Washington, DCAs we are about a month away from the selection of four bellwether Xarelto trials that are scheduled for early 2017, it’s instructive to compare the rocky road of Xarelto with the longevity of Coumadin (warfarin). The latter had been the gold standard for blood thinning well before the introduction of Xarelto and, before that, Pradaxa. In the short tenure of Xarelto as the currently leading anticoagulant, more than 1,700 plaintiffs have reported a Xarelto Bleeding Issue.
That’s a problem, because unlike Coumadin, when a Xarelto Bleedout issue occurs, there is no de facto antidote to stop it.
Warfarin has been around since the late 1940s, and was originally introduced as an effective poison against rats and mice. The references to the parallels between rat poison and blood thinning in humans over the years have been legion; however, the fact remains that warfarin, as Coumadin, has proven effective as a blood thinner since 1954.
Akin to Xarelto Side Effects, or the adverse reactions found with any and every medication ever designed, Coumadin has not been without its shortcomings. Blood and diet have to be strictly monitored in order to keep the thinning properties of warfarin in balance. The consumption of leafy greens, for example, carries the potential for weakening the blood-thinning properties of warfarin given generous amounts of vitamin K commonly found in such foods.
However, therein lay the secret weapon for reversing a bleeding event were one to occur in a patient on Coumadin: a fresh injection of vitamin K. While not a magic bullet, vitamin K provided a physician with an implement in his tool belt to deal with a bleeding issue, which, left unchecked, could result in a serious health issue - and possibly death.
With a Xarelto Bleedout, there is no such de facto standard, or antidote for reversing such an event - a fact the US Food and Drug Administration (FDA) acknowledges in a summary view of Xarelto dated January 2014:
“Reversal of Anticoagulant Effect: A specific antidote for rivaroxaban [Xarelto] is not available. Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable [see Clinical Pharmacology (12.3)]. Protamine sulfate and vitamin K are not expected…The use of other procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.”
While an antidote is being developed, it is not yet ready for implementation, or so it is reported. In the meantime, Xarelto has quickly risen to the top in the anticoagulant world.
It hasn’t taken that long, given that Xarelto was approved on July 1, 2011 for the prevention of deep vein thrombosis (blood clots) in patients undergoing knee or hip replacement surgery (a huge sector of the patient population). The FDA expanded the indications for Xarelto just a few months later, in November 2011, for the prevention of stroke in patients with atrial fibrillation. A year later, on November 2, 2012, the FDA gave Bayer AG and Janssen yet another early Christmas present - approval to expand the use of Xarelto for the treatment, reduction or recurrence of blood clots.
Xarelto - as many a Xarelto lawsuit alleges - was introduced to great fanfare as an alternative to Coumadin. The latter, as noted above, required constant monitoring of blood and diet to remain safe and effective. The time and effort to undertake and maintain such monitoring have left physicians and patients alike pining for an alternative that was equally safe and effective, with less effort. Pradaxa emerged as the first real alternative to warfarin since Coumadin was approved for blood thinning in 1954.
Xarelto soon followed, and was hailed as a safe and effective alternative to Coumadin without the same degree of intensive monitoring that has been the bastion, and the bane, of warfarin.
In the four years since Xarelto came on the market, rivaroxaban has since risen to the very top of the blood thinner category. And by September 2015, there were no fewer than 1,710 lawsuits alleging Xarelto Bleeding complications or even Xarelto Death, consolidated by the Judicial Panel Multidistrict Litigation in the Eastern District of Louisiana.
The lawsuits keep coming, with plaintiffs alleging they were not aware that a Xarelto Bleedout could not be stemmed in the same fashion as that which is available for Coumadin. What’s more, plaintiffs are now claiming that Bayer AG and Janssen were wrong to suggest that rivaroxaban did not require the kind of stringent monitoring associated with Coumadin - and - given the lack of a de facto method to reverse Xarelto Bleeding complications - monitoring should indeed be required. To suggest otherwise, it is alleged, would be and is completely irresponsible.
All eyes will be focused on January 2017, when the first of four bellwether Xarelto trials is set to begin. Who knows how many Xarelto lawsuits will have been filed and enveloped in multidistrict litigation by then.
By then, Xarelto would be entering its sixth full year as an approved anticoagulant in the United States.
At the same time, Coumadin will be well into its sixth full decade - quietly chugging along since 1954 with an antidote and the need for strict monitoring that pundits and plaintiffs say Xarelto should have required all along…
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