Xarelto is an anticoagulant that is prescribed to reduce a patient’s risk of blood clots (deep-vein thrombosis and pulmonary embolism) or to prevent strokes and other clotting events. It belongs to a class of anticoagulants called Factor Xa inhibitors that work by suppressing the body’s production of thrombin.
Xarelto has been sold as an easier alternative to older blood thinning drugs, such as Warfarin (Coumadin), as the manufacturer states routine blood monitoring is not required to monitor the risk of bleeding. However, routine monitoring may prevent bleeding events and the convenience may not outweigh the potentially deadly side effects.
Unlike Warfarin, there is no reversal agent in the case of a patient experiencing bleeding so doctors have no way of immediately stopping it. On June 6, 2013, the Food and Drug Administration (FDA) sent a letter to the drug manufacturer, Johnson & Johnson, warning the company that the overall presentation of their promotional material misleadingly minimizes the risks associated with Xarelto and misleadingly suggests that dose adjustments are not necessary. In January 2014, the FDA required additional language be added to the drug label regarding the risk of bleeding events.
There are many lawsuits filed throughout the country by individuals who suffered serious, uncontrolled bleeding while on Xarelto. The allegations against the drug manufacturer include a failure to advise routine monitoring to gauge a patient’s risk of bleeding.