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A new drug safety report highlights the potentially serious risks associated with Xarelto and other similar anticoagulants, indicating that the drugs were linked to more than 3,000 adverse event reports submitted to federal regulators last year involving deaths.
Data in the QuarterWatch report (PDF), released by the Institute for Safe Medication Practices (ISMP) on Wednesday, found that the FDA received 21,996 reports of severe injuries linked to anticoagulants like Xarelto, Pradaxa, Eliquis, Savaysa and Wafarin in 2016. Of those, most were associated with bleeding events, and 3,018 resulted in death.
The report outlines the ISMP’s annual review of all adverse event reports submitted to the FDA over the previous year. In looking at the FDA’s data, researchers found that the adverse event reports highlighted “unacceptably high risks” associated with blood thinners.
“Practically all these injuries (n = 17,218) were from hemorrhages, making bleeding one of the most frequently reported serious adverse drug effects of all types,” the ISMP report states. “A separate CDC study released in late 2016 showed that anticoagulant drugs accounted for more emergency department (ED) visits for outpatient adverse effects than any other class of drugs in therapeutic use, including opioids (non-abuse visits), antibiotics, and diabetes drugs. The anticoagulant events were mostly severe, with 48.8% requiring a hospital stay.”
The report concludes that harm from blood thinners was the highest priority drug safety problem of 2016 due to multiple factors, including the high rate of injury, their widespread use, and the seriousness of the injuries.
Of all of the oral anticoagulants examined, including both new and old drugs, Xarelto bleeding problems were the most common.
Of the 21,996 adverse event reports involving serious injuries with anticoagulants, 15,043, or 68.4%, were linked to Xarelto, with Eliquis coming in a distant second with 3,148 reports, or 14.3%. The ISMP notes that Xarelto’s popularity, mixed with the fact that many of the reports appear to be incidents from previous years that were only reported in 2016, likely drove the adverse event numbers for the blood thinner so high.
Xarelto (rivaroxoaban) is part of a new generation of novel oral anticoagulants and was introduced in 2011, as an alternative to Coumadin (warfarin), which has been the go-to anti-clotting treatment for decades. However, more than 18,000 Xarelto lawsuits have been filed against Bayer Healthcare and Janssen Pharmaceuticals, indicating that users suffered severe and uncontrollable bleeding events on the drug.
Given the similar questions of fact and law raised in the complaints, all federal cases are centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, as part of an MDL or multidistrict litigation.
While all blood thinners may cause bleeding, the side effects of warfarin can be quickly reversed with a widely known antidote. However, there was no Xarelto reversal agent when the drug was introduced, and plaintiffs allege that Bayer and Johnson & Johnson failed to adequately warn users and the medical community about the lack of an antidote, which led to severe and uncontrollable bleeds.
Similar allegations were raised in thousands of Pradaxa lawsuits filed several years ago, as that medication hit the market before Xarelto. However, the maker of that competing drug ultimately agreed to pay $650 million in Pradaxa settlements just before the first bellwether trials were set to begin, with an average of about $150,000 per claim.
As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, the number of complaints has surpassed the number of claims involved in the Pradaxa litigation, as the drug has become more widely used in recent years.
ISMP researchers say that a number of steps could be taken to reduce the risks of bleeding from Xarelto and similar drugs, including requiring that reversal agents, or antidotes are widely available for all of the newer medications, establishing guidelines for use with other anti-platelet agents, like aspirin, evaluating dosing schemes, and moving to prevent overuse.