Fields, Dehmlow & Vessels is representing those who have been injured by Xarelto® or died as a result of taking Xarelto®. Ethan Vessels is a Xarelto personal injury attorney licensed in both Ohio and West Virginia.
What is Xarelto®?
Xarelto® (also known as Rivaroxaban) is a blood-thinning drug manufactured by Bayer and marketed by Janssen Pharmaceutica. It was originally approved by the FDA in 2011 to help prevent deep vein thrombosis (DVT) and strokes for patients with non-valvular atrial fibrillation. It has been promoted as a better alternative to warfarin (aka Coumadin), a long-prescribed blood-thinning medication.
Why is Xarelto®dangerous?
All anti-coagulant drugs, blood-thinning drugs, can cause bleeding. However, doctors have traditionally been able to control bleeding events for patients taking warfarin with the administration of vitamin K.
Unfortunately, there is no antidote to Xarelto® if uncontrolled bleeding occurs. There is no reversal agent, leaving doctors unable to control bleeding in many cases. This has resulted in a significant increase in the number of adverse events involving severe hemorrhages and deaths. Significantly, in the original label, Xarelto’s manufacturers failed to warn the public and prescribing doctors of this problem. In fact, in our opinion, the warnings associated with Xarelto remain inadequate.
Xarelto’s manufacturers have spent millions of dollars promoting the drug, despite growing evidence that it is no better than warfarin; has higher incidences of bleeding events; and that there is no available reversing agent for bleeding events. In fact, in June of 2013, the FDA sent a letter to Xarelto’s manufacturers and distributors chastising them regarding Xarelto’s printed advertising materials. Per the FDA, “the print ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim” regarding dose adjustments, which violated FDA regulations.
According to the Institute of Safe Medication Practices, which reviews and analyzes event data submitted to the FDA, there has been a dramatic increase in the number of adverse events attributed to Xarelto®. By June 30, 2012, there were over 1,080 reported Xarelto-related serious bleeding events, including 65 deaths. By the end of 2012, there had been 2,081 additional Xarelto-related serious adverse events reported.
It is our opinion that there can be no adequate warnings given with Xarelto. There remains no approved reversal agent for bleeding events, which Xarelto’s manufacturers knew when they sought FDA approval. There is little evidence to suggest that Xarelto is better than warfarin, which does have a reversal agent. Put simply, we believe that Xarelto was never safe enough to ever bring to market at all.
Contact a Xarelto Personal Injury Attorney Today!
Those who have been injured by Xarelto are now filing lawsuits across the United States. Our firm is accepting these cases. If you, or your loved one, have suffered serious injury or death, because of a bleeding incident while taking Xarelto®, please call us at 740-374-5346. There is no fee for the consultation, and there is no fee if there is no recovery. Contact us today!