Approved by the U.S. Food and Drug Administration (FDA) in July 2011, Xarelto has been linked to a number of life-threatening side effects. It is co-marketed by Bayer and Johnson & Johnson (J&J). It is a prescription drug which belongs to a class of anticoagulants called direct factor XA inhibitors. However, Xarelto has been linked to a number of serious side effects. In fact, Xarelto lawsuits against J&J have already been filed by affected patients. For more information, plaintiffs may visit www.xareltolawsuit.us.
Xarelto has three primary uses. One is to lessen the risk of blood clots and stroke in patients with atrial fibrillation. Another is to treat deep vein thrombosis and pulmonary embolism. Lastly, it is made to decrease the risk of blood clots in patients undergoing knee or hip replacement surgery.
The Institute for Safe Medication Practices (ISMP) revealed that blood thinners, including Xarelto, were the most dangerous drugs with the highest number of serious side effects reported to the FDA.
Of the thousands adverse events linked to Xarelto, the most common events were pulmonary embolism, deep vein thrombosis, gastrointestinal hemorrhage and hemorrhage. Other adverse events reported included thrombosis, hemoglobin decrease, cerebrovascular accidents, hematoma, edema peripheral and dyspnea. According to reports, doctors have been using emergency treatments to stop Xarelto’s bleeding side effects, in an attempt to prevent serious injuries and deaths.
In 2013, the German newspaper Der Speigel reported that 968 adverse events including 72 deaths involving Xarelto were reported to German health officials. This is on top of the 750 adverse events and 58 deaths in 2012.
The plaintiffs accused the companies of failing to warn patients and doctors of the dangerous bleeding side effects. They also accused the companies of producing a flawed product because the company released the drug without an antidote. A number of people have died because doctors could not reverse the bleeding, reports say.
Furthermore, these Xarelto lawsuits also accuse the defendant company of concealing important safety information and not testing the drug enough before it was put on the market.
With this, the FDA announced that it is currently in the process of evaluating bleeding events among Xarelto patients for them to determine whether the risks outweigh the benefits of the drug.
References:
reuters.com/article/2014/06/14/us-bayer-suit-idUSKBN0EP0HW20140614
pharmatimes.com/Article/14-02-17/FDA_rejects_Bayer_J_J_s_Xarelto_again.aspx
medicaldaily.com/blood-thinner-xarelto-blamed-deaths-and-serious-injuries-lawsuit-276604