelto Caused Severe Blood Loss in Many Patients

Xarelto bleeding injuries and failure to prevent a stroke or pulmonary embolism topped the list of adverse events submitted to the FDA last year, according to the Institute for Safe Medication Practices (ISMP). More than 1,100 patients died as a result.

Xarelto’s biggest selling points is that unlike warfarin, Xarelto does not need blood monitoring in order to ensure a therapeutic level is maintained.

The Institute for Safe Medication Practices noted in 2012 that during the FDA’s review process of Xarelto, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto because blood level studies had proven a more steady level in the blood stream could be established with twice daily dosing.

The twice-daily dosing was brought up in an FDA review of Xarelto after it submitted a clinical study called ROCKET AF, a clinical trial that was faulted for control groups that were poorly managed and treated inconsistently.

The FDA review said that “the sponsor’s rationale for evaluating only once daily dosing during Phase 3 is not strong. Most importantly, there is clinical information from Phase 2 trials… and from clinical pharmacology studies suggesting that twice daily dosing, which would produce lower peak blood levels and higher through blood levels of (Xarelto), might have been associated with greater efficacy and/or a better safety profile.”

The Xarelto Wrongful Death Lawsuit is filed under MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana.