Bayer Healthcare’s blockbuster blood thinner Xarelto has been tied to an increased risk of serious bleeding complications possibly leading to hospitalization or death. As a result of these alleged health risks, product liability lawyers are now reviewing Xarelto bleeding claims brought on behalf of consumers across the country who believe they have been harmed by side effects of the anticoagulant drug, which is marketed by its manufacturing companies as safe and effective. If you or a loved one has suffered uncontrollable internal bleeding or another potentially life-threatening complication, and you believe the controversial anticoagulant Xarelto to be the cause, consult an experienced Xarelto lawyer today to discuss your legal options. You may have grounds to file a Xarelto lawsuit against Bayer Healthcare and Janssen Pharmaceuticals, in order to pursue the financial compensation you deserve for your injuries, medical expenses, pain and suffering, and other damages.
Xarelto (rivaroxaban) is a new-generation anticoagulant medication commonly prescribed to prevent blood clots, stroke and pulmonary embolism due to atrial fibrillation, a medical condition characterized by an irregular heartbeat, or following hip or knee replacement surgery. Xarelto is an oral medication manufactured by Bayer Healthcare and marketed in the U.S. by Johnson & Johnson’s Janssen Pharmaceuticals unit, and was approved by the U.S. Food and Drug Administration (FDA) in 2011, following a fast-track regulatory review. Since they first entered the market, Xarelto and similar new-generation blood thinners have been marketed as safer and more convenient alternatives to older anticoagulants, like warfarin, which requires regular checkups and changes in diet and lifestyle.
Unlike older blood thinner medications that require specific doses for each individual patient, Xarelto belongs to a newer class of anticoagulant drugs that are prescribed to most patients in one uniform dose. There are other factors that set Xarelto apart from other popular blood thinner medications. Xarelto and Pradaxa (dabigatran), for example, are both widely-prescribed blood thinners, but while Xarelto inhibits a protein involved in the coagulation process called Factor Xa, and therefore prevents another protein, thrombin, from forming, Pradaxa directly inhibits the protein thrombin. Also, while many other anticoagulant drugs have an antidote that can be used to reverse the blood thinning effects of the medications in the event of a bleeding complication, there is currently no approved reversal agent for Xarelto.
Atrial fibrillation, the most common condition for which Xarelto is prescribed, is an abnormal heart rhythm problem characterized by irregular and rapid beating that can cause poor blood flow. Symptoms of atrial fibrillation may include shortness of breath, fainting, heart palpitations, or chest pain, and patients diagnosed with atrial fibrillation may be at a greater risk for stroke, dementia and heart failure. Estimates indicate that atrial fibrillation affects approximately three million Americans, and many of these patients are prescribed Xarelto and other potentially dangerous anticoagulant medications to treat their condition. What they may not know, however, is that the very drug prescribed to reduce their risk of stroke, heart failure and other potentially deadly complications may put them at risk for others, like internal bleeding, brain hemorrhages, stroke and more.
Although Xarelto and other newer anticoagulant medications are touted by their manufacturing companies as safe, effective and convenient options for reducing the risk of blood clots, stroke and pulmonary embolism in patients with atrial fibrillation, there are a number of major side effects that have been tied to the prescription drugs in recent years. For instance, although Xarelto is designed to stop blood clots and prevent complications like stroke and pulmonary embolism, adverse event reports submitted to the FDA show that some patients may actually face an increased risk of clots while taking Xarelto. These clots can trigger heart attacks or strokes if they travel to the heart or brain, and may result in death or disability. In addition to internal bleeding and an increased risk of blood clots, other potential side effects of Xarelto include abdominal bleeding, brain hemorrhage, abnormal liver function, reduced platelet levels and wrongful death.
One of the most serious complications associated with Xarelto treatment is uncontrolled bleeding, which can lead to organ failure if the bleeding occurs near a major organ, such as the brain, kidneys or lungs, and prevents an adequate amount of blood from being delivered to that organ. While all blood thinners carry the risk of internal bleeding, warfarin and other older anticoagulant medications have their emergency antidotes, which can be a life-saving measure should a severe bleeding complication occur. Since Xarelto does not have an antidote, the risk of internal bleeding is more of a concern with this particular medication than with other blood thinners, and because the drug cannot be flushed out of the system through dialysis, bleeding problems from Xarelto may result in hospitalization, and possibly even death.
Although Xarelto and other new blood thinners, like Pradaxa, have been promoted as the first anticoagulants that can replace warfarin, the risk of potentially life-threatening bleeding complications tied to the drug, as well as the lack of an approved reversal agent, has led some of the top cardiologists in the country to doubt the safety of the medications. “The good news is you now have an alternative to warfarin,” said Dr. Alan Jacobson, director of anti-coagulation services for the Veterans Administration healthcare system in California, in reference to new-generation anticoagulants like Xarelto and Pradaxa. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug.”
In a 2011 study published in the New England Journal of Medicine, researchers discussed the results of the ROCKET AF study, which compared Xarelto to warfarin in patients with atrial fibrillation. The FDA reported that the study failed to show that Xarelto was more effective than warfarin for preventing blood clots from forming, and that the newer-generation anticoagulant drug is known to cause more abdominal bleeding complications than warfarin. Another early study linking Xarelto to serious complications in patients was published in the Journal of Bone and Joint Surgery in 2012, and found that patients taking Xarelto had a nearly four-fold increased risk of wound complications following hip or knee replacement surgery, compared to patients taking heparin.
In a Phase III study designed to examine the safety of Xarelto, 73% of the 16,041 study participants who took at least one dose of the blood thinner suffered complications, including anemia and internal bleeding events. Another study presented at the annual meeting of the American Academy of Orthopedic Surgeons in 2012 found that patients who used the blood thinner Xarelto had an unexpectedly high return-to-surgery rate within 30 days, which led doctors to switch certain patients from Xarelto to an older anticoagulant called tinzaparin. More recently, a study published in the British Medical Journal in 2015 indicated that Xarelto treatment could double the risk of gastrointestinal bleeding, compared to warfarin.
Patients who took Xarelto in the past, to reduce their risk of blood clots due to atrial fibrillation or after knee or hip replacement surgery, and subsequently experienced uncontrollable bleeding complications have filed lawsuits against Bayer and Janssen, seeking compensation for their injuries. All of the Xarelto lawsuits involve similar allegations that the drug manufacturing companies failed to adequately research the possible side effects of Xarelto treatment, and failed to provide consumers and the medical community with sufficient warnings about this risk. Similar complaints have been brought over bleeding injuries from the blood thinner Pradaxa, and its maker, Boehringer Ingelheim, recently paid $650 million to resolve approximately 4,000 Pradaxa side effect lawsuits.
Suffering a serious side effect from a pharmaceutical drug can be devastating, especially if it results in lasting injuries, costly medical bills, hospitalization or death. For patients who took the blood thinner Xarelto and subsequently experienced potentially life-threatening complications like uncontrollable internal bleeding, compensation may be available to cover the cost of medical bills, funeral expenses or long-term care. With more and more studies and FDA warnings detailing the alleged risk of side effects from Xarelto, and a growing number of actual patients experiencing side effects while taking the anticoagulant drug, it is important to know your rights. Contact a knowledgeable and compassionate Xarelto attorney today to explore your possible compensation options.
Although federal regulators have yet to issue a recall for Xarelto over deadly bleeding complications allegedly associated with the blockbuster blood thinner, the FDA has taken steps to warn consumers about the risk of uncontrollable bleeding and other side effects from Xarelto. In 2012, the FDA reported that patients taking Xarelto were three times more likely to experience fatal adverse events than patients taking warfarin, which has been the go-to anticoagulant in the United States for decades. The following year, the FDA sent a warning letter to Johnson & Johnson, accusing the company of using false or misleading claims in Xarelto advertising, which “minimize the risks associated with Xarelto.”
In 2014, the FDA required the makers of Xarelto to update the drug warning label to include information about bleeding events in users, and in Xarelto’s prescribing information, the following warning is now featured: “Xarelto increases the risk of bleeding and can cause serious or fatal bleeding.” The medication packet also indicates that, during clinical trials, “The most common adverse reactions with Xarelto were bleeding complications.” Earlier that year, the FDA again rejected a proposal from the makers of Xarelto to approve the medication for wider uses, including to prevent clogging of heart stents, and to prevent new strokes, heart attacks and death in patients with acute coronary syndrome.
According to Xarelto injury lawsuits brought on behalf of consumers across the country, hundreds of patients died and thousands were injured because of uncontrollable bleeding problems caused by the medication, and due to the large number of product liability claims brought over Xarelto complications, the U.S. Judicial Panel on Multidistrict Litigation consolidated the cases into a multidistrict litigation in Louisiana and a mass-tort in Philadelphia. If you used the controversial anticoagulant Xarelto in the past, and you have since suffered uncontrollable bleeding complications or another serious side effect allegedly caused by the medication, contact a reputable Xarelto attorney today for legal help. With a qualified product liability lawyer on your side, you can ensure that your legal rights are protected, and seek fair and timely compensation for your losses.