Xarelto is the brand name for the drug rivaroxaban, an oral anticoagulant manufactured by German pharmaceutical company Bayer. It is sold in the United States by Johnson & Johnson subsidiary Janssen Pharmaceutical.
Xarelto is among a class of newer-generation blood thinning drugs including Pradaxa and Eliquis that are designed to replace the traditional anticoagulant warfarin. While it has been used by millions of patients, experts have identified serious health risks.
Thousands of people have reported adverse side effects where Xarelto was the primary suspect, according to an FDA database.
Major side effects have been identified
Xarelto has not been recalled
Attorneys have filed lawsuits on behalf of Xarelto patients
Xarelto has been linked to internal bleeding or brain hemorrhaging. These might be identified with dizziness, fainting, heavy bruising or tissue damage.
Other complications include headaches, pain, swelling and lethargy. Some patients may be eligible for financial compensation.
Judges have ruled that those injured by Xarelto internal bleeding are eligible to file lawsuits. Lawyers are currently helping patients with these claims at no cost.
Contact us today for assistance or to be connected to a lawyer.
A judicial panel has transferred all pending Xarelto bleeding lawsuits to a special federal court in Louisiana for expedited handling.
Learn about the latest Xarelto information in our news section.
Xarelto is prescribed to prevent blood clots, strokes, deep vein thrombosis and pulmonary embolism in patients with the heart condition atrial fibrillation, as well as those who have recently undergone surgery or are at a general risk.
It works by inhibiting the enzyme prothrombinase to slow the body’s natural formation of blood clots. Xarelto is not recommended for those with prosthetic heart valves or mitral stenosis.
So far, Xarelto has been used by millions of patients and generated sales of more than $1 billion. It recently eclipsed Pradaxa as the most-prescribed anticoagulant on the market.
Taken orally, Xarelto is absorbed into the bloodstream from the digestive tract within the first four hours. It maintains its effectiveness for up to 12 hours with trace effects lasting as long as 24 hours. Therefore, it is most often prescribed as a once-per-day medication.
Xarelto is available in doses of 10, 15 and 20 mg tablets.
Xarelto was first approved for consumer use by Health Canada in September 2008 for the prevention of blood clots in those who had undergone hip or knee replacement operations. The European Medicines Agency approved it the same month for identical use.
In July 2011, the U.S. FDA approved Xarelto to prevent deep vein thrombosis (DVT) and pulmonary embolism in those who had undergone hip or knee surgery. That November, the agency approved it for stroke prevention in adults with atrial fibrillation.
In December 2011, Xarelto was approved by the European Medicines Agency to also prevent stroke and blood clots in adults with atrial fibrillation, to manage deep vein thrombosis (DVT), and to prevent recurring DVT and pulmonary embolism in those who had suffered a serious blood clot.
In November of 2012, the FDA granted approval to use Xarelto for the general treatment and prevention of DVT and pulmonary embolism. Finally, in May 2013, the EMA approved the drug to prevent blood clots in adults with verified acute coronary syndrome (ACS).
Unfortunately, reports have identified more serious side effects of Xarelto that can cause severe and uncontrollable internal bleeding. Unlike warfarin and Coumadin, which use vitamin K as a bleeding antidote, there is no FDA-approved drug or compound doctors can give to stop emergency bleeding from Xarelto.
So far, the FDA and European health officials have received nearly 2,000 reports of patients suffering injury or death from serious internal bleeding Xarelto side effects. In fact, studies have shown it may be 48% more likely to cause bleeding than traditional treatments.
While health experts have named Xarelto one of the 10 most dangerous drugs on the market, the manufacturer has failed to properly warn patients of these bleeding risks. Lawyers are helping those affected by internal bleeding Xarelto side effects file lawsuits. Contact us today for more information or to speak directly with a lawyer.
All anticoagulants have the potential to cause internal bleeding. However, Xarelto internal bleeding may produce more severe results since there is no FDA-approved antidote available to stop it in emergencies.
Doctors have expressed concern that Xarelto may have unsafe bleeding risks since 2011. Already, more than 1,000 patients in the United States have suffered injury, hospitalization or death from internal bleeding.
In most cases, Xarelto internal bleeding occurs in the intestines or stomach, called gastrointestinal bleeding; or in the brain, which is referred to as a brain hemorrhage. Either type can be severe.
Symptoms of internal bleeding include:
Traditional blood thinning medications like warfarin or Coumadin have the advantage that vitamin K injections serve as an antidote in cases of emergency bleeding. However, this does not work for newer-generation anticoagulants like Xarelto, Eliquis or Pradaxa.
Although Xarelto has become the number-one selling blood thinner on the market, most patients are still not properly warned of the risks.
In the years since Xarelto was introduced, numerous reports have warned that patients may face greater risk than with traditional medications.
In June of 2012, Reuters first reported concern by doctors over the bleeding risks, lack of clinical data and lack of safeguards like blood tests and antidotes associated with Xarelto. By the end of 2012, the FDA had received 593 adverse event reports of internal bleeding linked to Xarelto.
In March 2013, GastroJournal reported on a study warning that newer blood thinners like Xarelto had a 48% higher risk of intestinal bleeding than standard care methods.
In September of 2013, the German newspaper Der Speigel published data showing health officials in that country had received 968 reports of adverse events linked to Xarelto within the first 8 months of 2013, including 72 deaths.
In October, 2013, the Institute for Safe Medication Practices ranked anticoagulants among the most dangerous drugs on the market, and specifically listed Xarelto as the 10th most risky, based on the number of complications reported to FDA.
In November of 2013, research presented at an American Heart Association conference showed Xarelto could lead to three times the risk of major bleeding in acutely ill patients, and four times the risk in those with acute coronary syndrome.
In January of 2014, the FDA voted unanimously against approving Xarelto for use in patients with acute coronary syndrome, or sudden blockage of blood to the heart, citing risks of internal bleeding.
In April, 2014, the American Medical Association warned that blood thinners like Xarelto may double risk of bleeding when taken with a non-steroidal anti-inflammatory or aspirin for pain or headache.
For those who experience severe internal bleeding while taking Xarelto, the treatment options may be limited. Unlike with warfarin, where an injection of vitamin K can slow the effects of the medication, this has no effect on Xarelto.
Early studies from the American Heart Association identified Prothrombin as a possible Xarelto reversal agent to stop bleeding. However, this has been found to only work in certain cases and researchers caution that further testing is required.
For now, the makers of Xarelto and health experts advise anyone who experiences internal bleeding while taking the drug to stop using it and immediately seek medical attention.
In some cases, halting use of the drug can slow or stop internal bleeding within 24 hours. However, records show more than 1,000 patients have already suffered serious injury or death from internal bleeding due to the lack of an effective Xarelto reversal agent.
Anyone who experiences symptoms of internal bleeding while taking Xarelto should contact a doctor immediately.
Last year, the maker of Xarelto-competitor Pradaxa paid $650 million to settle more than 4,000 lawsuits over internal bleeding. Now, lawyers are helping those hurt by Xarelto.
In April 2014, the first lawsuit was filed by the family of a woman who died from severe internal bleeding while taking Xarelto. These cases are now growing quickly, and lawyers anticipate thousands may eventually come forward for help.
With the increasing rate of Xarelto claims, a government panel has now moved them into a special federal court in Louisiana for quicker gathering of evidence and resolution. For more information, visit our Xarelto litigation page.
If you or a loved one experienced internal bleeding after taking Xarelto, you may be entitled to substantial compensation. It costs nothing to speak with a lawyer about your claim or file a case unless you receive an award.
DrugNews only recommends lawyers who have already handled Xarelto lawsuits.
For more information on this drug, or to talk to a lawyer, contact us today. We are available 24 hours a day to help.
Injured by Xarelto? Speak with a lawyer who specializes in the Xarelto litigation.
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