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Approved by the FDA in 2011, Xarelto is part of a new class of anticoagulants known as direct thrombin inhibitors. Advertised as an alternative to Warfarin requiring less maintenance, it’s designed to reduce incidence of blood clots and strokes for patients living with atrial fibrillation, pulmonary embolism and deep vein thrombosis.

As a result of its popularity, Xarelto brought in $2 billion for manufacturers Janssen and Bayer in 2015 alone. But, while advertisements make the drug seem like it’s easier to use than Warfarin, its time on the market has revealed one extremely concerning flaw: Unlike Warfarin, Xarelto has no antidote if a patient starts bleeding uncontrollably. As a result, patients experiencing even small cuts have died or had to live with permanent damage resulting from an internal hemorrhage.

Background

Much like Pradaxa, this drug generically known as Rivaroxaban had been considered a medical breakthrough at the time. But, not long after its introduction, patients taking it would get severe, uncontrollable bleeding that would often lead to:

  • A stroke
  • Retinal hemorrhaging
  • Epidural hematoma
  • Intracranial hemorrhages
  • Pulmonary embolism
  • Decreased hemoglobin
  • Gastrointestinal hemorrhages
  • Deep vein thrombosis
  • Adrenal bleeding
  • Death

In several cases, patients would fall or get a cut, only to have the injury develop into an internal hemorrhage, particularly in the gastrointestinal tract. Because an antidote isn’t readily available, patients often require a blood transfusion to live and have to contend with permanent physical damage in the aftermath. Certain reports even indicate uncontrollable bleeding started just one month after the patient began the drug.

Along with internal bleeding, Xarelto usage has been associated with wound infections following hip and knee replacement, with risks increasing 10 times over. Patients may further have to get additional surgery as a result.

After multiple reports, the FDA issued a warning letter to the manufacturers regarding their print advertisement, alleging they made a misleading claim and hid the drug’s risks. Later, the government organization rejected Bayer and Janssen’s proposal to approve Xarelto for acute coronary syndrome, citing insufficient supporting clinical data. Yet, the FDA still considers Xarelto a safe alternative to Warfarin, keeping it on the market.

By 2016, data from the ROCKET-AF study, which involved the now-recalled Alere INRatio monitor and test strips, indicated that the device may have skewed results in Xarelto’s favor. However, the FDA claims the monitors didn’t have a substantial impact when comparing Xarelto’s effectiveness to Warfarin.

The following year, the Mayo Clinic published a study in Gastroenterology concerning the recent class of anticoagulants. Researchers found that, when monitoring 57,000 patients with atrial fibrillation over a five-year period, Xarelto is associated with higher rates of gastrointestinal bleeding than Eliquis or Pradaxa.

Around that same time, ProPublica published data about the payments physicians receive from drug manufacturers, uncovering that Xarelto received the greatest amount for speaking, consulting, meals, travels and gifts. The article further indicated that doctors receiving these types of payments, which don’t go toward research, are more likely to prescribe brand-name drugs.

Lawsuits

Plaintiffs started filing lawsuits against Bayer and Janssen as early as 2014, with 15,000 cases pending nationally as of 2017. Several have been consolidated into the U.S. District Court, Eastern District of Louisiana, with the first bellwether trial scheduled for March 2017.

In these cases, patients and their loved ones make multiple allegations against the manufacturers:

  • Xarelto prevents the patient’s blood from properly clotting, leading to a potentially fatal bleeding event.
  • Neither warned patients or medical professionals about a lack of a proper antidote. For Warfarin, severe bleeding could be reversed with Vitamin K.
  • Patients’ complications were more severe because an antidote wasn’t readily available.

At Trantolo & Trantolo we believe that before a drug enters the market, extensive testing must be done to prove its effectiveness and safety. Instead, manufacturers putting profits over patients’ health and wellbeing introduce a medication like Xarelto without providing medical professionals with enough information about its risks and thus preventing patients from making an adequate decision.