Preview Newsletter
XARELTO Media Monitoring Week of 3/13/15
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Xarelto Lawsuit Hotline Established for Bleeding and Injury Claims by McDonaldWorley Law Firm
Mar 11, 2015 | PR News Wire
By McDonaldWorley Law Firm
Lead trial attorney Donald S. Worley with the law firm McDonaldWorley has announced the creation of the Xarelto claims hotline. Family members or victims can speak to an attorney at 1-800-397-4046 in order confidentially share what happened with our top lawyers and learn what legal options they have if they qualify to file a claim. -
Legal-Bay Lawsuit Settlement Funding Reports Bayer and Johnson & Johnson to Pursue Further FDA Approvals for Xarelto while Cases against the Drug are Consolidated into Multidistrict Litigation
Mar 9, 2015 | PR Newswire
By Legal-Bay LLC
Legal-Bay LLC, The Lawsuit Settlement Funding Company, reports that Bayer and Johnson & Johnson made a recent announcement that they will pursue additional FDA approvals for Xarelto, even as cases against the blood thinner are consolidated into multidistrict litigation (MDL) in two U.S. courts. The announcement was made last month, according to Drug Watch, that Bayer and J&J are seeking further federal approvals for Xarelto for stroke patients. -
Bernstein Liebhard LLP Lawyers Await Discussion about Xarelto Lawsuits at Federal Litigation’s April Conference
Mar 8, 2015 | PR Web
By Bernstein Liebhard LLP
Attorneys at Bernstein Liebhard LLP are awaiting an upcoming status conference in the federal litigation established for Xarelto lawsuits, where the Firm has claims pending. -
Bernstein Liebhard LLP Comments on Filing of Class Action Lawsuit in Canada over Alleged Xarelto Bleeding Side Effects
Mar 7, 2015 | PR Web
By Bernstein Liebhard LLP
A recent report from the Calgary Herald indicates that a Xarleto class action lawsuit has been filed in Alberta, Canada on behalf of individuals who allegedly experienced uncontrollable bleeding due to their use of the blood thinner. Among other things, the Canadian lawsuit alleges that Xarelto has been implicated in more than 1,000 injuries in the country, including 12 deaths. The Statement of Claim also accuses the drug’s manufacturers of negligence in their marketing of Xarelto, the Herald reported. -
Xarelto Lawsuit Alleges Gastrointestinal Bleeding
Mar 13, 2015 | Top Class Actions
By Robert J. Boumis
A Xarelto bleeding lawsuit has joined the mass legal action against Jansen pharmaceuticals over alleged Xarelto complications. -
FDA Says No To Expansion Of Xarelto Use-For The Third Time
Mar 11, 2015 | The Legal Examiner
By Andy Childers
The U.S. Food and Drug Administration (FDA) has rejected three attempts by Johnson & Johnson to expand the approval of its anti-blood clotting drug, Xarelto, according to a report in the Wall Street Journal. -
Fla. Couple Files Xarelto Bleeding Case, Joins MDL
Mar 11, 2015 | Top Class Actions
By Meredith Friesen
A Florida husband and wife filed a Xarelto lawsuit and have joined the Xarelto multidistrict litigation (MDL) alleging severe Xarelto bleeding side effects. -
Pennsylvania Consolidates Xarelto Lawsuits Into Mass Tort
Mar 10, 2015 | The Legal Examiner
By Eric T. Chaffin
On December 12, 2014, the United States Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into the Eastern District of Louisiana for pre-trial proceedings. The consolidation is intended to reduce the risk of duplicative discovery and conflicting rulings, while serving the convenience of all parties involved. So far, at least 86 cases are pending there. -
Research Misconduct Involving Xarelto Goes Unreported
Mar 10, 2015 | Drug Reporter
By Ava Lawson
Note: This website is sponsored by Eisbrouch Marsh, LLC. JAMA Internal Medicine recently published a study by Charles Seife that highlights a profound flaw in how consumers obtain information about clinical drug trials. According to the New York University professor, only 4 percent of questionable practices or violations discovered by health regulators during pharmaceutical trials ever reaches the public. -
Xarelto Lawyers: What Top Litigators Are Saying About the Lawsuit
Mar 10, 2015 | McDonald Worley Attorneys at Law
Attorneys across the nation are scrambling to sign clients and families who claim to have suffered internal bleeding, severe hemorrhaging and death as a result of being treated with the blood thinner Xarelto. -
Xarelto Class Action Filed by Canadian Attorney Who Predicts More to Come
Mar 9, 2015 | The Xarelto Lawsuit
By Bernstein Liebhard LLP
A Xarelto lawsuit alleging episodes of uncontrollable internal bleeding has been filed in Calgary by a Canadian attorney who says that several others will be soon to follow. -
Canadian Attorney Files Xarelto Class Action Alleging Uncontrollable Bleeding Risk
Mar 9, 2015 | Consumer Injury Lawyers
By Bernstein Liebhard LLP
A class action Xarelto lawsuit has been filed in Canada by several individuals who allegedly sustained uncontrollable bleeding episodes due to the blood thinner, and will soon be followed by another, the Calgary Sun reports. -
Xarelto Class Action Lawsuit Filed in Canada Over Bleeding Problems
Mar 9, 2015 | About Lawsuits
By Austin Kirk
As a growing number of Xarelto lawsuits continue to be filed on behalf individuals throughout the United States, Bayer Healthcare now faces a class action lawsuit in Canada over bleeding problems associated with the controversial anticoagulant. -
XARELTO Use May Cause Fatal Bleeding Episodes
Mar 9, 2015 | St. Louis Personal Injury Attorneys
The amount of federal lawsuits that are mounting against the makers of the popular blood thinner, Xarelto continue to rise. In addition, patients are alleging that Bayer and Janssen Pharmaceuticals did not adequately warn them of the potential life threatening bleeding that could occur. To make matters worse, there is no antidote to stop bleeding once it has begun, which is unlike other popular anticoagulants on the market. As a result, many people are suffering serious side effects and even death related to the use of Xarelto. -
Xarelto Bleeding MDL Status Conference Held
Mar 9, 2015 | Top Class Actions
By Karina Basso
A Xarelto bleeding MDL status conference was held to determine and discuss the key issues of the ever-growing number of Xarelto lawsuits consolidated in this multidistrict litigation in order to move these cases forward. -
Pradaxa, Xarelto Bleeding Events More Dangerous To Dialysis Patients
Mar 7, 2015 | Righting Injustice
By Jennifer Walker-Journey
Note: Righting Injustice is published by the Beasley Allen Law Firm. Newer blood thinners Pradaxa (dabigatran) andXarelto (rivaroxaban), which are eliminated through the kidneys, are not be used in patients undergoingdialysis because the drugs can build up in their bloodstream and cause dangerous bleeding events. However many dialysis patients are being treated with the anticoagulants, according to researchers in the nephrology division at Massachusetts General Hospital and the clinical research division of Fresenius Medical Care North America.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Plaintiff Attorney Press Releases
Plaintiff Attorney Blogs
Full Text of Stories Below
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Xarelto Lawsuit Hotline Established for Bleeding and Injury Claims by McDonaldWorley Law Firm
Mar 11, 2015 | PR News Wire
By McDonaldWorley Law Firm
Lead trial attorney Donald S. Worley with the law firm McDonaldWorley has announced the creation of the Xarelto claims hotline. Family members or victims can speak to an attorney at 1-800-397-4046 in order confidentially share what happened with our top lawyers and learn what legal options they have if they qualify to file a claim.
The direct number has been made available for people nationally who allege they suffered the medication caused injuries or side effects ranging from stroke, heart problems, severe bleed events or the death of a loved one.
According to the firm, a number of recent Xarelto users have contacted their attorneys alleging the blood thinning medication caused health problems and seeking the latest information, prompting the creation of the dedicated phone number.
A free legal review is available for people who are have interest in more information regarding filing a Xarelto claim.
"People who may have suffered health complications, or families of those who suffered fatal hemorrhaging deserve to know simply, and clearly if they qualify to file a claim against Xarelto, and how it could impact their lives if they do," stated Donald Worley when asked why the phone hotline was established.
The popular blood thinner has made headlines recently with the announcement of cases of people suing across the nation being centralized and consolidated into a Multi-District Litigation (MDL) in New Orleans (Xarelto Lawsuit Update).
With the added awareness being generated by the multidistrict litigation announcement and the patient information hotline being made available, attorneys with the firm expect more patients to come forward to share how their lives were impacted by Xarelto use.
According to the firm, a number of serious side effects have been alleged in the lawsuit, from life threatening hemorrhages and uncontrolled bleeding events to non-life threatening complications believed related to the use of the popular blood thinner. Concerned parties can read an overview of the case against Xarelto here.
According to an FDA resource about atrial fibrillation and anticoagulant drugs, Xarelto, unlike other anticoagulants such as its alternative warfarin, no reversal agents exist for use when significant bleeding occurs. In addition, an FDA warning letter was issued to the makers of Xarelto advising an update to advertisements alleging they 'minimized the risks' and make 'misleading claims'.
For a time being, the firm's lawyers will be standing by, available via the Xarelto hotline to hear from patients who may have suffered health problems from using the blood thinner—callers are under no-obligation to file a lawsuit claim and their entire conversation is entirely confidential.
"Anyone who believes they were hurt as a result of taking Xarelto, can now call 1-800-397-4046 so the firm's attorneys can review their case and answer their most pressing questions," added Mr. Worley.
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Mar 9, 2015 | PR Newswire
By Legal-Bay LLC
Legal-Bay LLC, The Lawsuit Settlement Funding Company, reports that Bayer and Johnson & Johnson made a recent announcement that they will pursue additional FDA approvals for Xarelto, even as cases against the blood thinner are consolidated into multidistrict litigation (MDL) in two U.S. courts. The announcement was made last month, according to Drug Watch, that Bayer and J&J are seeking further federal approvals for Xarelto for stroke patients.
Reports have also come in that plaintiffs have continued to file lawsuits over the blood thinner, and in December and January, judges in both Pennsylvania and Louisiana consolidated the filed cases into multidistrict litigation as well as a mass tort program. Now, more than 100 filed lawsuits are awaiting trial. The lawsuits claim serious health problems and even death as a result of using the blood thinner, Xarelto. In light of the recent announcements, Legal-Bay is reaffirming the fact that they are sufficiently prepared to handle large Xarelto pre-settlement funding requests for those who have experienced complications from using the blood thinner.
Chris Janish, CEO of Legal-Bay, commented on the recent announcement, "We believe off of the last Pradaxa blood thinner settlement that Xarelto is a litigation that is also gaining a lot of traction. The injuries of serious uncontrollable bleeding, as well as death, make the potential liability very high for Xarelto's drug maker. Although Xarelto's maker continues to fight liability, and we expect this litigation to drag on for years, we are already committed to helping plaintiffs with lawsuit funding or assistance with getting a free Xarelto case evaluation from a qualified Xarelto law firm."
In order receive lawsuit funding you must have retained a Xarelto lawyer first. If you need lawsuit money or pre-settlement funding for your Xarelto claim, Legal-Bay is here to help. Legal-Bay is offering pre-settlement and settlement funding for Xarelto cases as well as other blood thinners – such as Pradaxa – and they are also providing free legal consultations for possible plaintiffs who have not yet retained a Xarelto lawyer. To learn more about Xarelto, Pradaxa, and other blood thinner cases, including services in helping you find a Xarelto law firm, visit: http://lawsuitssettlementfunding.com/pradaxa-settlement-funding.php
To speak with a live agent right now to discuss receiving pre-settlement lawsuit money or a free legal consultation on your potential Xarelto or Pradaxa blood thinner lawsuit, call Legal-Bay's toll-free hotline at: 877.571.0405. You may also apply online at: http://lawsuitssettlementfunding.com and an agent will respond to your request shortly.
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Mar 8, 2015 | PR Web
By Bernstein Liebhard LLP
Attorneys at Bernstein Liebhard LLP are awaiting an upcoming status conference in the federal litigation established for Xarelto lawsuits (http://www.xareltolawsuit2015.com/), where the Firm has claims pending.
A Calendar posted on the Court’s website indicates that the monthly meeting has been scheduled for April 1, 2015 at 9:00 a.m., and will take place in the U.S. District Court, Eastern District of Louisiana. Among the items listed on the Court’s agenda will be a discussion of lawsuits that allege life-threatening internal bleeding episodes caused by the anticoagulant, and other complications. Users claim they were inadequately warned about by the drug’s manufacturers, Bayer Healthcare and the Johnson & Johnson subsidiary, Janssen Pharmaceuticals. (In Re: Xarelto Products Liability Litigation, No. 2592)
“Since this litigation was established in December 2014, our Firm has not only filed numerous Xarelto lawsuits; we’ve also been actively monitoring updates that pertain to our clients. We are looking forward to information that may be discussed at the proceeding’s status conference in April,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs. The Firm is actively filing Xarelto lawsuits on behalf of individuals who allegedly suffered a life-threatening internal bleeding episode, a stroke, deep vein thrombosis or pulmonary embolism caused by the anticoagulant.
Xarelto Lawsuits
With more than 220 Xarelto lawsuits now pending in the U.S. District Court, Eastern District of Louisiana, parties involved in the blood thinner litigation will likely have a lot to discuss at its April status conference. The proceeding was created in December 2014 after a federal panel transferred several similar cases to the Court.
Plaintiffs involved in Xarelto lawsuits that were filed by Bernstein Liebhard LLP and other Firms involved in the Louisiana litigation allege episodes of uncontrollable internal bleeding, as well as strokes, deep vein thrombosis, pulmonary embolism, and other complications they claim to have been inadequately warned about. Plaintiffs further allege that Janssen and Bayer have been improperly marketing Xarelto as a convenient alternative to warfarin, a decades-old alternative, since it received U.S. market clearance in 2011. They further claim that the companies fail to fully tell consumers that there is no available reversal agent to stop Xarelto bleeding episodes once they begin, which may increase a patient’s risk for death. Warfarin is also associated with this complication, but the lawsuits point out that those episodes can be stopped with the administration of Vitamin K.
Xarelto patients who allegedly experienced internal bleeding episodes caused by the blood thinner may be entitled to compensation for out-of-pocket medical expenses, lost wages, pain and suffering and other damages. Learn more about the risk for Xarelto internal bleeding when you visit Bernstein Liebhard LLP’s website, or call 800-511-5092 to schedule a free, no obligation case review.
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Mar 7, 2015 | PR Web
By Bernstein Liebhard LLP
A recent report from the Calgary Herald indicates that a Xarleto class action lawsuit (http://www.xareltolawsuit2015.com/) has been filed in Alberta, Canada on behalf of individuals who allegedly experienced uncontrollable bleeding due to their use of the blood thinner. Among other things, the Canadian lawsuit alleges that Xarelto has been implicated in more than 1,000 injuries in the country, including 12 deaths. The Statement of Claim also accuses the drug’s manufacturers of negligence in their marketing of Xarelto, the Herald reported.
According to court documents, more than 200 Xarelto lawsuits have also been filed in U.S. courts that put forth similar allegations. The majority of those cases are currently pending in a federal multidistrict litigation underway in U.S. District Court, Eastern District of West Virginia.( In Re: Xarelto Products Liability Litigation, No. 2592)
“Our Firm is representing a number of U.S. Xarelto plaintiffs who have cases pending in federal court. We are not surprised that Canada has now seen a similar filing, as the bleeding complications allegedly related to Xarelto are quite serious, and can be life-threatening,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm continues to offer free, no-obligation legal reviews to individuals who allegedly suffered serious injuries from Xarelto, including uncontrollable bleeding, strokes, deep vein thrombosis or pulmonary embolism.
Xarelto Litigation
Xarelto was first cleared for sale in the U.S. by the Food & Drug Administration (FDA) in 2011. The blood thinner's approved uses now include the prevention of strokes in people with atrial fibrillation; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery. Like any anticoagulant, Xarelto can sometimes causes internal bleeding. However, there is currently no approved antidote for reversing Xarelto bleeding.According to court documents, the multidistrict litigation established in the Eastern District of Louisiana was created in December 2014 to allow all Xarelto lawsuits filed in U.S. federal courts to undergo coordinated pretrial proceedings. Among other things, plaintiffs claim that the medication was wrongly marketed as an improvement over warfarin, a blood thinner that has been in use for decades. The lawsuits point out that unlike Xarelto, bleeding associated with warfarin can be stopped via the administration of vitamin K. The complaints further note that during its first full year on the market, Xarelto was named in 2,081 adverse event reports submitted to the FDA, including at least 151 deaths. By contrast, warfarin was named in only 861 adverse event reports, including 56 fatalities, during the same period.
Xarelto patients who allegedly experienced life-threatening episodes of internal bleeding and other complications related to its use may be entitled to compensation for medical bills, lost wages, pain and suffering and more. Learn more about filing a Xarelto lawsuit by visiting Bernstein Liebhard LLP’s website, or by calling 800-511-5092 to schedule a free, no obligation case review.
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Xarelto Lawsuit Alleges Gastrointestinal Bleeding
Mar 13, 2015 | Top Class Actions
By Robert J. Boumis
A Xarelto bleeding lawsuit has joined the mass legal action against Jansen pharmaceuticals over alleged Xarelto complications.
According to the Xarelto bleeding lawsuit, plaintiff Kenneth S. of Alabama was prescribed Xarelto in December 2013.
Xarelto is a blood thinner, a drug designed to make it harder for blood to clot. While blood clotting is a normal part of the healing process, blood can clot inside the body, which can be potentially lethal.
These errant blood clots can block the flow of blood to various blood vessels, causing strokes, pulmonary embolisms, some types of heart attacks, and other serious complications depending on the exact location of the blood clot. Individuals like Kenneth, who are at risk of stroke or other clot-based problems are often prescribed blood-thinners like Xarelto. But Xarelto and other blood thinners may carry the risk of serious Xarelto complications.
Kenneth’s Xarelto lawsuit alleges that the drug caused him to suffer a medical emergency. According to the text of his Xarelto bleeding lawsuit, in October of 2014, less than a year after Kenneth started taking Xarelto, he was rushed to the emergency room.
Kenneth had experienced gastrointestinal bleeding, which is internal bleeding in the digestive tract. Kenneth required emergency treatment for anemia and his gastrointestinal bleeding, according to the Xarelto bleeding lawsuit.
All blood thinners, including Xarelto, carry the risk of uncontrollable bleeding. In uncontrollable bleeding, a blood thinner works too well. When this happens, a patient cannot form blood clots at all. This means a person can lose a dangerous amount of blood from a very minor injury. This can include minor internal injuries, as is the case with gastrointestinal bleeds. While this is a risk with all anticoagulants, Xarelto may have a special risk compared with other blood thinners.
Xarelto has been extensively marketed as being superior to blood thinners that are already on the market. Older anticoagulants like Warfarin work by interfering with vitamin K, which the body uses in the clotting process.
This means that Warfarin patients had to carefully control their diet and avoid foods rich in vitamin K. Additionally, Warfarin patients had to undergo regular blood testing to see how much of an effect the drug was having on their blood. This made sure the drug was working, but not working so well that they risked uncontrollable bleeding.
Xarelto works differently, so patients do not require changes in their diet. Additionally, Xarelto was marketed as not requiring these blood tests, though recent studies have suggested that Xarelto patients could strongly benefit from this type of blood testing.
However, the main problem with Xarelto and other newer-generation blood thinners is that they do not have a known reversal agent. Warfarin’s vitamin K shortcoming could actually work in the drug’s favor during an uncontrollable bleeding event. If a patient on Warfarin does suffer from uncontrollable bleeding, doctors can administer a very high dose of vitamin K to stop it. This effectively “turns off” the drug, allowing a patient to form clots.
When a Xarelto patient suffers uncontrolled bleeding like Kenneth allegedly did, there is not much that doctors can do, other than massive transfusions to try to offset the lack of clotting and keep the patient alive.
The Xarelto Bleeding Lawsuit is Case No. No. 0184, in the U.S. District Court for the Northern District of Alabama, Southern Division. The larger Xarelto Bleeding Lawsuit MDL is In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.
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FDA Says No To Expansion Of Xarelto Use-For The Third Time
Mar 11, 2015 | The Legal Examiner
By Andy Childers
The U.S. Food and Drug Administration (FDA) has rejected three attempts by Johnson & Johnson to expand the approval of its anti-blood clotting drug, Xarelto, according to a report in the Wall Street Journal.
Xarelto is approved as a preventative medicine for patients with pulmonary deep vein thrombosis, pulmonary embolism, and to reduce the risk of stroke and blood clots in people with irregular heartbeats not due to heart problems.
Johnson & Johnson was hoping to expand the drug’s use to include patients who have had previous heart attacks or other complications due to acute coronary syndrome (ACS). An application by J & J for the expanded approval of Xarelto to reduce the risk of stent thrombosis, a rare condition in which a blood clot forms on a stent, was also rejected by the FDA.
Why Won’t the FDA Expand its Approval of Xarelto?
Johnson & Johnson first tried to obtain expanded approval of Xarelto for use in patients with ACS in 2011, and last February’s rejections marked the third time the company’s application has been rejected for expanded use in ACS patients, and the second rejection for those with stent thrombosis.
In February 2014, an FDA advisory panel said that a large amount of data was missing from one of the company’s late stage trials in patients with ACS, making the information flawed and unreliable. In August 2014, Johnson & Johnson and Bayer AG announced plans to launch more clinical trials against three new diseases.
Johnson & Johnson isn’t the first company to try to replace warfarin, another anti-clotting drug – Britol-Myers Squibb Co., Pfizer Inc., and Boehringer Ingelheim GmbH all have similar medications currently in development. But while the new blood thinners are generally easier to take than warfarin, there have been numerous concerns voiced that dangerous bleeding episodes linked to the use of those drugs, including Xarelto, may be harder to control.
Get Help
If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.
Consultations are free and without obligation.
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Fla. Couple Files Xarelto Bleeding Case, Joins MDL
Mar 11, 2015 | Top Class Actions
By Meredith Friesen
A Florida husband and wife filed a Xarelto lawsuit and have joined the Xarelto multidistrict litigation (MDL) alleging severe Xarelto bleeding side effects.
Plaintiff Ronald L. used Xarelto for its intended use: “to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, and to reduce the risk of blood clots when undergoing hip or knee replacement surgery.” Following Xarelto use, Ronald suffered dangerous gastrointestinal bleeding. His wife, Grace L., filed the Xarelto lawsuit with claims of loss of consortium, or loss of intimacy with a spouse.
Ronald used Xarelto for approximately six months during the period of Feb. 1, 2014 until Aug. 11, 2014 when he suffered from gastrointestinal bleeding. Xarelto bleeding required Ronald to be hospitalized and undergo blood transfusions, according to the Xarelto lawsuit.
The Xarelto lawsuit claims that the defendants, Xarelto manufacturers Janssen Research and Development and Bayer Healthcare Pharmaceuticals, failed to adequately test Xarelto before releasing it on the market. Ronald and Grace are just two of hundreds of individuals who have filed Xarelto injury lawsuits against the manufacturers after suffering from dangerous Xarelto side effects including gastrointestinal bleeding or pulmonary bleeding.
Xarelto Side Effects
Xarelto is a Factor Xa inhibitor and part of the new generation of anticoagulant medications. It was marketed as an alternative to warfarin, the leading anticoagulant for decades. Warfarin required diet changes and additional monitoring. Xarelto is a pill that a patient could take once a day, though some have questioned the efficacy of this dosing schedule.
The primary danger that has arisen in Factor Xa medications is the lack of a bleeding antidote. Warfarin could cause gastrointestinal bleeding or pulmonary bleeding, but there was an antidote that would prevent the damage from being extensive. There is currently no such antidote for Xarelto bleeding. This fact has allegedly not been adequately displayed on the Xarelto warning label. The defendants “only mentioned this important fact in the overdosage section,” according to the Xarelto lawsuit.
While a Xarelto antidote is currently being developed to prevent Xarelto injury, over seven million individuals have already used the drug and have been put at risk of suffering from severe Xarelto bleeding.
This Xarelto lawsuit is “a potential tag-along action” seeking to join a growing Xarelto MDL. MDLs are often used when multiple complaints have been filed against the same defendant(s) in order to smooth the legal process and avoid repetition.
This Xarelto Lawsuit is Case No. 2:15-cv-00132, in the U.S. District Court for the Middle District of Florida, Orlando Division. The Xarelto MDL is In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, in the U.S. District Court for the Eastern District of Louisiana.
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Pennsylvania Consolidates Xarelto Lawsuits Into Mass Tort
Mar 10, 2015 | The Legal Examiner
By Eric T. Chaffin
On December 12, 2014, the United States Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into the Eastern District of Louisiana for pre-trial proceedings. The consolidation is intended to reduce the risk of duplicative discovery and conflicting rulings, while serving the convenience of all parties involved. So far, at least 86 cases are pending there.
Now, Pennsylvania state Xarelto lawsuits have also been consolidated into a mass tort. On January 14th, Philadelphia Court of Common Pleas Administrative Judge Kevin Dougherty transferred a total of about 75 cases to the state’s Complex Litigation Center.DRUG MAKERS OBJECT TO XARELTO MASS TORT
Manufacturers Bayer and Janssen Pharmaceuticals argued against consolidation in a December 2014 opposition statement. They said it wasn’t appropriate to bring the cases together in Philadelphia when company headquarters were in New Jersey, and when most plaintiffs, as well, were from out-of-state, with no ties to Pennsylvania. They also questioned whether the cases shared any common issues or questions of fact.
The Judge disagreed, apparently believing that a mass tort would streamline the process. Now all cases filed in the state will be transferred to the same location for pre-trial proceedings. This will allow attorneys to work together for the most efficient resolution of the cases. It is expected that litigation will grow as more people come forward claiming to have suffered serious injuries while using Xarelto.XARELTO BLEEDING EVENTS
The FDA approved Xarelto in 2011 for the prevention of stroke and blood clots in patients who had just undergone knee or hip replacement surgery. Similar to the leading anticoagulant, warfarin, Xarelto is a new-generation blood thinner that doesn’t require blood monitoring or special diets. It was also approved in 2012 to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation.
While the drug makers advertised Xarelto as being a more convenient option to warfarin, with a “one-size-fits-all” dosage, they downplayed the potential side effects, which included excessive bleeding, hemorrhage, and death. Plaintiffs who have filed Xarelto lawsuits add that the manufacturers failed to warn patients that there was no readily available antidote to Xarelto bleeding.
Whereas doctors can treat warfarin bleeding with injections of vitamin K, there is no such treatment for patients experiencing Xarelto bleeding, making it much more dangerous and potentially deadly. Early clinical studies on the drug also showed that it was more likely to cause gastrointestinal bleeding that warfarin, but plaintiffs agree that the manufacturers didn’t do enough to make that fact clear.DRUG MAKERS DOWNPLAYED XARELTO SIDE EFFECTS
In 2013, the FDA sent a warning letter to the manufacturers, stating that one of their print advertisements was false and misleading, and that it minimized the risks associated with Xarelto. In the first quarter of 2012, the Institute for Safe Medication Practices identified over 350 reports of serious, disabling or fatal injuries related to Xarelto.
Later research revealed that even though Xarelto was advertised as more convenient than warfarin, because it didn’t require blood monitoring, certain high-risk patients would have benefited from having their blood checked regularly to be sure they weren’t suffering adverse effects.
In 2014, for example, a study published in the Journal of Cardiology found that some patients with non-valvular atrial fibrillation who took Xarelto (rivaroxaban) experienced prolonged blood-thinning effects, making them more susceptible to bleeding events. These patients could have been identified with blood monitoring, and risks potentially lowered, had the manufacturers suggested blood monitoring for certain populations.
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Research Misconduct Involving Xarelto Goes Unreported
Mar 10, 2015 | Drug Reporter
By Ava Lawson
JAMA Internal Medicine recently published a study by Charles Seife that highlights a profound flaw in how consumers obtain information about clinical drug trials. According to the New York University professor, only 4 percent of questionable practices or violations discovered by health regulators during pharmaceutical trials ever reaches the public.
Numerous drug companies, who are charged with proving the safety and efficacy of their products prior to receiving FDA approval, were found to have deviated from proper trial protocols during site visits by the FDA. Common violations included inaccurate record keeping, submission of false data and failure to protect the safety of trial participants. Seife concluded that although the FDA frequently encounters examples of research misconduct and departures from good clinical practice during these site visits, those discoveries are rarely seen in peer-reviewed literature.
Seife questions why the FDA, whose mission it is to protect the health of the public, would withholdevidence of serious drug trial misconduct from the scientific and medical communities. Most medications in the documents he reviewed were blacked out, with the exception of Xarelto(rivaroxaban).
Out of more than a dozen FDA inspections of Xarelto trial sites, signs of deceitful and objectionable behavior were uncovered during eight occasions. These included unauthorized unblinding, submission of falsified data and the discarding of medical records, among other serious issues.
Questionable drug research practices go unreported
“Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection,” said Seife in his report. “No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.”
According to Seife’s research, the Xarelto study known as RECORD 4 was found to be completely unreliable by health regulators, yet the results were later published with no indication of misconduct or problems. Seife urges respected medical journals to take more initiative in ensuring the integrity of their published studies, including information on FDA protocol violations.
Medications like Xarelto have already been associated with life-threatening side effects, the extent of which are now becoming clearer. Just after the blood thinner was launched in 2011, an estimated 350“serious, disabling or fatal” injuries were reported to the FDA. Most of these involved pulmonary, venous, and other forms of thromboembolism, though Xarelto has also been blamed for uncontrolled bleeding events, since there is no approved antidote.
Litigation filed over Xarelto bleeding problems
Throughout the United States, patients who were prescribed Xarelto for their irregular heartbeat have suffered cerebral hemorrhages, gastrointestinal bleeds and other events that have sometimes proved fatal. Unlike Warfarin, which uses therapeutic doses of Vitamin K to stop bleeding, Xarelto bleeds are challenging to stabilize, since no reversal agent has been developed.
Bayer Pharmaceuticals and Janssen are being sued by dozens of plaintiffs who argue that deceptive advertising was employed and that defendants failed to sufficiently warn about Xarelto bleeding problems.
If the outcome of Pradaxa litigation ($650 million settlement) has any bearing on current and futureXarelto lawsuits, plaintiffs may witness similar recourse. Compensation is being sought to account for all related medical bills, lost income, pain and emotional suffering, diminished earnings and, in some cases, wrongful death.
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Xarelto Lawyers: What Top Litigators Are Saying About the Lawsuit
Mar 10, 2015 | McDonald Worley Attorneys at Law
Attorneys across the nation are scrambling to sign clients and families who claim to have suffered internal bleeding, severe hemorrhaging and death as a result of being treated with the blood thinner Xarelto.
We previously laid out the case being made against the companies marketing the medicine, Bayer and Johnson & Johnson–you can read it here. We aren’t the only attorneys with active clients and injury claims against Xarelto, some of the best trial lawyers across the nation are soliciting for alleged injury sufferers and you can see the latest Xarelto legal updates here.
The best attorneys know to be tight-lipped while a case makes its way through the courts, as results can be uncertain–but some statements can still be gathered from court documents and other news sources as a case makes its way through the court system.
Here is a roundup of what various Xarelto litigators their firms or legal analysts are saying about the case in the news and on the web:
“Our experience with litigating the Pradaxa lawsuits (also a blood thinner) will give us a good head start in the discovery process,” – Attorney Brian Barr via Legal Examiner
“We are pleased that the federal litigation is progressing, and look forward to the Status Conference later this month” — Bernstein Liebhard LLP via a recent Press Release
“The families of those who died, and those who have suffered deserve to have their claims heard in court. Real people, real lives have been impacted–they deserve to learn the truth, they deserve maximum compensation if the defendants are found liable.” — Donald S. Worley, Million Dollar Advocate via Top Lawyers release.
“However, defendants’ promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion among other serious bleeding concerns.” — Sonja Lemoins (Plaintiff Counsel: John J. Driscoll and Christopher J. Quinn of The Driscoll Firm in St. Louis) Complaint St. Clair County Circuit Court case number: 15-L-35 viaMadisonRecord
“As a result of using Defendants’ Xarelto, Plaintiff Shirley Boynton, was caused to suffer from life-threatening bleeding on or about August 31, 2012, and was caused to sustain severe and permanent personal injuries, pain, suffering, and emotional distress,” — Michael A. London of Douglas & London, P.C. Case 1:14-cv-05133-FB-RML via LawyersandSettlements
“Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, and Bayer HealthCare, knew or should have known that unreasonably dangerous side-effects were associated with Xarelto yet they continued to manufacture, distribute and market the blood thinner. According to the lawsuit, the woman wants to be compensated because she will need lifelong medical treatment, monitoring and medication as a result of using Xarelto.” — Complaint Filed in Court Documents Case: 1:14-cv-05133-FB-RM
“J&J May Have Committed a Grave Error ” adding later in the article, “manufacturers may have failed to provide not only adequate warnings about their product, but that they may have failed to provide patients and doctors with the proper prescribing information in the first place.” — The Legal Examiner
“My hope is that this litigation will create broader awareness in the medical community, the FDA, and the general public about the dangers of Xarelto as the drug is currently being prescribed,” — Morgan & Morgan’s Michael Goetz Member of Plaintiffs’ Steering Committee via Press Release
Our experience leads us to believe the number of claims against Xarelto will continue to rise as awareness grows across the nation and people seek help from the top lawyers to see if they qualify to file a claim as well. Whether the defendants choose to settle pre-trial as happened with the over 4,000 Pradaxa lawsuits, or whether the claims are fought in court only time will tell.
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Xarelto Class Action Filed by Canadian Attorney Who Predicts More to Come
Mar 9, 2015 | The Xarelto Lawsuit
By Bernstein Liebhard LLP
A Xarelto lawsuit alleging episodes of uncontrollable internal bleeding has been filed in Calgary by a Canadian attorney who says that several others will be soon to follow.
He told the Calgary Sun on February 13th that the first class action case has already been filed in Calgary, and is being represented by a woman who nearly suffered cardiac arrest in September 2012 after she began bleeding internally. The Xarelto attorney asserts in the claim that “The health care professionals who were treating Betty for this hemorrhaging had considerable difficulty in stopping her bleeding,” and that the plaintiff could be awarded millions in damages.
Also included in this Xarelto internal bleeding lawsuit are the results of a German report that found 130 Xarelto-related deaths in 2012 and 2013, and more than 1,100 adverse event reports filed in Health Canada’s database. A dozen of the adverse event reports filed with the Canadian regulator mentioned death, the claim states.
In addition to the Xarelto lawsuit in Calgary, a similar action involving the anticoagulant is on the road to being filed in Ontario. There, a 83-year old woman suffered a fatal episode of internal bleeding episode.
Xarelto Litigation Builds in Eastern District of Louisiana
As the litigation surrounding this blood thinner continues to mount in Canada, more claims are being filed in the U.S. A federal litigation involving similar claims over the medication, which is jointly manufactured by Bayer Healthcare and the Johnson & Johnson subsidiary, Janssen Pharmaceuticals, was created in December 2014, court document indicate. There are now more than 220 Xarelto lawsuits now pending in the proceeding, which has been established in the U.S. District Court, Eastern District of Louisiana.
Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011, and belongs to a class of new-generation anticoagulants referred to as direct thrombin inhibitors. Since then, Bayer and Janssen have marketed the treatment as a convenient alternative to warfarin, a similar drug that has been prescribed for decades.
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Canadian Attorney Files Xarelto Class Action Alleging Uncontrollable Bleeding Risk
Mar 9, 2015 | Consumer Injury Lawyers
By Bernstein Liebhard LLP
A class action Xarelto lawsuit has been filed in Canada by several individuals who allegedly sustained uncontrollable bleeding episodes due to the blood thinner, and will soon be followed by another, the Calgary Sun reports.
A report on February 13th indicates that the first case in the already-filed action is represented by a Calgary woman who nearly suffered cardiac arrest in September 2012 after she developed internal bleeding. Her Xarelto lawyer asserts in the claim that “The health care professionals who were treating Betty for this hemorrhaging had considerable difficulty in stopping her bleeding.”
The Toronto attorney estimates that the damage award in this case could be millions to the plaintiff, before adding that a similar action will soon be filed in Ontario, where a woman allegedly bled to death after taking the anticoagulant. Also included in her Xarelto lawsuit are the findings of a German report that linked 130 deaths to the medication in 2012 and 2013, and a statistic that 1,100 adverse event reports alleging uncontrollable bleeding and other complications have been logged in Health Canada’s database. “A dozen of those adverse events registered with Health Canada indicated that death had resulted from Xarelto,” the attorney noted.
Xarelto Bleeding Alleged in Hundreds of Federal Cases
As the litigation involving this anticoagulant continues to build in Canada, more lawsuits are being filed in the U.S. by individuals who allege life-threatening episodes of internal bleeding, as well as pulmonary embolism, deep vein thrombosis and other complications that may result in death. In December 2014, a federal panel issued a Transfer Order that moved all similar cases involving Xarelto to the U.S. District Court, Eastern District of Louisiana. There, a federal multidistrict litigation (MDL) has been established for cases that accuse Johnson & Johnson’s Janssen unit and Bayer Healthcare, who jointly market the anticoagulant, of failing to warn about the severity of its side effects. There is no available reversal agent to stop Xarelto internal bleeding once it begins, plaintiffs allege, meaning that they could result in a patient bleeding to death.
As of February 2015, at least 220 lawsuits over the blood thinner had been filed in the federal proceeding.
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Xarelto Class Action Lawsuit Filed in Canada Over Bleeding Problems
Mar 9, 2015 | About Lawsuits
By Austin Kirk
As a growing number of Xarelto lawsuits continue to be filed on behalf individuals throughout the United States, Bayer Healthcare now faces a class action lawsuit in Canada over bleeding problems associated with the controversial anticoagulant.
The Xarelto class action was filed recently in Calgary by Betty Samson, and it appears that a similar claim will soon be filed in the province of Ontario. The complaint seeks to include claims for Canadians who have suffered uncontrollable bleeding that was allegedly caused by side effects of Xarelto.
According to the complaint, Samson went into cardiac arrest when doctors were not able to quickly control bleeding associated with Xarelto use. The complaint indicates that Health Canada has received at least 1,100 adverse event reports linked to Xarelto, which is designed to reduce the risk of blood clots.
Xarelto Litigation the United States
The lawsuit raises similar claims to those brought in the United States, where more than 220 product liability cases have already been filed against Bayer and Johnson & Johnson’s Janssen subsidiary throughout the federal court system.
Since December 2014, complaints filed in U.S. District Courts nationwide have been consolidated for pretrial proceedings as part of a multidistrict litigation, or MDL. While the MDL proceedings are similar to a class action for Xarelto, each of the lawsuits remains an individual claim where plaintiffs must establish damages caused by the drug makers’ failure to warn.
All of the U.S. complaints are centralized before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts. However, each claim will ultimately go before an individual jury if the cases do not settle.
As part of the MDL process, it is expected that a small group of cases will be scheduled for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the U.S. litigation, potentially influencing eventual Xarelto settlement talks.
Judge Fallon has scheduled a status conference in the MDL for later this week.
Xarelto Bleeding Risks
Xarelto (rivaroxoaban) is a new-generation anticoagulant introduced in 2011 as a superior replacement for Coumadin (warfarin), which has been the “go-to” medication for prevention of blood clots and strokes among patients with atrial fibrillation for decades.
While all blood thinners carry a risk of bleeding injury, Xarelto has been linked to a surprising number of problems as more and more patients are switched to the novel anticoagulant.
Xarelto has been promoted as superior to warfarin, with the drug makers indicating that it is easier to use, since it does not require regular blood monitoring. However, several recent studies have raised questions about those claims, with researchers suggesting that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.
In addition to failing to warn about the risk of bleeding and importance of blood monitoring, plaintiffs claim that drug makers withheld information about the lack of a Xarelto reversal agent, which doctors could use to stop hemorrhaging that may develop among users.
While warfarin’s blooding thinning effects can be quickly reversed in an emergency, there is no antidote for Xarelto currently available. This has left many doctors unable to control bleeds, increasing the risk of severe injury or death.
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XARELTO Use May Cause Fatal Bleeding Episodes
Mar 9, 2015 | St. Louis Personal Injury Attorneys
The amount of federal lawsuits that are mounting against the makers of the popular blood thinner, Xarelto continue to rise. In addition, patients are alleging that Bayer and Janssen Pharmaceuticals did not adequately warn them of the potential life threatening bleeding that could occur. To make matters worse, there is no antidote to stop bleeding once it has begun, which is unlike other popular anticoagulants on the market. As a result, many people are suffering serious side effects and even death related to the use of Xarelto.
Xarelto is a new age anticoagulant, which was heavily marketed as the more convenient counterpart to other well-known blood thinners such as, Coumadin. Unlike older blood thinners, the users of Xarelto are not required to get frequent blood monitoring, as well as the need to avoid certain foods. For this reason, Xarelto became a popular choice among patients and physicians, although the warnings were not clearly defined. Now, there are many lawsuits pending against Xarelto makers, and consumers are looking for answers.
If you or a loved one were currently taking Xarelto, the skilled St. Louis wrongful death and personal injury attorneys at Meyerkord & Meyerkord would like to hear from you. Please contact us today to discuss your potential case.
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Xarelto Bleeding MDL Status Conference Held
Mar 9, 2015 | Top Class Actions
By Karina Basso
A Xarelto bleeding MDL status conference was held to determine and discuss the key issues of the ever-growing number of Xarelto lawsuits consolidated in this multidistrict litigation in order to move these cases forward.
At this Xarelto MDL status conference all parties involved in this litigation discussed a number of Xarelto pretrial issues with the presiding judge, including the potential for a Master Complaint, possible tolling agreement, document procedure for the discovery process, and finally a protective order to safeguard against revealing proprietary information in any documents submitted to the court.
Finally, the parties present at the status conference discussed the best way to coordinate the federal Xarelto MDL with the pending Xarelto lawsuits filed in various state courts.
In December, the U.S. Judicial Panel on Multidistrict Litigation (or JPML) consolidated hundreds of Xarelto lawsuits filed against Bayer Healthcare Pharmaceuticals Inc. and Janssen Pharmaceuticals for pretrial proceedings. The Xarelto lawsuits included in this Xarelto MDL similarly allege that hundreds of plaintiffs have suffered Xarelto side effects (such as uncontrollable bleeding) after taking the next-generation anti-coagulant.
These Xarelto lawsuits have been centralized in the U.S. District Court for the Eastern District of Louisiana before U.S. District Judge Eldon E. Fallon.
Drug-makers Bayer and Janssen (a Johnson & Johnson Inc. subsidiary) are facing 220 Xarelto lawsuits in the federal MDL alone, with hundreds more filed in state courts across the nation, which also claim numerous consumers suffered serious and even fatal Xarelto side effects.
Additionally, plaintiffs claim in these Xarelto lawsuits that Janssen and Bayer failed to sufficiently warn patients and physicians of all the risks associated with taking this relatively new blood thinner. The cases included in the Xarelto MDL also similarly claim that the pharmaceutical companies are liable because they neglected to make a reversal agent, leaving doctors with no way to stop the uncontrollable bleeding side effects associated with Xarelto use.Xarelto Bleeding Side Effects
In 2011, Xarelto was first introduced in the medical market as a superior blood thinning alternative to warfarin (or Coumadin), the more traditional anti-coagulant regularly prescribed to prevent stokes and blood clots in patients diagnosed with atrial fibrillation. Although all blood thinners, including warfarin, carry a risk of bleeding injury, the number of Xarelto injury cases and medical reports is startling.
Some potential Xarelto side effects include:
Deep vein thrombosis
Pulmonary bleeding
Abdominal bleeding
Gastrointestinal bleeding
Brain hemorrhaging
Abnormal liver function
Reduced platelet levels
Dizziness
Hemorrhaging in the eyes
Low blood pressure
Nose bleeds
Rectal bleeding
Headache
Muscle pain
Rapid heartbeat
Bruising
Edema
Many individuals are filing Xarelto lawsuits or joining Xarelto class action lawsuits to seek relief from Janssen for themselves or loved ones who have suffered uncontrollable bleeding that has led to permanent injury and even death.
Many of these cases have already consolidated in the Xarelto MDL. A small group of these lawsuits will be picked by Judge Fallon as bellwether cases, which will then be prepared for early trial dates. These Xarelto bellwether cases will help both plaintiffs and defendants gauge how juries may respond to some evidence and testimony in future Xarelto litigation.
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Pradaxa, Xarelto Bleeding Events More Dangerous To Dialysis Patients
Mar 7, 2015 | Righting Injustice
By Jennifer Walker-Journey
Newer blood thinners Pradaxa (dabigatran) andXarelto (rivaroxaban), which are eliminated through the kidneys, are not be used in patients undergoingdialysis because the drugs can build up in their bloodstream and cause dangerous bleeding events. However many dialysis patients are being treated with the anticoagulants, according to researchers in the nephrology division at Massachusetts General Hospital and the clinical research division of Fresenius Medical Care North America.
Pradaxa and Xarelto are used to prevent strokes in patients with a common heart malady known as atrial fibrillation. Xarelto is also used to prevent and treat blood clots in other conditions. Both drugs were introduced within the past five years and are from the same new class of blood thinners. While effective in treating blood clots and preventing strokes, the drugs have been linked with serious bleeding events including gastrointestinal bleeds andbrain hemorrhages.
The researchers used data from the Fresenius Medical Care North America End-Stage Renal Disease Database to track the use of Pradaxa and Xarelto in patients between October 2010 and October 2014. A total of 29,277 patients with atrial fibrillation were undergoing dialysis.
In a second analysis, researchers followed a group of patients for two years to assess their bleeding and stroke outcomes. Those tracked included atrial fibrillation patients who were either using the common bloodthinner warfarin, aspirin, Pradaxa or Xarelto. Overall, 5.9 percent of dialysis patients who required blood thinners were prescribed Pradaxa or Xarelto.
Researchers found that dialysis patients who were taking Pradaxa had a rate of 83.1 major bleeding events per 100 patient-years. Dialysis patients taking Xarelto had a rate of 68.4 major bleeding events per 100 patient-years. Patients taking warfarin had a rate of 35.9 events per patient-years. Death rates from bleeding events followed the same trend, withPradax and Xarelto reporting the most deaths compared to patients on warfarin and aspirin.
“Our study is the first to evaluate these drugs in the dialysis population, and suggests concern given the increasing use of dabigatran and rivaroxaban in the ESRD (end-stage renal disease) population despite formal FDA warnings of caution in renal failure,” the researchers wrote. “In fact, our secondary analyses suggest excess morbidity and mortality from bleeding are associatively higher with dabigatran and rivaroxaban when compared to warfarin.”
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