Levin Papantonio is investigating whether Bayer and Johnson & Johnson, the manufacturers of Xarelto, withheld vital information from users, doctors and regulators concerning the safe use of the drug, as part of a Xarelto lawsuit.

Xarelto is a part of a class of drugs called New Oral Anticoagulants (NOACs). This class of drugs is “new” in that they are the next generation of blood-thinning drug designed to replace warfarin – also known as Coumadin. Warfarin has been standard therapy for more than fifty years. Warfarin requires routine monitoring (measuring of the level of anticoagulation) and dose adjustments based on that measurement. This is required because doctors strive to achieve the perfect balance of thinning the blood enough so as to reduce the risk of a stroke, yet not thinning the blood so much so as to create an unacceptable risk of a bleeding event. This balance, between too little and too much, is commonly referred to as the therapeutic range or therapeutic window, a common subject of discussion in the Xarelto lawsuit.

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Xarelto demands a premium ($3,000 per year) over the cheaper generic warfarin ($400 per year) with patients and insurance companies because they claim there is no need to measure the degree of anticoagulation in patients treated with these pills.  A world-renowned vascular surgeon told the Levin Papantonio team that an anticoagulant that doesn’t require monitoring “is like Santa Claus or a free lunch – it doesn’t exist!” This is because monitoring is an absolutely critical component for the safe treatment of a patient on an anticoagulant. For reasons known and unknown, some patients experience much more of the blood-thinning effects of anticoagulants than others. These patients are at a much higher risk of experiencing a major bleed than others. Therefore it is absolutely critical for doctors to be able to identify those patients who are at a higher risk so that those patients can have their drug dose reduced, or discontinued entirely.

To be fair –Xarelto may not require the same degree of monitoring as is necessary with warfarin. Warfarin requires monthly (and some doctors are even moving to a weekly regimen) monitoring of the degree of anticoagulation. This is true because of a concept called intra individual variability. Warfarin, unlike Xarelto, has a high degree of intra individual variability. This means that if one were to measure the degree of anticoagulation in an individual warfarin patient – one who takes the same warfarin pill every day – that patient will have drastically different levels of anticoagulation over time. The same person taking the same pill. This is due to the pharmacokinetic and pharmacodynamic properties of warfarin. For example, numerous substances influence the degree of anticoagulation in a warfarin patient – like foods such as spinach or lettuce, drinks such as cranberry juice or alcohol, as well as other medications.  This is why warfarin requires routine monitoring – so as to keep the patient’s blood levels within the therapeutic range.

Notwithstanding the above, Xarelto patients would still benefit from measuring their degree of anticoagulation. This is because, while these drugs may have low intra individual variability, they have very high inter individual variability.  Inter individual variability means the difference in degree of anticoagulation in different patients – all of whom took the same pill. So, while intra individual variability measures the variation in one person, inter individual variability measures the variation across groups of people.

Variability is important because the patient with a higher concentration of the drug in their system are up to 5 times more likely to suffer a life threatening bleed than the patient with lower concentrations of the drug in their system – even though they took the exact same pill.

Wouldn’t it be a good thing for doctors to be able to identify those patients with such elevated risk of major or fatal bleeding so as to provide them with a lower dose (which will lower their blood level and thereby reduce their risk of a bleed) or alternative treatment that doesn’t confer such substantial risk of a bleed?

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The answer is yes. And making matters worse, the manufacturers of Xarelto have access to this data. If the makers of Xarelto shared this data along with guidance on what to do with that data in an individual patient with doctors could substantially reduce the risk of major bleeds.

But let’s discuss real numbers for a moment. In the pivotal clinical trial for Xarelto (ROCKET) results showed that Xarelto causes 3.6 major bleeds per 100 person years. If 1 million of the 2-3 million Americans estimated to suffer from Atrial Fibrillation took Xarelto, you would expect it to cause 36,000 major bleeds (think spending several nights in the hospital after receiving multiple blood transfusions) – per year. This is a shocking number of serious adverse events that are expected from a drug that is being so heavily promoted to America’s Greatest Generation.

Yet, despite being armed with this data – armed with information that could save thousands of lives – the makers of Xarelto are withholding this information from patients, doctors and regulators.

A Xarelto lawsuit will investigate this misconduct against the Johnson & Johnson and Bayer.

The law firm of Levin Papantonio is actively investigating potential Xarelto lawsuits against the makers of Xarelto for failing to provide information necessary for the safe and effective use of Xarelto. If you believe you have a claim for a Xarelto lawsuit, please call the law firm of Levin Papantonio.

Neil E. “Ned” McWilliams, Jr. is a partner with Levin Papantonio. His focus is on pharmaceutical and mass tort litigation.

Learn more about Xarelto Lawsuit.