According to a new study, patients who recently underwent successful transcatheter aortic-valve replacement (TAVR) surgery may face an increased risk of life-threatening bleeding events and death with Xarelto treatment compared to individuals taking antiplatelet-based therapy. Too often, patients taking an approved pharmaceutical drug prescribed with the intention of reducing their risk of developing a certain medical condition end up suffering serious or even life-threatening side effects as a result of the drug treatment. If you or someone you love has suffered a side effect you believe to be related to a potentially defective or dangerous medication like Xarelto, contact an experienced drug injury attorney as soon as possible to find out if you are eligible for compensation.
Xarelto, known generically as rivaroxaban, belongs to a new class of direct oral anticoagulants that have been aggressively marketed as superior alternatives to older blood thinners like warfarin for the prevention of blood clots. Originally approved as a method of reducing the risk of blood clots in patients undergoing hip or knee replacement surgery, Xarelto is more commonly prescribed to patients with atrial fibrillation to lower the risk of stroke caused by a blood clot. Since the blood thinner entered the market, there have been thousands of reports of serious and uncontrollable bleeding events and other side effects among patients taking Xarelto, many of which have resulted in serious injury or death, and a growing body of research has examined the potential adverse effects of Xarelto treatment. In 2018 alone, two studies were published analyzing the safety and efficacy of Xarelto. The first found that Xarelto failed to reduce the risk of blood clots or death in hospital patients who were bedridden and the second found that the blood thinner failed to prevent death in patients with heart failure.
In this latest Xarelto study, published this month in the New England Journal of Medicine, researchers working on the GALILEO clinical trial found that taking the blood thinner Xarelto increased the risk of life-threatening bleeding events by up to 50% and the risk of death by nearly 70% when compared to aspirin for preventing blood clots. The study involved 1,644 patients following successful TAVR surgery who were administered either Xarelto or aspirin for the prevention of blood clots. After a median of 17 months, the researchers found that 46 of the patients taking Xarelto suffered major, life-threatening bleeding events, compared to 31 of the aspirin patients, and 64 of the Xarelto patients died, compared to 38 of the aspirin patients.
TAVR is a type of heart surgery in which a narrowed aortic valve that fails to open properly is replaced through an artery in the leg rather than through open heart surgery. Previous research has suggested that oral anticoagulants like Xarelto may lower the risk of subclinical leaflet thrombosis after TAVR, which has been linked to stroke. However, during the GALILEO clinical trial, which was designed to test Xarelto treatment after TAVR surgery, it was discovered that a Xarelto-based treatment strategy worsened clinical outcomes and increased the risk of bleeding and death. Based on their findings, the researchers concluded that “In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy.” The researchers ended the clinical trial prematurely due to concerns about patient safety.
Uncontrollable bleeding, brain hemorrhages, stroke and death are all side effects that have been linked to the use of Xarelto and as many as 30,000 lawsuits have been filed against the makers of Xarelto on behalf of patients who suffered serious injury or death from irreversible bleeding events and other complications while taking the blood thinner. All of the Xarelto lawsuits involved similar allegations that Janssen Pharmaceuticals, the manufacturer of the anticoagulant drug, failed to adequately warn patients and the medical community about the potential side effects of Xarelto treatment and the lack of an effective reversal agent to stop the blood thinning effects of the medication in the event of a bleeding incident. Following a series of Xarelto bellwether trials in which the results were divided, a $775 million global settlement was reached in March 2019 that resolved nearly all of the pending Xarelto claims.