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A new study warns that far too many doctors are ignoring safe prescribing guidelines for blood thinners, potentially exposing patients to unnecessary side effects of Xarelto, Eliquis and similar drugs.
Researchers with the University of Birmingham indicate that many doctors give atrial fibrillation patients anticoagulants to prevent strokes, despite the patients having conditions that should have made them ineligible for those drugs. The findings were published on June 19 in the British Journal of General Practice.
The study looked at 12 cross-sectional analyses of primary care data from 645 general practices in the U.K. According to the findings, patients with factors that should have disqualified them from being given drugs like Xarelto and warfarin, such as those with bleeding peptic ulcers, diabetic eye disease or a history of brain bleeds, were prescribed the drugs at about the same rate as those who did not have the disqualifying conditions.
“Our study shows that safety advice seems not to influence the prescribing of anticoagulants,” co-author Professor Tom Marshall said in a University of Birmingham press release. “We found that patients considered a safety risk were just as likely to be prescribed the drugs as those without safety risks, and this occurred in every year between 2004 and 2015.”
Blood Thinner Health Risks
The findings come just days after a report warned that oral anticoagulants were linked to nearly 22,000 reports of serious injuries submitted to the FDA in 2016, and were associated with more than 3,000 reports of deaths.
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.
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 other new-generation anticoagulant 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.