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With Xarelto, bleeding not the only issue

The anticoagulant rivaroxaban, sold under the brand name Xarelto, has been associated with several injuries, with the risk of irreversible bleeding at the center of pharmaceutical injury litigation.

For instance, the American Journal of Therapeutics released May 27 a case study that suggested that there may be a relationship between the use of generic Xarelto and the occurrence of a life-threatening buildup of blood or fluid in the heart. The co-authors were with the Southern Illinois University School of Medicine.

Xarelto Vessel.jpg"We report a case of spontaneous pericardial hemorrhage associated with rivaroxaban," the abstract reads. "Within 10 days of starting rivaroxaban for atrial fibrillation, the patient developed a life-threatening cardiac tamponade leading to shock and multiorgan failure. After urgent pericardiocentesis/drainage, the patient recovered. This case highlights the necessity of larger clinical trials and consensus guideline on monitoring the effects of novel oral anticoagulants and development of an antidote for reversal in cases of major bleeding events."

Another disease has been linked to the generic version of Xarelto.

The journal Digestive Diseases and Sciences published in its current June 2015 edition another case study, this one out of the Indiana University School of Medicine. An elderly man was diagnosed with "drug-induced liver and skin injury with probable DRESS from rivaroxaban." DRESS stands for drug rash, eosinophilia and systemic symptoms.

If those injuries are not enough to worry about, there is a bleeding risk about which plaintiffs in many Xarelto lawsuits believe the drug's manufacturer, Janssen, failed to adequately warn.

A panel of judges in December centralized federal Xarelto lawsuits from across the nation before the U.S. District Court for the Eastern District of Louisiana. In so doing, the judges wrote that plaintiffs, some of whom have been represented by the product liability attorneys at Reich & Binstock, alleged that they "suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that defendants did not adequately warn prescribing physicians or consumers of the risks associated with Xarelto, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto's anticoagulation effects."

Xarelto bleeding is serious because, in too many cases, Xarelto bleeding can be uncontrollable. Plaintiffs claim that the manufacturer should have known about this serious risk from the data in the drug's trials. And it should have accordingly taken steps in the interest of public health.

Xarelto victims in Illinois in October 2014 submitted a memorandum to the federal judges who centralized this litigation in Louisiana. The plaintiffs wrote the following about the defendants' marketing practices with respect to the clinical data: "Defendants used the results of the ROCKET AF study, the RECORD studies, and the EINSTEIN studies to promote Xarelto in their promotional materials, including the Xarelto website, which tout the positive results of all of these studies. However, Defendants' promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and other bleeding events requiring transfusions demonstrated in these studies."

Moreover, wrote those Illinois plaintiffs, the makers and marketers of Xarelto left health professionals in a bind, telling the judges, "Similarly, Defendants also failed to warn emergency room physicians, surgeons and other critical care medical professionals that there is no reversal agent for Xarelto - which is a dramatic departure from [anticoagulant] warfarin. Therefore, Xarelto treatment leaves trauma professionals without effective means to treat and stabilize patients who experience uncontrolled or excessive bleeding while taking Xarelto."

Some of the litigation is not filed in federal court. A judge in the Pennsylvania Court of Common Pleas established a mass tort program to handle Xarelto lawsuits.

It is noteworthy that nephrologists in Massachusetts have already examined the risks that warfarin, generic Xarelto (rivaroxaban) and generic Pradaxa (dabigatran) pose to hemodialysis patients with atrial fibrillation, one of the heart conditions for which the U.S. Food and Drug Administration approved these anticoagulants. Co-authors of the study, which appeared in the March 2015 edition of the journal Circulation, wrote about the results of a Poisson statistical experiment.

The physicians wrote, "In covariate adjusted Poisson regression, dabigatran and rivaroxaban associated with a higher risk of hospitalization or death from bleeding when compared with warfarin. The risk of hemorrhagic death was even larger with dabigatran and rivaroxaban relative to warfarin."

Patients who suffered severe bleeding injury after starting to use Xarelto should contact an attorney to discuss whether they may be entitled to compensation. The same applies to the surviving family members of decedents who suffered fatal bleeding injury. At Reich & Binstock, the consultation is free.

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