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Skip to main content reports on the ongoing cases of many who filed lawsuits against Janssen Pharmaceuticals—a subsidiary of Johnson & Johnson—and Bayer AG. Their claims allege that they were exposed to a substantially increased risk of catastrophic bleeding events while taking the anticoagulant Xarelto. Several studies appear to lend credibility to these claims and have been thoroughly reviewed as a result.

Increased Risk Of Vitreous Hemorrhages

Drs. John C. Hwang and Judy Hun observed patients from their practice who were currently participating in a long-term blood thinner regimen and ranged in age from 70 to 89. While they were originally taking more traditional medications, they switched to Xarelto after its FDA approval in 2011. According to empirical observation, these patients showed a marked increase in incidents of vitreous hemorrhages or eye-bleeding that appeared to coincide with their change in medication.

The doctors noted that the bleeding events were most likely to occur in those who had an established history of blood thinner use, such as warfarin, and switched to the new-generation anticoagulant. Hwang and Hun published their complete findings in the June 2015 issue of JAMA Ophthalmology, and noted, “In all cases, an acute vitreous hemorrhage occurred shortly after rivaroxaban (Xarelto) treatment was initiated.”

Increased Risk Of Internal Bleeds

Another landmark study was published in the April 2015 issue of the British Medical Journal (BMJ) that indicated as high as a two-fold increase in the risk for stomach bleeds by patients taking Xarelto in lieu of warfarin. For the purposes of the study, investigators screened nearly 46,000 complete medical histories. It was noted that the bleeding events were most common in those who had been taking warfarin, but weaned off the drug in favor of the promising new treatment option presented by Xarelto.

Consolidation Of Lawsuits

In the United States, more than 2,800 individual cases against Xarelto and its manufacturers have been consolidated to form the multidistrict litigation (MDL) No. 2592. The common allegations of the plaintiffs in these cases include a substantially increased risk of catastrophic bleeding events, injury, and even death. Judge Eldon Fallon has been appointed to oversee the MDL proceedings in the Eastern District Court of Louisiana.

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