A recently filed lawsuit alleges Xarelto is dangerous, and advertisements have given the impression the blood thinner is safer than it actually is.

A Texas man claims he was prescribed Xarelto in July 2014 to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (an abnormal heart rhythm).

He also alleges that Xarelto is dangerous.

The plaintiff was admitted to the hospital because of gastrointestinal bleeding on Nov. 16, 2014. His doctors discontinued Xarelto at that time, because his “injuries were directly and proximately caused by Xarelto.”

Drug Manufacturer Hides Fact Xarelto Is Dangerous

Xarelto is backed by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, and by Bayer. These big names invested millions of dollars into the marketing of Xarelto.

According to the Xarelto lawsuit, “Defendants spent significant money in promoting Xarelto, which included at least $11,000,000.00 spent during 2013 alone on advertising in journals targeted at prescribers and consumers in the U.S.”

“In the third quarter of the 2013 fiscal year, Xarelto was the number one pharmaceutical product advertised in professional health journals based on pages and dollars spent,” the Xarelto lawsuit states.

In its first year on the market, Xarelto generated $582 million in worldwide sales.

In its ads, no mention was made that Xarelto is dangerous. In fact, Xarelto is accused of misleading the public and medical community by claiming the drug was more effective than warfarin and that no blood monitoring was needed to ensure its safety.

Marketing materials also failed to disclose that there is no antidote for Xarelto. If a patient develops uncontrollable bleeding, “such irreversibility could have permanently disabling, life-threatening and fatal consequences,” states the Xarelto lawsuit.

Up until June 30, 2012, 1,080 Xarelto “Serious Adverse Event” reports were filed with the FDA, including 65 deaths. At the end of the 2012 fiscal year, 2,081 adverse events were filed with the FDA and of those, 151 resulted in death.

Xarelto’s manufacturers are accused of designing their clinical studies to “under-represent the true risk of adverse bleeding events,” and to hide the fact that Xarelto is dangerous.

Studies named the ROCKET AF Study, the RECORD studies, and the EINSTEIN studies have been used to promote Xarelto, but “have failed to similarly highlight the increased risk of major internal bleeding among other serious bleeding concerns,” as alleged in the Xarelto lawsuit.

Highlight on Convenience Is Overstated

Xarelto was marketed as a convenient alternative to warfarin (Coumadin), which has been a trusted anticoagulant for more than 50 years.

In the event of surgery or injury, a patient taking warfarin can be given vitamin K to counteract the drug’s blood thinning effects. Warfarin patients do need to have blood levels of the medication monitored to assure a therapeutic dose is maintained in the body.

Xarelto is dangerous because it is promoted as setting a patient “free” from blood monitoring. The FDA’s reviews of the medication questioned the once daily dose, acknowledging that “peaks and troughs that could be eliminated by twice-a-day dosing.”

The Xarelto Bleeding Lawsuit is filed within the larger Xarelto MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana.