Failed to update warning or issue an Xarelto recall after it became clear that a large number of users were suffering severe and life-threatening injuries or death from uncontrollable bleeding.Sold an unreasonably dangerous and defective drug as it was initially formulated.Engaged in aggressive marketing that encouraged doctors to use the more expensive and more dangerous drug.Withheld information about the lack of an effective reversal agent.Failed to provide adequate warnings about the risk of Xarelto bleeds.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.Īllegations raised in Xarelto injury lawsuits nationwide claim that J&J and Bayer: Thrombocytopenia can cause bruising, bleeding into tissues, and slow clotting after injury or surgery. Platelets help your blood clot and in turn stop any internal or external bleeding. Xarelto Linked to Fatal Internal BleedingĪn 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. A second application is expected to be submitted before 2017. 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. In August 2016, the FDA rejected an antidote for uncontrolled bleeding associated with Xarelto and other similar blood thinners. FDA Rejects Xarelto Uncontrolled Bleeding Antidote Blood transfusions or replacements were recommended in the warning. The warning also announced that there is no antidote or reversal agent in Xarelto or its generic. The FDA issued a warning for Xarelto in January 2014 officially acknowledging the increased risk of bleeding while taking Xarelto. Neither of these antidotes counteract anticoagulant properties in Xarelto because it blocks thrombin, an enzyme in the blood that causes clotting. Typically, if a patient is experiencing blood loss or excessive bleeding, a physician can administer vitamin K or protamine sulfate to stop blood flow. Patients are also more susceptible to internal bleeding while taking Xarelto. However, Xarelto does not contain an antidote, thus increasing the risk for uncontrollable bleeding. Similar blood thinners contain a reversal agent, or antidote, that allow the blood to begin clotting once bleeding begins. Xarelto Fails to Warn of Antidote Resistance The most severe side effect of Xarelto is excessive, incurable bleeding. Common Side Effects of XareltoĬommon side effects of Xarelto include prolonged bleeding from cuts and bruising easily. Xarelto and other anticoagulants work by preventing blood clots from forming in the veins or arteries by blocking specific proteins in the blood. Patients may also be prescribed Xarelto if they recently had knee or hip replacement surgery.ĭespite its classification, Xarelto doesn’t actually make blood any thinner. Xarelto is used to prevent and treat blood clots and is prescribed to help lower the risk of stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT). Xarelto (Rivaroxaban) is an anticoagulant-commonly referred to as a blood thinner-and was first approved by the Food and Drug Administration (FDA) in July 2011. Call our Indianapolis Drug Injury Attorneys at 317.920.6400 or fill out an online contact form for a free, no-obligation case evaluation. Wilson Kehoe Winingham is now accepting clients who have taken Xarelto and suffered uncontrollable or excessive bleeding.
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