The NAVIGATE ESUS clinical trial recently came to abrupt end after the study’s Independent Data Monitoring Committee revealed that the anticoagulant medication Xarelto was no more effective than aspirin for preventing strokes.
The study has so far shown similar results between Xarelto and aspirin in the secondary prevention of stroke and systemic embolism among patients who had suffered a recent stroke. Bleeding rates were found to be very low overall and within the expected range, yet the patients taking Xarelto demonstrated increased bleeding as compared to those taking aspirin. Although a more complete review of the late-stage clinical study is expected next year, third party reviewers saw little potential that any overall benefit of Xarelto over that of aspirin would ultimately be shown.
Xarelto Connected With Serious Bleeding Events
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011 for the prevention and treatment of blood clots in patients at risk for stroke from atrial fibrillation. Since then, Xarelto has been approved for other indications, including as a general treatment for adults with deep vein thrombosis (DVT) or pulmonary embolism (PE).
Although all blood thinners increase the risk of severe bleeding somewhat, Xarelto has been connected to an increased number of uncontrollable bleeding events, primarily because there is no approved antidote for patients who use the medication, and many of the side effects associated with the drug have been particularly serious because the bleeding cannot be successfully controlled.
Since Xarelto’s 2011 approval, thousands of lawsuits have been filed against Bayer AG and Johnson & Johnson alleging side effects such as:
- Gastrointestinal, rectal, and internal bleeding
- Heart attack
- Pulmonary embolism
- Epidural hematoma
- Brain hemorrhage
More than 7,200 federal Xarelto lawsuits have been consolidated into multidistrict litigation (MDL) 2592 in the District of Louisiana, and a mass tort program has been formed in the state of Pennsylvania, where more than 800 cases have been centralized.