Xarelto Internal Bleeding Lawsuits


Our experienced dangerous drug attorneys are currently reviewing potential claims for individuals who have suffered severe and uncontrollable bleeding events while taking Xarelto.

Janssen Pharmaceuticals and Bayer Healthcare , as the manufacturers of Xarelto, had a duty to ensure the medication they sold was adequately tested and researched and to provide appropriate warnings about any potential risks, including the potential risk of uncontrolled bleeding, so consumers could make an informed decision about whether to use this medication.

Lawsuits currently pending against Bayer and Janssen allege that the use of Xarelto can lead to severe and/or fatal bleeding events because the patient’s blood does not properly clot, causing uncontrollable hemorrhaging to occur even from seemingly minor cuts. The lawsuit further alleges that the defendants did not properly warn patients about the lack of an antidote or reversal agent for Xarelto, which could result in uncontrolled bleeding.

Xarelto Dangers & Risks

Xarelto, manufactured and marketed in a joint partnership between Jansen Pharmaceuticals (a Johnson & Johnson company) and Bayer HealthCare AG, is an anticoagulant blood thinner designed to prevent the formation of blood clots. Approved by the F.D.A. in July 2011 for the prevention of a type of blood clot known as deep vein thrombosis (DVT) (a condition that commonly occurs after certain types of surgeries), the drug is also now commonly prescribed to reduce the risk of stroke in patients with a certain type of heart rhythm disorder, known as A-Fib. Xarelto belongs to a class of drugs known as factor Xa inhibitors, which also includes Pradaxa, which has also been the subject of numerous lawsuits.

The largest clinical trial conducted to date on Xarelto was ROCKET Trial (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial). This trial looked at data on over 14,000 patients and compared the use of Xarelto to warfarin, another type of anticoagulant medication. The study determined that Xarelto was no more effective than warfarin, and that the health risks associated with the drugs were similar. The most commonly reported side effect was internal bleeding, with rates similar to that of warfarin.

However, many experts have questioned the safety of Xarelto as a result of internal bleeding reports and the lack of antidote or reversal agentswhen these events do occur. The FDA gave a negative review of Xarelto for patients with atrial fibrillation (afib), citing multiple problems with the ROCKET study. The agency also requested that Janssen and Bayer conduct additional research to better understand the link between Xarelto, internal bleeding and stroke.

A November 2013 study published in Medscape identified a link between Xarelto and a nearly 3-fold increased risk of bleeding in acutely ill patients, as well as a 4-fold increased risk of major bleeding in patients diagnosed with Acute Coronary Syndrome (ACS). These findings were based on data from four dozen clinical trials involving Xarelto, Pradaxa, Eliquis, Lixiana and darexaban, all of which have been approved since 2010. The study’s authors wanted to know how these drugs performed against each other, as well as how they compared to warfarin and heparin, staple anticoagulants that have been in use for more than 50 years in the U.S.

In January 2012, Reuters reported that the U.K.’s National Institute for Health and Clinical Excellence (NICE) had refused to recommend or approve Xarelto for use in state health services until Bayer can provide more safety data on the drug.

Xarelto & Internal Bleeding

Xarelto has been linked to an increased risk for internal bleeding events. Signs and symptoms of Xarelto-induced internal bleeding may vary, depending on the location of the bleeding, but some symptoms of internal bleeding may include:

  • unusual bleeding
  • discolored urine (blood in the urine)
  • red or black-colored stool
    coughing up blood
  • vomiting blood that looks like coffee grounds
  • frequent nose bleed or gum bleeding
  • weakness and swelling in the extremities

The FDA has announced that it is currently in the process of evaluating bleeding events in patients being treated with Xarelto to determine whether the risks outweigh the benefits of the drug.

Other Xarelto Side Effects

In addition to having the potential to cause blood clots and serious internal bleeding events, Xarelto has also been associated with a number of other side effects including:

  • brain hemorrhage
  • epidural hematoma
  • gastrointestinal bleeding
  • pulmonary embolism
  • severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
  • coughing up blood
  • stiff, sore, hot, or painful joints
  • symptoms of anemia (e.g., unusual paleness, severe or persistent headache, shortness of breath, fast heartbeat, chest pain, unusual tiredness or weakness)
  • symptoms of bleeding in the brain (e.g., sudden, severe headache; one-sided weakness; vision problems; slurred speech; confusion)
  • symptoms of low blood pressure (e.g., fainting, light-headedness, severe or persistent dizziness)
  • unexplained swelling
  • unusual or prolonged bruising or bleeding
  • yellowing of the skin or eyes (jaundice)