A woman has filed a claim against the manufacturers of Xarelto claiming that she suffered adverse effects and serious bleeding complications after taking the anticoagulant medication.

Plaintiff Rosemarie B. files her gastrointestinal bleeding lawsuit in Louisiana federal court as part of the multidistrict litigation that is currently in progress against Bayer Healthcare Pharmaceuticals and Johnson & Johnson, and other related companies.

According to the gastrointestinal bleeding lawsuit, Rosemarie, a resident of Connecticut, was advised by her physician to begin taking Xarelto in May 2014 up until February 2015. She says she was prescribed Xarelto for treatment of the risk of stroke that comes with atrial fibrillation, commonly known as an irregular and often a rapid heart rate.

According to the gastrointestinal bleeding lawsuit, however, “as a direct and proximate result of plaintiff’s use of Xarelto, she suffered serious and severe injuries, including gastrointestinal bleeding, blood loss anemia, melanotic stools, and rectal bleeding on approximately February 14, 2015.”

The gastrointestinal bleeding lawsuit further maintains that she had to undergo several blood transfusions, and had required hospitalization in Bridgeport, Conn., at St. Vincent’s Medical Center.

Xarelto is one of a new generation of anticoagulant drugs used to treat patients who suffer from risks of developing blood clots. Although reports have illustrated that Xarelto does have its benefits, several patients have reported dangerous and serious complications, including gastrointestinal bleeding.

The U.S. Food and Drug Administration (FDA) had specifically approved the drug to prevent heart attacks and strokes in patients with atrial fibrillation, or an abnormal heart arrhythmia.

The anticoagulant medication is also prescribed to patients to treat deep vein thrombosis (DVT), or the formation of a blood clot in deep vein, particularly in the legs, and pulmonary embolism (PE), or the condition in which one or more arteries in the lungs gets blocked by a blood clot. It can also be used to prevent the blood clots associated with major surgery like a knee or hip replacement.

Before receiving approval by the FDA, Xarelto was required to conduct several studies to show the drug’s efficacy and safety.

According to the gastrointestinal bleeding lawsuit, Xarelto’s manufacturers conducted a study termed ROCKET AF. In the study, they discovered that Xarelto was not inferior to another drug on the market, warfarin, and had a similar risk of bleeding.

However, what was thereafter discovered instead was that “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 gastrointestinal bleeding lawsuit states. Rivaroxaban is the generic name for Xarelto.

The EINSTEIN study illustrates that Xarelto was noninferior to warfarin, but they also illustrated that patients had an increased risk of developing serious adverse side effects and complications. The patients had to permanently stop its use.

The Gastrointestinal Bleeding Lawsuit is Case No. 2:17-cv-07882-EEF-MBN and is part of the Xarelto MDL Lawsuit is MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.