Xarelto gastrointestinal bleeding is the subject of a product liability lawsuit filed by plaintiff Sandra M., who says she also became anemic.

Sandra says she took the blood thinner from January 2014 through July 2015. She was diagnosed with anemia in June 2015, then suffered a gastrointestinal bleed a month later. She claims her injuries were a direct result of Xarelto.

Xarelto (rivaroxaban) belongs to a new class of blood thinners known as New Oral Anticoagulants (NOACs). Xarelto has been marketed as “the next generation of blood-thinning drugs to replace warfarin (Coumadin), an established safe treatment for preventing stroke and systemic embolism for the past 60 years.”

Xarelto is a product of Johnson & Johnson, Janssen Pharmaceuticals, and Bayer.

Xarelto Gastrointestinal Bleeding Lawsuit Alleges Mismanaged Clinical Studies

Xarelto received FDA approval in July 2011 for the prevention of DVT (deep vein thrombosis) and PE (pulmonary embolism) in patients undergoing hip or knee replacement surgeries.

The FDA approval was based on a series of clinical trials known as the RECORD studies (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism).

According to the Xarelto gastrointestinal bleeding complaint, the FDA determined the RECORD studies were not reliable because FDA inspections “in 2009 disclosed rampant violations including ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization.’”

Despite the FDA’s concerns,  Xarelto received additional approval to reduce the risk of stroke in patients with no-valvular atrial fibrillation in November 2011. This approval was based on a clinical trial called 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 ROCKET AF study concluded Xarelto was not inferior to warfarin for stroke in such patients with a similar risk of major bleeding. However, the ROCKET AF study indicated “’bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.’”

The Xarelto gastrointestinal bleeding lawsuit alleges that in order to prove Xarelto’s superiority, the warfarin study group would have needed to be closely managed. Sandra’s complaint says the warfarin study group in the ROCKET AF study was the “worst managed warfarin study group in any previously reported clinical trial involving warfarin.”

“The poor management of the warfarin group in the ROCKET AF study was not lost on the FDA, which noted ‘the data comparing (Xarelto) to warfarin are not adequate to determine whether (Xarelto) is as effective for its proposed indication in comparison to warfarin when the latter is used skillfully,’” says the Xarelto gastrointestinal bleeding complaint, quoting an FDA Advisory Committee Briefing document.

The Xarelto gastrointestinal bleeding lawsuit says Public Citizen, a non-profit consumer rights advocacy group, wrote to the FDA, saying they “strongly oppose FDA approval” because the ROCKET AF clinical trial had a “suboptimal control arm.”

The Xarelto Gastrointestinal Bleeding Lawsuit is Case No. 2:17-cv-06538-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.