Introduced in late 2011, Xarelto (rivaroxaban) is a prescription medicine used to treat people with atrial fibrillation. The blood thinner reduces the risk of strokes, blood clots, deep vein thrombosis (DVT), and pulmonary embolism (PE). It didn’t take long before concerns regarding hemorrhage risks grew due to reports of severe and fatal instances of uncontrollable bleeding.
Xarelto, the Blood Thinner
Developed by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer HealthCare, Xarelto is for treating patients with DVT, PE, and other blood clot injuries. It reduces the risk of stroke and is widely prescribed to people with non-valvular atrial fibrillation after undergoing knee and hip replacement surgery. The anticoagulant also prevents the recurrence of clots and other conditions.
Where the Complaints Stem from
While using blood thinners carry the risk of internal bleeding, Xarelto is associated with higher risks and fatal side effects, like uncontrolled bleeding and brain hemorrhaging. The manufacturer’s lack of precaution in use and the absence of a reversal agent have placed a large number of individuals at risk, and scores of families in mourning.
Bernripka.com notes that thousands of individuals have suffered experiencing the side effects. The Institute of Safe Medication Practices lists the drug among the most dangerous due to the potential harm it can cause patients.
As of April 2016, Legal-Bay reports that the number of lawsuits filed against Janssen Pharmaceuticals amounts to more than 3,400. The lawsuits include claims of serious health conditions, extended hospital stays, and death.
Plaintiffs allege that the manufacturers failed to provide accurate warnings regarding excessive bleeding, while withholding information about the absence of an antidote. Aggrieved individuals are also pursuing claims that Johnson & Johnson and Bayer engaged in aggressive marketing to encourage doctors and specialists to use the dangerous drug. And lastly, complainants claim that the company’s failure to issue warnings, despite earlier occurrences of life-threatening injuries, placed more patients at risk.
Will Xarelto be Pulled Out from the Market?
Although many lawsuits have called for a Xarelto recall, it appears unlikely that the FDA will require drug manufacturers to remove the blood thinner from the market. The U.S. regulatory agency leans towards requiring stronger warnings instead. Information about the risk of hemorrhage will be indicated in a “black box” — the strongest warning on prescription medication.