Anticoagulant Xarelto Carries Risk of Uncontrollable Bleeding

Xarelto Carries Risk of Uncontrollable Bleeding

Xarelto Carries Risk of Uncontrollable Bleeding


Xarelto (rivaroxaban) is a new generation anticoagulant that is used to prevent blood clots, but some are worried about the drug’s bleeding risks. Lawsuits have been mounting against Johnson & Johnson subsidiary Janssen and Bayer HealthCare Pharmaceuticals alleging that the drug makers failed to warn about the risk of uncontrollable bleeding associated with the blood thinner.

The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011 for patients who have undergone knee or hip replacement surgery and in patients with atrial fibrillation. Later, the drug was approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). In DVT, a blood clot forms in one of the deep veins of the leg. If part, or all, of the clot breaks loose, it can result in a potentially life-threatening condition known as pulmonary embolism (PE) where a clot becomes lodged in the lungs.

Xarelto and other newer blood thinners, such as Pradaxa and Eliquis, are often compared to warfarin, a much older anticoagulant sold under the brand name Coumadin. Warfarin has been on the market for decades, but requires blood monitoring and dietary restrictions. Xarelto does not have these restrictions, but has other drawbacks; there is no reversal agent. This means that if a patient taking Xarelto starts to hemorrhage, there is no antidote to reverse the bleeding. In warfarin patients, bleeding can be reversed with vitamin K.

While there is some risk of bleeding with all blood thinners, Xarelto leaves hemorrhaging patients with few options for treatment. Many lawsuits allege that drug makers should have informed the public of this risk, as it would have dissuaded some doctors and patients. If you or someone you know suffered from bleeding complications as a result of Xarelto and you want more information about filing a lawsuit, contact Parker Waichman LLP today.

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Pradaxa was the first anticoagulant of its kind, and is therefore more commonly known than Xarelto. Xarelto and Pradaxa are similar medications with different mechanisms. While they are both anticoagulants, Boehringer-Ingelheim’s Pradaxa is a direct thrombin inhibitor while Xarelto inhibits Factor Xa.

The Institute for Safe Medication Practices’ (ISMP’s) QuarterWatch report released an update on anticoagulants last May. The report found that adverse events associated with Xarelto exceeded that of Pradaxa, which is “the drug that had been the main focus of safety concerns in QuarterWatch and elsewhere”. ISMP indicated that these statistics are most likely due to the fact that Xarelto prescriptions had been on the rise while Pradaxa prescriptions decreased. ISMP reported 680 serious adverse event reports related to Xarelto and 528 adverse event reports associated with Pradaxa over the past year. According to the report, bleeding risks of Pradaxa could be reduced with a lower dosage and with laboratory tests assessing patients’ needs for a dose adjustment. ISMP notes that these options are not approved in the United States, but are “available in most advanced countries”.

Litigation has been mounting over Xarelto, with plaintiffs alleging that the drug caused uncontrollable bleeding. In January, a mass tort was created for Xarelto claims in the Philadelphia Court of Common Pleas. The court’s Complex Litigation Center received about 75 cases alleging that the drug caused irreversible bleeding, which was fatal in some cases. Late last year, the U.S. Judicial Panel on Multidistrict Litigation announced that all Xarelto cases filed in federal court would be consolidated into a multidistrict litigation (MDL) in the Eastern District of Louisiana. Judge Eldon E. Fallon is overseeing the MDL. Court documents indicate that there were 2,080 Xarelto-related injuries by the end of 2012, including 151 deaths.

Parker Waichman LLP has spent decades fighting for the rights of patients who were injured due to defective medications and failure to warn. If you or someone you know suffered bleeding injuries after taking Xarelto, we urge you to contact one of our attorneys today.

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