Xarelto (generic: rivaroxaban) is a direct factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, and to reduce the risk of stroke in people who have abnormal heart rhythm. However, the anticoagulation medication has managed to become affiliated with severe complications in just a brief stint on the U.S. market. Reports suggest that the use of Xarelto may result in severe bleeding events with potentially fatal complications.
If you or a loved one has been injured by Xarelto, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Xarelto Lawsuit Overview
Xarelto was developed and manufactured by Janssen Pharmaceuticals Inc., a subsidiary of Bayer. As a relatively new prescription medication, Xarelto was originally approved by the U.S. Food and Drug Administration (FDA) on July 1, 2011 to reduce the risk of forming a blood clot in the legs and lungs of patients who had recently undergone knee or hip replacement surgery. However, Xarelto received a subsequent approval on November 4, 2011 for its ability to reduce the risk of stroke and blood clots in patients diagnosed with atrial fibrillation.
Rivaroxaban, the active ingredient found in Xarelto, belongs to a distinct class of drugs known as direct factor Xa inhibitors. As their name suggests, direct factor Xa inhibitors are responsible for the inhibition of factor Xa, a protein that assists in the clotting of blood. The inhibition of factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi. In doing so, these distinct mechanisms of action have served as preventative measures against the formation of deep vein thrombosis, stroke, and other related complications.
Unfortunately, the pharmacodynamics of Xarelto may also be responsible for a variety of associated adverse bleeding events with varying degrees of severity. Subsequently, internal and uncontrolled bleeding have become associated with the use of Xarelto. Due to the severe nature of adverse bleeding events, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Xarelto lawsuit.
Xarelto Side Effects
During clinical development for the approved Xarelto indications, 11,598 patients were exposed to the anticoagulation medication. These included 7,111 patients who received Xarelto treatment to reduce the risk of stroke and systemic embolism in nonvalvular atrial fibrillation (ROCKET AF study) and 4,487 patients who received Xarelto treatment for prophylaxis of deep vein thrombosis following hip or knee replacement surgery. The most common adverse reactions with Xarelto were bleeding complications. However, the following is a comprehensive list of other side effects:
- Severe allergic reactions
- Difficulty breathing
- Tightness in chest
- Bloody or black stool
- Coughing up blood
- Dark urine
- Painful joints
- Symptoms of anemia
Internal bleeding occurs when damage to an artery or vein allows blood to escape the circulatory system and collect inside the body. The amount of bleeding depends upon the amount of damage to an organ and the blood vessels that supply it, as well as the body’s ability to repair breaks in the walls of the blood vessels. The repair mechanisms available include both the blood clotting system and the ability of blood vessels to go into spasm to decrease blood flow to an injured area.
However, patients who take anti-clotting medications such as Xarelto or Pradaxa may be more prone to bleeding than people who do not take these medications. These individuals may experience significant bleeding even with a relatively minor injury or illness because of the anticoagulation process exhibited by the medications. Accordingly, the body is unable to produce a blood clot in the presence of a minor injury, which can lead to severe, life-threatening internal bleeding complications.
Blood outside the circulatory system (the heart and blood vessels) is very irritating to tissues, causing inflammation and pain. In the event that significant amount of blood has been displaced, internal bleeding may result in fatal circumstances. The signs and symptoms associated with internal bleeding are directly correlated to the location of the injury and how much blood has been displaced. Signs and symptoms may include:
- Bloody bowel movements
- Blood in vomit
- Blood in urine
- Compartment syndrome
- Rigid feeling at location of injury
According to data that was presented at last years annual scientific meeting of the American College of Cardiology in New Orleans, patients with acute illnesses who took Xarelto for 35 days had more than twice the risk of bleeding when compared to that of similar medications.
The study tracked approximately 8,101 patients who had already been hospitalized with acute illnesses such as heart failure, infectious diseases, and breathing difficulty. While rivaroxaban exhibited a propensity for reduction of blood clots, the study indicated an increase in the risk of adverse bleeding events. 2.8 percent of patients taking rivaroxaban had clinically relevant bleeding after just 10 days. At 35 days, 4.1 percent of the rivaroxaban group experienced bleeding. If you or a loved one have experienced similar bleeding events after using this anticoagulation medication, you may be entitled to compensation by filing your own Xarelto lawsuit.
Do I Have a Xarelto Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Xarelto lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Xarelto, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.