Preview Newsletter
XARELTO Media Monitoring Week of 3/20/2015
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Xarelto Lawsuit Accuses Janssen of Fraud and Negligence
Mar 19, 2015 | PR Web
By Onder Law Firm
A new Xarelto lawsuit* filed in U.S. District Court in the Northern District of West Virginia alleges that the drug’s maker, Janssen Research and Development, wrongfully represented the product by failing to share knowledge of Xarelto defects, according to court documents. The defendant, Jermaine Tavon McMillan, alleges that he suffered severe internal bleeding and other life-threatening side effects as a result of taking Xarelto, according to court documents. Attorneys handling Xarelto lawsuits nationwide for the Onder Law Firm provide this news update. -
Xarelto Lawsuit Alleges Uncontrollable Bleeding
Mar 20, 2015 | Top Class Actions
By Robert J. Boumis
A Xarelto lawsuit filed by a Tennessee resident has joined the larger body of litigation over allegations that the blood thinner Xarelto causes uncontrollable internal bleeding. -
Attorney: Why Would Patients Pay for Xarelto?
Mar 19, 2015 | Lawyers & Settlements
By Heidi Turner
It may be early in the Xarelto litigation process, but that means there is still time for plaintiffs to file a Xarelto lawsuit and join the multidistrict litigation. Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, says the only real benefit to Xarelto over an older drug is the lack of blood monitoring, but compared with the added risks and the increased price, that benefit may not be as substantial as drugmakers claim. -
Bayer Faces Xarelto Class Action Lawsuit in Canada
Mar 18, 2015 | Drug Reporter
By Laura Woods
*Note: This website is sponsored by Eisbrouch Marsh, LLC. In addition to a growing number of cases in the United States, Bayer now faces a Xarelto class action lawsuit in Canada. Plaintiff Betty Samson filed the complaint in Calgary and another is likely to follow in Ontario, where anelderly woman bled to death while taking the drug. The complaint includes claims for Canadian residents who have suffered uncontrollable bleeding incidents that were allegedly caused by the anticoagulant. -
Xarelto Lawsuit Filed Against Janssen and Bayer in Texas
Mar 18, 2015 | Top Class Actions
By Laura Schultz
A new Xarelto lawsuit was filed in Texas federal court against Janssen Research & Development and Bayer Pharmaceuticals. The Xarelto lawsuit is brought by Sara S. on behalf of the estate of Jerry S. and claims that the drug manufacturers negligently or fraudulently concealed risks associated with taking Xarelto. -
Johnson & Johnson Still Unable to Expand Use of Xarelto
Mar 16, 2015 | Childers, Schlueter, & Smith LLC
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. -
Lawsuit Blames Xarelto for Woman’s Death
Mar 16, 2015 | Top Class Actions
By Amanda Antell
A Xarelto lawsuit was filed against Bayer and Jansen Pharmaceuticals by the daughter of a Florida woman who allegedly bled to death after taking the medication. -
Dosing Logic For Xarelto, Other New Blood Thinners Questioned By JAMA Editorial
Mar 16, 2015 | About Lawsuits
By Irvin Jackson
Amid continuing concerns about the risk of bleeding with Xarelto and other new-generation blood thinners, new research suggests that the medications may be safer if the dosage is individualized for each patient, instead of the current one-size-fits-all promoted by the manufacturers, according to one doctor.
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Xarelto Lawsuit Accuses Janssen of Fraud and Negligence
Mar 19, 2015 | PR Web
By Onder Law Firm
A new Xarelto lawsuit* filed in U.S. District Court in the Northern District of West Virginia alleges that the drug’s maker, Janssen Research and Development, wrongfully represented the product by failing to share knowledge of Xarelto defects, according to court documents. The defendant, Jermaine Tavon McMillan, alleges that he suffered severe internal bleeding and other life-threatening side effects as a result of taking Xarelto, according to court documents. Attorneys handling Xarelto lawsuits nationwide for the Onder Law Firm provide this news update.
McMillan claims the company’s failure to publicize its knowledge of Xarelto risks resulted in his medical providers using inadequate drug safety information, according to court documents. The lawsuit alleges that this failure to share the information it possessed about Xarelto safety risks constitutes negligence and fraud, according to court documents.
“While this particular claim has not been transferred for inclusion with the Xarelto lawsuit MDL, the allegations Mr. McMillan has made against Janssen Research & Development are comparable to those listed in the MDL. Plaintiffs are saying the company had a responsibility to share information about Xarelto risks they allege the company has known for some time, according to court documents. The MDL is relatively new, but as it gathers traction, we anticipate seeing many more Xarelto lawsuits surface around the country,” commented James Onder, of the Onder Law Firm.
These Xarelto lawyers are welcoming inquiries from persons who believe they may have grounds to file a Xarelto lawsuit. National Xarelto lawsuits were first consolidated in Louisiana during December of 2014 under the name Xarelto (Rivaroxaban) Products Liability Litigation (MDL No. 2592), according to court documents from the Judicial Panel on Multidistrict Litigation, and new cases are being added as they surface.
Attorneys handling Xarelto lawsuits throughout the United States are now accepting claims from persons and their loved ones who suffered from severe internal bleeding or hemorrhagic stroke while taking Xarelto. Lawyers are investigating these inquiries for possible Xarelto lawsuits. The Onder Law Firm is renowned for its achievements in product and consumer safety litigation, with a strong track record of winning meaningful settlements for clients. The firm is nationally-renowned for its work on window blind strangulation, and has notable expertise in fighting on behalf of individuals against powerful corporations. Individuals and the family members of individuals who have suffered from internal bleeding and have taken Xarelto are eligible for a no-cost, no-obligation Xarelto lawsuit case review, and may contact the firm through its Xarelto Contingency Lawsuit website.
The Onder Law Firm also welcomes Xarelto lawsuit inquiries from other law firms, either to handle these inquiries or work as co-counsel.
About The Onder Law Firm
Onder, Shelton, O’Leary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O’Leary & Peterson has represented clients throughout the United States, and other firms throughout the nation often seek its experience and expertise on complex litigation. It is a recognized leader in products liability cases such as window blind cord strangulation and pharmaceutical litigation. The Onder Law Firms Xarelto attorneys provide information to the public at http://www.xareltocontingencylawsuit.com.*McMillian v. Janssen Research & Development, LLC, et al, Case No. 3:15-cv-00019, U.S. District Court, Northern District of West Virginia
Link to press release: http://www.prweb.com/releases/xarelto-attorneys/bleeding-lawsuit/prweb12590276.htm
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Xarelto Lawsuit Alleges Uncontrollable Bleeding
Mar 20, 2015 | Top Class Actions
By Robert J. Boumis
A Xarelto lawsuit filed by a Tennessee resident has joined the larger body of litigation over allegations that the blood thinner Xarelto causes uncontrollable internal bleeding.
This Xarelto lawsuit was filed by plaintiff Mattie H. who used Xarelto, allegedly in accordance with the prescribing information included with the medication. However, despite this, Mattie reportedly developed uncontrollable bleeding. Mattie seeks to recoup the costs of medical care, lost wages, lost income potential, and other costs allegedly stemming from Xarelto bleeding. Since she seeks to recoup more than $75,000 from the makers of Xarelto, the Xarelto bleeding lawsuit was filed directly in a Tennessee District Court.
What is Xarelto?
Xarelto is a type of drug called a blood thinner or anticoagulant. Blood thinners like Xarelto interfere with the clotting process, making it harder for the body to form blood clots. Humans need blood clots to stop bleeding when they are injured, but this process can misfire, and blood clots can form inside the circulatory system. This can cause serious medical problems, as blood clots can block the supply of blood to vital organs like the brain, blood, and heart. In patients with risk factors for dangerous blood clots, blood thinners like Xarelto can reduce their chances of suffering a stroke or heart attack. However, all blood thinners carry the risk of working too well.
Xarelto Bleeding
When a blood thinners like Xarelto works too well, a patient can sufferuncontrollable Xarelto bleeding. In this situation, a person can bleed to death from a very minor injury, including nearly-microscopic internal injuries. But with older blood thinners like Warfarin, doctors can reverse the effects of the blood thinner if the patient suffers uncontrollable bleeding with a second drug called a reversal agent.
However, newer-generation blood thinners like Xarelto do not have known reversal agents. This means that if a patient taking Xarelto suffers uncontrollable bleeding, doctors have relatively few options. Often, doctors have to perform massive transfusions to keep a patient alive through the medical crisis. Even then, uncontrollable bleeding is a medical emergency in any patient, and possibly even more dangerous on Xarelto. Xarelto lawsuits like this one have been filed, alleging that drug makers have not done enough to protect the public from the risk of Xarelto bleeding.
The Xarelto Lawsuit is Case No. 2166, in the U.S. District Court for the Western District of Tennessee.
Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/51951-xarelto-lawsuit-alleges-uncontrollable-bleeding/
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Attorney: Why Would Patients Pay for Xarelto?
Mar 19, 2015 | Lawyers & Settlements
By Heidi Turner
It may be early in the Xarelto litigation process, but that means there is still time for plaintiffs to file a Xarelto lawsuit and join the multidistrict litigation. Dr. Shezad Malik, founder of the Dr. Shezad Malik Law Firm, says the only real benefit to Xarelto over an older drug is the lack of blood monitoring, but compared with the added risks and the increased price, that benefit may not be as substantial as drugmakers claim.
“Xarelto is one of the three newer, novel anticoagulants available on the market,” Dr. Malik says. “The first was Pradaxa, FDA-approved as of 2010, then Xarelto in 2011, and then Eliquis is the most recently released. These drugs all work by affecting coagulation pathways and thinning out the blood.”
Xarelto is a direct thrombin inhibitor and is approved to treat nonvalvular atrial fibrillation and to prevent blood clots after knee or hip surgery. Atrial fibrillation is linked to an increased risk of blood clots in the heart, which can break off and travel to the brain, causing a stroke. Xarelto is prescribed to prevent that.
For a long time, warfarin (known by its brand name of Coumadin) was the gold standard for preventing blood clots and strokes. The problem, however, was patients taking warfarin had to have regular blood monitoring to ensure they were staying within the therapeutic levels for the drug. Moving out of the therapeutic range meant having the dosage adjusted up or down, and monitoring blood levels meant regular visits to the doctor.
Because Xarelto and other direct thrombin inhibitors have a different mechanism for preventing blood clots than warfarin, they have been marketed as “one dose fits all” drugs, Dr. Malik says. This means patients do not require regular blood monitoring, giving the drugs an advantage over warfarin.
“Drug companies pushed Xarelto saying it was comparable to warfarin, but with no required blood tests,” Dr. Malik says. “All anticoagulants have a problem with blood thinning and risk of bleeding. The benefit of warfarin is that you can reverse the effects of warfarin with vitamin k concentrates or fresh frozen plasma. There is no such antidote for Xarelto and that’s the problem. If you start to bleed while on Xarelto, it’s difficult for doctors to reverse the effect and there are instances where patients have died or suffered severe bleeding injuries due to the lack of an antidote.”
Lawsuits have been filed against Bayer and Janssen Pharmaceuticals, makers of Xarelto, alleging the drugmakers failed to adequately warn about the risk and further alleging that the companies knew or should have known about the lack of an antidote. A multidistrict litigation with approximately 315 cases has been approved in the Eastern District of Louisiana under Judge Eldon Fallon (MDL No 2592). More lawsuits are expected as the filing process is streamlined.“Why would patients pay $250 to $300 monthly for Xarelto as opposed to 50 cents a day for warfarin, and have no superior benefit to preventing strokes or blood clots while having the added risk of bleeding with no antidote? [Lawsuits allege] there was a lack of adequate testing, they tried to usurp the benefits of warfarin - which was tried and tested - and now Xarelto is one of the most complained about drugs concerning side effects with the FDA.”
Lawsuits have been filed on behalf of patients - or in the case of patients who died from their injuries, their loved ones - who suffered a severe bleeding episode such as bleeding in the brain or gastrointestinal bleeding requiring transfusion or hospitalization.
Litigation concerning Pradaxa involved almost 9,000 lawsuits in federal and state courts. Those lawsuits also alleged patients suffered uncontrolled bleeding and claimed the drugmaker, Boehringer Ingelheim, failed to adequately warn about the risks. The bulk of those lawsuits were settled in 2014.Link to blog post: http://www.lawyersandsettlements.com/articles/xarelto/interview-xarelto-lawsuit-bleeding-events-20522.html#.VQyLzo7F9R0
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Bayer Faces Xarelto Class Action Lawsuit in Canada
Mar 18, 2015 | Drug Reporter
By Laura Woods
In addition to a growing number of cases in the United States, Bayer now faces a Xarelto class action lawsuit in Canada. Plaintiff Betty Samson filed the complaint in Calgary and another is likely to follow in Ontario, where anelderly woman bled to death while taking the drug. The complaint includes claims for Canadian residents who have suffered uncontrollable bleeding incidents that were allegedly caused by the anticoagulant.
Xarelto is a prescription drug used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, not caused by a heart valve problem. The drug is also used to treat people with deep vein thrombosis and pulmonary embolism and to reduce the risk of forming a blood clot in the legs and lungs of those who have recently had knee or hip replacement surgery.
This next-generation anticoagulant received FDA approval in 2011 and was widely considered as an effective alternative to Coumadin (warfarin), which was previously the leading medication used to prevent blood clots and strokes by patients with atrial fibrillation.
Xarelto class action lawsuit
The complaint alleges that Samson went into cardiac arrest in September 2012, when doctors were unable to quickly stabilize internal bleeding linked to her Xarelto use.
“The health care professionals who were treating Betty for this hemorrhaging had considerable difficulty in stopping her bleeding,” states the claim. “They advised her that Xarelto was the cause of her hemorrhaging and that, unlike other anticoagulants such as Warfarin, there was no way to reverse the anticoagulant effects of Xarelto.”
According to the complaint, Health Canada has received at minimum of 1,100 adverse event reports concerning Xarelto side effects.
Samson’s lawsuit raises complaints similar to those filed in by plaintiffs in the United States. Americans have filed more than 220 product liability cases against Bayer and Johnson & Johnson’s Janssen subsidiary in federal courts across the country.
Xarelto MDL
In December 2014, Xarelto complaints in the U.S. were consolidated under multidistrict litigation in the Eastern District of Louisiana. U.S. District Judge Eldon E. Fallon is overseeing the cases. The MDL process is designed to avoid conflicting pretrial rulings, avoid duplicate discovery and help each side conserve resources. A small group of cases will be scheduled for early trial dates, known as bellwether trials, to help both sides gauge the jury reaction to certain evidence and testimony that is likely to be repeated in a significant number of cases.
Risks of internal bleeding
All patients taking blood thinning medication are at a risk of a bleeding injury, but Xarelto has been connected to a large number of adverse incidents. The drug has been marketed as a superior alternative to warfarin, as it doesn’t require regular blood monitoring, but several recent studies have suggested that regular blood monitoring may in fact help doctors identify Xarelto patients with the greatest risk of suffering from a bleeding incident.
Additionally, plaintiffs claim Xarelto drug makers purposely withheld information about the lack of a reversal agent for the drug, which doctors could use in the event of hemorrhaging. Warfarin’s blood thinning effects can be quickly reversed in an emergency, but there is currently no reversal agent for Xarelto. Consequently, many doctors have been unable to control internal bleeding incidents that have left patents with severe injuries or even led to their untimely death.
Link to blog post: http://drugreporter.com/2015/03/bayer-faces-xarelto-class-action-lawsuit-canada/
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Xarelto Lawsuit Filed Against Janssen and Bayer in Texas
Mar 18, 2015 | Top Class Actions
By Laura Schultz
A new Xarelto lawsuit was filed in Texas federal court against Janssen Research & Development and Bayer Pharmaceuticals. The Xarelto lawsuit is brought by Sara S. on behalf of the estate of Jerry S. and claims that the drug manufacturers negligently or fraudulently concealed risks associated with taking Xarelto.
According to the Xarelto lawsuit, Jerry began taking Xarelto in January 2013. Jerry’s medical provider prescribed Xarelto to treat Jerry’s atrial fibrillation, an irregular, often rapid heart beat condition that commonly causes poor blood flow. Approximately three months after Jerry began taking the blood thinner medication, he allegedly began to experience gastrointestinal bleeding and hemorrhaging. The Xarelto side effects lawsuit alleges that Jerry suffered a life-threatening, irreversible bleed due to taking Xarelto.
The Xarelto lawsuit claims that in the course of the defendants’ aggressive marketing approach, Janssen and Bayer overstated the efficacy of Xarelto and failed to adequately warn consumers and the medical community that no means existed to reverse the anticoagulant effects. According to U.S. Food and Drug Administration (FDA) adverse event reports, Xarelto is one of the more dangerous anticoagulants currently sold on the American drug market. The claims the Xarelto lawsuit alleges against the pharmaceutical companies include negligence, strict product liability, breach of warranty, misrepresentation, and fraud and deceit.
History of Xarelto Bleeding Complications
Xarelto is an anticoagulant taken 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 injury from blood clots in patients who undergo knee and/or hip replacement surgery. Xarelto is a part of a new generation of blood thinner that have been marketed as superior to the well-established blood thinner, Warfarin. Warfarin, unlike Xarelto, requires patients taking the drug to follow strict dietary restrictions and undergo periodic blood monitoring. But while Xarelto appears to require less blood monitoring, it has no known antidote for cases of uncontrolled bleeding. Warfarin users who experience internal bleeding, a potential side effect of may blood thinning medications, can be given a dose of vitamin K sometimes mixed with plasma to stop them from bleeding out. Although medical researchers are looking for a similar antidote to drugs like Xarelto, they haven’t found a solution yet.
The FDA approved Xarelto in July 2011. The Xarelto website claims that over 7 million people have been prescribed Xarelto worldwide since its approval, and that in 2013 along, over 1 million prescriptions had been written in the United States. Significant funds were spent by the defendants to market Xarelto to medical providers and the general public alike. The Xarelto lawsuit alleges that in 2013, Xarelto manufacturers spent approximately 11 million dollars on advertising. Xarelto sales for 2013 reached “blockbuster status” and approximated $2 billion. On a global scale, Xarelto is considered the leading anticoagulant.
Multiple Xarelto lawsuits have been filed against pharmaceutical companies like Janssen and Bayer for violating consumer protection laws. Victims of Xarelto side effects and family members who have allegedly lost loved ones to Xarelto complications are filing lawsuits in both state and federal courts. These plaintiffs hope to receive compensation for past and future medical bills as well as compensation for the pain and suffering they allege they were forced to endure.
The Xarelto Lawsuit is Case No. 6:15-cv-78, in the U.S. District Court for the Western District of Texas, Waco Division.
Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/51822-xarelto-lawsuit-filed-against-janssen-and-bayer-in-texas/
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Johnson & Johnson Still Unable to Expand Use of Xarelto
Mar 16, 2015 | Childers, Schlueter, & Smith LLC
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, pulmonaryembolism, 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 rejectionsmarked 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 thatdangerous bleeding episodes linked to the use of those drugs, including Xarelto, may be harder to control.
Link to blog post: http://www.cssfirm.com/2015/03/16/johnson-johnson-still-unable-expand-use-xarelto/
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Lawsuit Blames Xarelto for Woman’s Death
Mar 16, 2015 | Top Class Actions
By Amanda Antell
A Xarelto lawsuit was filed against Bayer and Jansen Pharmaceuticals by the daughter of a Florida woman who allegedly bled to death after taking the medication.
Like millions of Americans, Tara H.’s mother had been prescribed Xarelto to treat her atrial fibrillation and to ultimately prevent stroke. The lawsuit says the plaintiff and her mother were unaware of the potentially fatal bleeding associated with Xarelto.
Her mother was prescribed Xarelto in July 2012, and stayed on it for several months without experiencing complications. However, on Nov. 26, 2012, she suffered uncontrollable gastrointestinal bleeding and was hospitalized. She died three days later.
The Xarelto lawsuit accused Jansen and Bayer of failure to warn about the possibility of such bleeding episodes. The plaintiff insists that her mother never would have used Xarelto if she had known about the possible side effect of uncontrollable bleeding, especially when Xarelto has no reversal agent.
As the manufacturing companies, Tara’s lawyers state that Janssen and Bayer had the responsibility to warn their client and other Xarelto patients of any potential side effects that could occur when using their product.
Among the allegations made in the Xarelto lawsuit are negligence, false advertising, concealing information, and misrepresenting a product.
This Xarelto Lawsuit is Case No. 2:15-cv-00189-EEF-MBN, in the U.S. District Court for the Middle District of Florida, Tampa Division.Overview of Xarelto Bleeding Complications
Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011 to treat atrial fibrillation in high-risk stroke patients, and has become the most popular new-generation anticoagulant. It was released as a joint effort by Bayer Pharmaceuticals and Johnson & Johnson’s subsidiary, Jansen Pharmaceuticals, and has proven to be successful.
Due to aggressive marketing by these companies, Xarelto propelled its way to the top of the blood-thinner market. Unlike their predecessor Warfarin, Pradaxa and Xarelto allegedly have the same design defects that cause bleeding injuries and no stopping agent.
Essentially, if a Xarelto or Pradaxa patient were to suffer internal bleeding, there would be no way to stop the bleeding without medical intervention. This differs greatly from Warfarin, which has vitamin K as its stopping agent, and had various requirements for the patient to follow such as frequent doctor visits, blood monitoring, and dose adjustment.
Xarelto and Pradaxa have no such requirements, which had been a main advertising point. With no need for maintaining dose regulation and frequent doctor appoints, as well as having a reportedly faster-acting mechanism than Warfarin, patients found the prospect of these new anticoagulants very appealing.
Unfortunately, Xarelto now faces the same intense litigation pressure as Pradaxa, with experts expecting lawsuits to continue.
Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/51491-lawsuit-blames-xarelto-for-womans-death/
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Dosing Logic For Xarelto, Other New Blood Thinners Questioned By JAMA Editorial
Mar 16, 2015 | About Lawsuits
By Irvin Jackson
Amid continuing concerns about the risk of bleeding with Xarelto and other new-generation blood thinners, new research suggests that the medications may be safer if the dosage is individualized for each patient, instead of the current one-size-fits-all promoted by the manufacturers, according to one doctor.
In this month’s edition of the Journal of the American Medical Association (JAMA), Dr. J. Robert Powell of the Eschelman School of Pharmacy at the University of North Carolina, Chapel Hill, wrote an editorial questioning dosing procedures involving new direct-acting oral anticoagulant (DOAC), such as Xarelto, Eliquis and Pradaxa
The medications have been introduced in recent years as superior alternatives to warfarin, with drug makers indicating that they are safer and require less blood monitoring. However, reports have emerged about uncontrollable bleeding problems experienced by some users since there are no approved antidotes to reverse the blood thinning effects of the drug. In addition, research suggests that some blood monitoring may help doctors identify those at risk for bleeds.
In the editorial, Powell notes that it took 60 years for doctors to figure out the best way to administer warfarin, which has been the most widely used anticoagulant for prevention of strokes for several decades.
Powell urges the medical community not to take as long with these drugs, warning that the marketing push to make the drugs appear easy to use may be sacrificing some measure of patient safety.
“It is not a coincidence that 3 US-marketed DOACs share the same strategy of 1 dose for all patients and no need for laboratory testing,” he wrote. “This is in part the marketing profile each company used at the drug discovery phase that then guided development decisions through phase 3 trial design, execution, and New Drug Application submission.”
Powell notes that the drugs have naturally narrow therapeutic indices, even though drug plasma concentrations in patients can vary widely. The controversial RE-LY trial reported a 400-fold inter-patient difference at peak plasma concentration, and a 700-fold difference at trough (low) drug concentration, Powell points out.
Boehringer Ingelheim’s RE-LY trial, which was used to get Pradaxa, the first of the DOACs, approved, has been mired in controversy. An investigation by the British Medical Journal in July 2014 found that the company failed to give the FDA important clinical trial data which suggested that patients taking the drug may benefit from regular drug monitoring to decrease the risk of potentially fatal bleeding events.
RE-LY, has come under intense fire and scrutiny. It has been amended twice, and one of the amendments included data on bleeding events Boehringer Ingelheim admits were left out of the original findings.
A number of allegations have been raised questioning the accuracy of the RE-LY clinical trial, which was published in September 2009.
Powell notes that information since provided by Boehringer Ingelhemi suggests that there is a high likelihood that individualized dosing will be just as effective and cause fewer bleeding events than the current 150 mg catch-all dose.
Powell urged the FDA or the European Medicines Agency to release individualized patient data from DOAC phase 2 and phase 3 clinical trials available.
“Data such as these are unlikely to be replicated soon,” he notes. “From these models, new dosing recommendations could be constructed and tested by clinical trial simulations to better understand which patients will benefit most from dose individualization.”Bleeding Problems with Pradaxa, Xarelto, Eliquis
Pradaxa (dabigatran) was the first member of this new generation of anticoagulants to hit the market, designed to replace Coumadin (warfarin) as the “go-to” medication for prevention of strokes due to atrial fibrillation. Other members of this new class introduced after Pradaxa include Xarelto and Eliquis.
All of the medications have been promoted as superior alternatives to warfarin, because they are supposedly easier to use and do not require frequent doctor visits for blood monitoring to adjust treatment doses. However, with warfarin doctors are able to give a dose a vitamin K and fresh frozen plasma to users who experience bleeding problems, quickly reversing the older drug’s blood thinning effects. No such reversal agents are currently available for Pradaxa, Xarelto or Eliquis.
Within a year after Pradaxa hit the market, it quickly earned the dubious distinction as one of the medications most commonly associated with adverse event reports submitted to the FDA.
Boehringer Ingelheim faced over 4,000 product liability lawsuits alleging that inadequate warnings were provided about the lack of an available reversal agent for their medication, which eventually led to a $650 million Pradaxa settlement last year, with an average of about $150,000 to be awarded to former users who experienced injuries associated with uncontrollable bleeds.
Xarelto (rivaroxaban) was the second member of this new class of anticoagulants to be approved by the FDA, hitting the market about a year after Pradaxa. However, as Boehringer Ingelheim faced mounting lawsuits and publicity over severe bleeding events associated with Pradaxa, Xarelto quickly overtook the top spot among the new medications, with sales exceeding those of Pradaxa in 2013.
A growing number of Xarelto bleeding lawsuits are now being pursued on behalf of former users, raising similar allegations that inadequate warnings were provided about the lack of an approved reversal agent and claiming that the drug makers should have never introduced the medication without an antidote to allow doctors to reverse bleeding events.
Link to blog post: http://www.aboutlawsuits.com/dosing-logic-xarelto-questioned-79411/
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