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Xarelto boxXarelto first entered the U.S. market in 2011 to reduce the risk of clotting and stroke among knee or hip replacement surgery patients. Prior to that point, Coumadin (warfarin) had been the standard treatment to inhibit blood clotting over the last 60 years. Coumadin was inexpensive, but had its drawbacks: it was difficult to administer, given its many interactions with other drugs, and it required frequent and expensive patient monitoring. Patients also had to avoid foods that contained Vitamin K, quit smoking, and avoid contact sports. By comparison, Xarelto had fewer interactions, could be prescribed in a one-size-fits-all dose, and didn’t require monitoring or lifestyle restrictions.

Since Xarelto’s debut, manufacturer Bayer Pharmaceuticals has sold more than 1.4 million prescriptions, including prescriptions for expanded uses in patients considered “at risk” for stroke, deep vein thrombosis, or pulmonary embolism. The European Medicines Agency approved the use of Xarelto for acute coronary syndrome, but U.S. Food and Drug Administration panel members resoundingly voted against approving the drug for these patients in 2011 and 2014, stating that there wasn’t enough data and that “the benefits, at this point, are outweighed by the risk.”

What risks are associated with Xarelto?

Sudden, uncontrolled bleeding is the biggest risk in taking new blood thinners like Xarelto, Pradaxa and Eliquis.

Other adverse reactions reported in the EINSTEIN Extension study included:

  • Abdominal pain
  • Back pain
  • Dyspepsia
  • Fatigue
  • Mouth and throat pain
  • Osteoarthritis
  • Sinusitis
  • Toothache
  • Urinary tract infection

Other rare side effects include dizziness, weakness, sudden loss of movement in a limb, coughing up blood, yellowing of the skin, painful wounds, discolored urine and stools, and irregular heartbeat.

How common are Xarelto side effects?

A watchdog group, The Institute for Safe Medicine Practices, reported that more than 350 instances of “serious, disabling or fatal injuries” were submitted to the FDA, making Xarelto the 10th “most frequent suspect drug in serious or fatal adverse events in 2012.” They claim that the number of adverse events linked to Xarelto have now surpassed complaints about Pradaxa – a comparable drug by Boehringer Ingelheim, who recently paid out $650 million to resolve 4,000 lawsuits.

Xarelto studies and research

The first alarming report related to Xarelto was published in the New England Journal of Medicine In 2011. The results of the ROCKET AF study found that Xarelto was no more effective than warfarin, but caused more abdominal bleeding episodes than its predecessor.

More recently, researchers from the Johns Hopkins Bloomberg School of Public Health and George Washington University published an April 24th article in the British Medical Journal showing that Xarelto doubles warfarin’s risk of gastrointestinal bleeding.

Another study published in the journal of Academic Emergency Medicine found that Xarelto worked as prescribed in pulmonary embolism patients with low to moderate risk of blood clots, but presented significant danger of adverse events in those with a higher risk. Adverse events included blood clots, fatal pulmonary embolism and major bleeding. The high risk patients were deemed twice as likely to suffer from adverse events.

What increases bleeding risk?

The decision to take a potentially life-saving drug is complicated by adverse reports suggesting the risk of uncontrolled bleeding. Doctors generally describe all blood thinners as a “high risk, high reward” type of treatment. Patients who need to use Xarelto have to stay on the drug for the long term or they will revert to a higher risk of stroke and embolism once they discontinue the product. Therefore, patients and doctors should carefully weigh the risk factors relative to the individual patient.

The results of the ROCKET AF Trial found an increased risk of complications in older men who had been on the drug for a long time and who were current or former smokers. Risks increased for people with mild anemia, high blood pressure, and a history of obstructive pulmonary disease or gastrointestinal bleeding.

Patients should not take Xarelto if they are on:

  • Antifungals or antibacterials (like ketoconazole, clarithromycin, fluconazole, or erythromycin)
  • Blood pressure medication (like diltiazem or verapamil)
  • Blood clot medication
  • Over-the-counter NSAIDS (like aspirin, ibuprofen or naproxen)

Patients should also avoid Xarelto if they have:

  • Genetic bleeding disorders
  • Artificial heart valves
  • History of spinal defects or spinal surgery
  • Uncontrolled blood pressure
  • Stomach ulcers
  • Colitis or intestinal bleeding
  • Liver or kidney disease

Pregnant women and nursing mothers should also avoid the drug, since it has not been well studied in this population.

Experts warn there is no antidote for Xarelto bleeding

The real problem, says Dr. Sanjay Kaul from the Cedars-Sinai Medical Center in Los Angeles, is “the lack of a specific antidote to reverse life-threatening bleeding.” He told The Huffington Post that older drugs like Coumadin can be flushed from the system through dialysis or neutralized with a manufacturer-provided antidote, but no such antidote exists for Xarelto or Pradaxa patients. He also found that the labeling provided insufficient information, leading many doctors to prescribe the drug without first testing patient kidney function. Since 80 percent of the drug is excreted by the kidneys, weak kidney function can cause uncontrolled bleeding when blood levels of the drug get too high.

Litigation continues to emerge

As of April 2015, more than 400 Xarelto lawsuits were consolidated in the U.S. Federal District Court of Eastern Louisiana under Judge Eldon E. Fallon in MDL 2592. An additional 180 cases have been filed in a mass tort in Pennsylvania, according to Ring of Fire Radio. Once consolidated, the judge and panel of advisors select a number of bellwether trials to assess the strength and weakness of the central arguments. From there, Bayer Pharmaceuticals may decide to settle all the cases or litigate each claim one by one.

In one Xarelto lawsuit, California man Kenneth Niemeier is suing for $50,000 to cover the cost of medical expenses, loss of earnings, and emotional distress related to injuries he believes resulted from the anticoagulant. The case claims that the manufacturer and marketers failed to fully research the product’s safety or provide adequate instructions, disclosures and warnings, and intentionally concealed known defects from the public.

One may compare the burgeoning Xarelto case load with Pradaxa’s landmark settlement in May 2014. Boehringer Ingelheim paid out $650 million to settle at least 4,000 state and federal lawsuits. “This settlement does not change the facts about Pradaxa or its importance to patients,” the manufacturer stated, refusing to admit any wrongdoing. Comparisons have been made between Pradaxa and Xarelto, with analysts wondering “just how big will the number of Xarelto lawsuits get,” and “will they settle to put the issue to rest in a similar fashion?”

  1. Xarelto - Einstein Clinical Trial

  2. The Madison St. Clair Record - Xarelto patient alleges fraud, negligence

  3. New England Journal of Medicine - Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation

  4. ISMP - QuarterWatch ™ 2012 Annual Report Anticoagulants, Anti-TNF Drugs, FentaNYL Patches, And Alendronate

  5. Huffington Post - Pradaxa And Xarelto: Top Heart Doctors Concerned Over New Blood Thinners