Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011 for the purpose of preventing strokes and blood clots in patients recovering from hip and knee replacement surgeries, as well as other medical conditions. The treatment of atrial fibrillation, a common heart condition, was subsequently added according to the Digital Journal.
Since Xarelto’s approval it has been the focus of over 3,400 lawsuits as well as two black box warnings by the FDA, which could mark a product’s potential removal from the consumer market. Up until 2015, all of the lawsuits filed against the makers of Xarelto, Bayer AG and a Johnson & Johnson subsidiary, Janssen Pharmaceuticals, focused on plaintiffs’ allegations that the drug may cause serious uncontrollable and sometimes fatal internal bleeding, reports the Legal Examiner.
The difference in this new case, filed in October 2015, was the focus veered from these allegations and instead targeted the daily dosage requirement. The suit alleges Xarelto did not take into account a patient’s size or weight and is only prescribed to be taken once daily. Other blood-thinning drugs on the market require a patient to take them twice daily to keep the drug in the patient’s system for a 24-hour period, reports the Legal Examiner.
The plaintiff in this noteworthy case claims the once daily requirement is ineffective. He was prescribed Xarelto to prevent strokes due to his atrial fibrillation. After only taking the drug for 4 days, the patient suffered a stroke. The plaintiff is alleging that not only did the drug not prevent his stroke, but he firmly believes it may have actually caused it to happen, the Legal Examiner reports.