Xarelto (rivaroxaban) was approved by the FDA in July of 2011 and is marketed by Bayer and Johnson & Johnson. Xarelto is a prescription medicine with three main uses. The first is it reduces the risk of blood clots and strokes in patients with atrial fibrillation. Next is treats deep vein thrombosis and pulmonary embolism. Last but not least it reduces the risk of blood clots in patients undergoing knee replacement surgery. Xarelto belongs to a class of anticoagulants called direct factor Xa inhibitors. Sometimes referred to as blood thinners, anticoagulants interfere with the normal clotting of the blood. Clotting is essential if a person is to stop bleeding from an open wound, but some people experience clotting when they are not injured. Atrial fibrillation is a heart condition characterized by an irregular heartbeat that can cause blood to pool in the heart and may lead to clots. If these travel to the brain, they may cause a stroke. Blood clots that develop in the legs (deep vein thrombosis) and pulmonary embolism (blood clots in the lungs) can cause serious complications and/or death if left untreated.

Recent reports have shown Xarelto, in some patients, may increase the risk of serious, potentially fatal bleeding events that could be extremely difficult to treat. Xarelto has no known antidote or reversal agent, which means that there is no effective way of stopping hemorrhages that can be caused by the drug. Xarelto (rivaroxaban) is an oral anti-clotting medication or “blood thinner,” which is prescribed to prevent and to treat deep vein thrombosis (blood clots in the legs) and pulmonary embolism (blood clots to the lungs). It also is used to reduce the risk of stroke in some patients with a common heart arrhythmia known as atrial fibrillation. It may also be prescribed to patients undergoing knee or hip replacement surgery to prevent clots from forming in the legs and traveling to the lungs. The FDA approved Xarelto to reduce the risk of deep vein thrombosis and pulmonary embolism in July 2011. The FDA then expanded its approval to the ongoing treatment and prevention of deep vein thrombosis and pulmonary embolism in November 2012. The FDA also approved Xarelto for reduction of stroke risk in certain patients with atrial fibrillation in November 2011. Xarelto is manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. In 2013, the institute for Safe Medication’s Practice QuarterWatch reported a steady increase in adverse events reported to the FDA for Xarelto. In January 2014, the FDA’s safety surveillance agency announced a plan to monitor and study Xarelto for serious events such as ischemic strokes, intracranial hemorrhages, and gastrointestinal bleeding. There is currently no reversal agent for Xarelto.

Xarelto’s original FDA-approved use was as a blood thinner for patients recovering from knee or hip replacement surgery. In the RECORD study, a Phase III clinical trial of more than 9,500 participants, researchers found that Xarelto was more effective than another blood thinner, enoxaparin (Levenox), in reducing incidence of blood clots in the legs following hip or knee replacement surgery. Xarelto is also used for preventing strokes in people with atrial fibrillation (AF). AF affects about 3 million Americans, and it is projected that 12 million people in the United States will be diagnosed with AF by 2020, so it is expected that newer anticoagulants such as Xarelto will become more popular. One of the most severe side effects of Xarelto is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Also, pools of blood may form within the body and can cause other severe health risks. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system. Like Pradaxa, Xarelto has no known antidote for uncontrolled bleeding, while warfarin does. The drug’s manufacturers have yet to release information for doctors on how to treat uncontrolled bleeding.

Xarelto has been the subject of recent lawsuits for causing alleged serious injuries, including stroke or death, and the Institute for Safe Medication Practices (ISMP), a nonprofit organization that tracks medication errors, reports more than 350 instances of serious, disabling or fatal injuries involving Xarelto. According to ISMP, direct reports submitted to the FDA by health professionals and consumers identified the Xarelto as the 10th “most frequent suspect drug in serious or fatal adverse events in 2012.” The FDA initially approved Xarelto in July 2011 to reduce the risk of DVT or PE specifically following hip or knee replacement surgery. In November 2011, it was approved for treating patients with irregular heart rhythms (non-valvular atrial fibrillation) to reduce the risk of stroke. At this same time, the warnings were updated to include a boxed warning that “discontinuing Xarelto in patients with non-valvular atrial fibrillation increases the risk of stroke, and spinal/epidural hematoma.” A warning was also added indicating that an antidote for Xarelto is not available, putting patients at risk of severe bleeding. A year later, after expedited review, FDA expanded the approved use of Xarelto to include the treatment and prevention of DVT or PE beyond hip or knee replacement surgeries. Additional warnings were added to the Xarelo safety label in August 2013, indicating that stopping the use of Xarelto prematurely can increase the risk of thrombotic events, or blood clots. A warning was also added that Xarelto is not recommended for patients with prosthetic heart valves as the safety and efficacy of Xarelto has not been studied in that patient population. Another warning was added to the Xarelto label in January 2014, including that the drug could increase the risk of an acute pulmonary embolism “in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.” Following this addition, an FDA committee denied the drug manufacturer’s request to add the treatment of recent acute coronary syndrome (ACS) to Xarelto’s list of primary uses due to lack of data from the drug’s original clinical trials, among other issues. Another safety label addition in February 2014 included the study results of Xarelto along with multiple doses of the antibiotic erythromycin in patients with poorly functioning kidneys (renal insufficiency). The study suggested that patients with these conditions may have an increased risk of bleeding.