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The Xarelto Drug Lawsuit

Xarelto (rivaroxaban) is a prescription medicine used to reduce the risk of stroke and blood clots. It is an anticoagulant or blood thinner which can prevent or reduce the risk of developing a blood clot called deep vein thrombosis or DVT. Xarelto can also be used to lower the risk from blood clots in patients with atrial fibrillation, a heart rhythm disorder.

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What is Xarelto?

Rivaroxaban is an oral prescription currently marketed and sold in the United States, Canada, and Europe under the brand name Xarelto. Xarelto is an anticoagulant and is used to prevent pulmonary embolism and deep vein thrombosis after hip or knee replacement. It is also used for patients who have an increased risk of stroke from atrial fibrillation.

What is Xarelto used for?

Blood clots can be a serious concern following surgery due to the immobilization of the patient. In fact, chances of developing blood clots can increase for up to three months following surgery, necessitating the need to take a blood thinner. Although an anticoagulant does not actually thin the blood it does make it make it more difficult for it to clot. In the United States, Xarelto is currently only authorized as an anticoagulant to prevent pulmonary embolism and deep vein thrombosis after hip or knee replacement and in patients who have an increased risk of stroke from atrial fibrillation. The FDA has denied its use for patients with acute coronary syndrome (ACS).

Xarelto Usage and Statistics

The anticoagulant Xarelto is expected to have record sales this year exceeding $1 billion. Johnson & Johnson and Bayer AG have been attempting to expand the use of Xarelto for patients with acute coronary syndrome, but the FDA has rejected their proposal. Xarelto is currently used to treat ACS in more than 40 countries, excluding the United States.

How Xarelto Works

Blood contains platelets, a type of blood cell, and proteins, called clotting factors, which flow through the blood. If a person is cut or is sedentary for an extended period of time their blood flow slows allowing clotting factors and platelets to work in conjunction to form a clot by activating chemicals within the body, resulting in the formation of an enzyme called thrombin. After thrombin is formed it initiates a protein called fibrinogen to be converted into another protein called fibrin, which attaches to platelets and forms a blood clot.

Side Effects of Xarelto

  • Bleeding of the nose or gums
  • Bruising
  • Bleeding in the bladder and intestines
  • Persistent headaches
  • Dizziness
  • Itching
  • Fainting
  • Blisters
  • Muscle spasms
  • Increased fluid drainage from the surgery site
  • Vomiting blood
  • Bright red or black stool
  • Coughing up blood clots
  • Weakness
  • Red, pink, or brown urine.

Xarelto Medical Studies

Thousands of patients each year are looking for treatment for deep vein thrombosis (DVT), a formation of a blood clot in a deep vein, usually in the legs. If left untreated DVT can progress and create a potentially fatal pulmonary embolism, especially if the blood clot travels to the lungs. Clinical trials suggest that Xarelto can be a convenient treatment option for some patients, by preventing the formation of blood clots and minimizing the risk that a blood clot could become deadly. In three clinical studies called the EINSTEIN-DVT, EINSTEIN-PE and EINSTEIN-Extension the medication rivaroxaban was evaluated for the treatment of patients with acute symptomatic DVT or PE for the prevention of recurrent venous thromboembolic events. More than 8,000 patients in centers around the world were studied. The first two studies contained patients with acute, symptomatic deep vein thrombosis (EINSTEIN-DVT) or pulmonary embolism (EINSTEIN-PE). In each of the studies the patients were given oral rivaroxaban 15 mg twice-daily for the first three weeks, then they were orally given rivaroxaban 20 mg once-daily (compared with initial enoxaparin treatment followed by a vitamin K antagonist). Finally, the third study the EINSTEIN-Extension enrolled approximately 1,200 patients with symptomatic DVT or PE and compared the efficacy and safety of rivaroxaban to placebo in the secondary prevention of recurrent symptomatic venous blood clots. In the study researchers extended the preventative treatment by 6 or 12 months beyond a previously completed treatment regimen. Researchers found that “oral rivaroxaban 20 mg once-daily significantly reduced the risk of recurrent symptomatic VTE by 82% compared to placebo in patients who had been treated for a previous DVT or PE. The rate of major bleeding was low

Xarelto Black Box Warnings

  • The most common side-effect of Xarelto is increased bruising and bleeding. Medical professionals should be notified if you are taking this medication and you are scheduled for surgery, if you high blood pressure, if you have had problems with the blood vessels at the back of the eye (vascular retinopathy), if you going to have an epidural, if you have an indwelling catheter for spinal pain relief, or if you are taking any other medications which can increase your risk of bleeding (i.e. antidepressants, ibuprofen, diclofenac, antiplatelet medications, or clopidogrel). Patients should also not take Xarelto if they are pregnant or breastfeeding, they are taking any other anticoagulant medicines to treat or prevent blood clots, if they have liver disease, if they have acute coronary syndrome and have had a stroke or mini-stroke (TIA), if they have had brain or spinal surgery, if they have an artificial heart valve or they are less than 18 years of age. Patients should notify their doctor if they experience any of the following:
  • Increased signs of bruising or bleeding
  • Any signs of blood in the urine
  • Coughing up blood
  • Bleeding in the eyes
  • Bleeding in the stomach or intestines
  • Vomiting Blood
  • Passing black, tarry, or blood-stained stools.

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