Bayer Healthcare and Janssen Pharmaceuticals, manufacturers of the anti-coagulant Xarelto (rivaroxaban), currently face more than 15,000 lawsuits, alleging that they were aware of the risk of dangerous and even fatal bleed-outs and failed to inform the public as well as the medical community.

Although there is at present no approved antidote or treatment other than emergency dialysis, the FDA has approved Xarelto for patients who are at risk for blood clots due to hip and joint surgery and for the prevention of stroke in patients suffering from non-valvular atrial fibrillation. Now, despite having to defend themselves against growing litigation, Janssen and Bayer are looking to expand the market for Xarelto.

The new patients they are targeting for Xarelto are those at risk for heart attacks. According to a recent company press release, results from Phase 3 of recent study, known as COMPASS (“Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease”), Xarelto shows “great promise” in preventing coronary events in such patients. The Phase 3 study, which was scheduled to continue until March of 2018, was ended over a year ahead of schedule because the manufacturers were satisfied with the results.

A detailed analysis of those results have yet to be released to the general lay public, although Janssen representatives did present the research at a recent meeting of the American College of Cardiology. According to Dr. Paul Burton, Vice President of Medical Affairs at Janssen, the effectiveness of Xaretlo compares favorably with aspirin. He adds:

With cardiovascular diseases on the rise and nearly 44 percent of Americans predicted to have some form by 2030, Janssen remains deeply committed to reducing the burden of these conditions and helping to improve the lives of these patients.”

What Dr. Burton did not say is that the manufacturers of Xarelto are also salivating over the prospect of greater revenues and profits expected to be generated by additional sales of the product. Over the past year, Xarelto sales totaled approximately $2.3 billion. If the FDA approves the new use of Xarelto next year, as is expected, that figure could more than double. Currently, there are approximately 7 million patients taking Xarelto. FDA approval for the treatment of people at risk for cardiac arrest would add an additional 10 million patients to that number.

It also means an additional 10 million patients at risk for potentially fatal hemorrhaging, since the antidote being developed at a small, San Francisco biotech firm has yet to get FDA approval.  

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K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.