A woman has filed a lawsuit against several drug companies after she allegedly suffered several Xarelto uncontrollable bleeding episodes.

Plaintiff Barbara D. says she began taking the anticoagulant drug Xarelto in November 2016. She claims she suffered the following:

• Rectal bleeding in December 2016
• Severe nose bleed in spring 2018
• Uncontrolled bleeding from her leg in June 2018

Xarelto (rivaroxaban) is a blood thinner in a category known as factor Xa inhibitors. The drug is backed by pharmaceutical companies Johnson & Johnson, Janssen and Bayer.

Xarelto is a New Oral Anticoagulant (NOAC), approved by the FDA in July 2011 for the prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery. In November 2011, the FDA approved the use of Xarelto to prevent stroke in people with a common type of abnormal heart rhythm.

The FDA approval of Xarelto for the prevention of deep vein thrombosis and pulmonary embolism in patients needing hip or knee replacement surgeries was based on clinical trials known as the RECORD (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism) studies.

The RECORD studies allegedly showed that Xarelto was a superior anticoagulant. However, they also showed a greater incidence of Xarelto uncontrollable bleeding — leading to decreased hemoglobin levels, resulting in more blood transfusions.

When the FDA reviewed the RECORD studies, the federal agency found that the studies suffered from design flaws and negligent handling. The conclusions from the RECORD studies were deemed unreliable by the FDA, which found violations that included “systemic discarding of medical records” and “concerns regarding improprieties in randomization.”

Despite issues with the RECORD studies, the FDA granted additional approval for the use of Xarelto to reduce the risk of stroke and systemic embolism in patients suffering a common irregular heartbeat known as non-valvular atrial fibrillation. Xarelto received this approval in November 2011 based on a clinical trial known as the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) study.

Xarelto Uncontrollable Bleeding Seen in Gastrointestinal System

The ROCKET AF study indicated Xarelto was not inferior to warfarin, a commonly used anticoagulant with a 60 year history, to reduce the risk of stroke or pulmonary embolism and had a similar risk of major bleeding. However, Xarelto uncontrollable bleeding episodes occurred more frequently in the gastrointestinal areas and were more likely to be so severe the patients required blood transfusions more often than those in the warfarin group.

The FDA again faulted Xarelto’s study, this time noting that the ROCKET AF’s warfarin group was not well managed and that the data was not adequate to make a fair comparison between the two drugs.

Despite the criticisms of these clinical studies, Xarelto spent millions of dollars marketing the “Xarelto Difference” directly to consumers. The advertisements promoted Xarelto as a single daily dose pill that required no testing of blood plasma levels, unlike warfarin, which was depicted as a dated drug with too many restrictions. The marketing materials allegedly downplayed or even failed to mention the possibility of Xarelto uncontrollable bleeding.

However, warfarin’s anticoagulating effects can be stopped with an IV dose of vitamin K in the event the patient is in a serious accident or needs emergency surgery.

There was no antidote for Xarelto until April 2018 when the FDA approved AndexXa as the first reversal agent effective on factor Xa inhibitors.

The Xarelto Uncontrollable Bleeding Lawsuit is Case No. 2:18-cv-07919-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.