A new Xarelto lawsuit filed by a woman from Georgia seeks compensation for gastrointestinal bleeding that she says was caused by the anticoagulant drug.

Plaintiff Mary H. says she began using Xarelto in October 2013 to reduce the risk of stroke and systemic embolism caused by atrial fibrillation. She continued using it into May 2014, when she was hospitalized with complaints of rectal bleeding and anemia.

Her doctors found she was suffering from gastrointestinal bleeding and had gone into shock. Treatment required blood transfusions and several days of hospitalization.

Mary now argues that side effects of Xarelto caused her gastrointestinal bleeding. She says her injuries will require “lifelong medical treatment, monitoring and/or medications,” more so than she needed before she began taking Xarelto.

Xarelto, or rivaroxaban, is one of a new generation of anticoagulant drugs that only a few years ago began to supplant warfarin’s position as the only drug approved for prevention of stroke in patients with atrial fibrillation.

The makers of these anticoagulants promote them as having certain advantages over warfarin such as fewer reactions with food and no need for ongoing blood monitoring.

The manufactuer’s website says over seven million people have been prescribed Xarelto, according to Mary’s Xarelto lawsuit. She says that it earned about $582 million in sales in its first year on the market, and that by 2013 sales had surpassed $2 billion.

Xarelto Lawsuit Claims

Mary argues that evidence from the clinical trials used to secure FDA approval for Xarelto shows the drug creates an unacceptable risk of gastrointestinal bleeding. She says that according to studies known collectively as the RECORD studies, the side effects of Xarelto include a greater incidence of major bleeding events that led to decreased hemoglobin levels and required blood transfusions.

Mary says that another clinical trial known as the ROCKET AF study, which compared Xarelto to warfarin in their effectiveness for preventing stroke, revealed that gastrointestinal bleeding occurred more frequently in the patients taking Xarelto.

Another study called the EINSTEIN-PE study found that Xarelto was related to an increased risk of adverse events serious enough to require prolonged hospitalization or permanent discontinuation of Xarelto, says Mary.

Mary also alleges the manufacturers over-promoted the drug while failing to address the alleged risks associated with side effects of Xarelto. She says the manufacturers emphasized that Xarelto could be taken only once a day and did not require repeated blood tests and dosage adjustments, like warfarin did.

However, Mary notes that FDA reviewers questioned the safety of unmonitored Xarelto use under a once-a-day dosing schedule. The reviewers referred to blood level studies that revealed peaks and troughs in Xarelto blood levels, which they said could be eliminated by using twice-daily dosing.

Defendants named in Mary’s Xarelto lawsuit include Janssen Pharmaceuticals, Johnson & Johnson, Bayer Healthcare Pharmaceuticals, and their related companies.

Johnson & Johnson is the parent company of Janssen Pharmaceuticals. Mary alleges these companies were involved in the development, marketing and distribution of Xarelto.

The Xarelto lawsuit is Case No. 4:2016cv00062 in the U.S. District Court for the Northern District of Georgia, Rome Division.