A woman has filed a Xarelto medication side effects lawsuit after she suffered severe gastrointestinal bleeding.

Plaintiff Betty G. says she took Xarelto from mid-2013 through mid-August 2014 to treat atrial fibrillation, which is an irregular heartbeat that increases the risks of blood clots and stroke.

Xarelto is a new anticoagulant from Johnson & Johnson and its subsidiary Janssen, and another pharmaceutical giant, Bayer.

Xarelto blocks a blood protein called Factor Xa, which is responsible for starting the clotting process. This effectively stops the body’s production of thrombin, a clotting enzyme. As a result, blood clots are kept from forming because the clotting process cannot occur.

Drug powerhouses Johnson & Johnson, Janssen and Bayer marketed Xarelto as a more convenient blood thinner than warfarin (Coumadin), which has been used as a relatively safe anticoagulant for nearly 60 years.

Warfarin does need to be monitored through regular blood tests to ensure a therapeutic level is maintained. Xarelto is promoted as a “one dose fits all” blood thinner that needs no such monitoring. These facts have been heavily marketed as the “Xarelto Difference.”

Still, the FDA noted in its reviews of the blood thinner that a twice-a-day dosing could result in a steadier level of the medication, which fluctuates from low to high levels with once-a-day dosing.

Although Xarelto says it sets patients “free” from blood monitoring, the Xarelto medication side effects lawsuit alleges blood monitoring could ensure the correct therapeutic level is maintained.

In the event of an injury accident or surgery, warfarin’s anticoagulating side effects can be stopped with a dose of vitamin K given by a physician. Every emergency room doctor in the U.S. is aware of this procedure.

Importantly, Xarelto has no known reversal agent. In the event of hemorrhaging, there is no medication that can stop Xarelto’s blood-thinning effects.

Facts of Xarelto Medication Side Effects Lawsuit

According to her Xarelto medication side effects lawsuit, Betty not only suffered gastrointestinal bleeding, but also endured respiratory failure in August 2014. She was forced to undergo a blood transfusion and become hospitalized at the time. Her doctor told her to stop taking Xarelto.

The Xarelto medication side effects lawsuit alleges, “The use of Xarelto without appropriate blood monitoring, dose adjustment and twice a day dosing can cause major, life-threatening bleeding events.”

More than 1,080 Serious Adverse Event reports regarding Xarelto were filed with the FDA in the year leading up to June 30, 2012. Among those reports were a minimum 65 deaths.

“Of the reported hemorrhage events associated with Xarelto, 8% resulted in death, which was approximately twofold the risk of a hemorrhage-related death with warfarin,” adds the Xarelto medication side effects lawsuit.

Xarelto stands accused of failing to adequately warn patients of the drug’s degree of anticoagulation and the risks of uncontrollable bleeding.

The drug’s makers are also accused of failing to properly and completely investigate, research, study and define Xarelto’s safety profile before the drug entered the market.

The Xarelto Medication Side Effects Lawsuit is Case No. 2:17-cv-15310 in the U.S. District Court for the Eastern District of Louisiana.