901 Calle Amanecer, Suite 350, San Clemente CA

(844) 331-6700 info@lawfirm-connect.com

Xarelto

xarelto lawsuit bleeding

After Bayer released its billion dollar drug Xarelto – used to prevent blood clots – reports of internal bleeding and death rained down on the company bringing costly lawsuits with them. Patients allege that Bayer failed to warn the public adequately about possible risks while taking the drug and are fighting against Bayer to remove Xarelto from the market.

Rivaroxaban, more commonly known as Xarelto is a rookie drug to the market created to help aid with troublesome blood clots. Created by Bayer and Johnson & Johnson’s New Jersey unit – Janssen Pharmaceuticals – this drug came to the public with good intentions, but now very good reviews. Xarelto was approved by the FDA originally for use with patients undergoing hip or knee replacement surgery in hopes to lessen the risks of blood clots and in turn reducing the risk of stroke. Shortly after its release the Food and Drug Administration ratified the drug for the broad treatment of DVT or deep vein thrombosis and PE – pulmonary embolism.

Noted side effects of Xarelto have been uncontrolled bleeding and hemorrhaging. If the internal bleeding happens near a major organ such as the lungs, brain or kidneys, the normal blood flow directed to that organ is disturbed which can cause the organ to fail. While taking Xarelto, blood is also likely to pool in the body which can lead to extensive austere health risks. Due to the drugs capabilities as a blood thinner, bleeding is unlikely to stop unless the drug is flushed out of the patients systems. Xarelto is often compared to its rival, Pradaxa, manufactured through Boehringer-Ingelheim. The two drugs are similar in many ways except that Xarelto uses a protein called Factor Xa which aids in the coagulation process by preventing a secondary protein known as thrombin from being formed. Pradaxa instantaneously stops thrombin from formation without the aid of proteins.

The anticoagulant market involves drugs like Xarelto, Pradaxa and Warfarin. The differences between these drugs determine which one the patients will be prescribed with. Warfarin, the drug originally prescribed to patients costs around $200, yet it requires a change in diet, lifestyle and also regular checkups. On top of that it permits risk of hemorrhaging of the brain; for these reasons Xarelto and Pradaxa were introduced to the market. Although these drugs are universal, and patients don’t have to meet certain criteria to use them, they do however cost an extraordinary amount of $3,000 a year while also posing a possibility of hazardous side effects that have encouraged lawsuits to ensue.

Uses and Studies of Xarelto

Originally used to prevent blood clots after hip or knee replacement surgery. Then used at general anticoagulant also aiding in irregular heartbeats (atrial fibrillation).
Commonly compared with Warfarin, it was believed that Xarelto was more effective. However, Xarelto is more expensive, less or equal to in effectiveness and causes more internal bleeding.
Xarelto carries no antidote like Warfarin and carries dangers like uncontrolled and inexorable bleeding.

Side effects and risks of taking Xarelto include

  • Uncontrolled internal bleeding
  • Liver failure
  • Brain hemorrhaging
  • Decreased platelet levels
  • Paralysis in patients receiving spinal injections or surgery and in those who take aspirin and ibuprofen

The Phase III Study

During this trial period, various volunteers took at least a single dose of Xarelto. Out of 16,041 people, 73% of them experienced side effects like anemia and bleeding. Participants who took a higher does had an increased chance of bleeding.

Drugs with adverse reactions while taking Xarelto
Carbamazepine Indinavir
Itraconazole Ketoconazole
Phenobarbital Phentoin
Rifampin Ritonavir
Lopinavir St. John’s Wort

Participants of the study not only experienced bleeding side effects but also rectal bleeding, hemorrhaging of the eye, bruising, muscle pain, vomiting and dizziness among others.

Lawsuits Concerning Xarelto

Loved ones and patients who have experience the side effects the Xarelto are suing Bayer and Johnson & Johnson for compensation from medical costs, injuries and emotional suffering. Pradaxa itself has already encountered thousands of lawsuits against its maker due to uncontrolled bleeding and even death. Boehringer-Ingelheim – creater of Pradaxa – has already paid $650 million to settle 4,000 claims.

The public is screaming out against Bayer and Johnson & Johnson for the drug Xarelto claiming that the manufacturers knew of the drugs’ safety hazards yet sold it on the market against protocol and without warning patients and doctors. Many patients were forced to be hospitalized due to uncontrolled bleeding and other side effects that have caused severe disturbance in their lives. If you have taken Xarelto and experienced dangerous side effects, you are not alone in your attempt to attain compensation.

Sources:

Pierson, R. (2012, June 14). Insight: Top heart doctors fret over new blood thinners. Reuters. Retrieved from http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614

Ansell, J. (2007). Factor Xa or thrombin: is factors Xa a better target? Journal of Thrombosis and Heamostasis, 5 (Suppl. 1): 60–4. U.S. Food and Drug Administration. (2012, November 2). FDA expands use of Xarelto to treat, reduce recurrence of blood clots. Press release. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm

Nguyen, A. (2012, May 29). Advisory panel recommends against anticoagulant drug approval. Wolters Kluwer Law and Health. Retrieved from http://health.wolterskluwerlb.com/2012/05/advisory-panel-recommends-against-anticoagulant-drug-approval/

EMC. (2012). Xarelto 10 mg film-coated tablets. Retrieved from http://www.medicines.org.uk/emc/medicine/21265/SPC/Xarelto+10+mg+film-coated+tablets/#UNDESIRABLE_EFFECTS

Freeman, D. (2011, November 4). Xarelto okayed by FDA for treating atrial fibrillation. CBS News. Retrieved from http://www.cbsnews.com/news/xarelto-okayed-by-fda-for-treating-atrial-fibrillation/

Janssen Pharmaceuticals. (2012). Xarelto. Retrieved from https://www.xarelto-us.com/

Leave a Reply

Your email address will not be published. Required fields are marked *