New blood thinning medication from Bayer, Xarelto (Rivaroxaban), has not been approved for use in cases of Acute Coronary Syndrome. The US FDA was unanimous in it’s decision not to allow the drug to be used as treatment for anyone who suddenly experiences reduced blood flow to the heart. This includes chest pain and heart attacks.
Acute Coronary Syndrome is said to affect 1.2 million Americans each year. If it were to be approved, this would no doubt help bolster profits of the medication. The panel, however, felt prevention of new heart attacks and strokes should not be a reason to use the drug.
This is not the first time the company has received bad news from the Food and Drug Administration. However, this is unlikely to affect the companies bottom line. Xarelto sales have been seeing healthy profits and sales are expected to grow to $3.68 billion annually by 2018. The drug was originally approved for more uses than Pradaxa.
There is speculation that the companies will continue studying it’s use in cases of heart attack and stroke. They may also test the drug for use in cases of chronic artery disease and heart failure. The rejection by the FDA happened a mere months before the first few Xarelto lawsuits were filed. You can learn more about the various lawsuits against Xarelto and information about Xarelto lawyers on this page.
Plaintiffs in these lawsuits allege that Bayer and J&J sold Xarelto without adequate warnings to patients about potentially deadly side effects, while knowing about the risks. The first lawsuit was filed in the U.S District Court of the Eastern District of Pennsylvania.