Study: Xarelto Bleeding Risk Same as Warfarin

Home » Drug Injury » Study: Xarelto Bleeding Risk Same as Warfarin

According to a recent study in Canada, the risk of Xarelto bleeding is the same as warfarin, an older oral anticoagulant Xarelto was intended to replace.

Scientists looked at the records of nearly 150,000 patients who took either a new generation drug, like Xarelto, or warfarin between 2013 and 2015.

Researchers discovered that major bleeding events from the new direct oral anticoagulants like Xarelto and Pradaxa were almost identical as those associated with warfarin – just over three percent suffered major bleeding and almost two percent of those taking the new generation drugs, including Xarelto died from those bleeding events.

“Overall, the risk of major bleeding associated with use among patients with incident venous thromboembolism was similar to that with warfarin use,” stated the researchers in their report to the BMJ

synthetic hernia mesh study finds high failure rateResearchers have attempted to prove that Xarelto and other new generation blood thinners are less risky than warfarin; however, another study conducted in South Korea a few months earlier than the Canadian study resulted in similar findings that the drugs presented the same amount of risk of major bleeding events.

The South Korean study also looked at other side effects, including ischemic stroke, lesions, and new intracranial hemorrhage and found that presented nearly the same risk as warfarin. In fact, nearly half of the South Korean study participants taking Xarelto suffered these side effects.

While all blood thinners present the risk of major bleeding events that can be uncontrollable, the older drug, warfarin, has an antidote. There is no antidote for patients who take Xarelto and suffer uncontrollable bleeding events.

Bleeding Lawsuits

Drug makers are facing thousands of lawsuits over allegations that they did not provide warnings to patients and doctors about the risk of bleeding associated with Xarelto.

According to the lawsuits, within a year of approval by the Food and Drug Administration in 2001, more than 1,000 reports of bleeding events and 65 deaths were submitted to the agency.

Further, say those affected by Xarelto bleeding, drug makers exacerbated the problem by touting the drug as a convenient alternative to warfarin requiring only once a day dosing and no blood monitoring.

However, the so-called “Xarelto Difference” allegedly put patients at risk for severe bleeding events and other complications. In fact, allege the lawsuits, studies showed that blood monitoring and multiple daily doses resulted in better outcomes for patients.

But the drug makers discarded the research results that did not support their marketing claims, say the plaintiffs in the lawsuits.

The makers of Xarelto have also faced criticism from the former director of the FDA who testified in a recent lawsuit that the warnings provided were inadequate.

If you’ve experienced Xarelto bleeding, consider contacting an attorney. The attorneys at McDonald Worley are currently investigating claims.