A woman has filed a Xarelto lawsuit alleging her mother died of bleeding from Xarelto in February 2017.

Linda L. was prescribed the new blood thinner Xarelto and took the medication from September 2013 until just days before her death in February 2017.

Plaintiff Judy E., Linda’s daughter, alleges her mother suffered rectal bleeding and hematochezia in mid-December 2016. Linda was hospitalized for this alleged bleeding from Xarelto.

Drug Maker Allegedly Knew Bleeding from Xarelto Dangers

Xarelto was approved by the FDA in July 2011 for the prevention of deep vein thrombosis (DVT) and pulmonary embolisms (PE) in patients undergoing hip or knee replacement surgeries. This 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 FDA faulted the studies for the “’systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’”

Despite the issues with the RECORD studies, the FDA provided additional approval for Xarleto to be used for patients who needed a reduced risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. This additional approval granted in November 2011 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).

The latter study indicated Xarelto had a similar risk of major bleeding as warfarin, but Xarelto caused more incidents of gastrointestinal bleeding.

The FDA found the warfarin group in the ROCKET AF study was not managed adequately, which led the FDA to question the comparison of the two drugs.

The bleeding from Xarelto lawsuit says “if the warfarin group was poorly managed, it would be easy for Xarelto to appear non-inferior to warfarin, which, in turn, would provide Defendants a study to ‘support’ Xarelto’s use.”

Xarelto Marketed as Better Choice

Xarelto belongs to a class of drugs known as New Oral Anticoagulants (NOACs), which includes Pradaxa and Eliquis as well. These drugs have been marketed as the next generation of blood thinners and were designed to replace warfarin, which has been a relatively safe anticoagulant used for the past 60 years.

Xarelto’s maker, Bayer, promoted the drug as a once daily pill that did not require the monitoring of blood plasma levels, touting it as more convenient than warfarin. Marketing materials also noted that a patient’s diet was not limited with the new anticoagulant, and deemed these new “freedoms” the “Xarelto Difference.”

Despite these claims, the bleeding from Xarelto complaint notes “Xarelto’s clinical studies show that Xarelto is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”

If you or someone you love has experienced bleeding from Xarelto, you could benefit from speaking with an attorney regarding your legal options.

The Bleeding From Xarelto Lawsuit is Case No. 2:17-cv-10241-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.