Xarelto Linked to Serious Bleeding, Complications, and Death

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Xarelto (rivaroxaban)—an anticoagulant (or blood thinner) developed by Bayer Pharmaceuticals and Johnson & Johnson’s Janssen Pharmaceuticals—is linked to serious, sometimes fatal bleeding events.

Xarelto is marketed as being more effective and safe than the longtime industry standard anticoagulant, warfarin. Research, however, shows that Xarelto might neither be superior nor safer than warfarin. In fact, a number of studies demonstrate that Xarelto can cause dangerous and sometimes fatal internal bleeding that cannot be stopped through the use of a reversing agent.


Morgan & Morgan attorneys have filed personal injury and wrongful death claims on behalf of consumers who suffered bleeding complications, blood clots, or other injuries as an alleged result of using Xarelto. In addition to providing free case reviews, we also want to provide the following information for Xarelto users who have heard about problems with the drug and want to learn more.


What Dangerous Side Effects are Associated with Xarelto?

Anticoagulants work by inhibiting the body’s ability to form blood clots. Because of this, all anticoagulants can cause bleeding that, in rare cases, may lead to death.

There have been reported cases of Xarelto not performing its intended anti-blood clotting function and leading to thromboembolism in post-surgical patients. More commonly, the dangerous side effects associated with Xarelto relate to the drug’s ability to cause uncontrolled bleeding. This may result in:

  • Internal bleeding
  • Wound infection and complication
  • Intracranial hemorrhaging
  • Abdominal bleeding
  • Excessive blood loss
  • Eye bleeding

Studies have been published which support allegations of Xarelto’s alleged bleeding risks. These studies include:

  • A 2015 study in the British Medical Journal that found, compared to warfarin, Xarelto users have a twofold higher risk of gastrointestinal bleeding.
  • A 2015 study in JAMA Ophthalmology links Xarelto with spontaneous vitreous hemorrhage (eye hemorrhage).
  • A 2012 AAOS study as well as a 2012 study published in the Journal of Bone & Joint Surgery, concluded that joint replacement patients receiving Xarelto had a significantly higher wound complication rate than patients receiving other types of anticoagulant.

Is Xarelto More Dangerous Than Other Anti-Clotting Drugs?

Warfarin was the industry-standard anticoagulant from the 1950s until just a few years ago, when a new class of anticoagulants that includes Xarelto was introduced. As noted, all anticoagulants, because they disturb the body’s natural blood-clotting mechanism, can cause uncontrolled bleeding. Xarelto is unexceptional in this regard.

Drugs like Xarelto, however, unlike warfarin, do not have a “reversing agent” that can stop uncontrolled patient bleeding. When Xarelto users do experience bleeding events, their doctor can do little or nothing to alleviate it. In this regard, Xarelto is much more dangerous than warfarin.

Xarelto also is marketed as more convenient for patients than warfarin because it does not require regular visits to the doctor for blood tests. A simple blood test, however, can help doctors identify potential drug complications that may lead to uncontrolled bleeding. While not requiring blood tests may be more convenient for patients, a blood test may prevent dangerous bleeding and is an important safety precaution.

If Xarelto Isn’t Safer or More Effective Than Alternatives, Why is it Sold?

New generations of drugs are typically touted as being more effective or safer than older drugs. Although if Xarelto is not superior in effect or safety than warfarin, it begs the question of why it is on the market at all.

As usual, it pays to follow the money. The global anticoagulant market is worth roughly $10 billion per year. The annual cost of warfarin to a patient is about $300. The annual cost of Xarelto a patient is around $3,000. In 2014 alone, Xarelto brought in $1.5 billion in U.S. sales and captured 15% of the U.S. anticoagulant market. One expert estimate that Xarelto has penetrated one-third of the warfarin market.

Since Xarelto was initially approved by the FDA in 2011 for deep vein thrombosis, J&J/Bayer have steadily sought to increase Xarelto prescriptions by seeking FDA approval for a variety of blood clot related treatment purposes. Through direct-to-consumer ads, the drugmakers have promised Xarelto users significant improvements to their health and lifestyle. But the companies may have played up the drug’s benefits while failing to minimize its risks.

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