The anticoagulant drug Xarelto (rivaroxaban) is currently the subject of over 15,000 personal injury lawsuits pending in the Eastern District of Louisiana in a consolidated MDL litigation. Plaintiffs in these suits allege that after taking the drug, they suffered excessive bleeding events, and seek compensation for medical expenses and pain and suffering.
The FDA has approved Xarelto for preventing blood clots in patients going through knee and hip replacement surgery, to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), and to help prevent stroke in patients with non-valvular atrial fibrillation.
Now, manufacturers Janssen Pharmaceuticals, a division of Johnson & Johnson, and Bayer Healthcare want to expand the use of Xarelto to a new population of patients: those at risk for heart attack. The drug manufacturer has claimed in a recent press release that clinical trials are showing promise for the drug for this patient group.
Manufacturers Want to Use Xarelto in New Population of Patients
The Phase 3 COMPASS trial was designed to evaluate the safety and efficacy of Xarelto for the prevention of heart attacks, strokes, and other cardiac events in patients with coronary artery disease (CAD) or peripheral artery disease (PAD). Researchers recently stopped the study prematurely because the results were overwhelmingly positive.
Patients with either of these diseases are at a higher risk for blood-clot-related health problems. Both conditions are caused by narrowed and blocked arteries (atherosclerosis) in various regions of the body. These narrowed arteries increase the risk that a blood clot will form, which can then cause a heart attack or stroke.
The manufacturers didn’t share details of the Phase 3 COMPASS trial, stating that a complete analysis will be presented at “a medical meeting in 2017.” Meanwhile, they have stated only that the study was ended prematurely since the drug had proved to be effective at preventing cardiac events in patients with PAD and CAD. Paul Burton, Vice President of Medical Affairs for Janssen, stated that the company is excited about the possibility of making Xarelto available for this new group of patients and that they were looking forward to discussing the trial results with the FDA as soon as possible.
If the Drug is Approved for a New Indication, More Patients Will be at Risk for Dangerous Bleeding Events
Xarelto is a new-generation blood thinner and reduces the blood’s ability to clot. This is why it may also increase the risk of excessive bleeding in some cases. It’s also why the manufacturers thought to expand the drug to be used in this new patient population.
If the FDA does approve Xarelto for this new use, thousands of more people would be exposed to potential bleeding problems. Xarelto still has no readily available antidote to excessive bleeding, which makes it especially dangerous and sometimes deadly.