A woman has filed suit against the makers of a recently released anticoagulant, alleging she suffered gastrointestinal bleeding from Xarelto (rivaroxaban).

Gloria W. took the blood thinner from August 2013 through early October 2015 and again from February through October of 2016.

She became anemic around Feb. 23, 2016 and experienced chronic blood loss anemia on May 21, 2016. Gloria was diagnosed with gastrointestinal bleeding from Xarelto in both September and October of 2016.

Xarelto is one of the newer blood thinners created to compete with Coumadin (warfarin), which needs close blood-level monitoring. Coumadin’s anticoagulating effects can be compromised, however, by administering vitamin K in the event of a bleeding emergency.

There is no such antidote for Xarelto.

Studies Indicate Possible Gastrointestinal Bleeding from Xarelto

The FDA approved Xarelto in July 2011 for the prevention of deep vein thrombosis (DVT) and pulmonary embolisms (PE) in patients receiving hip or knee replacement surgeries.

That FDA approval was based upon clinical trials known as the “Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism” studies (RECORD).

The RECORD studies reportedly showed that Xarelto was a superior blood thinner, but the FDA took issue with the studies because they included “’systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’”

But even though the RECORD studies were not reliable, the FDA provided additional approval for Xarelto to be used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. This additional approval was granted in November 2011 and was based upon a clinical trial known as “Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation” study (ROCKET AF).

While ROCKET AF indicated that Xarelto was non-inferior to warfarin and had a similar risk of major bleeding, gastrointestinal bleeding from Xarelto was seen more often than in those taking warfarin.

Because ROCKET AF compared Xarelto only to warfarin, the warfarin group should have been closely monitored and managed, but it allegedly was not.

According to the lawsuit, “The warfarin group in the ROCKET AF study was the worst managed warfarin study group in any previously reported clinical trial involving warfarin.”

The FDA also faulted the ROCKET AF study, and additionally took issue with the once daily dosing of Xarelto. FDA clinical reviewers noted that twice daily dosing might result in fewer peaks and valleys with the medication, increasing its effectiveness, and perhaps, even its safety.

Major Bleeds from Xarelto on FDA Adverse Events List

Patients reported 1,080 serious adverse events to the FDA in the year ending June 30, 2012. Among those were 65 deaths. By the close of fiscal year 2012, more than 2,080 Xarelto-related serious adverse event reports had been sent to the FDA; 151 ended with death. During the same time period, 56 deaths were affiliated with warfarin use.

According to the lawsuit regarding gastrointestinal bleeding from Xarelto, “Despite the wealth of scientific evidence, Defendants have ignored the increased risk of the development of the aforementioned injuries associated with the use of Xarelto, but they have, through their marketing and advertising campaigns, urged consumers to use Xarelto without regular blood monitoring or instead of anticoagulants that present a safer alternative.”

The Gastrointestinal Bleeding from Xarelto Lawsuit is Case No. 2:17-cv-015155-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.