Xarelto Lawsuit | Xarelto Blood Clots | Xarelto Bleeding
Xarelto Lawsuit | Xarelto Internal Bleeding, Xarelto Gastrointestinal Bleeding (GI), Xarelto Brain Hemorrhage, Xarelto Kidney Bleeding, Xarelto DeathXarelto Bleeding | Side Effects : Internal Bleeding, Hemorrhaging, Deep Vein Thrombosis, Pulmonary Embolism
Xarelto is a blood thinner medication, similar to Pradaxa and Coumadin (warfarin), used to reduce the risk of blood clots and strokes in patients with atrial fibrillation (irregular heart rhythms) not caused by heart valve problems. Patients taking the oral anticoagulant have reported serous side effects, including internal bleeding and hemorrhaging for which there is no antidote. Additionally, Xarelto came to market in November 2011 with a black box warning from the U.S. Food & Drug Administration (FDA) that sudden discontinuation of the medication increases a patient’s risk for heart attack or stroke.
The defective drug attorneys at Alonso Krangle LLP are investigating potential Xarelto lawsuits. If you or a loved one have taken Xarelto and experienced severe bleeding, blood clots, heart attack, stroke or death, contact our law firm for a free case evaluation at 1-800-403-6191.
What is Xarelto?
Xarelto, generically known as rivaroxaban, helps patients with atrial fibrillation lower their chances of having a stroke by preventing blood clots from forming, according to the official website for Xarelto. The prescription medication also prevents blood clots from forming in patients who undergo knee or hip replacement surgery, the website further states. The blood thinner is also used in general to prevent blood clots from forming in veins deep within the body (deep vein thrombosis) and in the lungs (pulmonary embolism), according to the website. Xarelto is manufactured by Bayer and marketed in the U.S. by Janssen Pharmaceutica, a division of Johnson & Johnson. There is no antidote for rivaroxaban, and other coagulants such as dabigatran (Praxdaxa) or apixaban (Eliquis) nor is there any specific treatment with proven effectiveness for handling severe bleeding linked to these anti-clotting drugs, according to an abstract by the U.S. National Institutes of Health.
[ncbi.nlm.nih.gov/pubmed/23866358, June 22, 2013]
Xarelto Side Effects
The most commonly reported side effects of the blood thinner is uncontrolled bleeding, and severe internal bleeding. Other known complications include:
- Red, pink or brown urine
- Bright red or black stools
- Vomiting blood or vomit that looks like “coffee grounds”
- Unexpected or long-term bleeding
- Pain, swelling, or new drainage at wound sites.
In approving the prescription blood thinner in November 2011, for treating patients with atrial fibrillation, the FDA issued its most serious warning, called a “black box warning” that patients who suddenly stop taking Xarelto without are at an increased risk for stroke if the medication is not replaced by another blood thinner to prevent a blood clot from developing. The FDA further warned that epidural or spinal hematomas have occurred in patients taking Xarelto who were receiving anesthesia or undergoing spinal puncture. The hematomas could result in long-term or permanent paralysis.
[fda.gov/safety/medwatch/safetyinformation/ucm367392.htm, April 11, 2014]
[accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf, December 2011]
Clinical Study on Xarelto
The effectiveness of Xarelto was examined in a clinical study published in the September 2011 issue of the New England Journal of Medicine. The double-blind trial, called ROCKET AF, used 14,264 patients with atrial fibrillation who were at increased risk of stroke. The patients were assigned to take either a daily dose of 20 mg of rivaroxaban or a dose-adjusted warfarin blood thinner. The research found that patients who took Xarelto had a reduced risk of problems with bleeding in the brain compared to patients who took warfarin. However, rivaroxaban was shown to be “noninferior” or just as effective for preventing stroke or systemic embolism as warfarin.
[nejm.org/doi/full/10.1056/NEJMoa1009638#t=article, September 8, 2011]
Reuters reported that Germany-based Bayer AG is facing its first lawsuits in the United States over Xarelto, which is among the company’s top-selling medications. According to Reuters, Xarelto made $1.3 billion in sales in 2013. Court records indicate that a Xarelto lawsuit was filed earlier this year on behalf of a Kentucky woman who alleged that she suffered severe internal bleeding after using the blood thinner. According to the complaint, the Kentucky woman was prescribed Xarelto in July 2012 to treat atrial fibrillation, and was hospitalized six months later with severe internal and gastrointestinal bleeding. The blood-thinning lawsuit contends that Johnson & Johnson should not have sold the medication and should have known Xarelto was associated with “irreversible bleeds.” The lawsuit against Johnson & Johnson and Bayer AG was filed on February 18, 2014, in the Pennsylvania Court of Common Pleas, Philadelphia County. (Stuntebeck v. Janssen Research & Development LLC et al, Case Number 140201754)
[reuters.com/article/2014/06/14/us-bayer-suit-idUSKBN0EP0HW20140614, June 14, 2014]
Learn More About Filing An Xarelto Lawsuit
If you or someone you love suffered serious side effects, such as severe bleeding, internal bleeding, blood clots, stroke or heart attack from taking Xarelto, you may be eligible to file a Xarelto lawsuit against the manufacturer of the blood thinner. For more information on the legal options available to you or to file a Xarelto lawsuit, please contact Alonso Krangle LLP by filling out our online form or by calling us at 800-403-6191.