Bayer Healthcare announced that it plans to release additional clinical data for its anticoagulant drug Xarelto at the upcoming Congress of the International Society on Thrombosis Haemostasis in Toronto. Certain health groups such as the Australian Therapeutic Goods Administration have criticized the lack of usable Xarelto clinical data.
The blood thinner is manufactured in tandem by Bayer and Janssen Pharmaceuticals and was approved for use in certain patients in 2011. However, several studies have shown that the drug and others in its class, known as Xa inhibitors, could increase the risk of serious and sometimes fatal side effects.
Since 2011, more than 1,800 Xarelto adverse events have been reported to the U.S. Food and Drug Administration, including reports of heart attacks, strokes and blood clots. At least 891 of the reported Xarelto side effects resulted in hospitalization, and more than 180 cases resulted in a patient’s death.