Xarelto Reversal Agent Not Fully Researched Before Drug Introduced
Although Xarelto has been promoted as a superior alternative to warfarin (Coumadin), because it is easier to take and requires less monitoring during treatment, there is currently no Xarelto reversal agent available to allow doctors to quickly stop hemorrhages that may develop.
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Xarelto bleeding lawsuits for individuals throughout the United States, as the drug maker withheld critical warnings when this medication was introduced and it does not appear that all possible antidotes for Xarelto were fully explored before aggressively marketing the blood thinner as a replacement for warfarin.
It appears that a number of severe and often fatal injuries suffered a as a result of brain bleeding, gastrointestinal bleeding, kidney bleeding and other hemorrhaging may have been avoided if a reversal agent for Xarelto had been available to doctors.
Uncontrollable Bleeding on Xarelto
Xarelto (rivaroxaban) was just approved by the FDA in November 2011, for prevention of strokes among patients with atrial fibrillation, to prevent blood clots among patients after a hip or knee replacement and as a general blood thinner to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism.
During the three years the medication has been on the market, hundreds of adverse events have been reported involving severe and uncontrollable bleeding from Xarelto side effects.
If stronger warnings had been provided about the bleeding risks and lack of a Xarelto antidote, many patients may have elected not to use the newer medication instead of warfarin, and doctors would not have been left in a position where they were unable to stop hemorrhaging that did develop among some users of the medication.
While Xarelto is promoted as a replacement for the decades-old anticoagulant warfarin, which is marketed under the brand name Coumadin, it lacks an approved reversal agent. Doctors can reverse the blood thinning effects of warfarin with a dose of vitamin K, but no such solution was available for Xarelto when it was introduced.
Failure to warn about the lack of a means of reversing Xarelto blood thinning effects resulted in confusion within the medical community, leaving doctors unable to stop bleeds and increase the severity of injury.
The only mention about the lack of a reversal agent is buried deep in the Xarelto warning label “Full Prescribing Information”. However, this information highlights the lack of effort made by the drug makers to test for all possible reversal agents that could have made Xarelto safer to use.
As the Full Prescribing Information indicates: “procoagulant reversal agents like activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (rFVIIa) has not been evaluated.”
According to allegations raised in Xarelto lawsuits, the makers of this medication rushed it onto the market without fully researching the potential side effects or antidotes that may have allowed doctors to reverse bleeding events that occur among users.
Rather than delaying the medication or issuing a Xarelto recall after a large number of severe injuries and deaths were reported, the drug makers decided to continue aggressively marketed the drug with confusing and misleading information for physicians and consumers. At a minimum, a Xarelto “black box” warning should have been placed prominently on the label to make sure that the risks associated with the medication were understood.
Now that the new generation blood thinner has reached blockbuster status, generating an estimated $2 billion in annual sales, the drug makers are scrambling to find a reversal agent for Xarelto to make sure it maintains it’s new status as a leading anticoagulant.
Lawsuits Over Lack of Xarelto Antidote
The Xarelto lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits filed by patients who suffered severe injuries that may have been prevented if a Xarelto reversal agent had been available, including:
- Gastrointestinal Bleeding
- Internal Bleeding
- Brain Hemorrhaging
- Kidney Bleeds
- Hemorrhagic Stroke
- Wrongful Death
All Xarelto cases are handled by our attorneys on a contingency fee basis, which means that there are never any out-of-pocket expenses to hire our law firm and we receive no fees or expense reimbursement unless a recovery is obtained. All legal claims do have a statute of limitations, or deadline that requires any lawsuit be filed by a certain date. Therefore, it is important to review any potential case as soon as possible.
1 Comment • Add Your Comments
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Posted on August 11, 2014 at 4:56 am