Xarelto Lawsuit Information
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Xarelto is a blood thinner that was supposed to be more effective and safer than Coumadin (warfarin). It was approved by the FDA in 2011 for the U.S. market and shortly thereafter people began to experience life-threatening adverse events including uncontrollable bleeding and bleeding to death.
Xarelto was promoted as safer and more effective than the alternative, however, whereas warfarin bleeding event can be reversed with vitamin K, there is no known antidote for patients who are experiencing a bleeding event with Xarelto.
If you are someone you love has suffered an adverse bleeding event while on Xarelto, call us today. You may be eligible for compensation for your injuries.
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Xarelto, generic name rivaroxaban, is an anticoagulant made by Bayer and Janssen Pharmaceuticals that is given in a uniform dose, unlike its competitor warfarin which is adjusted regularly dependent upon blood test results. Also, unlike warfarin, Xarelto has no known bleeding reversal agent, and thousands of patients have suffered a host of complications including deep vein thrombosis and pulmonary embolism, and wound infections.
Other serious side effects of Xarelto include potentially life-threatening side effects are the increased risk of brain bleeds, eye hemorrhages, and internal bleeding as well as stroke, adrenal bleeding, and death.
Because Xarelto has no known reversal agent, those who take it can suffer uncontrolled bleeding even from minor injuries, and there may be little physicians can do to stop the bleeding and save the patient’s life. Tens of thousands of complaints have been filed by the families of patients who bleed to death or suffered other fatal side effects, and by those who suffered serious bleeding events while on Xarelto.
If you or your loved one had suffered a serious bleeding event after taking Xarelto, you might be eligible for compensation for your injuries. Call today to learn more.
Though by nature all anticoagulant medications can cause serious bleeding events, the difference is that, like Coumadin, the medications have a reversal agent to stem the flow of blood. However, Xarelto does not have a reversal agent, and the body can’t be cleaned from the body with dialysis.
To make matters worse, research has shown that Xarelto users have a greater chance of experiencing a serious bleeding event. In fact, researchers published data in the British Medical Journal that Xarelto users were twice as likely as non-users to bleed, and have a higher risk of gastrointestinal bleeding than warfarin users.
The journal Gastroenterology also published a study finding a link between higher rates of stomach and intestinal bleeding events and Xarelto. Researchers reported that as much as a 50 percent increased risk of gastrointestinal bleeding for patients on Xarelto as compared to patients taking older medication.
The disturbing fact is that Xarelto has injured and killed so many people that more than 10,000 lawsuits are currently pending in multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana under District Judge Eldon E. Fallon. Over one thousand more cases have been centralized in Philadelphia.
If you or someone you loved was serious injured or suffered a fatal bleeding event, contact us today to learn if you have the right to collect compensation.
The anticoagulant medication Xarelto works by decreasing the ability of the blood to clot. It does this by decreasing the enzyme thrombin which is needed to make clots, and by inhibiting how blood platelets aggregate. Unfortunately, despite how effective the drug may be, tens of thousands of people have experienced serious and potentially deadly side effects that they were not warned about.
The Institute for Safe Medicine Practices (ISMP) reported that an analyzation of the FDA’s adverse event reporting system found growing evidence of the high risks of Xarelto and similar drugs. In 2015, nearly 347,765 adverse events had been reported including 9,523 events that required hospitalization and 2,997 deaths. About 16,222 of these complaints involved hemorrhages, including 4,828 gastrointestinal bleeds 3,711 brain and central nervous system bleeds. The FDA recognizes that only a percentage of adverse events are reported, and some experts believe the actual number of Xarelto related deaths and injuries could be as much as 100 times higher than the numbers reflected in the FAERs database.
Bleeding Risk Research
A study published in JAMA Internal Medicine in 2016 showed Xarelto users had a greater risk of bleeding events than users of Pradaxa. Researchers reported that Xarelto patients had significantly increased rates of brain bleeding, extracranial bleeds, gastrointestinal bleeds, and death as compared with Pradaxa. What makes this study particularly important, is that shows Xarelto is more dangerous than Pradaxa.
Yet Pradaxa maker Boehringer Ingelheim paid $650 million to resolve more than 4,000 federal and state lawsuits filed on behalf of patients who suffered uncontrolled bleeding events and the families of those who bled to death because of the drug.
Most of these lawsuits claim that the maker failed to warn the public about the increased risk of potentially fatal bleeding events. Many said that if they had known of the increased risks, they would have used a similar, safer medication that had a reversal agent. Call us today to learn if you are legally eligible to seek compensation for Xarelto injuries.
Xarelto was approved by the U.S. Food and Drug Administration in 2011.
In 2013, the FDA warned that that Xarelto advertising was misleading and downplayed the risks of the drug and made inaccurate claims about dosage. The agency said the drug maker failed to draw attention to the risks of the drug yet promoted its efficacy. The FDA also required the manufacturer to include a Black Box warning regarding the increased risk of thrombotic events if Xarelto is discontinued prematurely.
In January 2014, the FDA included five warnings and precautions to the label regarding the risks of bleeding and the lack of the reversal agent. The following month, the agency expanded the drug interaction warnings. By March, the FDA required Xarelto manufacturers to add to the warning and precautions of the drug and to update the Black Box warning on the label to report that safe timing between the use of Xarelto and spinal/epidural anesthesia is unknown. Black Box warnings are the strongest medicine warnings issued by the Food and Drug Administration.
In December, the FDA updated the adverse events warning following an updated postmarketing experience to include the thrombocytopenia and hepatitis.
In 2016, the adverse reactions label and Warning and Precautions label were updated for bleeding events, the lack of information for use in patients with renal impairment, and drug interactions with those patients who are taking some serotonin reuptake inhibitors, and serotonin-norepinephrine reuptake inhibitors.
If you or your loved one was injured by the blood thinner Xarelto, contact us today. You may be eligible for legal compensation for your injuries and losses.