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ISMP Report Emphasizes High Incidence of Xarelto Injuries

Xarelto boxA review of adverse event reporting to the FDA in 2015 conducted by the Institute for Safe Medication Practices (ISMP) has revealed that Xarelto (rivaroaban) and its side effects were connected to more cases of serious harm than any other drug included in the survey.

The next-generation anticoagulant drug came on the scene in 2011, but has since raised significant controversy and concern regarding uncontrolled internal bleeding, embolic-thrombolic events and the drug’s lack of an antidote with which to reverse its effects.

Concerns about Xarelto safety

Issued in late June, the ISMP’s recent QuarterWatch report reviewed all adverse event information submitted to the FDA in 2015 as a means to examine the safety of a range of prescription drugs currently on the American market. According to the data, serious complications and events involving the use of Xarelto were greater in number than those linked to any other medication. This is alarming news indeed, as Xarelto was long touted as a safe, effective, more convenient replacement for Coumadin (warfarin), an anticoagulant used for decades.

The ISMP report includes statistics that call the safety of Xarelto into real question. For instance, it is stated that Xarelto was involved in 10,674 adverse event reports related to disabling, serious or fatal injuries, a total exceeding that of any of the other 1,395 drugs monitored by the organization. This stands in stark contrast to the median number of adverse event reports for other drugs, which stood at 7 instances for 2015, and 25% of all drugs coming in at no more than 4 serious event reports.

Xarelto injury reports highlighted in ongoing litigation

When the adverse event reports were distilled into categories, it was found that just over 80% of them had to do with hemorrhaging or uncontrolled bleeding in patients using the drug. Slightly more than 10 percent involved a blood clot or embolic-thrombotic event. In total, the FDA received reports of 1,121 Xarelto-linked fatalities.

These findings come as no surprise to the legions of patients and families who have already initiated Xarelto litigation in courts across the country. At present, well over 5,000 product liability suits have been brought in federal courts by those who have allegedly suffered injuries and death as a result of taking Xarelto.

Common allegations in Xarelto lawsuits include arguments that drug makers Bayer and Janssen failed to warn the medical community and consumers of known dangers presented by the medication, engaged in misrepresentation and fraud, violated consumer protection laws and breached warranties. With such a large number of cases with similar fact patterns and legal theories currently pending, multidistrict litigation (MDL) has been established.

Bellwether trials set for early 2017

MDL processes are designed to provide convenience to the parties, simplify discovery processes, prevent conflicting pretrial evidentiary rulings and, when possible, facilitate settlement discussions among the litigants.

Judge Eldon Fallon of the U.S. District Court for the Eastern District of Louisiana is responsible for overseeing the consolidated litigation, and he has scheduled so-called “bellwether” trials in the Xarelto matter for February of 2017. Though not legally binding on other plaintiffs, the outcomes in these cases often provide critical insights about jury responses to legal arguments and witness testimony, therefore easing the way to achieving a global settlement.

  1. Institute for Safe Medication Practices, Quarter Watch – June 29, 2016,
  2. United States District Court Eastern District of Louisiana, MDL-2592 Xarelto Products Liability Litigation,
  3. British Medical Journal, Risk of gastrointestinal bleeding associated with oral anticoagulants: population based retrospective cohort study,