Xarelto (generic: rivaroxaban) belongs to a class of drugs called New Oral Anticoagulants (NOACs) that were designed to replace warfarin, a staple blood thinner that’s been in use for more than 50 years in the U.S. Warfarin requires intensive patient monitoring and dose adjustments in order to achieve the ideal balance of thinning the blood enough so as to reduce the risk of stroke, yet not thinning the blood so much so as to increase the risk of internal bleeding. This balance is called a therapeutic window, and is a common topic in Xarelto lawsuits.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Xarelto side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.
What’s the Problem?
Xarelto costs about $3,000 per year compared to the cheaper generic warfarin ($400 per year) because the manufacturer claims there is no need to measure the degree of anticoagulation with Xarelto. However, many feel this claim is false because monitoring is a critical component of safe treatment with anticoagulants. Some patients experience much more of the drugs’ blood-thinning effects than others, and are at a much greater risk of suffering uncontrollable internal bleeding events. Therefore, it is important that physicians be able to identify high-risk patients so they can have their dose reduced or discontinued.
It might be more accurate to say that Xarelto requires less intensive patient monitoring than warfarin. Warfarin requires monthly – and in some cases even weekly – monitoring to adjust the degree of anticoagulation. This is due to a concept known as “intra individual variability.” Warfarin, unlike Xarelto, has a high degree of intra individual variability. This means that if the degree of anticoagulation in an individual warfarin patient is measured, that patient will have dramatically different levels of anticoagulation over time. This is caused by the pharmacokinetic and pharmacodynamic properties of warfarin, and is why the drug requires routine monitoring.
However, Xarelto users should also have their anticoagulation levels monitored on a regular basis. This is because, while it may have low intra individual variability, Xarelto also has extremely high “inter individual” variability, which refers to the difference in degree of anticoagulation among different users of the same drug. So, while intra individual variability measures the variation that occurs within one specific person, inter individual variability measures the variation across different groups of patients.
Variability is critical because a person with a higher concentration of Xarelto in their bloodstream is up to five times more likely to experience internal bleeding compared to patients with lower concentrations of the drug in their system – even though they used the exact same drug.
This is why doctors should be able to identify patients who have an increased risk of internal bleeding, so as to provide them with a lower dose or alternative treatment. Making matters worse, Xarelto’s manufacturers have access to this data. If the companies shared this information, it could significantly reduce the occurrence of major bleeding episodes.
In the pivotal ROCKET clinical trial for Xarelto, results indicated that the drug causes 3.6 major bleeds per 100 person years. If 1 million of the 2-3 million Americans estimated to have afib took Xarelto, it would result in approximately 36,000 major bleeds each year. This is a huge number of adverse events expected from a product that is being so heavily marketed to America’s Greatest Generation. Yet, despite being aware of this data, the makers of Xarelto have withheld this information from the public and medical communities.
Do I Have a Xarelto Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Xarelto Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Xarelto side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.