Xarelto® (Rivaroxaban)

Xarelto Linked to Severe Uncontrolled Internal Bleeding and Death: No Antidote Available

Xarelto®, a blood thinner that is manufactured and sold by Bayer and Janssen Pharmaceuticals, has been linked to uncontrolled bleeding that can result in serious side effects, including death. The Food and Drug Administration (FDA) has received reports of blood clots caused by abdominal bleeding, rectal bleeding, brain hemorrhage, and liver problems.

There is no current antidote that can reverse the internal bleeding that may be caused by Xarelto. Furthermore, these problems may be compounded by the manufacturer’s claims that Xarelto does not require close blood monitoring or doctor follow-ups.

What is Xarelto?

Xarelto (rivaroxaban) is a newer anti-coagulant medication which works by inhibiting a protein involved in the blood clotting process called Factor Xa. It was developed and manufactured by Bayer and is marketed in the United States by Janssen Pharmaceuticals, a unit of Johnson & Johnson.

In 2011, the FDA approved the use of Xarelto as a potentially safer alternative to warfarin for the prevention of stroke or blood clots in patients suffering from atrial fibrillation. In addition, Xarelto was approved to aid in the reduction of blood clots, deep vein thrombosis, and pulmonary embolism in patients undergoing knee or hip replacement surgery. In 2012, the FDA approved the use of Xarelto in connection with the general treatment of deep vein thrombosis or pulmonary embolism.

Unlike warfarin, which has been used for decades, Xarelto does not require frequent monitoring or changes in diet and lifestyle. Warfarin’s effects can be greatly influenced by a number of factors including other medications, diet, age, liver volume, genetics, and the amount of vitamin K ingested. Consequently, warfarin dosing may vary considerably among different patients and therefore must be tailored to each patient and frequently monitored. In contrast, Xarelto does not require significant modifications to diet or lifestyle, provides a consistent once-daily dosing for all types of patients, and as stated by the manufacturer, does not require routine coagulation monitoring.

Although Xarelto provides convenient and consistent dosing, a major concern among some physicians is that there is no antidote to stop Xarelto’s anti-coagulation effect, which could lead to life-threatening uncontrollable bleeding. In contrast, warfarin’s effects can be reversed with Vitamin K.

Another major difference between Xarelto and warfarin is cost – Xarelto costs about $3,000 a year, versus just $200 for warfarin. Xarelto is also a “blockbuster” drug which generated more than $1.3 billion in sales in 2013.

Serious Side Effects

The use of Xarelto may result in the following side effects:

  • Uncontrolled bleeding resulting in death
  • Abdominal bleeding
  • Rectal bleeding
  • Brain Hemorrhage
  • Abnormal liver function
  • Reduced platelet level
  • Hematoma

Xarelto Lawsuits Filed

Lawsuits have been filed against Bayer, Janssen Pharmaceuticals, and Johnson & Johnson alleging that the companies failed to adequately test the drug prior to marketing it, and failed to adequately warn doctors and patients about the risks of Xarelto.

Pradaxa, another anti-coagulant which was approved in 2010, a year ahead of Xarelto, also raised safety concerns about uncontrolled bleeding and led to thousands of lawsuits. Like Xarelto, Pradaxa also did not have an antidote to counteract its anti-coagulant effects. In May 2014, the manufacture of Pradaxa agreed to pay $650 million to settle about 4,000 lawsuits.

How We Can Help

The product liability lawyers at Robinson Calcagnie, Inc. are currently investigating claims on behalf of Xarelto users who have suffered serious injuries related to uncontrolled bleeding caused by Xarelto. Our firm has established a reputation throughout the country as one of the nation’s leading personal injury and product liability law firms. Our attorneys have represented thousands of clients in cases involving dangerous or defective drugs and have obtained dozens of multi-million dollar settlements, verdicts and judgments.

If you or someone you know has taken Xarelto and suffered uncontrolled bleeding or other serious injury, please don’t hesitate to call our drug injury attorneys at (888) 348-8855 or fill out an online form for a free case evaluation.