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What XARELTO Is Used For?

Xarelto is the brand name of the drug rivaroxaban, an oral anticoagulant manufactured by the German pharmaceutical company Bayer.

It is sold in the United States by Janssen Pharmaceutical, a subsidiary of Johnson & Johnson.

Xarelto is part of a class of next-generation anticoagulant drugs, including Pradaxa and Eliquis, designed to replace traditional warfarin anticoagulant. Although millions of patients have used it, experts have identified serious health risks.

According to an FDA database, thousands of people reported adverse reactions when Xarelto was the main suspect.

Xarelto is prescribed to prevent blood clots, stroke, deep vein thrombosis, and pulmonary embolism in patients with atrial fibrillation with heart disease, as well as those who have undergone recent or risky surgery. general.


It works by inhibiting the enzyme prothrombinase to slow the natural formation of blood clots in the body. Xarelto is not recommended for people with prosthetic heart valves or mitral stenosis.

So far, Xarelto has been used by millions of patients and has generated sales of more than $ 1 billion. He recently overshadowed Pradaxa as the most prescribed anticoagulant on the market.

When taken orally, Xarelto is absorbed into the bloodstream by the digestive tract during the first four hours. It retains its effectiveness up to 12 hours with trace effects lasting up to 24 hours. Therefore, it is most often prescribed as a medicine to be taken once a day.

Xarelto is available in 10, 15 and 20 mg tablets.


Although health experts have identified Xarelto as one of the 10 most dangerous drugs on the market, the manufacturer has not warned patients of these bleeding risks.

Symptoms of Internal Bleeding

Symptoms of internal bleeding include:

  • Frequent nosebleeds
  • Bleeding in the gums
  • Heavy menstrual bleeding
  • Urine red, pink or brown
  • Stool red or bright black
  • Cough or vomiting of blood
  • Headache, dizziness or weakness
  • Pain, swelling or new drainage at the site of the wound.

Traditional anticoagulant medications such as warfarin or Coumadin have the advantage that vitamin K injections serve as an antidote for emergency bleeding. However, this does not work for new generation anticoagulants such as Xarelto, Eliquis or Pradaxa.

Although Xarelto has become the first anticoagulant sold on the market, most patients are still not well informed about the risks.

Xarelto Clinical Studies

Since the introduction of Xarelto, numerous reports have warned that patients may be at a higher risk than traditional medicines.

In June 2012, Reuters reported for the first time that doctors were worried about the risk of bleeding, lack of clinical data, and lack of safeguards such as Xarelto blood tests and antidotes. By the end of 2012, the FDA had received 593 reports of internal bleeding events related to Xarelto.

In March 2013, GastroJournal reported on a study warning that new anticoagulants such as Xarelto had a 48% higher risk of bleeding than standard methods of care.

In September 2013, the German newspaper Der Speigel published data showing that health officials in that country had received 968 reports of adverse events related to Xarelto in 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 ranked Xarelto as the 10th highest risk, based on the number of complications reported to the FDA.

In November 2013, a study presented at a conference of the American Heart Association showed that Xarelto could entail three times more risk of major hemorrhages in critically ill patients and four times more risk in patients with acute coronary syndrome.

In January 2014, the FDA voted unanimously against Xarelto’s approval for use in patients with acute coronary syndrome or sudden blockage of blood to the heart, suggesting risks of internal bleeding.

In April 2014, the American Medical Association warned that anticoagulants like Xarelto can double the risk of bleeding when taken with a nonsteroidal anti-inflammatory drug or aspirin to relieve pain or headache.

Xarelto Reversal

For patients with severe internal bleeding while taking Xarelto, treatment options may be limited. Unlike warfarin, where an injection of vitamin K can slow the effects of the drug, it has no effect on Xarelto.

Early studies of the American Heart Association have identified prothrombin as a possible Xarelto reversal agent to stop bleeding. However, it has been found that this only works in some cases and researchers warn that additional tests are needed.

For now, Xarelto’s manufacturers and health experts advise anyone who experiences internal bleeding while taking this medicine to stop taking it and seek immediate medical attention.

In some cases, stopping the use of the drug may slow down or stop internal bleeding within 24 hours. However, records show that more than 1,000 patients have already suffered a serious injury or death from internal bleeding due to the lack of an effective Xarelto reversal agent.

Anyone with symptoms of internal bleeding while taking Xarelto should contact a doctor immediately.

Xarelto Lawsuits

Last year, competitor Xarelto’s manufacturer, Pradaxa, paid $ 650 million to settle more than 4,000 lawsuits for internal bleeding. Now lawyers help those who have been injured by Xarelto.

In April 2014, the first lawsuit was filed by the family of a woman who died of severe internal bleeding while taking Xarelto. These cases are now growing rapidly and lawyers predict that thousands of people could eventually seek help.

With the growing number of Xarelto claims, a government panel has now transferred them to a special federal court in Louisiana to gather evidence more quickly and resolve it. For more information, visit our Xarelto Litigation page.

Internal Bleeding Risks

All anticoagulants can cause internal bleeding. However, internal bleeding from Xarelto can produce more serious results because there is no FDA-approved antidote to stop it in an emergency.

Doctors are concerned that Xarelto poses a dangerous haemorrhagic risk since 2011. Already, in the United States, more than 1,000 patients have been injured, hospitalized or died as a result of internal bleeding.

In most cases, Xarelto internal bleeding occurs in the intestines or stomach, called gastrointestinal bleeding. or in the brain, which is called a cerebral hemorrhage. Both types can be serious.

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Latest XARELTO News & Recalls

In June 2014, Reuters reported that Bayer AG had admitted ten trials in the United States for bleeding from Xarelto. Bayer and Johnson & Johnson have not published details or information on possible agreements.

Three known lawsuits include:

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  • A lawsuit filed in February 2014 on Common Pleas Court in Pennsylvania, County of Philadelphia, on behalf of a Kentucky patient who claims to have developed uncontrolled subdural hemorrhage (brain) after taking Xarelto.
  • A lawsuit filed in June 2014 against Johnson & Johnson and Bayer in the US District Court. UU In South Florida. The lawsuit was filed by the wife of a patient who presented uncontrolled bleeding and died as a result of the use of Xarelto.
  • A lawsuit filed on July 25, 2014 in the US District Court. UU From the District of Vermont by the family of a man who died as a result of an uncontrolled brain hemorrhage. The episode of bleeding occurred only 10 days after the start of treatment with Xarelto.

The plaintiffs’ attorneys say the companies (Bayer and Johnson & Johnson) have withheld warnings and information from consumers and health professionals about the risks associated with Xarelto. They also state that the companies did not adequately warn about the absence of antidotes and the lack of dose adjustment. Many other tests are expected.

Lawsuits & Settlements

A court panel has transferred all ongoing lawsuits against Xarelto bleeding to a special MDL federal court in Louisiana for expedited treatment.

Find the latest information on Xarelto litigation in our news section. All MDL current affairs updates will be in our prosecution update section.


Xarelto has been associated with internal hemorrhage of cerebral hemorrhage. These can be identified with vertigo, fainting, bruising or tissue damage.

Other complications include headache, pain, swelling and lethargy. Some patients may be eligible for financial compensation.

Do you want to learn if you have a case? The lawsuits are being filed on behalf of those patients who suffered:

  • Extreme fatigue or dizziness
  • Pale skin
  • Abdominal swelling
  • Easy or unexplained bruising
  • Tarry stool
  • Rectal, Urinary or Genital bleeding
  • Eye or Nose bleeding
  • Sudden or extreme pain which is unexplainable
  • Loss of consciousness or stroke symptoms

Lawyers expect that thousands of patients will ultimately come forward with injuries to file claims. As is often the case with drug injury lawsuits, cases may eventually be consolidated in a central federal court for expedited handling.

A lawyer can speak with you today to determine if your case qualifies, and it costs nothing to investigate or file your claim unless you receive compensation.

Do you have a case?

Speak with someone today who can help!