Xarelto Lawsuit

Xarelto (Rivaroxaban) was developed by Bayer Pharmaceuticals and is now marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit.

Gaining FDA approval in 2011, Xarelto is prescribed to block clotting of the blood, specifically, a particular type of blood clot called deep vein thrombosis (DVT).

It is also used in individuals with atrial fibrillation to decrease the risk of stroke caused by a blood clot.

Patients prescribed Xarelto or other new oral anticoagulants need to understand that taking these drugs comes with some risk.

In instances of an emergency situation, traumatic accident, or cerebral hemorrhage, bleeding can be difficult to stop in patients taking Xarelto.

As of January 2018, an antidote has still not been released to prevent the severe, uncontrollable bleeding from occurring.

The uncontrollable severe bleeding events, including gastrointestinal bleeds, could lead to blood transfusions, hospitalization, or even death.

However, there is a drug, AndexXa, currently undergoing an approval process by the FDA that would cease potentially fatal Xarelto bleeding side effects.

More information on the approval process should be released in May 2018.

According to the Institute for Safe Medicine Practices (ISMP), a watchdog group, anticoagulant drugs are a “high-risk treatment” and cause bleeding in approximately 15% of patients with atrial fibrillation.

Many physicians are wary of the newer anticoagulants since there is limited data on how to manage bleeding in patients taking them.

The pharmaceutical companies that produced Xarelto are now under fire for not only causing side effects in individuals but for failing to provide adequate warnings of the risks.

Bayer AG and Johnson & Johnson pharmaceuticals pulled the plug in 2017 on an in-house study on Xarelto’s benefits weighed against a potentially life-threatening Xarelto side effect. The NAVIGATE ESUS trial was suspended following the release of findings from a third-party research group, which indicated that Xarelto’s use in secondary stroke prevention performed no better than normal standard of care.

The independent research showed that as compared to standard of care, preventing secondary stroke with use of aspirin or similar over-the-counter medication, Xarelto faired the same in terms of efficacy.

NAVIGATE ESUS is scheduled to resume in 2018, but there are certain deterrents that could eventually halt the manufacturer’s research permanently.

While there is no indication that Xarelto offers any greater benefit to patients than more standard forms of care, the drug seems to pose substantial health risks to users. Internal bleeding, a Xarelto side effect which J&J failed to warn consumers of, is one of these risks.

According to the FDA, the blood thinner medication has been linked to more than 370 deaths related to internal bleeding.

Xarelto is Bayer’s highest sales product, producing $5.74 billion in the last two years alone. Cutting Xarelto from the U.S. market would decimate the manufacturer’s sales. But with the growing number of Xarelto bleeding lawsuit litigations, along with independent research that indicates that safer and cheaper over-the-counter medications are as equally effective, it will be difficult for Bayer to downplay the imbalance between Xarelto side effects and benefits.

For now, Bayer AG and J&J will regroup. The manufacturers are left with the difficult decision of either accepting that Xarelto is inefficient – and accepting the lost sales — or continuing with the NAVIGATE ESUS study in 2018, hoping to disprove the independent research and extenuate the life-threatening Xarelto side effect with some potential benefits.