The widely-used blood thinner Xarelto has been linked to an increased risk of serious and potentially life-threatening side effects like uncontrollable internal bleeding, hemorrhagic stroke and brain hemorrhage. As a result of these alleged Xarelto complications, which may lead to death in some cases, attorneys throughout the country are investigating claims filed on behalf of Xarelto users who believe they may be entitled to financial compensation for their injuries and medical expenses. If you took the anticoagulant Xarelto, and you have since suffered from gastrointestinal bleeding, stroke or another serious side effect, contact a reputable Xarelto attorney to discuss your legal options. With a qualified product liability lawyer on your side, you can protect your legal rights and seek fair and timely reimbursement for your losses.
A growing body of research has indicated that Xarelto treatment may be extremely risky for some people, with hundreds of adverse event reports linking Xarelto to severe and potentially life-threatening bleeding injuries. Fortunately, there are a number of possible alternatives to Xarelto for reducing the risk of stroke in certain patients, including the following:
Xarelto (rivaroxaban) is an FXa inhibitor medication introduced in 2011 as a joint product by Bayer Health Care and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. The FDA initially approved the billion-dollar blood thinner to reduce the risk of blood clots among patients undergoing knee or hip replacement surgery, and the medication has since been additionally approved to prevent blood clots in patients with atrial fibrillation. The FDA has also indicated Xarelto for the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) through its fast-track regulatory review process.
Until recently, the older blood thinner warfarin was the industry standard, and the medication has been available in the United States for over 50 years. However, because warfarin requires regular checkups and changes in diet and lifestyle during treatment, drug companies have been working to develop and market newer blood thinners like Xarelto and Pradaxa, claiming that they are safer, more convenient alternatives to warfarin. However, new information suggests that Xarelto treatment may actually put patients at a higher risk for serious and potentially deadly bleeding complications.
Unlike warfarin, which has an approved reversal agent that allows doctors to reverse the blood thinning effects of the drug in the event of an internal bleeding incident, there is no approved antidote for Xarelto bleeding complications. This puts Xarelto users at an increased risk for devastating side effects like:
According to reports, when bleeding from Xarelto occurs near a major organ, like the lungs, brain or kidneys, blood flow to that organ is interrupted, which may cause the organ to lose some or all of its functionality. In some cases, pools of blood may form within the body, possibly putting Xarelto users at risk for additional complications.
As more and more patients begin Xarelto treatment to reduce their risk of stroke, the number of internal bleeding reports associated with the blood thinner continues to rise. According to a report issued in 2013 by the Institute for Safe Medication Practices (ISMP), Xarelto ranked tenth among the medications most commonly named in adverse event reports submitted to the FDA during the anticoagulant’s first full year on the market. According to the FDA, Xarelto was named as the suspected cause of serious complications in 2,081 reports in 2012 alone, including at least 151 deaths. In May 2014, the ISMP issued another report indicating that Xarelto side effect reports were “steadily increasing” as more patients used the blood thinner, with 680 adverse events reported to federal regulators during the first quarter of 2013. These numbers surpassed even the rate of adverse event reports involving Pradaxa, another potentially dangerous anticoagulant drug that has been on the market since 2010.
Consumers who took Xarelto in the past and have suffered from irreversible bleeding complications have filed lawsuits against Bayer and Janssen in pursuit of compensation for injuries, medical expenses and emotional trauma. Family members who have lost loved ones due to alleged Xarelto bleeding complications have also taken legal action against the drug makers, seeking reimbursement for their considerable losses. The following are some of the more recent lawsuits filed against Bayer and Janssen over potential Xarelto side effects:
June 23, 2014 – Nancy Packard filed a complaint against Bayer and Janssen on behalf of her deceased husband, William, who took Xarelto for six months before suffering bleeding in his brain. According to her lawsuit, doctors tried to save William’s life by drilling a hole in his skull to reduce the pressure on his brain, but they were unable to stop the bleeding, which ultimately caused his death.
December 30, 2014 – Ruth McGowan filed a product liability lawsuit on behalf of her deceased father, Thomas Dunkley, who took Xarelto to lower his risk of stroke. He also suffered severe bleeding in his brain after taking Xarelto for just one month, and he died shortly thereafter.
December 2014 – Dozens of Xarelto lawsuits filed in federal court were centralized for coordinated pretrial proceedings in the U.S. District Court for the Eastern District of Louisiana, as part of a multidistrict litigation (MDL).
January 2015 – About 75 Xarelto bleeding lawsuits brought against Bayer Healthcare and Janssen Pharmaceuticals were centralized in a mass-tort action in Philadelphia.
March 20, 2015 – Bayer and Janssen face a wrongful death lawsuit filed by the son of a Tennessee man who died from uncontrollable bleeding complications after being prescribed Xarelto to prevent strokes associated with atrial fibrillation.
April 2015 – As of April 15, 2015, reports indicate that more than 400 lawsuits involving uncontrollable bleeding problems from Xarelto have been centralized in Louisiana as part of the federal MDL. An additional 180 Xarelto cases are pending at the state-court level in Pennsylvania.
In 2012, the Institute for Safe Medication Practices (ISMP) found that there were 365 instances of serious and fatal injuries associated with the generic version of Xarelto, rivaroxaban.
That same year, the FDA reported that three times more people died from adverse events associated with Xarelto, compared to warfarin.
In the first few months of 2013, there were 968 injuries linked to Xarelto treatment, and drug regulators in Germany reported 72 alleged Xarelto-related deaths during the same period of time.
According to the ISMP, patients undergoing knee or hip replacement surgery have the highest risk of experiencing serious clots while taking Xarelto, which may result in potentially life-threatening side effects like stroke or heart attack.
The FDA has warned that premature discontinuation of Xarelto may increase the risk of serious bleeding events. The agency has also advised against the use of Xarelto in patients with prosthetic heart valves, due to a lack of safety and efficacy information regarding this particular use of the drug.
As concerns continue to mount regarding the alleged risk of bleeding complications among Xarelto patients, a growing number of studies have examined the potential health risks associated with Xarelto treatment. The following are Xarelto side effect studies published over the past several years:
September 8, 2011 – The New England Journal of Medicine published the results of the ROCKET AF study, which compared Xarelto treatment to warfarin, which has been the go-to blood thinner for decades. After reviewing the results of the research, the FDA reported that the study failed to provide evidence that Xarelto treatment was more effective than warfarin.
February 2012 – A British study presented at the 2012 meeting of the American Academy of Orthopaedic Surgeons indicated that patients who took Xarelto had a significant return-to-surgery rate within 30 days. According to the research, the rate of wound complications in patients undergoing total hip or knee replacement rose considerably when Xarelto was used in place of older anticoagulants.
September 5, 2012 – Research published in the Journal of Bone and Joint Surgery followed more than 13,000 people after hip or knee replacement surgery, and found that the patients who took Xarelto had a nearly four-times increased risk of experiencing wound complications.
April 24, 2015 – A study published in the British Medical Journal involving nearly 50,000 individuals in the United States taking blood thinners like Xarelto and Pradaxa, found that Xarelto users may face double the risk of gastrointestinal bleeding side effects, compared to patients taking the older blood thinner warfarin.
July 2013 – Patients administered newer oral blood thinners like Xarelto may have a 55% higher risk of suffering gastrointestinal bleeding than patients receiving standard care, according to a study published in the medical journal Gastroenterology.
In a Phase III study designed to examine the safety of Xarelto treatment, 73% of the 16,041 study participants who took at least one dose of the blood thinner suffered side effects, including anemia and uncontrollable bleeding. Patients who took higher doses of Xarelto were reportedly more likely to experience internal bleeding and other serious complications.
The current market for blood thinner drugs like Xarelto is estimated to be valued at $10 billion, and many pharmaceutical drug companies are developing newer anticoagulants to get a piece of this market share. At the same time, critics are accusing these drug companies of developing potentially dangerous drugs in an effort to protect their bottom line, without concern for the safety of the patients taking their medications. Xarelto lawsuits filed against Bayer Healthcare and Janssen Pharmaceuticals over side effects from the controversial blood thinner allege that:
A growing number of product liability lawsuits have been filed against Bayer Healthcare and Janssen Pharmaceuticals over uncontrollable bleeding events and other alleged side effects of Xarelto, and as more consumers and medical professionals become aware of the risks potentially associated with the medication, additional complaints are expected to be filed in the future. If you believe you have been adversely affected by Xarelto complications like uncontrollable internal bleeding, hemorrhaging, stroke or gastrointestinal bleeding, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous medications, and can help put you in touch with a qualified attorney who has experience handling Xarelto side effect claims.