Xarelto Bleeding Injury Lawsuits: Frequently Asked Questions

What is Xarelto? Xarelto (Rivaroxaban) is an anticoagulant drug which many doctors are prescribing as an alternative to Warfarin, which has been used since 1954. Blood thinners are prescribed by doctors as a method of preventing blood clots. Warfarin can be more difficult for doctors to prescribe as it must be tailored to the patient’s age, weight and gender; Xarelto is prescribed in one uniform dosage. Those on Warfarin must undergo regular blood testing and must also take care to avoid certain foods and drugs as there could be serious interactions. Xarelto has no known food interactions and no regular blood testing is required. Xarelto is often used in patients who have undergone knee or hip replacement surgery in an effort to ward off blood clots.

Xarelto is also used to treat blood clots in patients who have a history of blood clots, have had a deep vein thrombosis or a pulmonary embolism. Doctors may also prescribe Xarelto for the treatment of atrial fibrillation. Unfortunately, Xarelto may have some other issues that make it a potentially dangerous drug. Unlike Warfarin, there is no known antidote to Xarelto should an uncontrolled bleeding event occur. Xarelto is manufactured by Bayer, and a subsidiary of Johnson & Johnson, Janssen Pharmaceuticals.

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What is the FDA’s Stance on Xarelto? 

Xarelto was first approved by the FDA in July, 2011. This approval was for the treatment of deep vein thrombosis in patients who had undergone hip or knee replacement surgery. Bayer applied four months later for the use of Xarelto in stroke prevention for those with abnormal heart rhythms, and was granted approval. A year later, Bayer received FDA approval to use Xarelto for treatment and reducing recurrence of blood clots. As the FDA began to receive adverse event reports, however, they were not so quick to approve the next applications by Bayer to use Xarelto to treat patients with blocked coronary arteries, for use in reduction of stent thrombosis and as an oral anticoagulant in the treatment of acute coronary syndrome.

Bayer’s last denial came at a vote of 10-1 by the Cardiovascular and Renal Drugs Advisory Committee. The safety and effectiveness of using Xarelto for acute coronary syndrome and stent thrombosis was evaluated in three clinical studies; a slightly higher number of those treated with Xarelto had recurrent episodes of DVT and PE than those taking Warfarin and Vitamin K. Even after issuing approval for Xarelto, the FDA required Janssen and Bayer to warn patients of the following potential risks:

  • If Xarelto is prematurely discontinued without the introduction of an alternative anticoagulant, the risk of thrombotic events exists.
  • If Xarelto is not taken with the evening meal, there is a potential risk of decreased efficacy.
  • Patients taking Xarelto who receive neuraxial anesthesia or undergo a spinal puncture may have a risk of epidural or spinal hematomas which can result in long-term or permanent paralysis.

What are the Dangers/Risks Associated With Xarelto?

As more and more adverse event reports have come in to the FDA, some cardiologists have been hesitant to prescribe the drug, and many believe more rigorous monitoring is necessary for patients taking Xarelto. Perhaps the primary issue associated with Xarelto is that there is no known antidote for a bleeding emergency. Of particular concern are elderly patients who could suffer a fall, receive a relatively minor wound, yet bleed excessively (to the point of death in some case) due to Xarelto. In clinical trials approximately one in 100 people taking Xarelto experienced nose bleeds, bleeding into the brain or spine, gastrointestinal bleeding, bleeding from the genitals, blood in the urine, and bleeding from eyes, skin, joints or muscles. Kidney issues, rashes, pain in the extremities, tiredness, weakness and vomiting are also seen among some of those taking Xarelto. Bleeding that is so severe it cannot be controlled.

What Side Effects are Associated With Xarelto?

Those patients taking Xarelto who have any of the following symptoms should speak to their physician immediately:
More commonly seen (yet still serious) Xarelto symptoms:

  • Upper or lower back pain
  • Bleeding gums
  • Bloody Stools
  • Tingling or “pins and needles” feeling
  • Coughing up blood or blood clots
  • Difficulty swallowing or breathing
  • Dizziness
  • Increased menstrual flow
  • Nosebleeds
  • Weakness in the legs or other extremities
  • Numbness
  • Headaches, extreme weakness or dizziness
  • Red, pink or brown urine
Less common side effects of Xarelto:
  • Pain, swelling or unusual drainage at the site of a wound
  • Fainting
  • Pain in the arms and legs
Rare side effects of those taking Xarelto:
  • Burning upon urination
  • Difficult or painful urination
Other potential side effects of Xarelto (incidence not known):
  • Blistering, peeling or loosening of the skin
  • Pain in the abdomen or abdominal swelling
  • Blurry vision
  • Chills and fever
  • Fast or irregular heartbeat
  • Dark-colored urine
  • Diarrhea
  • Hives
  • Loss of appetite
  • Puffiness of the eyelids, face, lips or tongue
  • Red skin lesions with a purple center
  • Mouth ulcers
  • Chest pains
  • Jaundice
  • Unusual tiredness, bleeding or bruising

Do I Have a Xarelto Claim?

As of this date, ten lawsuits have been filed against Bayer and Janssen Pharmaceuticals, however in 2012, 58 deaths were tied to Xarelto and in 2013, 72 deaths were attributed to Xarelto. In July, 2014, a Xarelto lawsuit was filed by the daughter of a Vermont man who suffered irreversible brain bleeding after taking Xarelto for less than ten days. That particular lawsuit notes that on June 6, 2013, Bayer and Janssen were cited by the FDA for distributing promotional materials which were false or misleading because the materials in question minimized the potential Xarelto risks. A lawsuit by a Kentucky woman alleges she nearly bled to death after taking Xarelto. This woman alleges in her lawsuit that Xarelto is an unreasonably dangerous drug and that Bayer and Janssen failed to adequately warn consumers regarding the risks of internal bleeding—which can be irreversible in some cases. If you have suffered injury after using Xarelto, you may have a valid claim against Bayer and Janssen Pharmaceuticals. Due to the statute of limitations in each state for product liability claims, it is important that you not miss your window of opportunity to make a Xarelto claim.

How Can a Xarelto Lawyer Help Me?

You may be unsure of whether you have a valid Xarelto claim or not. Speaking to a knowledgeable Xarelto attorney is crucial to determine how to proceed. Your Xarelto lawyer will thoroughly assess the specific facts of your case, then help you decide on the best course of action. The primary goal of your Xarelto attorney is to protect your rights, as well as your future. Xarelto use can, in some instances, be life-threatening, and can be responsible for paralysis, whether long-term or permanent. If you have experienced any serious side effect after taking Xarelto, you are strongly encouraged to speak to a knowledgeable Xarelto attorney about what happened to you, and have that attorney review your medical records. You could be entitled to pursue financial compensation for your medical expenses associated with your Xarelto injuries, ongoing medical expenses, lost earnings, loss of future earnings, and pain and suffering.

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