Two studies have brought new concerns to light regarding blood-thinner Xarelto and dangerous, uncontrollable bleeding episodes. Each study appears to link the anticoagulant to serious and even fatal side effects for patients taking it.
Xarelto was initially approved by the U.S. Food and Drug Administration in 2011, and was released to the market as a revolutionary new blood thinner. It was originally approved specifically to treat patients who had recently undergone hip or knee replacement surgeries, and this approved use was later expanded, approving the drug for patients with atrial fibrillation, pulmonary embolism, or deep vein thrombosis.
After only its first year on the market, the drug quickly became considered one of the most dangerous blood thinners. It was suddenly linked to hundreds of reports of adverse events, with patients claiming it had caused them blood clots, strokes, pulmonary embolisms, and other serious complications.
One study that illustrates problems with the drug was done by doctors Judy H. Hun and John C. Hwang. They noted that three of their patients had developed “spontaneous vitreous hemorrhage” (also known as eye bleeding) while using Xarelto. The doctors’ studies also concluded that the risk of eye bleeding may be increasingly elevated for patients who had switched from a traditional blood thinner, such as warfarin, to Xarelto.
Another study took place from October 1st 2010 to March 31st, 2012, and evaluated many people from the U.S. who were using Xarelto, Pradaxa, and Warfarin as blood thinners. The study details note that their final sample of patients included 46,000 total, 39,607 of which used warfarin, 4,907 of which used Pradaxa, and 1,649 of which used Xarelto. Research done on these individuals highlighted “as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban (Xarelto) when compared with warfarin.”
Lawsuits filed against Xarelto now number near 2,000 in federal court. They have been consolidated to form multidistrict litigation number 2592, and are being overseen by Judge Eldon Fallon in the Eastern District of Louisiana. As they await trial, their numbers are only expected to increase.