Nearly 2,000 Xarelto lawsuits have been filed by plaintiffs who allege the blood thinner caused serious internal bleeding, yet manufacturer Johnson & Johnson continues to claim that Xarelto is safe.

Xarelto (generic, Rivaroxaban) is a fairly new anticoagulant as it has only been on the U.S. market since 2011. Since that time, the FDA has received thousands of adverse event reports claiming the drug caused life-threatening Xarelto side effects, with hundreds of those reports stating Xarelto caused a hemorrhage related death.

Meanwhile, Xarelto maker Johnson & Johnson cites a new study that allegedly proves the safety and effectiveness of the blood thinning medication. The manufacturer points to a Post-Market Safety Surveillance study titled “XARELTO for Prevention of Stroke in Patients with Atrial Fibrillation.” According to the Xarelto study, researchers determined that fatal bleeding events only occurred in 0.1 per 100 patients.

“Real-world research is an essential complement to clinical trials and helps inform treatment decisions, and these studies confirm the safety profile of rivaroxaban in real-world settings around the globe,” said PMSS study investigator W. Frank Peacock, M.D.

The Xarelto study was designed and funded by Bayer, who partners with Johnson & Johnson for the marketing of Xarelto. It was admittedly a “retrospective study” with no other similar studies to measure it against.

Johnson & Johnson, Janssen Pharmaceuticals and Bayer have considerable motivation to continue to promote Xarelto worldwide despite thousands who claim the drug is dangerous. Due to an overall increase of average life-expectancy, anticoagulant sales are anticipated to reach more than $15 billion by 2018.

Xarelto Complications

Xarelto came on the U.S. market as part of a “new” class of blood thinners designed to take over the traditionally prescribed anticoagulant Warfarin (Coumadin). Xarelto was marketed as “more convenient” to consumers through advertisements that encouraged them to ask their physicians about the new medication.

In just a short amount of time, Xarelto became the number one blood thinner in its class with 11 million prescriptions filled in the U.S. alone. However, reports of severe Xarelto side effects began to surface from patients who claim they experienced internal bleeding event and were unaware there was no reversal agent to stop it.

Unlike Coumadin users who can take a large dose of vitamin K to stop a bleeding event, Xarelto patients have no antidote. A recent announcement from manufacturers of Pradaxa, which is a blood thinner in the same class as Xarelto, claimed that they were working on a bleeding reversal agent but there is no word yet on when that will arrive on the market or if Xarelto users will be able to benefit from it.

Commonly reported Xarelto side effects include:

• Abnormal liver function
• Rapid heartbeat
• Gastrointestinal bleeding
• Low blood pressure
• Reduced platelet levels
• Rectal bleeding
• Brain hemorrhaging
• Bruising
• Nose bleeds
• Dizziness
• Hemorrhaging in the eyes

Xarelto Bleeding Studies

An Xarelto study published in the British Medical Journal this year found that Xarelto carries twice the bleeding risk of Warfarin (Coumadin.)

This study followed a 2013 Xarelto report that discovered patients taking the new class of blood thinners (including Xarelto) had a significantly increased risk of a gastrointestinal bleeding event compared to Warfarin users.

Another study published in the American Medical Association concluded that Xarelto is also linked to severe, symptomatic liver injury.

Xarelto Lawsuits

The growing number of Xarelto lawsuits allege that Bayer, Janssen and Johnson & Johnson knew about the bleeding risks associated with the drug but failed to warn either the medical community or general public.

Contact an Xarelto attorney if you are interested in joining an Xarelto class action lawsuit, or to find out if it would be better for you to file individually.