A woman has filed a lawsuit after she suffered Xarelto GI bleeding and anemia.

Plaintiff Alicia W. alleges she took Xarelto from April 30, 2014 to May 11, 2014, which is the date she endured the injuries.

Xarelto is a new oral anticoagulant (NOAC), also known as a blood thinner. According to the lawsuit, Johnson & Johnson and its subsidiary Janssen Research joined fellow pharmaceutical powerhouse Bayer Healthcare to research, develop and market Xarelto as an alternative to warfarin for the prevention of blood clots.

Warfarin, brand name Coumadin, has been an established and relatively safe medication used to prevent strokes and systemic embolisms for the past 60 years, alleges the plaintiff. Warfarin’s anti-clotting abilities can be stopped with an IV dose of vitamin K administered by a doctor. All emergency room staff know this in the event an unforeseen surgery is needed or an injurious accident occurs to a patient on warfarin. Xarelto has no such antidote.

Patients on warfarin do have some dietary restrictions and must have a blood test performed regularly to ensure a maintenance level of the medication holds steady. Advertising for Xarelto has focused on the “convenience” of not needing blood tests, of taking Xarelto only once daily, and of no reason for dietary changes, says the complaint. However, FDA clinical reviewers have indicated some patients could benefit from twice daily dosing to avoid experiencing high and low peaks of the medication in their blood, alleges the lawsuit, which could make it more effective and safe.

Xarelto GI Bleeding Lawsuit Faults Studies

Xarelto’s initial clinical trials were known as RECORD  (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism) studies, alleges the lawsuit, and showed that Xarelto was a better anticoagulant over competitor Lovenox (enoxaparin) to prevent deep vein thrombosis after knee or hip replacement surgery. However, Xarelto also caused more sporadic bleeding, which rapidly decreased hemoglobin levels and resulted in the need for blood transfusions, says the Xarelto GI bleeding lawsuit.

The FDA determined in 2009 that the RECORD studies were flawed due to negligence during the clinical trials, says the plaintiff. The RECORD studies were deemed unreliable because of accusations of medical records being discarded or falsified.

Another Xarelto study also under scrutiny was the ROCKET AF study that compared the new blood thinner to warfarin. The Xarelto GI bleeding lawsuit alleges the warfarin study group was so poorly managed that the ROCKET AF results also were considered unreliable and invalid.

The studies were designed to justify the single dose and no blood testing requirements that the pharmaceutical companies marketed as the “Xarelto Difference.” However, according to the Xarelto GI bleeding lawsuit, “Xarelto’s clinical studies show that Xarelto is safer and more effective when there is blood monitoring, dose adjustments and twice a day dosing.”

The Xarelto GI Bleeding Lawsuit is Case No. 2:18-cv-03045-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.