A new study has come out that closely examines the safety of the new family of anticoagulants including Xarelto and discusses possible Xarelto bleeding side effects.

For many years, warfarin (Coumadin) was the drug of choice for doctors putting their patients on anticoagulant medication to prevent strokes or other blood clot related complications. However, with warfarin, a patient must closely monitor his or her diet.

Part of a new family of blood thinner medications called factor xa medications, Xarelto was approved by the FDA in July 2011 for the prevention of deep vein thrombosis and pulmonary embolism in patients that have undergone hip or knee replacement surgery.

Also part of this new group of medications were Pradaxa and Eliquis, both approved for the same or similar conditions.

Soon after the approval, however, many adverse Xarelto bleeding side effects were reported. By June 2012, just one year after approval, over 1,000 serious Xarelto bleeding side effects were reported to the FDA. Sixty-five of those were deaths.

Xarelto Bleeding Side Effects Study

A new study conducted by the Loyola Medicine and Loyola University Chicago Stritch School of Medicine and published in Current Treatment Options in Cardiovascular Medicine found some interesting results regarding Xarelto bleeding side effects.

The study looked at all of the factor xa drugs, Xarelto, Pradaxa and Eliquis.

According to the researchers, in atrial fibrillation patients these medications appear to decrease the risk of stroke. This occurs without the need for frequent monitoring or dietary controls.

However, the research also shows that the drugs may come with a concern about adverse bleeding events. Since Xarelto was approved, many patients have reported Xarelto bleeding side effects such as uncontrollable bleeding.

Xarelto does not have a reversal agent like its predecessor, warfarin. Vitamin K can be administered to a warfarin patient who suffers from uncontrolled bleeding as a reversal agent.

Last year, Praxbind was approved to be a reversal agent for Pradaxa. Xarelto and Eliquis do not have such an agent.

However, recently it was announced that Portola Pharmaceuticals had developed a reversal agent for Xarelto called andexanet alfa. The FDA has yet to approve andexanet alfa, but the first stages of clinical trials show promising results.

The Loyola Medicine study also found that “the novel oral anticoagulants are overall safer than warfarin, despite the need to take into account age, renal function, bleeding risk, cardiovascular comorbidities, cost and drug interactions.”

Critics do not agree. They point to the numerous product liability lawsuits against the drugs for uncontrollable bleeding events that caused serious harm or even death.

Currently, Johnson & Johnson is under fire for more than 4,500 lawsuits in the U.S. for Xarelto bleeding side effects. Since 2014, these cases have been brought under a multidistrict litigation (MDL) in Eastern District of Lousiana.

Nearly all of these separate lawsuits raise almost identical claims saying that the medical community was not offered proper warnings about Xarelto bleeding side effects and that an adequate reversal agent was not available for life-threatening complications.