Preview Newsletter
Xarelto May 29th
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Meldofsky Firm LLC Tackles the Controversies About Xarelto and Its Deceptive Marketing Claims Resulting to 430 Lawsuits
May 28, 2015 | Meldofsky Firm LLC
By ReleaseWire
With the current documentation, there have been a total of 430 patients who have filed the Xarelto lawsuit to at least file for claims for the serious medical health conditions that the use of the drug has resulted into. -
Defending Clients Who've Suffered from Side-Effects of Xarelto
May 26, 2015 | Johnson and Biscone
By Digital Journal
Those who have suffered adverse side-effects from the medication Xarelto will find that Johnson and Biscone are defending victims who want their due compensation. There are a number of adverse side-effects that can come with using this medication, including back pain, bleeding gums, headache, dizziness, nosebleeds, paralysis, and many more. -
ALLEY CLARK GREIWE
May 28, 2015 | Alley, Clark, Greiwe
By Law.com
Currently, the firm is handling vaginal mesh and metal-on-metal hip implant litigation, as well cases against the drug manufacturers for testosterone replacement therapy, Xarelto, Benicar, and Zofran among many others. -
Court Overseeing Federal Xarelto Lawsuits Establishes Procedures Governing Preservation of Documents, Electronically Stored Information
May 22, 2015 | Bernstein Liebhard LLP
By PRWeb
Hundreds of federal Xarelto lawsuits filed on behalf of individuals who allegedly experienced serious internal bleeding and other complications due to its use continue to move forward in the U.S. District Court, Eastern District of Louisiana. According to a Pretrial Order dated May 4, 2015, the Court has established procedures governing the preservation of documents and electronically stored information. -
Federal Xarelto Lawsuits Move Forward, as Court Establishes Procedures for Upcoming Science Day
May 26, 2015 | Bernstein and Liebhard LLP
By PRWeb
The federal court overseeing more than 400 Xarelto lawsuits filed on behalf of individuals who were allegedly injured by the medication has established procedures for the litigation's June 11th Science Day. -
Caseloads for Xarelto Blood Thinner Getting Fatter
May 28, 2015 | LawyersandSettlements.com
By Gordon Gibb
There are a plethora of signs and markers that appear to suggest that Xarelto is going to become a caseload juggernaut in the litigation world. First, the cases in multidistrict litigation are growing steadily, from just over 300 in March to more than 400 now. Funding firms are actively promoting case funding options for plaintiffs requiring funding in order to proceed with a Xarelto lawsuit. -
Bayer HealthCare Extends Clinical Investigation Of Xarelto
May 28, 2015 | Nasdaq.com
By RTT News
Bayer HealthCare, a subgroup of Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L) and its development partner Janssen Pharmaceuticals, Inc. announced the initiation of the CALLISTO Clinical Research Programme to explore the potential benefits of the oral Factor Xa inhibitor Xarelto (rivaroxaban) for the prevention and treatment of pulmonary embolism and deep vein thrombosis in patients with various types of cancer. -
Illinois Woman Claims Xarelto Caused Serious Gastrointestinal Bleed
May 28, 2015 | The Legal Examiner
By Roopal Luhana
The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into one court in the Eastern District of Louisiana on December 12, 2014. At the time, 21 cases were transferred from ten districts to Louisiana. Since then, many more have joined the litigation. -
New Clinical Research Program Initiated for the Prevention and Treatment of Life-Threatening Blood Clots in Patients with Cancer
May 29, 2015 | PipelineReview.com
By PipelineReview.com
Janssen Pharmaceuticals, Inc. (Janssen) and its development partner, Bayer HealthCare, today announced the initiation of CALLISTO, a new comprehensive clinical research program for their novel oral anticoagulant, rivaroxaban, in patients with active cancer. -
Bayer and Janssen extend clinical investigation of cancer drug Xarelto
May 29, 2015 | Pharmaceutical Business Review
By PBR Staff Writer
Bayer HealthCare and Janssen Pharmaceuticals have started the Callisto Clinical Research Program to explore the potential benefits of the oral Factor Xa inhibitor Xarelto (rivaroxaban) to prevent and treat pulmonary embolism and deep vein thrombosis in patients with various types of cancer. -
Vermont Xarelto Lawsuit Claims Drug Caused Death Through Brain Hemorrhage
May 28, 2015 | The Legal Examiner
By Marc Goldich
The decedent was prescribed Xarelto by his doctor to prevent blood clots and stroke for atrial fibrillation, a heart condition for which Xarelto is FDA approved to treat. After taking Xarelto, the decedent was admitted to hospital for a brain bleed, which was diagnosed as a parenchymal hemorrhage. -
Warfarin and Xarelto: What's the Difference Between These Two Popular Blood Thinners?
May 27, 2015 | News Max
By Tim Hrenchir
The blood thinner warfarin was approved by the Federal Drug Administration in 1954 to help lower the risk of blood clots leading to stroke for the more than 2 million Americans who have an abnormal heart rhythm known as atrial fibrillation. For many years, warfarin (Coumadin) was the only medication available. -
How Often Do Patients Taking Blood Thinners Need Blood Tests?
May 28, 2015 | Newsmax
By Tim Hrenchir
Patients taking the medication warfarin generally must undergo blood testing between once a week and once a month, as directed by the attending physician. Patients who use one of the three newer blood thinners don’t need regular testing, according to WebMD. Still, critics have questioned whether regular testing should be required for at least one of the newer drugs. -
ISMP Urges Caution With New Oral Anticoagulants
May 28, 2015 | Genera Surgery News
By David Wild
The new oral anticoagulants introduced over the past several years are touted for being safer and requiring less monitoring than warfarin, but experts are urging clinicians to study the intricacies of administering these agents.
Plaintiff Attorney Press Releases
Plaintiff Attorney Blogs
Scientific Assessments
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May 28, 2015 | Meldofsky Firm LLC
By ReleaseWire
Medical health professional practitioners should really be very careful in dealing with patients as misdosage or the choice of drugs to be prescribed to patients because certain substances and medications would greatly affect any human being; hence, this may produce irreversible disabling, serious medical conditions and worse, death.
One of the most recent controversies in the medical and health industry is the use of anticoagulant drugs such as the Xarelto (Rivaroxaban). The primary action of this drug is to prevent increased blood viscosity and clotting because of its anticoagulant effects. This very promising drug has been used to replace other anticoagulants such as the Warfarin or Coumadin because the latter entails very serious monitoring and blood levels of the drug should consistently be checked to prevent untoward effects such as profuse bleeding, arrhythmias, severe headache. Long-term and use of these drugs without proper monitoring and follow-up from the prescribing physician may also cause serious complications such as hypotension, internal hemorrhage from vital organs, loss of consciousness and maybe even death in severe cases.
The use of Xarelto has become very famous because of its very promising marketing claims that the drug promotes better and safer treatments than other well-known branded blood thinners in the market. The inaccuracy in the information, especially about the other possible side effects of Xarelto not being clearly stated and reported to the FDA, seem to be where the problem rooted from; this is why a lot of people are misled to its use and, in the long run, have suffered from its fatal effects. Another matter of fact is that the general public was not informed if there are antidotes that can be used to reverse the effects of the drugs in case adverse effects may be experienced by patients. Hence for those who have been severely affected by the drug are left with no other choice than to file a Xarelto lawsuit.
With the current documentation, there have been a total of 430 patients who have filed the Xarelto lawsuit to at least file for claims for the serious medical health conditions that the use of the drug has resulted into. Some of the worst cases that these complainants had to deal with is severe intestinal and rectal bleeding, intracranial hemorrhage and bleeding in the kidneys.
Another point of controversy dealing with the effects of Xarelto is that since it is an anticoagulant, It is supposed to prevent formation of clots; but in some cases, patients are complaining that the drug has been the recognized cause of the impeded blood supply due to clot formation. Moreover, in cases where the patients have been taking anticoagulant drugs, clots could not be surgically removed because of the great probability of uncontrolled hemorrhage even when a small and simple incision is made; and when bleeding becomes impossible to control, the patient may get into a coma because of the severe blood loss and may eventually die if the bleeding continues.
About Meldofsky Firm LLC
The Meldofsky Firm LLC is a law firm located in Lake Forest, CA aims to help people who are in need for legal assistance. The law firm is manned by exceptional professional competent lawyers who provide their clients with legal representations even of clients residing outside California. The Meldofsky Law Firm provides legal assistance with claims and compensation in cases of medication-related court cases like the Xarelto Lawsuit. -
Defending Clients Who've Suffered from Side-Effects of Xarelto
May 26, 2015 | Johnson and Biscone
By Digital Journal
Those who have suffered adverse side-effects from the medication Xarelto will find that Johnson and Biscone are defending victims who want their due compensation. There are a number of adverse side-effects that can come with using this medication, including back pain, bleeding gums, headache, dizziness, nosebleeds, paralysis, and many more. Anyone who has experienced serious side-effects from Xarelto should seek legal representation immediately to get what they deserve.
The law offices of Johnson and Biscone are just one of the many law firms that are pursuing lawsuits against the makers of Xarelto, but they have an outstanding reputation for winning cases that other firms cannot.
This medication has been linked to a wide variety of dangerous side-effects, even those which include burning while urinating as well as pain in the arms and legs. There have been lawsuits that suggest Xarelto causes hemorrhaging or led directly to stroke, which are both very serious side-effects. Excessive bleeding is one of the most serious side-effects of this drug, and it is often hard to stop when it starts.
There is a very good chance that many of the people who have experienced these symptoms as a direct result of taking Xarelto can get monetary compensation, but it is necessary to hire an experienced, skilled attorney for professional representation. This drug has been proven to be very dangerous for many people, which is why there are so many active lawsuits against the makers of it as of right now.
With many different Xarelto-related lawsuits pending, more and more people are becoming aware of how dangerous this drug really is and what they can do to get the compensation they deserve. Those who are ready to pursue litigation in the Oklahoma area against Xarelto can contact Johnson and Biscone for representation and legal advice that will give them the upper hand in court. While none of these kinds of cases are ever a sure thing, the lawyer that a person chooses to represent them will largely determine how much they will get if anything.
About Johnson & Biscone Law Firm
Johnson & Biscone law firm in Oklahoma City provides legal representation and counsel for people suffering from personal injury in Oklahoma City and the greater Oklahoma area. Specializing in workers' compensation, auto fraud and personal injury cases, the entire legal team has the ability and knowledge to obtain complete compensation for clients. Well regarded and trusted in the area, the team will help anyone get back on their feet and receive the justice they deserve in Oklahoma. First time consultations are free.
Contact:
Johnson & Biscone
Hightower Building
105 North Hudson Avenue, Suite 100
Oklahoma City, OK 73102
Phone: 405-232-6490
URL: http://oklalegal.com/ -
May 28, 2015 | Alley, Clark, Greiwe
By Law.com
The attorneys at Alley, Clark & Greiwe have established a solid reputation of seeking justice for injured persons throughout the State of Florida. Alley, Clark & Greiwe devotes its entire civil practice to complex personal injury, mass tort, and medical malpractice cases. The firm has successfully litigated a wide variety of complex product liability and mass tort claims. Currently, the firm is handling vaginal mesh and metal-on-metal hip implant litigation, as well cases against the drug manufacturers for testosterone replacement therapy, Xarelto, Benicar, and Zofran among many others.
“We are committed to providing the highest quality legal representation available, and because of that, we have represented thousands of people across the state,” says partner C. Todd Alley, who is joined at the firm by fellow partners James D. Clark and Don Greiwe and associate Katherine Chambers.
In recognition of their legal ability and professional ethics, the firm’s three partners have been AV Preeminent® rated by Martindale-Hubbell®. They are also regularly included in The Best Lawyers in America, with Greiwe being named as the Best Lawyers 2013 Tampa Lawyer of the Year for plaintiffs’ medical malpractice law (Clark was previously honored with the same award in 2011).
As a whole, Alley, Clark & Greiwe has been ranked Tier 1 in Tampa by U.S. News – Best Lawyers “Best Law Firms” for both plaintiffs’ medical malpractice law and plaintiffs’ personal injury litigation. “We are very proud that for the fifth straight year we’ve received a first-tier ranking,” Clark notes. Greiwe adds: “The peer recognition we’ve received over the years really speaks to the breadth of our expertise.”
701 E. Washington Street Tampa, FL 33602
ph: 813.222.0977 | fax: 813.224.0373 | www.tampatriallawyers.com -
May 22, 2015 | Bernstein Liebhard LLP
By PRWeb
Bernstein Liebhard LLP represents plaintiffs in federal Xarelto lawsuits, and this order will help ensure the preservation of evidence that may prove relevant to these cases.
New York, New York (PRWEB) May 22, 2015
Hundreds of federal Xarelto lawsuits (http://www.xareltolawsuit2015.com/) filed on behalf of individuals who allegedly experienced serious internal bleeding and other complications due to its use continue to move forward in the U.S. District Court, Eastern District of Louisiana. According to a Pretrial Order dated May 4, 2015, the Court has established procedures governing the preservation of documents and electronically stored information. Among other things, the Order sets forth preservation obligations for plaintiffs and defendants, as well as the acceptable methods of preservation. (In Re: Xarelto Products Liability Litigation, No. 2592)
"Our Firm is currently representing plaintiffs in federal Xarelto lawsuits, and we are pleased that this proceeding is moving forward. The procedures set forth in this order will help to ensure that any evidence which might prove relevant to these cases is preserved," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs. The Firm is actively filing Xarelto lawsuits in U.S. courts, and continues to evaluate claims on behalf of individuals who allegedly suffered a life-threatening internal bleeding episode, a stroke, deep vein thrombosis or pulmonary embolism due to their use of this blood thinner.
Xarelto Litigation
Court documents indicate that more than 430 Xarelto lawsuits have been filed in the multidistrict litigation underway in Louisiana, all of which allege that the drug's manufacturers failed to provide adequate warnings regarding its association with serious side effects, including internal bleeding, strokes, deep vein thrombosis and pulmonary embolism. Among other things, plaintiffs cite allegedly misleading marketing claims which positioned Xarelto as a superior alternative to warfarin, a blood thinner that has been on the market for decades. The lawsuits point out that while hemorrhaging associated with warfarin can be stopped via the administration of vitamin K, there is currently no approved antidote to reverse Xarelto bleeding. Plaintiffs also assert that Xarelto users would benefit from regular blood monitoring, regardless of the manufacturers' contention that monitoring is unnecessary.In addition to the Xarelto lawsuits pending in the federal multidistrict litigation, at least 243 similar claims have been filed in a Pennsylvania mass tort litigation now underway in the Philadelphia Court of Common Pleas. (In Re: Xarelto Litigation, Case ID 150102349)
According to court documents, Xarelto was cleared for sale by the U.S. Food & Drug Administration in 2011, and is now approved for 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. A black box warning on the Xarelto label includes information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation.*
Individuals who allegedly experienced internal bleeding and other complications related to Xarelto may be entitled to compensation for their medical bills, lost wages, pain and suffering, and other damages. 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.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The National Law Journal has recognized Bernstein Liebhard for twelve consecutive years as one of the top plaintiffs' firms in the country. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092 -
Federal Xarelto Lawsuits Move Forward, as Court Establishes Procedures for Upcoming Science Day
May 26, 2015 | Bernstein and Liebhard LLP
By PRWeb
The federal court overseeing more than 400 Xarelto lawsuits (http://www.xareltolawsuit2015.com/) filed on behalf of individuals who were allegedly injured by the medication has established procedures for the litigation's June 11th Science Day. According to an Order issued in the U.S. District Court, Eastern District of Louisiana, on May 21st, topics to be addressed include Xarelto adverse events, clinical trials pertaining to the drug, the use of blood test based testing with Xarelto, and Xarelto pharmacology. All presentations will be made by scientists and physicians, and the Court will have the opportunity to question these experts as it deems appropriate. The Order stipulates that the parties must provide the Court with copies of their presentations on or before June 5, 2015. (In Re: Xarelto Products Liability Litigation, No. 2592)
"All of the presentations made during Science Day will be considered off-the-record, and are not to be used for any other purpose in the litigation other than the Court's benefit. Our Firm is representing clients in federal Xarelto lawsuits, and this proceeding will serve to apprise the Court of scientific and medical issues that may prove relevant to our clients' claims," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs. The Firm is actively filing Xarelto lawsuits in U.S. courts, and continues to evaluate claims on behalf of individuals who allegedly suffered a life-threatening internal bleeding and other dangerous complications related to its use.
Xarelto Litigation
According to court documents, Xarelto was initially approved by the U.S. Food & Drug Administration in 2011, and is now indicated for 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. The Xarelto label includes a black box warning that contains information about the increased risk of blood clot formation after premature discontinuation of the medication in the absence of adequate alternative anticoagulation.*According to court documents, all of the Xarelto lawsuits pending in the Eastern District of Louisiana involve similar allegations regarding the medication's potential to cause uncontrollable internal bleeding and other serious side effects, including strokes, deep vein thrombosis and pulmonary embolism. Plaintiffs further allege that the manufacturers of Xarelto were wrong to market the blood thinner as a superior alternative to warfarin, a blood thinner that has been on the market for decades. Among other things, they point out that bleeding associated with warfarin can be stopped via the administration of vitamin K, while there is currently no approved antidote to stop Xarelto bleeding.
In addition to the Xarelto lawsuits pending in the federal multidistrict litigation, at least 243 similar claims have been filed in a Pennsylvania mass tort litigation now underway in the Philadelphia Court of Common Pleas. (In Re: Xarelto Litigation, Case ID 150102349)
Xarelto patients may be entitled to compensation if they experienced dangerous episodes of internal bleeding or other complications allegedly related to its use. 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.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The National Law Journal has recognized Bernstein Liebhard for twelve consecutive years as one of the top plaintiffs' firms in the country. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003. -
Caseloads for Xarelto Blood Thinner Getting Fatter
May 28, 2015 | LawyersandSettlements.com
By Gordon Gibb
There are a plethora of signs and markers that appear to suggest that Xarelto is going to become a caseload juggernaut in the litigation world. First, the cases in multidistrict litigation are growing steadily, from just over 300 in March to more than 400 now. Funding firms are actively promoting case funding options for plaintiffs requiring funding in order to proceed with a Xarelto lawsuit. And just the optics involving Xarelto leave much to be desired.
To that end, Xarelto is an example of a new-age blood thinner that aims to knock Coumadin (warfarin) away from its 50-plus-year reign as the King of Blood Thinners. Coumadin is effective, provided stringent and ongoing monitoring is maintained in order to avoid bleedouts or hemorrhages. Were that to happen, at least Coumadin has an “out” - an antidote or reversing agent that can be administered in order to counteract the anticoagulating properties of warfarin in an effort to halt serious bleeding events.
Compare this with Xarelto, one of at least two latest-generation blood thinners that reportedly do not require the strict ongoing monitoring that has been the bastion of warfarin. Thus, it is much more convenient for both patient and healthcare provider. It’s also more expensive, but new drugs usually are.
And Xarelto, it seems, lacks a reversing agent. It has been reported that ongoing research is continuing in an effort to find one (the thinning properties of Coumadin are reversed with an immediate injection of vitamin K), but it hasn’t happened yet and Xarelto was brought to market without one.
Plaintiffs experiencing a Xarelto Bleeding Issue have assumed, akin to Coumadin, that a hemorrhage could be controlled. The truth - at least at the moment - is that a Xarelto Bleedout is much harder to control once it starts. In some cases it can’t be controlled, and Xarelto Death results.
One of the reasons why Xarelto Bleedout lawsuits appear to be growing so quickly could be the realities of multiple plaintiffs, as seen in a Xarelto lawsuit filed this past March by 12 plaintiffs alleging Xarelto Bleeding complications (Walker et al v. Janssen Research & Development LLC et al, Case No. 2:15-vc-01971, in the US District Court for the Central District of California).
As for the Xarelto MDL (In re: Xarelto Products Liability Litigation, case number 2592, before the US Judicial Panel on Multidistrict Litigation), discussions are currently ongoing toward the identification of cases best suited for serving as bellwether cases. According to Case Management Order No.1, filed earlier this month on May 4, “The parties are discussing the scope of discovery, especially the length and breadth of document production, which will influence the setting of the date of the first bellwether trial.”A subsequent Case Management Order is expected to be filed in June once a pool of cases and plaintiffs are examined in-depth for discovery and suitability as a bellwether case.
Blood thinners comprise an important aspect of ongoing health for an aging US population - the baby boomer. The largest single demographic segment is heading into retirement. While modern-day retirees are more active and by and large healthier than previous generations, the need to thin blood as a hedge against strokes and other cardiovascular issues continues, and the market for blood thinners will only get bigger.
To be fair, both patients and their doctors have for years been seeking a blood thinner that is easier to use than Coumadin, and requires less stringent monitoring. Xarelto, along with competitor Pradaxa, appeared to be the answer. However, it is the lack of a reversing agent against Xarelto side effects and bleeding that is prompting plaintiffs to state that Xarelto, even more so than Coumadin, needs continued monitoring in an effort to prevent a Xarelto Bleedout.
That’s because once a Xarelto Bleeding Issue starts, it’s almost impossible to turn off the tap. Plaintiffs claim they were not aware of this lack of antidote, and that the manufacturers of Xarelto had acted irresponsibly in bringing Xarelto to market without one… -
Bayer HealthCare Extends Clinical Investigation Of Xarelto
May 28, 2015 | Nasdaq.com
By RTT News
Bayer HealthCare, a subgroup of Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L) and its development partner Janssen Pharmaceuticals, Inc. announced the initiation of the CALLISTO Clinical Research Programme to explore the potential benefits of the oral Factor Xa inhibitor Xarelto (rivaroxaban) for the prevention and treatment of pulmonary embolism and deep vein thrombosis in patients with various types of cancer.
In patients with active cancer, the risk of VTE is four to seven times higher than in people of the same age without cancer. And importantly, chemotherapy significantly increases the risk further by up to 6.5 times. Despite this, none of the current Clinical Guidelines recommend the routine use of VTE prevention in most ambulatory cancer patients. Regarding the use of anticoagulation therapy for the treatment and secondary prevention of VTE, current Clinical Guideline recommendations are based on few and small clinical trials.
The CALLISTO Programme is a multi-trial prospective clinical research initiative aimed at generating new evidence to help manage cancer-associated thrombosis (CAT). The Programme will consist of nine initiatives in total, comprising both clinical studies and Registries, and will involve more than 4,000 patients worldwide.
The CALLISTO Clinical Research Programme will add to the overall investigation of rivaroxaban, which - by the time of its completion - is expected to include more than 275,000 patients in both clinical trials and real world settings.
Rivaroxaban is the most broadly indicated novel oral anticoagulant and is marketed under the brand name Xarelto. Xarelto is approved for seven indications, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel oral anticoagulant.
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Illinois Woman Claims Xarelto Caused Serious Gastrointestinal Bleed
May 28, 2015 | The Legal Examiner
By Roopal Luhana
The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into one court in the Eastern District of Louisiana on December 12, 2014. At the time, 21 cases were transferred from ten districts to Louisiana. Since then, many more have joined the litigation.
One of those cases was recently filed by plaintiff Cheryl Butler, a resident of Bedford Park, Illinois. According to her complaint, Ms. Butler suffered significant injuries after taking Xarelto, and seeks in excess of $75,000 in damages.
Plaintiff Takes Xarelto, Suffers Life-Threatening Gastrointestinal Bleed
Butler states that she was prescribed Xarelto (rivaroxaban) by her doctor in 2013, to treat her deep vein thrombosis (DVT) and saddle pulmonary embolism (large blood clot that straddles the two branches of the main pulmonary artery). Her condition was serious, as a clot in this location can block both the left and right pulmonary arteries, potentially resulting in heart failure and even death.
Ms. Butler continued to take Xarelto until about April 12, 2013. At that time, she suffered a severe gastrointestinal bleed, for which she was hospitalized. The condition was life-threatening. According to the plaintiff, it caused her physical pain, mental anguish, and diminished enjoyment of life, and has resulted in a shortened life expectancy.
The plaintiff blames manufacturers Janssen Pharmaceuticals and Bayer Healthcare Pharmaceuticals for failing to provide adequate warnings about the risks associated with Xarelto, and seeks to be compensated for her hospital bills, medical treatments, and lost wages.
Studies Link Xarelto with Serious Gastrointestinal Bleeding
The FDA first approved Xarelto in July 2011 to reduce the risk of blood clots in patients undergoing knee and hip replacement surgery. They later approved it for the treatment of patients with DVT and pulmonary embolism, as well as for long-term treatment to reduce risk of recurrence, as was the case with Ms. Butler.
Manufacturers highlighted the fact that Xarelto came in a once-a-day convenient dose and did not require blood monitoring—as does the main competitor, warfarin. They failed, however, to provide equal attention to the fact that in their initial clinical trials on the product, Xarelto caused more gastrointestinal bleeds that warfarin, and resulted in patients requiring more transfusions.
A 2014 study also questioned the wisdom of once-a-day dosing, noting that peaks and troughs in the drug’s potency in the blood could be eliminated with twice-a-day dosing, potentially reducing the risk of excessive bleeding events.
Despite reports of adverse events associated with Xarelto—the Institute for Safe Medication Practices noted in the first quarter of 2012 that 356 reports of serious, disabling, or fatal injuries had rivaroxaban as the primary suspect drug—the defendants failed to provide an adequate “black box” warning about the dangers. They also failed to make it clear that unlike warfarin, Xarelto had no readily available antidote to bleeding, making side effects potentially more dangerous and even deadly.
Plaintiff Claims GSK Negligent
Ms. Butler alleges that GSK engaged in aggressive and misleading marketing that put many patients at risk of serious and life-threatening injuries. Instead they focused on the convenience of the dosing while downplaying the potential consequences. She brings counts of defective design, failure to warn, manufacturing defect, negligence, and breach of warranties.
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May 29, 2015 | PipelineReview.com
By PipelineReview.com
Janssen Pharmaceuticals, Inc. (Janssen) and its development partner, Bayer HealthCare, today announced the initiation of CALLISTO, a new comprehensive clinical research program for their novel oral anticoagulant, rivaroxaban, in patients with active cancer. The studies are evaluating the medicine for the prevention and treatment of life-threatening blood clots in patients with a wide range of cancer types.
In patients with cancer, the risk of venous thromboembolism (VTE), which is a blood clot in the deep veins or the lungs, is up to five times higher compared to people the same age without cancer, and the risk magnifies in those receiving chemotherapy. The occurrence of VTE may also cause delays in patients receiving critical treatment for their cancer, including surgery or chemotherapy. Blood clots are the second leading cause of death in patients with cancer and preventing their occurrence represents a significant unmet need for patients and their providers.
"Not only are blood clots more severe and widespread in the body of patients with cancer, but their development is also linked to the management of cancer," said Gerald A. Soff, MD, Chief, Hematology Service, Memorial Sloan Kettering Cancer Center, New York, NY, and a principal investigator in CALLISTO. "Though blood clots are largely preventable, current therapy is only approved for the treatment of these clots after they've formed, or to prevent clots in patients who are hospitalized. This means a large number of the one million patients who are treating their cancer outside the hospital each year are at risk of developing blood clots, and reducing their incidence is a high priority in cancer care." Dr. Soff is compensated by Janssen Pharmaceuticals, Inc., for his role as a principal investigator in the clinical research program.
Known as CALLISTO, the new oncology research program is part of Janssen and Bayer HealthCare's broader EXPLORER clinical development program, evaluating patient populations being treated for blood clots or at high risk for developing them. The CALLISTO program will encompass the field of cancer-associated thrombosis (blood clots) through nine studies, including seven clinical trials and two registries across various cancer types, in more than 4,000 patients globally.
The advisory council for the program will be chaired by Alok A. Khorana, MD, FACP, Sondra and Stephen Hardis Chair in Oncology, Vice Chair for Clinical Services, Director of the GI Malignancies Program, Taussig Cancer Institute Cleveland Clinic, Cleveland, OH.
"Cancer-associated thrombosis is a highly prevalent complication of cancer treatments, including chemotherapy, targeted therapy and small molecules. Occurrence of clots can disrupt patient quality of life, affect delivery of cancer treatments and increase the number of hospitalizations and use of healthcare resources," said Dr. Khorana. "Although it may be largely preventable, focused studies in the cancer population using newer, more patient-friendly agents have not yet been conducted. This planned program that will engage cancer researchers nationwide seeks to address this unmet need of cancer patients, and the prevention and treatment of cancer-associated thrombosis." Dr. Khorana is compensated by Janssen Pharmaceuticals, Inc., for his role as chair of the CALLISTO advisory council and co-chair of the VTE prevention study steering committee.
The research will evaluate rivaroxaban in the following studies:Prevention of VTE. A prospective, randomized, double-blind, placebo-controlled trial for the primary prevention of blood clots in adult patients with active cancer who are scheduled to receive therapy to control, slow or eradicate the cancer, such as chemotherapy, in the outpatient setting. Endpoints include incidence of VTE and major bleeding events. The trial will enroll patients at high risk of developing blood clots based on their modified Khorana risk score (a recognized scoring system for predicting blood clots in patients with cancer), and will study patients with solid cancers, including but not limited to the pancreas, lung, stomach, colon, rectum, bladder, breast, kidney and ovary, and those with lymphoma. As one-third of all VTE events are "silent," or asymptomatic, the study will follow patients over a six-month period and use periodic medical imaging to evaluate the occurrence of "silent" clot formation, which will help identify when these events are happening.Treatment of VTE. Three studies comparing rivaroxaban to the low-molecular-weight heparin (LMWH) dalteparin, the current standard of care, for the treatment of blood clots in patients with active cancer. Endpoints include incidence of recurrent events and major bleeding. The studies will enroll patients with various cancer types, and will include two randomized studies and one quality of care improvement analysis.Two observational registries, one in the U.S. and one outside the U.S., will follow various outcomes of cancer patients with blood clots who are treated with an anticoagulant to better understand the treatment of VTE and the prevention of recurrent events in this patient population. A sub-study will assess the treatment of blood clots specifically in patients with cancer who must undergo surgical procedures.Relevant Clinical Aspects. Three additional studies will focus on important clinical aspects, such as concomitant use of rivaroxaban with standard cancer therapies, like chemotherapy, and assessment of a bridging strategy for patients taking rivaroxaban or LMWH in instances where chemotherapy-induced vomiting makes oral therapies challenging.
"CALLISTO is unlike any other initiative for cancer-associated blood clots in its scope, size and ambition," said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. "The program will harness our deep experience in oncology and thrombosis so that we can better assess how to reduce the burden of blood clots in patients with cancer, while also improving our understanding of how rivaroxaban may be used in the context of complex cancer treatment strategies.
"Through CALLISTO, part of our broader EXPLORER program which includes six additional indication-seeking studies underway in collaboration with Bayer HealthCare, we are striving to uncover the full potential of our medicine in making a difference for patients with critical medical needs," he continued.
The EXPLORER program is evaluating patients with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome, embolic stroke of undetermined source and now, active cancer. By the time of its completion, more than 275,000 patients will have participated in the clinical development program, other completed and ongoing clinical trials, investigative registries, and non-interventional studies.
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment. Please visit oncology.janssenrnd.com for additional information.About XARELTO® (rivaroxaban)
XARELTO® works by blocking the blood clotting Factor Xa. XARELTO® does not require routine blood monitoring. XARELTO® has a broad indication profile and is approved for six indications that include:To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.To treat patients with deep vein thrombosis (DVT).To treat patients with pulmonary embolism (PE).To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.IMPORTANT SAFETY INFORMATION:
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
• For people taking XARELTO® for atrial fibrillation:
People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO® lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO®, you may have increased risk of forming a clot in your blood.
Do not stop taking XARELTO® without talking to the doctor who prescribes it for you. Stopping XARELTO® increases your risk of having a stroke.
If you have to stop taking XARELTO®, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
• XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop.
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:Aspirin or aspirin-containing productsNon-steroidal anti-inflammatory drugs (NSAIDs)Warfarin sodium (Coumadin®, Jantoven®)Any medicine that contains heparinClopidogrel (Plavix®)Other medicines to prevent or treat blood clots
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:Unexpected bleeding or bleeding that lasts a long time, such as:Nosebleeds that happen oftenUnusual bleeding from gumsMenstrual bleeding that is heavier than normal, or vaginal bleedingBleeding that is severe or that you cannot controlRed, pink, or brown urineBright red or black stools (looks like tar)Cough up blood or blood clotsVomit blood or your vomit looks like "coffee grounds"Headaches, feeling dizzy or weakPain, swelling, or new drainage at wound sites
Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:A thin tube called an epidural catheter is placed in your back to give you certain medicineYou take NSAIDs or a medicine to prevent blood from clottingYou have a history of difficult or repeated epidural or spinal puncturesYou have a history of problems with your spine or have had surgery on your spine
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
XARELTO® is not for patients with artificial heart valves.
WHO SHOULD NOT TAKE XARELTO®?
Do not take XARELTO® if you:Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.Are allergic to rivaroxaban or any of the ingredients of XARELTO®.WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO®, tell your doctor if you:Have ever had bleeding problemsHave liver or kidney problemsHave any other medical conditionAre pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby. Tell your doctor right away if you become pregnant while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about XARELTO®?"
Especially tell your doctor if you take:Ketoconazole (Nizoral®)Itraconazole (Onmel™, Sporanox®)Ritonavir (Norvir®)Lopinavir/ritonavir (Kaletra®)Indinavir (Crixivan®)Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)Phenytoin (Dilantin-125®, Dilantin®)Phenobarbital (Solfoton™)Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)St. John's wort (Hypericum perforatum)
Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
HOW SHOULD I TAKE XARELTO®?
Take XARELTO® exactly as prescribed by your doctor.
Do not change your dose or stop taking XARELTO® unless your doctor tells you to.Your doctor will tell you how much XARELTO® to take and when to take it.Your doctor may change your dose if needed.
If you take XARELTO® for:Atrial Fibrillation: Take XARELTO® 1 time a day with your evening meal.
If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in the veins of your legs or lungs:Take XARELTO® once or twice a day as prescribed by your doctor.Take XARELTO® with food at the same time each day.If you miss a dose of XARELTO®:and take XARELTO® 2 times a day: Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.and take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO® without talking to your doctor first.Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
Please see "What is the most important information I should know about XARELTO®?" above.
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
Janssen and Bayer HealthCare together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto-us.com. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visit www.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO® CarePath™ resources focused on access, education and adherence.
About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit JanssenPharmaceuticalsInc.com for more information -
Bayer and Janssen extend clinical investigation of cancer drug Xarelto
May 29, 2015 | Pharmaceutical Business Review
By PBR Staff Writer
Bayer HealthCare and Janssen Pharmaceuticals have started the Callisto Clinical Research Program to explore the potential benefits of the oral Factor Xa inhibitor Xarelto (rivaroxaban) to prevent and treat pulmonary embolism and deep vein thrombosis in patients with various types of cancer.
In patients with active cancer, the risk of venous thromboembolism (VTE) is four to seven times higher than in people of the same age without cancer, while chemotherapy increases the risk further by up to 6.5 times.
European Hospital Georges Pompidou Université Paris Descartes professor and one of the principal investigators within the Callisto Program Guy Meyer said: "Today, there is limited evidence and guidance on the routine use of anticoagulants for the long-term treatment and prevention of pulmonary embolism and deep vein thrombosis in patients with cancer, despite blood clots being the leading cause of death in patients with cancer outside the cancer itself.
"I am optimistic that results from the Callisto Program will provide important clinical insights to help reduce the risk of pulmonary embolism and deep vein thrombosis, conditions that can be treated and prevented."
Callisto is a multi-trial prospective clinical research initiative in the management of cancer-associated thrombosis (CAT). It will address three key areas of CAT: prevention of VTE, treatment and secondary prevention of VTE and important clinical aspects.
This program will include nine initiatives in total, comprising both clinical studies and Registries, and will involve over 4,000 patients worldwide.
Bayer HealthCare member of the Executive Committee and chief medical officer Dr Michael Devoy said: "The Callisto Program is an important milestone for Bayer in our ongoing work to address unmet medical needs through our experience in both oncology as well as thrombosis management.
"Callisto will build on the existing clinical evidence for rivaroxaban in the prevention and treatment of potentially deadly blood clots across a broad range of indications and patients."
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Vermont Xarelto Lawsuit Claims Drug Caused Death Through Brain Hemorrhage
May 28, 2015 | The Legal Examiner
By Marc Goldich
According to BloodThinnerHelp.com, the manufacturers of Xarelto are facing a lawsuit in Vermont based on allegations that Bayer AG and Janssen failed to warn patients and the medical community about the risks of irreversible bleeding, and Bayer AG and Janssen negligently placed a dangerous product in the market that did not offer any benefits over other existing products that outweighed the risks.
This lawsuit was filed on July 25, 2014 in federal court under case number 2:14-CV-00159 by the daughter of a deceased man who succumbed to internal bleeding that the lawsuit alleged was caused by Xarelto.A Summary Of The Xarelto Lawsuit
The decedent was prescribed Xarelto by his doctor to prevent blood clots and stroke for atrial fibrillation, a heart condition for which Xarelto is FDA approved to treat. After taking Xarelto, the decedent was admitted to hospital for a brain bleed, which was diagnosed as a parenchymal hemorrhage. The blood thinner prevented the decedent’s blood from clotting and stopping the bleed, which unfortunately lead to the death of the plaintiff’s father. According to the complaint, the plaintiff’s father was hospitalized for 6 days while extreme measures were taken to stem the bleeding. While the complaint did not identify what caused the brain bleed to commence, a parenchymal hemorrhage usually occurs in patients with hypertension or from some form of head trauma.What Is The Problem With Xarelto?
Xarelto is a new form of blood thinner that is marketed by it’s manufacturers for its convenience compared to traditional blood thinners like Warfarin. The marketing for Xarelto states that there is one uniform dose which does not require frequent blood monitoring. The main problem with Xarelto is that there is no known antidote that can reverse the anti-coagulation effect of the drug. For Warfarin, a dosage of vitamin K will assist coagulation. Xarelto is part of a class of Xa inhibitor, which is not effected by Vitamin K. As a result, this lawsuit, along with many other Xarelto wrongful death and personal injury lawsuits are based on claims that the manufacturers were negligent to place this blood thinner in the market where there was no reversal agent.Sheller P.C. Helping Families With Xarelto Lawsuit Information
“We understand the range of emotions families are going through when they learn that Xarelto may have caused a serious injury or resulted in the death of a loved one. We are proud to assist these families in their pursuit of justice”, commented Stephen Sheller, Esq., the managing partner of Sheller P.C.
For media contacts and any questions about Xarelto litigation please contact 866-425-8902
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Warfarin and Xarelto: What's the Difference Between These Two Popular Blood Thinners?
May 27, 2015 | News Max
By Tim Hrenchir
The blood thinner warfarin was approved by the Federal Drug Administration in 1954 to help lower the risk of blood clots leading to stroke for the more than 2 million Americans who have an abnormal heart rhythm known as atrial fibrillation. For many years, warfarin (Coumadin) was the only medication available.
Atrial fibrillation disrupts the flow of blood through the heart, allowing it to pool and clot, and then travel to the brain where it causes a stroke.
In 2011, the FDA approved Johnson & Johnson’s blood thinner Xarelto to treat atrial fibrillation. A clinical trial with more than 14,000 patients found Xarelto was similar to warfarin in the ability to prevent strokes. Here are some differences between the two popular blood thinners.
1. They work differently. Warfarin works by making the blood less likely to clot by blocking the body's capacity to recycle vitamin K, which it uses to form clots. With less vitamin K in circulation, blood takes longer to clot, but patients need constant testing to determine dosage. Xarelto doesn't affect vitamin K, and constant monitoring isn't needed.
2. Dosage. For stroke risk reduction, the usual dose of Xarelto is 20 milligrams once a day, taken with the evening meal, according to WebMD. The optimal dosage of Warfarin varies from person to person and can depend on diet, age and other medications. “The dosing is delicate," said WebMD. "Give too much, and the risk of bleeding rises, sometimes dangerously. Give too little, and the stroke risk remains.”
3. Price. Xarelto is much more expensive. Goodrx.com says shows the lowest available price for 30 20mg tablets of Xarelto is $325.95 while the lowest available price for 30 5mg tablets of generic Warfarin is $4.
ALERT: 4 Things You'll Feel Before a Heart Attack
4. Bleeding. Warfarin carries a risk of brain hemorrhage, which is uncommon but deadly. But a patient takes too much warfarin, the side effects can be countered by giving the patient Vitamin K. According to WebMD, there’s no antidote for overshooting with Xarelto, unless it’s fresh plasma. Although significant bleeding events occur less frequently when taking Xarelto than with warfarin, they can occur. Fortunately the serum half-life of Xarelto is relatively short -- five to nine hours -- so its effect will vanish within about 24 hours.
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5. Dietary concerns. Patients on warfarin must undergo blood tests at least monthly and watch their intake of Vitamin K, a nutrient that can lessen the effectiveness of warfarin and can be found in leafy green vegetables such as spinach, chard and kale. No dietary issues are present with Xarelto.
6. Hips and knees. In studies on hip and knee replacement patients, those taking Xarelto were much less likely than those on other anti-clot therapies, including warfarin, to have clot problems, according to WebMD. -
How Often Do Patients Taking Blood Thinners Need Blood Tests?
May 28, 2015 | Newsmax
By Tim Hrenchir
Patients taking the medication warfarin generally must undergo blood testing between once a week and once a month, as directed by the attending physician. Patients who use one of the three newer blood thinners don’t need regular testing, according to WebMD. Still, critics have questioned whether regular testing should be required for at least one of the newer drugs.
In 1954, the Food and Drug Administration approved the use of warfarin to help lower the risk of blood clots leading to stroke. It said people using warfarin must undergo regular blood tests to enable their physician to determine the correct dosage of the drug for them.
The test determines the patient’s International Normalized Ratio (INR), which helps the physician determine how fast the patient’s blood is clotting and whether his or her medication dosage needs to be changed, said WebMD. Illness, diet, medication changes, and physical activities may affect the INR.
Between 2010 and 2013, the FDA approved the use of blood thinners Pradaxa, Xarelto, and Eliquis to treat atrial fibrillation. Warfarin works by making the blood less likely to clot by blocking the body's capacity to recycle vitamin K, which it uses to form clots.
With less vitamin K in circulation, blood takes longer to clot, but patients need constant testing to determine dosage. The new drugs don't affect vitamin K, and constant monitoring isn't needed.
When Pradaxa was approved by the FDA in 2010, a major selling point was that it didn't require frequent blood tests, and according to healthinaging, regular blood testing also isn’t required for users of Xarelto and Eliquis.Pradaxa, Xarelto and Eliquis were found in clinical trials to be equal to or more effective than warfarin, according to WebMD, but the three new drugs also are much more expensive. A typical dose of Pradaxa costs about $300 a month, compared to $4 a month for a typical dose of warfarin.
In 2014, the Institute for Safe Medication Practices questioned the assertion by Pradaxa producer Boehringer Ingelhim that patients didn’t need regular blood-level monitoring. That institute contended they had data covering several years showing the amount of anti-coagulation [blood thinning] varied from patient to patient more than fivefold.
Boehringer Ingelheim responded that they had also conducted studies and concluded that more frequent monitoring wasn't needed. -
ISMP Urges Caution With New Oral Anticoagulants
May 28, 2015 | Genera Surgery News
By David Wild
The new oral anticoagulants introduced over the past several years are touted for being safer and requiring less monitoring than warfarin, but experts are urging clinicians to study the intricacies of administering these agents.
“Dosing these agents can get pretty complicated,” Matthew Fricker, MS, RPh, the program director at the Institute for Safe Medication Practices (ISMP), in Horsham, Pa., said during a recent ISMP webinar. “For example, not only do dosing recommendations differ by indication, there are loading and maintenance doses, which can confuse some patients.”
Indeed, a lack of clarity surrounding rivaroxaban’s (Xarelto, Bayer/Janssen) dosing regimen for venous thromboembolism (VTE) treatment (it should be administered at 15 mg twice daily for 21 days and 20 mg once daily thereafter) may have been why one patient receiving the drug for this indication self-administered 50 mg daily of the drug (ISMP Acute Care Medication Safety Alert! 2014;19[19]).
“The patient took both the loading dose and the maintenance dose together, probably because both prescriptions were filled at the same time,” said Mr. Fricker, emphasizing the importance of patient education at discharge.
The dosing formula is made more complex as renal function enters the equation, Michael Gulseth, PharmD, the program director for anticoagulation services at Sanford USD Medical Center in Sioux Falls, S.D., said during the ISMP webinar. “This is something practitioners are not used to thinking about with warfarin,” he explained.
Manufacturers of two of the four new oral anticoagulants recommend that non-valvular atrial fibrillation patients who are given their medications for stroke prophylaxis undergo dosing adjustments, while the other two agents either have no recommendations when renal function is poor, or recommend against using the drug altogether for this indication, Dr. Gulseth pointed out. Additionally, for the treatment or long-term prophylaxis of VTE, there are no indications for dabigatran (Pradaxa, Boehringer Ingelheim) in patients with creatinine clearance (CrCl) less than 30 mL/min, and rivaroxaban is not recommended for use in patients with this level of renal impairment, he noted. When dabigatran is used, declining renal function is accompanied by an increase in the risk for extracranial bleeding that is greater than the rise in bleeding risk with warfarin, Dr. Gulseth warned (Circulation 2014;129[9]:961-970).
Pharmacists and many providers are accustomed to considering renal function when prescribing a variety of medications, but Dr. Gulseth said a “completely unique situation” exists with edoxaban (Savaysa, Daiichi Sankyo): normal renal function (CrCl >95 mL/min) precludes use of the drug for stroke prophylaxis in non-valvular atrial fibrillation. (The drug’s boxed warning indicates that in individuals with CrCl >95 mL/min, the risk for ischemic stroke with the 60-mg dose is significantly greater than with warfarin. Therefore, the drug shouldn’t be used in patients with CrCl >95 mL/min, according to the manufacturer.)
“Getting providers and pharmacists to think about good renal function as a safety concern is definitely a challenge,” Dr. Gulseth added.
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