Washington, DCAlthough it is a relatively new drug on the market, Xarelto side effects reports have reportedly surpassed those of rival drug Pradaxa, according to one organization. Both drugs are anticoagulants and both have been linked to an increased risk of bleeding complications. But while some Pradaxa lawsuits have been settled, Xarelto litigation is just now gearing up.
QuarterWatch is an independent report produced by the Institute for Safe Medication Practices (ISMP). The organization monitors serious adverse drug events in the US as reported to the FDA. According to the May 7, 2014 issue of QuarterWatch, adverse events associated with Xarelto (known generically as rivaroxaban) have now surpassed those associated with Pradaxa (known generically as dabigatran).
The publication attributes the increase in adverse event reports to an increase in Xarelto prescriptions. “Total dispensed outpatient prescriptions for rivaroxaban have rapidly increased to nearly 1 million prescriptions per quarter, while dabigatran utilization has steadily declined since a peak in early 2012,” ISMP notes. According to the organization, by late 2013, Xarelto was prescribed almost twice as often as Pradaxa.
Both Xarelto and Pradaxa were designed to replace Coumadin (generic name, warfarin). Xarelto and Pradaxa were marketed as being easier to use than the older drug, which has been around for decades. All three drugs are anticoagulants that have been linked to an increased risk of bleeding events. In the case of Coumadin, however, there is an antidote to uncontrolled bleeding. There is currently no antidote for Pradaxa or Xarelto that is approved for use in the US.
This lack of an antidote means that patients who suffer seemingly minor injuries are at risk of uncontrolled bleeding that could be fatal.
In May 2014, Boehringer Ingelheim agreed to pay approximately $650 million to settle around 4,000 claims in state and federal court concerning the risk of uncontrollable bleeding in patients who took Pradaxa. In agreeing to the settlement, the company did not admit to any liability.
Very few lawsuits have been filed concerning Xarelto. One lawsuit was reportedly filed (McGowan v. Janssen Research and Development, et al, case number 2:14-cv-00159-cr), but the number of lawsuits so far is believed to be at less than 10.
Xarelto is marketed by Bayer and Johnson & Johnson. Johnson & Johnson reportedly told Ed Silver, writing for The Wall Street Journal (8/29/14), that Xarelto’s warning label clearly states the risk of bleeding, which is common for all blood thinners.
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