Are You Considering Filing a Xarelto Lawsuit?

Our Xarelto lawsuit lawyers are pursuing cases where Xarelto users have suffered injuries such as pulmonary embolism, deep vein thrombosis, gastrointestinal hemorrhage and hemorrhage and death. There is no minimum exposure to Xarelto required. If this describes you or a family member, contact us for a free consultation and speak to a lawyer who can help you today.

Anticoagulant drugs like Xarelto (also known as rivaroxaban) are a high-risk treatment and cause bleeding in approximately 15% of patients with atrial fibrillation exposed for a year. There is an increasing number of serious adverse event reports reported to the FDA with both Xarelto and a similar drug called Pradaxa. Both are associated with serious and sometimes deadly bleeding events. Xarelto (rivaroxaban) adverse events reported continue to increase as the number of people being prescribed Xarelto increases. There are close to 4 million annual prescriptions being issued so it is no surprise that the number of harmful events are on the rise. In the past few years it is Pradaxa (dabigatran) that was being watched closely because of the related side effects but now Xarelto has more bleeding events reported as more people are being treated with the drug. Total dispensed outpatient prescriptions for Xarelto has jumped up to nearly 1 million prescriptions per quarter while Pradaxa use has declined since it peaked in 2012. According to IMs Health, Inc. Institute for Safe MEdicaiton Practices, rivaroxaban prescriptions outnumbered dabigatran by almost 2 to 1.

According to the Newly published data also show that the bleeding risks of dabigatran could be substantially reduced if two therapeutic options available in most advanced countries were approved in the United States. Those options are a lower, 110 mg twice daily (BID) dose, and a laboratory test capable of identifying patients who need a dose adjustment because the effect on thrombin inhibition is either excessive, increasing the risk of severe bleeding, or sub-therapeutic, exposing the patient to a higher risk of stroke or other blood-clot related adverse event. ISMP has explained the need for the FDA to make these options available in its February 13, 2014, newsletter, the ISMP Medication Safety Alert! Acute Care edition.

What are the most common Xarelto adverse events reported to the FDA?

Xarelto adverse events graph

Embolism And Thrombosis 788 (8.04%)
Pulmonary Vascular 643 (6.56%)
Central Nervous System Vascular 525 (5.35%)
Gastrointestinal Hemorrhages 495 (5.05%)
Hematology Investigations 423 (4.31%)
Vascular Hemorrhagic 379 (3.86%)
Injuries 336 (3.43%)
Gastrointestinal Signs 317 (3.23%)
Neurological 277 (2.82%)
Hepatobiliary 214 (2.18%)
Epidermal And Dermal Conditions 213 (2.17%)
Respiratory 209 (2.13%)
Procedural And Device Related Injur… 205 (2.09%)
Infections – Pathogen Unspecified 176 (1.79%)
Hepatic And Hepatobiliary 163 (1.66%)
Anemias Nonhemolytic And Marrow Dep… 160 (1.63%)
Renal Disorders 145 (1.48%)
Medication Errors 130 (1.33%)
Cardiac Arrhythmias 129 (1.32%)
Joint 128 (1.31%)
Renal And Urinary Tract Investigati… 127 (1.3%)
Urinary Tract Signs 116 (1.18%)
Therapeutic And Nontherapeutic Effe… 114 (1.16%)
Fatal Outcomes 107 (1.09%)
Decreased And Nonspecific Blood Pre… 103 (1.05%)
Headaches 103 (1.05%)
Gastrointestinal Ulceration And Per… 99 (1.01%)
Upper Respiratory Tract Disorders 91 (.93%)
Musculoskeletal And Connective Tiss… 87 (.89%)
Cardiac And Vascular Investigations 83 (.85%)
Pericardial 83 (.85%)
Coronary Artery 78 (.8%)
Gastrointestinal Motility And Defec… 73 (.74%)
Therapeutic Procedures And Supporti… 66 (.67%)
Appetite And General Nutritional 57 (.58%)
Skin Vascular Abnormalities 57 (.58%)
Muscle 52 (.53%)
Movement Disorders 51 (.52%)
Platelet 50 (.51%)
Disturbances In Thinking 47 (.48%)
Oral Soft Tissue Conditions 42 (.43%)
Heart Failures 41 (.42%)
Bone And Joint Injuries 39 (.4%)
Gastrointestinal Inflammatory Condi… 39 (.4%)
Anxiety Disorders 38 (.39%)
Electrolyte And Fluid Balance Condi… 34 (.35%)
Bacterial Infectious 33 (.34%)
Cardiac Disorder Signs 31 (.32%)
Enzyme 31 (.32%)
Tissue 31 (.32%)
Angiedema And Urticaria 30 (.31%)
Deliria 30 (.31%)
Seizures 30 (.31%)
Sleep Disorders 30 (.31%)
Lower Respiratory Tract Disorders 29 (.3%)
Allergic Conditions 28 (.29%)
Body Temperature Conditions 27 (.28%)
Dental And Gingival Conditions 27 (.28%)
Hematological And Lymphoid Tissue T… 27 (.28%)
Lifestyle Issues 26 (.27%)
Physical Examination Topics 26 (.27%)
Vascular Hypertensive 26 (.27%)
Gastrointestinal Vascular Condition… 25 (.25%)
Vision 25 (.25%)
Gastrointestinal 24 (.24%)
Pleural 24 (.24%)
Ocular Hemorrhages And Vascular 23 (.23%)
Cardiac Therapeutic Procedures 21 (.21%)
Tongue Conditions 21 (.21%)
Coagulopathies And Bleeding Diathes… 20 (.2%)
Gastrointestinal Neoplasms Malignan… 20 (.2%)
Skin Appendage Conditions 19 (.19%)
Water, Electrolyte And Mineral 18 (.18%)
Adrenal Gland 17 (.17%)
Gastrointestinal Conditions 17 (.17%)
Inner Ear And Viiith Cranial Nerve 16 (.16%)
Menstrual Cycle And Uterine Bleedin… 16 (.16%)
Vascular Inflammations 16 (.16%)
Bone And Joint Therapeutic Procedur… 15 (.15%)
Product Quality Issues 14 (.14%)
Respiratory And Mediastinal Neoplas… 14 (.14%)
Bladder And Bladder Neck Disorders 13 (.13%)
Gastrointestinal Stenosis And Obstr… 13 (.13%)
Arteriosclerosis, Stenosis, Vascula… 12 (.12%)
Diverticular 12 (.12%)
Eating Disorders 12 (.12%)
Mental Impairment 12 (.12%)
Bronchial Disorders 11 (.11%)
Metabolic, Nutritional And Blood Ga… 11 (.11%)
Protein And Chemistry Analyses 11 (.11%)
Eye 10 (.1%)
Glucose Metabolism Disorders 10 (.1%)
Vascular 10 (.1%)
Vulvovaginal Disorders 10 (.1%)
Anal And Rectal Conditions 9 (.09%)
Cardiac And Vascular Disorders Cong… 9 (.09%)
Encephalopathies 9 (.09%)
Neurological Disorders Of The Eye 9 (.09%)
Peritoneal And Retroperitoneal Cond… 9 (.09%)
Sleep Disturbances 9 (.09%)
Spinal Cord And Nerve Root 9 (.09%)

 

 

About Xarelto

Xarelto (rivaroxaban) is a newer prescription drug that came on the market in 2011. Xarelto is an anticoagulant (blood thinner) medication used to reduce the risk of blood clot leading to stroke in those with irregular heartbeat (a condition called atrial fibrillation, or AF). This medication may also be prescribed to treat deep vein thrombosis (blood clots deep in the vein) and pulmonary embolism (a blockage in an artery in the lung).

Deep vein thrombosis (DVT) is a dangerous condition that typically occurs in the larger veins of the leg or thigh. When clots break loose, they can travel through your bloodstream to other smaller veins and become lodged in the lungs (called a pulmonary embolism, or PE), heart, or other vital areas. This blockage of blood flow can result in severe damage to the organ or may even result in death.

In 2012, the FDA expanded the approved use of Xarelto. While it was already being used to treat the prevention of AF, DVT, and PE, as well as venous blood clots after knee or hip replacement surgery, this new expansion would increase its use for the treatment and reduction of the recurrence of blood clots following initial treatment.

While there have been a number of drugs on the market over the years that have been used to treat these conditions, including Coumadin (Warfarin), Pradaxa (Dabigatran), and Eliquis (Apixaban), Xarelto is currently the mostly widely prescribed drug in this class, despite the fact that there are so many concerns regarding its safety. Unlike Coumadin, for example, there is no emergency antidote in the case of uncontrolled hemorrhaging or internal bleeding, which is a huge problem with such drugs.

In 2014, Xarelto Sales totaled more than $1.3 billion, and it is expected that sales will continue to climb. Sales outpaced Pradaxa two to one in 2013, with prescriptions totaling more than one million per quarter, despite the fact that so many concerns over the safety of this product have been increasing with use. Serious side effects reported in a number of those using the drug include:

  • Uncontrolled bleeding
  • Bleeding into internal organs
  • Gastrointestinal bleeding
  • Brain hemorrhaging

It is important to note that the companies that manufactures the drug, Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, are currently facing multiple lawsuits due to safety issues related to Xarelto. In 2014, over 4000 people who filed lawsuits against the manufacturers of Pradaxa, Boehringer Ingleheim, were awarded compensation for the serious side effects that drug caused, including gastrointestinal, rectal, and brain bleeding, and hundreds died as a result of its side effects. It is estimated that the damages from Xarelto will exceed that of Pradaxa, as side effect injuries appear to be even more serious.

While Xarelto cases are still in their infancy, and attorneys say it is still too soon to tell how many will hit U.S. courts, they do believe that the manufacturers have placed financial gain above the safety and wellbeing of consumers by not fully disclosing the extent of the risks associated with their drug.

 

Serious Side Effects Associated With Xarelto

A Black Box Warning has been issued for this drug for epidural/spinal hematoma risk and for use discontinuation. If you experience signs of DVT or PE you should call your doctor immediately.

Warning Signs of Deep Vein Thrombosis (DVT)

  • Pain or tenderness in the leg (may be felt only when standing or walking)
  • Swelling of the leg or along a vein in the leg
  • Increased warmth in the area of the leg where there is swelling or pain
  • Red or discolored skin

Warning Signs of Pulmonary Embolism (PE)

  • Unexplained shortness of breath
  • Problems breathing
  • Chest pain
  • Coughing
  • Coughing up blood
  • Irregular heartbeat also may suggest that you have PE

Call your doctor right away if you have any of the following serious side effects such as:

  • Easy bruising, unusual bleeding (nose, mouth, vagina, or rectum)
  • Bleeding from wounds or needle injections
  • Any bleeding that will not stop
  • Headache, dizziness, weakness, feeling like you might pass out
  • Red or pink urine
  • Black or bloody stools
  • Coughing up blood or vomit that looks like coffee grounds
  • Numbness, tingling, or muscle weakness (especially in your legs and feet)
  • Loss of movement in any part of your body (paralysis)
  • Back pain
  • Bleeding gums
  • Bloody stools
  • Bowel or bladder dysfunction
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Difficulty with breathing or swallowing
  • Dizziness
  • Headache
  • Increased menstrual flow or vaginal bleeding
  • Leg weakness
  • Nosebleeds
  • Prolonged bleeding from cuts
  • Red or black, tarry stools
  • Red or dark brown urine

Less serious side effects may include:

  • Muscle pain
  • Itching
  • Pain in arms or legs

Request a Free Xarelto Case Evaluation

If you or a family member has experienced pulmonary embolism, deep vein thrombosis, gastrointestinal hemorrhage or a loved one has died contact us today for a free consultation. There is no minimum exposure to Xarelto required. There are no upfront fees required to hire our Xarelto attorneys, you pay only if your case is successfully resolved and money is recovered on your behalf.