A woman who says she suffered Xarelto dosage side effects that included gastrointestinal bleeding has filed a lawsuit against the drug makers.

Plaintiff Patricia H. says she was prescribed Xarelto in April 2015 to treat deep vein thrombosis (DVT) or the development of a blood clot deep in a leg vein. DVT is a serious condition because a blood clot can become loose and travel to the lungs.

Xarelto is supposed to prevent such blood clots from forming in the first place. FDA-approved in 2011, Xarelto is one of the New Oral Anticoagulants (NOACs) that was marketed as an improvement over Coumadin (warfarin), a blood thinner that has been used for more than 50 years.

On Sept. 20, 2016, Patricia says she suffered a gastrointestinal bleed that allegedly was caused by Xarelto. At that time, no antidote was available to stem Xarelto’s anticoagulating properties. As a result, she suffered “a life-threatening, irreversible bleed from the use of Xarelto,” says Patricia’s complaint.

GI Bleed Among Xarelto Dosage Side Effects

Bayer, Janssen Pharmaceuticals and Johnson & Johnson jointly created Xarelto, and they spent millions of dollars to market the drug. Sales in 2013 reached $2 billion globally.

Their marketing campaign included direct-to-consumer advertising with big-name celebrities who touted the “Xarelto Difference.”

Xarelto’s main competitor at the time was warfarin, which required periodic blood tests to ensure a therapeutic dose was maintained, dietary restrictions, and more than one dose a day. If a patient taking warfarin suffers an unexpected accident or needs surgery, an IV dose of vitamin K can counteract warfarin’s blood-thinning properties.

The “Xarelto Difference” painted the NOAC in a better light than warfarin. Xarelto only had to be taken once daily, had no dietary restrictions, and needed no blood test monitoring. However, at the time Patricia was prescribed Xarelto, there was no reversal agent to stop the medicine’s blood-thinning effects.

According to Patricia’s lawsuit, Xarelto failed to warn patients that there was no reversal agent available at that time, and that “if serious bleeding occurs, it may be irreversible, permanently disabling, and life-threatening.”

In the year leading up to June 30, 2012, the FDA received 1,080 Xarelto Serious Adverse Event (SAE) Medwatch reports, including 65 deaths. Xarelto’s death rate was nearly twice the risk associated with hemorrhage-related deaths linked to warfarin.

“At the close of the 2012 fiscal year, a total of 2,081 new Xarelto-associated SAE reports were filed with the FDA in its first full year on the market, ranking tenth among other pharmaceuticals in direct reports to the FDA,” says the Xarelto dosage side effects lawsuit.

Of those 2,081 reported events, 151 resulted in death.

Xarelto’s makers are accused of under-reporting, underestimating and downplaying Xarelto dosage side effects, according to Patricia’s lawsuit.

Patricia contends that as a result of the GI bleed she suffered, among other Xarelto dosage side effects, she continues to suffer severe and personal injuries and financial damages.

The Xarelto Dosage Side Effects Lawsuit is Case No. 2:18-cv-06318-EEF-MBN in the U.S. District Court for the Eastern District of Louisiana.