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Xarelto (Rivaroxaban) is an anticoagulant—commonly referred to as a blood thinner—and was first approved by the FDA in July 2011. Xarelto is used to prevent and treat blood clots.
Xarelto is prescribed to help lower the risk of stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT). Patients may also be prescribed Xarelto if they recently had knee or hip replacement surgery.
Despite its classification, Xarelto doesn’t actually make blood any thinner. Xarelto and other anticoagulants work by preventing blood clots from forming in the veins or arteries by blocking specific proteins in the blood.
Common side effects of Xarelto include prolonged bleeding from cuts and bruising easily. The most severe side effect of Xarelto is severe, incurable bleeding.
Similar blood thinners contain a reversal agent, or antidote, that allow the blood to begin clotting once bleeding begins. However, Xarelto does not contain an antidote, thus increasing the risk for uncontrollable bleeding. Patients are also more susceptible to internal bleeding while taking Xarelto.
Typically, if a patient is experiencing blood loss or excessive bleeding, a physician can administer vitamin K or protamine sulfate to stop blood flow. Neither of these antidotes counteract anticoagulant properties in Xarelto because it blocks Thrombin, an enzyme in the blood that causes clotting.
The Food and Drug Administration (FDA) issued a warning for Xarelto in January 2014 officially acknowledging the increased risk of bleeding while taking Xarelto. The warning also announced that there is no antidote or reversal agent in Xarelto or its generic. Blood transfusions or replacements were recommended in the warning.
In August 2016, the FDA rejected an antidote for uncontrolled bleeding associated with Xarelto and other similar blood thinners. The FDA’s response letter requested further information regarding Xarelto’s manufacturing, as well as a thorough review of the changes made to all post-marketing commitments. A second application is expected to be submitted before 2017.
An adverse reaction (AR) report was issued for Xarelto less than a year later in December 2014 stating that Xarelto may cause thrombocytopenia, a condition where an individual has a low platelet count. Platelets help your blood clot, and in turn stop any internal or external bleeding. Thrombocytopenia can cause bruising, bleeding into tissues, and slow clotting after injury or surgery.
Xarelto lawsuits are being filed for a number of reasons–one being that injured patients claim that profits gained from Xarelto drugs have priority over their health: Xarelto brought in $2 billion for Bayer and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals in 2015 despite thousands of reports for uncontrollable bleeding and fatalities.
Allegations raised in Xarelto injury lawsuits nationwide claim that J&J and Bayer:
Patients who have suffered from severe, uncontrollable bleeding or other harmful side effects from taking Xarelto may be eligible for compensation for:
Family members of patients killed while taking Xarelto may be eligible for damages.
If you or a loved one has suffered from excessive bleeding after taking Xarelto, contact our Indianapolis drug injury and product liability attorneys at Wilson Kehoe Winingham. Pharmaceutical companies have a duty to adequately warn patients about side effects to manufacture safe, honest products. Hold them accountable. Call our office at 317.920.6400 or fill out the contact form below for a free case review.