Xarelto Case Evaluation Criteria

Xarelto is a Direct Thrombin Inhibitor Anticoagulant that is used orally to reduce the risk of stroke and blood clots in people with atrial fibrillation.

FDA:

In 2011, the U.S. Food and Drug Administration (FDA) first approved Xarelto (Rivaroxoaban), indicated to reduce the risk of strokes, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and blood clots in patients who have undergone hip or knee replacement surgery. Despite at least three attempts, it has not been approved to reduce blood clots in patients with coronary artery disease.

Lawsuit Focus:

 

  • Failure to warn patients of side effects of Xarelto i.e. uncontrollable internal bleeding side effects
  • Failure to warn patients that the uncontrollable internal bleeding caused by Xarelto could not be reversed as easily as with other anticoagulants


Serious and Life-threatening Side Effects of Xarelto, including:

  • Uncontrolled bleeding events
  • Gastrointestinal Hemorrhage
  • Hematoma
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Hemoglobin Decrease
  • Cerebrovascular Accidents
  • Peripheral Edema
  • Dyspnea


Symptoms of Xarelto bleeding side effects may include:

  • Lethargy
  • Unusual bruising or bleeding
  • Pink or brown urine
  • Red or black tarry stools
  • Coughing up blood
  • Vomiting that resembles blood or looks like coffee grounds
  • Headaches
  • Bleeding from the gums
  • Frequent nose bleeds
  • Weakness and swelling in the hands, arms, lower legs, ankles or feet
  • Joint pain or swelling
  • Dizziness
  • Death

Case Evaluation Criteria:

  1. Whether the patient was prescribed Xarelto? Reason for prescription? (Non valvular Afib)
  2. Was the patient using other oral anticoagulants prior to being placed on Xarelto? (Warfarin/Coumadin, Pradaxa, Heparin, Plavix, Aspirin, NSAIDs)
  1. Did the patient have any preexisting conditions, allergies or contraindications for Xarelto?
  1. Dosage and Intake details (to be included under pharmacy log)

 

Critical Review of

  • Physician Drug Prescription Details
  • Pharmacy Dispensing Details
  • Pharmacy Refill Details
  • Details of Pharmacy Dispensing Details are taken as Confirmatory

 

  1. What was the injury due to Xarelto? (Bleeding, Adverse GI reactions, Hypersensitivity)? How did it occur? (eg. Fall resulting in bleeding)
  2. Death? Due to bleeding? Death certificate available (Y/N)
  3. When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization.
  4. Treatment/management. Any complications
  5. Follow-up visits for treatment/management of injury.
  6. Future anticoagulant therapy/type/medication name.
  7. Outcome/prognosis. Resolution of injury?
  8. Medical History of Atrial Fibrillation, Stroke, Embolism, DVT etc.
  9. Did the patient have any preexisting conditions, allergies or contraindications for Xarelto use? i.e. >75 years old, Kidney problems, internal bleeding issues

 

Specific Focus

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient took Xarelto but did not develop any injuries
  2. No Xarelto intake: Patient was given a different drug and not Xarelto. Hold case and communicate to client.
  3. Xarelto contraindicated in patient but still prescribed
  4. Any medical/surgical history, social history that could have had an effect on the injury

Missing Record Communication:

Identify and report on missing medical records/pharmacy bills

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

missing-rec