Xarelto Lawsuit: Uncontrolled Bleeding

Basis of Xarelto Lawsuit

The Xarelto lawsuit is against the manufacturers for releasing a drug that increasing the risk of uncontrolled bleeding, when safer alternative anticoagulants were already on the market. Prior to Xarelto entering the stream of commerce, Coumadin (warfarin) was the the go to anticoagulant. Unlike Coumadin, Xarelto does not have a reversal agent if the patient begins to experience a bleed. Coumadin’s anti-coagulant effects are able to be quickly reversed by the administration of vitamin K. The manufacturers of Xarelto launched the drug knowing it had no reversal agent. A reversal agent for Xarelto has been in development for years, but the manufacturers pushed Xarelto to the market early to corner the entire market. The manufacturers market Xarelto as a once daily pill, when Xarelto is safer to take at a smaller dose twice a day. Additionally, regular blood test to ensure that the patient is not at risk of bleeding is not recommended with Xarelto. Our Xarelto lawyers believe that these are marketing gimmicks, designed to entice patients to switch off of Coumadin, which requires frequent blood test.

Status of Xarelto Lawsuits

All Xarelto cases filed in Federal court nationwide were consolidated into multi-district litigation (MDL) 2592 on December 12, 2014. The Xarelto MDL, officially titled the “Xarelto (Rivaroxaban) Products Liability Litigation” is in front Judge Eldon E. Fallon in the United States District Court for the District of Louisiana (New Orleans). There have been over 18,000 cases filed into the Xarelto MDL, which makes the Xarelto MDL the second largest currently active MDL. Additionally, another 1,500 Xarelto cases are pending in a consolidated action in a Philadelphia, Pennsylvania court in front of Judge Arnold L. New.

About Xarelto

Xarelto, also known by its chemical name rivaroxaban, was developed and manufactured by Bayer and Janssen Pharmaceuticals. On July 1, 2011, Xarelto was approved by the United States Food and Drug  Administration (FDA) for the treatment of deep vein thrombosis in patients undergoing knee or hip replacement surgery. On November 4, 2011, the FDA expanded the scope of use for Xarelto, allowing it to be prescribed to prevent stroke in people with common types of abnormal heart rhythms. Xarelto then underwent a fast-track regulatory review by the FDA, and on November 2, 2012, the FDA approved Xarelto for the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The potential market for Xarelto drastically expanded after the FDA approved it for the treatment of DVT and PE, and to reduce the recurrence of such events.

Xarelto Side Effect: Internal Bleeding

Gastrointestinal Bleeding

Xarelto has been associated with an increased risk of gastrointestinal (GI) bleeding. A GI bleed is a serious medical condition that can result in the patient bleeding out and dying. There is no reversal agent or quick way to stop a patient on Xarelto who is experiencing a gastrointestinal bleed. It is quick and easy to reverse other anticoagulants, such as Coumadin. With Coumadin, the administration of a vitamin K shot is all that’s needed to quickly reverse the drugs effect and enable the blood to clot. Signs of a GI bleed include stomach pain, dark tarry stools, and fatigue. Seek medical treatment immediately if you are taking Xarelto and suspect that you are experiencing a GI bleed.

Intracranial Hemorrhage

Xarelto has also been associated with an increased risk of intracranial hemorrhage, or brain bleeds. Intracranial hemorrhages are rare, but potentially fatal events. Signs of an intracranial hemorrhage include sudden severe headaches, confusion, drowsiness, vomiting, and seizures. Immediate medical treatment is necessary to prevent the patient from slipping into a coma or even death. Again, the blood thinning effect of Xarelto can not be reversed, which is especially problematic in situations such as a brain bleed.

What are other anticoagulants that are similar to Xarelto?

Now that Xarelto is raising concerns on the market, many doctors are turning to the trusted Warfarin. Warfarin is commonly used in patients with AF and has been on the public market for over 50 years. Unlike Xarelto, Warfarin has an antidote if patients need it as well as requires patient’s platelet levels to be monitored. The New England Journal of Medicine published results from their 2011 “ROCKET AF” study that compared the effectiveness of Xarelto against the effectiveness of Warfarin and found that there is not a significant difference in the two prescription drugs. If you or a loved one has experienced life threatening side effects after taking Xarelto for an extended period of time, pick up a phone and contact the Hollis Law Firm to determine if you qualify for a Xarelto claim.

Scientific Articles on Xarelto

Oct 2017: Spontaneous Spinal Epidural Hematoma in a Patient on Rivaroxaban: Case Report and Literature Review

A case report of a 72-year old on Xarelto who presented with a 4-day history of non-traumatic back pain. While in the emergency department, the patient “developed lower-extremity weakness and numbness, followed by urinary incontinence.” Imaging revealed the patient was suffering from a spinal hematoma. The authors note that this potential Xarelto side effect is important to be aware of, because early recognition and surgical intervention for spinal hematomas are key to a favorable outcome.

Dec 2016: Direct Comparison of Dabigatran, Rivaroxaban, and Apixaban for Effectiveness and Safety in Nonvalvular Atrial Fibrillation

A large US administrative claims data base was evaluated for patients with nonvalvular atrial fibrillation who were taking Pradaxa, Xarelto, or Eliquis from 2010 to 2015. Out of the three anticoagulants, Xarelto was associated with an increased risk of major bleeding and intracranial bleeding.

Sept 2016: A Nationwide Registry Study to Compare Bleeding Rates in patients with Atrial Fibrillation Being Prescribed Oral Anticoagulants

A search of the Norwegian patient registry and Norwegian prescription database identified 32,675 patients with atrial fibrillation who were taking an oral anticoagulant. 11,427 of the Norwegian patients were taking Coumadin, 7,925 were on Pradaxa, 6,506 were on Xarelto, and 6,506 were taking Eliquis. Out of the four anticoagulants, Xarelto was associated with the highest risk of GI bleeding.

Jul 2016: Intracranial Subdural Hematomas with Elevated Rivaroxaban Concentration and Subsequently Detected Spinal Subdural Hematoma: A Case Report

A 79-year-old man receiving Xarelto developed an intracranial subdural hematoma. The patients Xarelto was reduced from 15 mg to 10 mg a day. Two weeks later, the patient developed bilateral intracranial subdural hematomas. The patients kidneys were noted to be impaired, with a creatinine clearance of 44 (60+ normal). Blood Xarelto levels were checked using the anti-factor Xa chromogenic assay, which revealed elevated Xarelto levels. The authors of the study believed the labs indicated that the patients Xarelto was excessively accumulating. The patient’s Xarelto was discontinued and he was started on warfarin (Coumadin). The authors opined that the “main cause of the increased concentration of rivaroxaban was believed to be his older age and low body weight.”

Jun 2016: Effectiveness and Safety of Dabigatran, Rivaroxaban, and Apixaban Versus Warfarin in Nonvalvular Atrial Fibrillation

Pradaxa (Dabigatran), Xarelto (Rivaroxaban), Eliquis (Apixaban), and Coumadin (Warfarin) were compared. Out of the four anticoagulants, Xarelto was associated with the highest risk of major bleeding events.

Jun 2016: Comparative Effectiveness and Safety of Non-Vitamin K Antagonist Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation: Propensity Weighted Nationwide Cohort Study

61,678 patients with non-valvular atrial fibrillation taking oral anticoagulants were identified across three Danish nationwide databases. 35,436 patients were taking Coumadin, 12,701 were taking Pradaxa, 7,192 were taking Xarelto, and 6,349 were taking Eliquis. Of the four anticoagulants, Xarelto had the highest risk of major bleeding events and any bleeding events.

Jun 2015: Non-Traumatic Spontaneous Spinal Subdural Hematoma in a Patient with Non-Valvular Atrial Fibrillation During Treatment with Rivaroxaban

A 69-year-old man presented with a sudden onset of excruciating upper and lower back pain after minimal movement. Soon after, the patient lost feeling in his legs and lost control of his bladder. The patient had been anticoagulated on 20 mg of Xarelto for approximately a year and a half. Imaging revealed an acute spinal subdural hematoma. The patient underwent cervical and lumbar drainage procedures for six months, but did not recover function of his bowel, bladder, or lower extremities.

Apr 2015: Efficacy and Safety of Rivaroxaban in Real-Life Patients with atrial Fibrillation

The authors note that “attention should be paid to making a correct prescription of [Xarelto], particularly in fragile patients, to reduce the risk of bleeding.”

Xarelto Lawsuit

You may have an Xarelto claim if you or a closed loved one has suffered life threatening side effects after taking Xarelto (rivaroxaban) for a long period of time. To find out if you or a loved can file a Xarelto lawsuit claim, speak to an experienced Xarelto attorney today at the Hollis Law Firm. The attorneys at the Hollis Law Firm offer free case reviews for Xarelto claims. Each case is reviewed on an individual bases. The Hollis Law Firm represents clients from Kansas and Missouri, and partners with Xarelto injury lawyers in all 50 states to provide representation to clients throughout the country. To speak to a member of the Hollis Law team about your case, please contact the Hollis Law Firm by completing a contact form or by calling 1-800-701-3672.

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