Studies Say No Difference in Safety Between Xarelto and Warfarin

In a new study published by the British Medical Journal (BMJ), researchers reported that so-called “new-generation” blood thinners like Xarelto and Eliquis were no safer when it came to the risk of excessive bleeding than warfarin, the leading blood thinner for decades.

A second study reported similar results. Researcher publishing in JAMA Neurology stated that Xarelto (rivaroxaban) was no safer than warfarin for patients with atrial fibrillation.

Manufacturers of these drugs have asserted that their drugs are superior to warfarin in many ways.  The findings from these studies, however, call those statements into question. Additionally, unlike warfarin, the newer drugs have no readily available antidote to stop excessive bleeding if a patient develops a bleed.  This can create a life-threatening situation for patients taking Xarelto or Eliquis.

Study Finds No Difference in Risk of Bleeding Between Warfarin and Newer Drugs

In the first study, researchers wanted to find out how safe these newer drugs were compared to warfarin when they are used to help prevent blood clots. They looked at medical data from nearly 60,000 adults who had received prescriptions for warfarin or for one of these newer drugs (like Xarelto, Eliquis, and Pradaxa) within 30 days of a diagnosis of venous thromboembolism (i.e., a blood clot that starts in a vein).

The researchers identified anyone was hospitalized or had an emergency room visit for major bleeding or who died within 90 days of when they started taking the drugs. They found that of all the participants, 1,967 (3.3 percent) had a major bleeding event and 1,029 (1.7 percent) died over the follow-up period. The risk of this happening, though, was similar for both the newer generation drugs and warfarin.

“The risk of major bleeding was similar,” the researchers wrote, and no “difference was found in the risk of death” for the newer drugs compared with warfarin.

Study Finds No Difference Between Warfarin and Xarelto in Preventing Stroke

In the second study, researchers wanted to see if Xarelto was safer and more effective than warfarin at preventing recurrent atrial fibrillation-related acute ischemic stroke. They evaluated data from 195 patients who had suffered a mild acute ischemic atrial fibrillation-related stroke between April 28, 2014 and December 7, 2015, at 14 academic medical centers.  Each patient received a prescription for either Xarelto or warfarin.

Using magnetic resonance imaging (MRI), the researchers identified any of the patients who developed another ischemic lesion (brain injury) or a new brain hemorrhage within four weeks. They found no differences between the two groups—those taking warfarin or those taking Xarelto—for either of these outcomes.

“In mild AF-related acute ischemic stroke,” the researchers wrote, “rivaroxaban and warfarin had comparable safety and efficacy.”

Are the Newer-Generation Blood Thinners Really Safer?

These studies suggest that what the manufacturers’ assertions that their products are superior to warfarin may not, in fact, be true. In addition, it is even more concerning if patients are being led to believe that these drugs are safer than warfarin because all blood-thinning drugs carry a risk of bleeding, but the newer drugs have no antidote to stop the bleeding if it develops, whereas warfarin does have an antidote.

Some patients are at an increased risk of bleeding with Xarelto and other similar drugs and don’t even know it. A 2015 study, for example, showed that Japanese patients were at increased risk of bleeding with Xarelto, and a 2015 study also warned that patients over the age of 75 with atrial fibrillation had a higher risk of gastrointestinal bleeding when taking Xarelto than when taking warfarin.

Currently, more than 21,000 Xarelto lawsuits are pending in courts around the nation. All federally-filed cases have been centralized in the Eastern District of Louisiana.