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According to an independent analysis of adverse events submitted to the FDA last year, side effects of Xarelto were linked to more serious injuries than any other drug monitored by the Institute for Safe Medication Practices (ISMP), including more than 1,100 patient deaths.
In the group’s QuarterWatch (PDF) issued late last week, ISMP summarized adverse event reports submitted to the U.S. Food and Drug Administration last year, which are widely considered to be an important safety signal for prescription medications on the market.
According to the findings, severe complications with Xarelto exceed those linked to all other drugs, mainly involving injuries associated with uncontrolled bleeding and failure to prevent a stroke or pulmonary embolism, which is what the drug is designed to do.
Xarelto (rivaroxoaban) was introduced in 2011 as a new-generation anticoagulant, designed to replace Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades. However, since it has hit the marketing, Xarelto bleeding problems have raised serious concerns within the medical community, as there is no known and effective antidote to reverse the blood thinning effects of the drug in an emergency.
“The anticoagulant rivaroxaban (XARELTO) accounted for 10,674 reports of fatal, disabling, and serious injury in the U.S., more than any other of the 1,395 identifiable drugs we regularly monitor in this category,” the ISMP report notes. “For comparison, the median number of reports per drug was 7 cases, with 25% of drugs accounting for 4 or fewer serious cases in 2015, and 25% accounting for 103 cases or more.”
Of the reports received regarding Xarelto injuries submitted to the FDA, at least 8,643 (80.9%) involved bleeding or hemorrhaging, and 1,611 (10.9%) were due to an embolic-thrombotic or blood clot event. There were 1,121 Xarelto deaths reported.
The findings come as thousands of individuals and families nationwide are pursuing Xarelto injury lawsuits against the drug makers, alleging that inadequate warnings about the bleeding risks were provided to consumers and the medical community.
The report points out that increased focus on Xarelto safety problems over the past year, as well as the drug makers’ own marketing push to make the medication more well known, may have contributed to the large number of adverse events reported. Approximately 36% of the reports submitted in 2015 were regarding injuries that occurred in prior years, ISMP points out. However, the group acknowledges that this number indicates that Xarelto injuries were being underreported in previous years.
Xarelto is part of a controversial new class of anticoagulants introduced in recent years to help prevent blood clots among individuals at risk for deep vein thrombosis or pulmonary embolism. The drug has been promoted as easier to use than warfarin, which has been on the market for years and has an established safety record. However, while the blood thinning effects of warfarin can be quickly reversed, there is no available antidote for Xarelto and many critics indicate that the drug makers failed to adequately warn about this important difference.
There are currently more than 5,250 product liability lawsuits pending in the federal court system over severe, and often fatal, bleeding injuries on Xarelto. Given the similar questions of fact and law raised in the cases, the lawsuits have been consolidated as part of a federal multidistrict litigation (MDL), which is is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the courts.
Judge Fallon has scheduled a series of early Xarleto bellwether trials in the MDL, which are expected to begin in February 2017. While the outcomes of these early trial dates will not be binding on other claims, they may help the parties negotiate Xarelto settlements that could avoid the need for thousands of individual cases to go before juries nationwide.
On July 2, both plaintiffs and defendants involved in ongoing Xarelto litigation filed a joint status report (PDF) on the cases, indicating that discovery in 40 cases selected for potential bellwether trials is moving forward. The status report was filed ahead of a conference on Xarelto lawsuits planned for today.
As Xarelto injury lawyers continue to review potential cases for individuals and families nationwide, it is expected that the number of lawsuits involved in the MDL will continue to grow over the coming months.