What is Xarelto?
Xarelto (rivaroxaban) was first approved by the FDA in July of 2011. The blood thinner has three main uses:
- Reducing the risk of blood clots and stroke in patients with atrial fibrillation,
- Treating deep vein thrombosis and pulmonary embolisms, and
- Reducing the risk of blood clots in patients undergoing knee or hip replacement surgery.
To treat a clotting disorder (which can lead to strokes or embolisms), a medication like Xarelto may be prescribed which will keep the blood from clotting. As a result of the action of this drugs, patients must be very careful to avoid injury, as the blood can no longer clot naturally.
Patients must be very careful to avoid injury, as the blood can no longer clot naturally.
Older blood thinners like warfarin (Coumadin) have been around for over 50 years. Warfarin has an antidote, and its blood thinning effects can be reversed with a shot of Vitamin K.
Unlike warfarin, Xarelto does not have an antidote. If a patient taking Xarelto is injured or needs surgery, there is no shot which will reverse its effects and allow the body to resume clotting normally. Patients who begin hemorrhaging while taking Xarelto may not be able to stop, leading to massive blood loss and possibly death.
Common Side Effect and Complications
Adverse side effects of Xarelto have increased dramatically as the drug becomes more common. Xarelto side effects are being reported at a rate of 2 to 1 over Pradaxa, another new drug thinner on the market. In addition, Xarelto has paradoxically been linked to reports of increased blood clots, especially in younger patients who have had hip or knee surgery.
These patients and their doctors have reported clotting complications and serious ailments:
- Pulmonary embolisms
- Deep vein thrombosis
- Excessive blood loss
- Intracranial hemorrhaging
- Gastrointestinal bleeding
Three years ago, a non-profit consumer safety group evaluated the adverse events reported to the Food & Drug Administration and found that Xarelto had been linked to more than 350 adverse events. These events included serious, disabling, and fatal injuries. Nearly half of the events were blood clots.
In 2011, a ROCKET AF clinical trial of Xarelto revealed that the drug was no more effective than warfarin and the risks were comparable. However, a common side effect of Xarelto was intestinal bleeding.
Xarelto Claims and Lawsuits
Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, Inc. are facing several Xarelto lawsuits alleging that the drug is dangerous and the manufacturer failed to warn consumers about the risks. Lawsuits claim that doctors have no effective means of combating bleeding in the event of the emergency.
Furthermore, lawsuits filed claim that the manufacturers marketed Xarelto as a superior anticoagulant despite the number of adverse events reported to the FDA. Doctors and medical staff were also allegedly not properly made aware of the risks and how to treat someone using Xarelto in the event of bleeding complications.
You and your family rely on your doctor and your medication to keep you healthy. If Xarelto’s manufacturer failed to inform you or your doctor of the potential side effects, or you suffered unforeseen adverse reactions after taking Xarelto, you may have grounds to pursue a Xarelto claim and or a Xarelto lawsuit.
Victims of a Xarelto bleeding event may be entitled to compensation for past and future medical bills, lost wages and their pain and suffering. If you are interested in filing a Xarelto bleeding claim, a Xarelto lawyer at our firm can help.
In July 2008 the Rivaroxaban, an anticoagulant was submitted to the FDA for approval in the United States of America. In 2009 the FDA advisory committee found a favorable risk to benefit profile for the drug for use after some knee and hip surgeries to help prevent or reduce the risk of DVT (Deep Vein Thrombosis) or Pulmonary Embolism. In July of 2011 the Federal Drug Administration approved Xarelto, the brand name for the generic drug Rivaroxaban, “to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery”. Later that same year the FDA approved Xarelto for prevention of Stroke in people with certain types of Abnormal Heart Rhythm. Finally, in November of 2012, the FDA approved an expanded use of Xarelto to treat and/or reduce the occurrence of blood clots.
At least six state and federal lawsuits were filed in 2014 related to the use of Xarelto. Four of the six were on behalf of a deceased loved one and two were filed by plaintiffs who claim injury due to the use of the drug. The claimants all list excessive or hemorrhagic bleeding after the prescribed use of the drug. The period of ingestion was varied from as little as 10 days in one claim and up to eight months in another.
By 2015 many claims had been brought against Xarelto manufacturers Bayer and Johnson and Johnson in relation to excessive bleeding, but in October of 2015 the first suit was brought claiming that the drug failed to prevent stroke. It had been approved for such use by the FDA in 2012. The claimant filed suit on behalf of her father, who died four days after being prescribed and using Xarelto for Atrial Fibrillation. She alleges that the medicine did not prevent stroke as it was prescribed and advertised to do and that her father’s stroke and sudden death was both a direct result of the use of Xarelto and its failure to perform as advertised.
MARCH – CBS News cited a New York Times article about controversial Xarelto research by Duke Clinical Research Institute and findings that may have been withheld. The controversy surrounds results shared by Duke researchers in The New England Journal of Medicine and the possibility that the results may have been skewed by faulty testing equipment. The original testing was to measure Xarelto’s effectiveness against Warfarin, another more common clotting drug.
AUGUST – The FDA failed to approve an antidote to the anticoagulants Xarelto and Eliquis. The drugs themselves were approved as anticoagulants in 2012 by The Food and Drug Administration, specifically for treating Atrial Fibrillation and preventing resulting blood clots from that condition. (Xarelto had been approved earlier, in 2009 for use after hip replacement and knee replacement surgeries as a preventative measure against DVT (Deep Vein Thrombosis) and / or Pulmonary Embolism, and the drug’s use approval was expanded to include treatment of or prevention from blood clots due to Atrial Fibrillation) The antidote was created for use in cases where excessive bleeding or hemorrhaging occurred in patients who used Xarelto and other drugs of its kind. The medication called AndexXa was developed to “act as a decoy” for the medication in Xarelto that would allow a patient’s body to develop blood clots, thereby slowing or stopping the excessive bleeding. The FDA has not outright denied the approval of AndexXa, but has delayed the approval pending further information regarding usage, manufacturing practices, and clinical studies.
OCTOBER – Over 9000 cases had been filed against the makers of Xarelto including over 7000 in Louisiana and around 1000 in both Philadelphia and Delaware. The claimants allege that use of the drug caused severe bleeding that resulted in critical injury and in some cases, death and that the consumers had not been properly warned of these possible risks related to use of the product.
Because the complaints and questions of law are common in so many of the cases filed across the nation, four “bellwether” cases have been scheduled to begin in February of 2017. A bellwether case is a sort of a “test case” that is used when there are many similarities in a multidistrict litigation. The outcome of a bellwether trial is not binding on other plaintiff’s cases but does offer an idea of the outcome of other cases which helps in negotiations and possible settlements. The cases are chosen specific to a federal judge’s detailed orders of process from a pool of cases representing the commonality of arguments and facts. Because of the overwhelming number of cases being filed against the manufacturers and distributors of Xarelto, this process and these cases are chosen to expedite the process so that the volume of cases does not overload the judicial system.
The number of cases filed against the manufacturers of Xarelto continues to grow.