Xarelto Studies Question Drugs Benefits and Risks and Reveal Eye Bleeding in Some Cases

A number of study results are prompting questions over Xarelto (rivaroxaban) and other new-generation anticoagulant drugs (blood thinners). Bayer Healthcare and Janssen Pharmaceuticals, a division of the Johnson & Johnson Corporation, manufacture Xarelto.

Xarelto received U.S. Food and Drug Administration (FDA) clearance in 2011 and was released to the market to treat patients who may be at an increased risk of developing blood clots or undergoing stroke due to medical conditions, including atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism. Xarelto is also approved for individuals recovering from hip or knee replacement surgery.

Soon after its release, Xarelto’s potentially serious side effects were revealed. Emerging studies found a possible tie to spontaneous and severe bleeding episodes that include stomach bleeds and vitreous hemorrhage (bleeding of the eyes). One of two noteworthy studies, conducted by doctors John C. Hwang and Judy H. Hun, revealed that patients in their practice who were taking Xarelto experienced some significant health issues. The individuals were between the ages of 70 and 89 and had used the traditional blood thinner Coumadin (warfarin) initially, later changing to Xarelto. The physicians noticed that the patients were, more and more, suffering from vitreous hemorrhages and that the most significant eye bleeding occurred during the time in which patients were being weaned off warfarin and beginning Xarelto. Study results were published in the June 2015 issue of JAMA Ophthalmology; the physicians indicated that, “In all cases, an acute vitreous hemorrhage occurred shortly after rivaroxaban (Xarelto) treatment was initiated.”

Another study—involving nearly 46,000 patients and the blood thinners Xarelto, Pradaxa, or warfarin—published in the April 2015 issue of BMJ found that research involving the different blood thinners were not able to rule out an increased risk of stomach bleeding that was at least two-fold greater for those individuals taking Xarelto when compared to individuals taking Warfarin.

There is no antidote to reverse the bleeding if it occurs for those patients taking Xarelto and other newer blood thinners, such as Pradaxa. There is treatment for bleeding in patients taking warfarin.

Meanwhile, nearly 2,800 individuals have filed lawsuits against the makers of Xarelto that similarly allege the drug caused them suffer dangerous and uncontrollable bleeding episodes, such as gastrointestinal bleeds, strokes, and brain hemorrhages; in some cases, the patients died. Allegations also include that Bayer and Janssen did not sufficiently warn about the bleeding risks associated with Xarelto.

All federally filed Xarelto lawsuits have been consolidated by the U.S. Judicial Panel on Multidistrict Litigation and are being overseen New Orleans, Louisiana. To date, four cases are have been selected for initial trials known as bellwether trials. The outcome of bellwether trials may have significant impact on the remaining litigation as the bellwethers are typically chosen to provide a sense of how similar lawsuits will proceed and conclude.

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