Risks of Xarelto

Xarelto 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.

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.


Xarelto Blood Clots

Although excessive bleeding events are the most commonly reported side effect associated with Xarelto, there has been increasing concern about the development of blood clots in patients who are administered Xarelto as a prophylaxis during surgical procedures. According to a report issued by the Institute for Safe Medication Practices (ISMP), of the 356 adverse events reported in the first quarter of 2012, at least 158 cases of blood clots or thromboembolic events were reported to the FDA.

Signs and symptoms of a Xarelto blood clot may include:

  • exhaustion or unexplained fatigue
  • redness, inflammation or varicose veins
  • shortness of breath
  • chest pain or pain with deep breathing
  • fever or sweats
  • dizziness or fainting
  • increased heart rate
  • unexplained cough
  • asymptomatic (no symptoms)
  • bloody mucus with worsening cough


Xarelto & Stroke

Blood clots that travel to  the brain can cause a transient ischemia attack (TIA), also known as a “mini-stroke.” . If blood flow is obstructed for more than a few seconds, the brain begins being deprived of blood and oxygen, brain cells can then die, causing permanent damage.

  • Signs and symptoms of a Xarelto stroke may include:
  • One side of the face may droop or become numb
  • Sudden numbness or weakness in an arm or a leg
  • Slurred speech or speech that is difficult to understand
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking
  • Sudden dizziness, loss of balance or coordination
  • Sudden severe headache with no known cause


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)


Contact a Xarelto Attorney Today

If you or a loved one has experienced any of the above signs or symptoms after using Xarelto, contact an experienced attorney at Bernheim Dolinsky Kelley, LLC today. We will work tirelessly to ensure you receive the compensation you are entitled to.