Millions of people in the United States are being treated with blood thinners, with statistics showing that about one-in-30 of these patients experience serious bleeding complications associated with blood thinners like Xarelto.

However, a recent study published in the July issue of the journal Circulation suggests that the anticoagulant Xarelto poses no greater risk than warfarin in regards to internal bleeding events, heart attacks, and strokes.

Study Looks At Xarelto, Warfarin Bleeding Risks

Researchers from France’s National Health Insurance Strategy and Research Department conducted a nationwide cohort study which used data from three groups: 19,713 VKA (warfarin) users; 8,443 Pradaxa users; and 4,651 Xarelto users to analyze the differences between warfarin, Pradaxa and Xarelto bleeding risks.

The study focused on the safety of these blood thinning medications during initial phases of preventative treatment where patients were prescribed the anticoagulants to treat their nonvalvular atrial fibrillation, specifically to prevent the occurrence of strokes.

After gathering and analyzing the data, the researchers concluded that there was no difference in the occurrence of bleeding events in any of the groups during the first 90 days.

However, the researchers caution that the findings do not alleviate concerns that Xarelto and other new generation anticoagulants are safer than warfarin (or VKAs) as there is still no reversal agent for Xarelto bleeding events.

“NOAC cannot be considered to be safer than VKA during the early phase of treatment,” the researchers stated. “On the contrary, the clinical implications of our results are that physicians must be just as cautious when initiating NOAC as when initiating VKA, particularly in view of the absence of an antidote and objective monitoring of the extent of anticoagulation.”

Xarelto Claims to Lower Bleeding Risks

Xarelto has been aggressively marketed as being safer than warfarin. One of its most significant selling points has been that patients, who take Xarelto to treat atrial fibrillation, are less likely to suffer from a bleeding event.

Manufacturers claim that the new drugs posed less of a risk of a hemorrhage or other bleeding complication than warfarin.This study certainly challenges this claim as researchers called into questions whether Xarelto provides additional safety to a patient than its predecessor warfarin.

Xarelto was marketed as being significantly more convenient than warfarin. Warfarin always demanded that the patient stick to a careful diet, submit to frequent blood monitoring and more.

As a new generation anticoagulant, Xarelto has no such monitoring or dietary restriction requirements.

Some say that this convenience factor was aggressively marketed to the medical community and consumers alike. Research suggests, however, that for people who take Xarelto, strict and regular patient monitoring may actually reduce the risk of potential bleeding events.

 No Xarelto Bleeding Antidote

While, the risk of bleeding associated with Xarelto and warfarin was essentially the same according to the study, all blood thinners present at least some risk of bleeding or hemorrhage. Their very nature alone contributes to that risk.

With warfarin, if a patient experiences a bleeding event, even a life-threatening one, the bleeding could be stopped with a dose of vitamin K. Vitamin K quickly and easily reverses the “thinning” effects of warfarin.

Currently, there is no such approved reversal agent to help patients taking Xarelto. In the event of a life threatening bleed, where time is of the essence, there is no way to stop the effects of the drug.

The results of this study do raise concerns about the benefits of taking Xarelto as the lack of an active antidote makes it difficult for doctors to stop or control bleeding events.

Xarelto Lawsuits

The fact that there is no reversal agent for Xarelto is one of the subjects of several Xarelto lawsuits that have been filed against the drug’s manufacturers, Bayer and Janssen.  The number of filed Xarelto lawsuits continue to rise, all similarly alleging uncontrollable or life-threatening bleeding.

In December 2014, an order was issued establishing a Xarelto MDL and at least 500 Xarelto lawsuits have been consolidated as of August 2015, in the U.S. District Court for the Eastern District of Louisiana.