Xarelto: Purpose, Side Effects & LitigationManufactured by Bayer and marketed in the US by Janssen Pharmaceuticals (part of Johnson & Johnson), Xarelto received approval by the Food and Drug Administration (FDA) in 2011 to prevent blood clots in patients undergoing knee and hip surgeries. The drug’s use was later extended to patients with irregular heartbeats and potentially deadly leg and lung blood clots.
Known generically as rivaroxaban, Xarelto is a blood thinner belonging to a new generation of oral anticoagulants and introduced as a superior substitute for Coumadin (warfarin).Coumadin, which has been used since the 1960s for prevention of blood clots and strokes among patients with atrial fibrillation, requires patients to follow careful dietary restrictions and undergo continuous monitoring. Xarelto was marketed not only as more effective at preventing strokes than Coumadin, but also easier to use because Xarelto patients didn’t need frequent tests to monitor their blood-plasma levels or have to limit their diet. However, bleeding events while on Coumadin could be reversed with an application of Vitamin K. There is no agent that can counteract an uncontrolled hemorrhage in a patient taking Xarelto. The FDA’s MedWatch website received more than 1,000 Xarelto associated serious adverse event reports in the year immediately following the drug’s approval. According to these reports, 65 patients died as a result of using Xarelto. The number of adverse event reports jumped to more than 2,000 by the end of 2012.
Nevertheless, by 2013, Xarelto had racked up more $2 billion in sales and reached “blockbuster” status because of large multimillion-dollar direct to consumer (DTC) advertising campaigns.Was Xarelto properly tested before it was put on the market? Did the drug’s manufacturer or marketer hide the fact the blood thinner had no antidote? Did they overstate the drug’s effectiveness? Countless personal injury and wrongful death lawsuits relating to GI bleeds, intracranial hemorrhages and other bleeding-related injuries attributable to Xarelto seek answers to these questions. If you have or a loved one has taken Xarelto and suffered an injury, contact the Mann Law Firm by calling (478) 742-3381 in Macon, Dublin, Warner Robbins or Milledgeville, or through our online form.