The U.S. Food and Drug Administration (FDA) approved the anticoagulant Xarelto in 2011. The medication’s purpose is to prevent strokes and blood clots in people recovering from certain surgical procedures such as hip and knee replacements, deep vein thrombosis, or a number of other medical conditions. Added later to Xarelto’s purpose was the treatment of atrial fibrillation, a common heart condition, the Digital Journal reports.
Xarelto has been a subject of controversy since its approval. Two black box warnings, the harshest warnings a product can receive before it is potentially removed from the market, were given by the FDA, according to the Digital Journal.
Xarelto is made by a subsidiary company of the Johnson & Johnson Corporation, Janssen Pharmaceuticals, and Bayer AG. Since Xarelto was released on the market, the drug and its manufacturers have been the target of thousands of lawsuits, including 550 in Philadelphia, PA, and over 2,800 others consolidated in a multidistrict litigation (MDL) in Eastern Louisiana. The plaintiffs in all of these cases have claimed that Xarelto causes sudden episodes of uncontrollable bleeding.
However, one case stands out in that it focuses on a new concern having to do with the marketed once-daily dosage, regardless of the size or weight of the patient. Whereas other blood thinners need to be taken twice daily, Xarelto is promoted as needing only to be taken once daily. The new suit alleges that this amount is an ineffective dosage. In this particular case, the plaintiff suffered a stroke only 4 days after starting his treatment as he suffered from atrial fibrillation and was told he would be at risk of strokes.
The lawsuit was filed in October of 2015. The plaintiff claims that not only did the drug not prevent his stroke, but he feels that Xarelto may actually have been the cause of it, reports the Digital Journal.