Dallas Fort Worth Injury Lawyer Blog
An independent study conducted by the Institute for Safe Medication Practices (ISMP) showed that side effects of Xarelto were linked to more serious injuries than any other drug studied by the institute. The study, which was submitted the U.S. Food and Drug Administration (FDA) last year, links more than 1,100 patient deaths to Xarelto.
In the group’s quarterly report issued 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.
The study found that “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 most widely used 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 by the FDA regarding Xarelto injuries, at least 1,611 (10.09%) were due to a blood clot event, and 8,864 (80.9%) involved bleeding or hemorrhaging. There were 1,121 Xarelto deaths reported.
The study comes as thousands of individuals and families nationwide are pursuing Xarelto injury lawsuits. These individuals and families allege that Xarelto failed to provide adequate warning about bleeding risks to consumers and doctors. Our law office is currently investigating Xarelto lawsuits from across the country. If you or a loved was injured as a result of using Xarelto, contact our office immediately.