Xarelto lawsuits are alleging that the manufacturer failed to warn about Xeralto’s dangerous side effects, including bloods clots, bleeding, and even stroke. Our law firm is currently working with experienced Xeralto lawyers around the country, who can file a claim on your behalf, and there are no legal fees until you receive a settlement or award. Feel free to contact us online or call us toll-free for a free (no obligation) case evaluation 24/7.
Basic Facts About the Dangers of Xeralto
Xeralto (rivaroxaban) is manufactured by Bayer but marketed by Johnson and Johnson’s subsidiary; Janssen Pharmaceuticals. It is a prescription blood thinner and one of the first “direct Xa inhibitor” taken orally. Its makers say that it is more convenient and safer than older blood thinners like Warfarin. Xarelto is an anticoagulant which means it prevents blood from clotting. These types of medicines are often used to prevent or treat deep vein thrombosis, atrial fibrillation, pulmonary embolism, stroke, and other conditions. However, there is no way to reverse the anticoagulant effect of Xarelto in the case of a major bleeding event like gastrointestinal hemorrhage, cerebral hemorrhage, or intracranial hemorrhage.
Understanding the FDA approval of Xarelto:
- In July 2011, the U.S Food and Drug Administration (FDA) approved the medicine for sale on the market initially for a limited group of people. This included people who had knee or hip replacement surgery because they were considered to be at a higher risk of blood clotting, and Xarelto could help manage that risk.
- Later that year, in November 2011, it was approved for a larger group of people. This included people with an abnormal heart rhythm, and was used in this case to prevent stroke.
- It was later approved for general treatment of deep vein thrombosis (DVT) and pulmonary embolism after a fast track regulatory review on the part of the FDA.
Over 2 million people in the United States suffer from abnormal heart rhythm and other similar conditions that are treated with anticoagulants. These people are likely to purchase a drug like Xarelto to help control their disease. This means very successful sales for the manufacturer of the blood thinner, however there have been serious concerns regarding the safety of the product.
Dangerous Side Effects:
The most dangerous side effect for people prescribed Xarelto, like all blood thinners, is uncontrollable bleeding. Blood thinning drugs have also been associated with bleeding complications. For example, Xarelto patients take the medicine either once or twice a day. The effects of the drug last 8-12 hours and the body’s Xa activity does not return to normal until after 24 hours. This means that if a patient suffers a serious bleeding event this medicine may continue to prevent normal clotting for hours. Other side effects include:
- Blood clots
- Gastrointestinal hemorrhage
- Spinal hemorrhage
- Intracranial hemorrhage
- Epidural hemorrhage
- Cerebral hemorrhage
If you have suffered serious side effects of Xarelto, then it is important that you speak with a personal injury lawyer. You may be entitled to compensation for your injuries.
Adverse Events and Medical Studies
The FDA has received a number of adverse event reports regarding Xarelto and medical studies have examined the safety of this drug.In September 2011, the New England Journal of Medicine published the ROCKET-AF study, which compared the medicine to Warfarin in patients suffering from atrial fibrillation. This was the biggest clinical trial of Xarelto, it compared the effects of the drug to the effects of a similar drug known as Warfarin in over 14,000 patients. The study concluded that “there was not significant between-group difference in the risk of major bleeding” (i).
In June 2012, an FDA advisory panel voted against approving this medicine for the treatment of acute coronary syndrome. The primary concern raised by the panel was the fact that 15% of study participants dropped out of the Phase 3 ATLAS ACS 2 TIMI 51 study. Read The New York Times article here. Later that same year, the Institute for Safe Medication Practices (ISMP) issued its QuarterWatch report based on FDA data from the first quarter of 2012. During this period, the FDA received 356 adverse event reports of Xarelto side effects including “serious, disabling, or fatal injury.” Additionally, 158 reports indicated blood clots were the serious side effect (ii). More recently, in February 2013, the New England Journal of Medicine published the results of the MAGELLAN study, which found the Xarelto may carry an increased risk of bleeding (iii).
Timeline of Xarelto Events and Lawsuits:
September 28, 2012 – There was a new study published in the Archives of Internal Medicine, that the risk of uncontrollable bleeding outweighed the benefits for several different blood thinners including Xarelto. The researchers in this study found that there was a tripled risk of bleeding among the patients who were given the drug, and no improvement in overall survival rates.
October 4, 2013 – It was reported that Xarelto was linked to as many as 968 adverse events, including 72 deaths in the year 2013. It was also associated with alarming numbers in the year 2012 with 750 adverse events including 58 deaths.
November 25, 2013 – Researchers from Medscape found this blood thinning drug is associated with a higher risk of bleeding in certain patients. Xarelto caused a nearly 3-fold increase of the risk of bleeding in “acutely ill patients” and 4-fold increased risk of major bleeding in patients that had “Acute Coronary Syndrome” (ACS).
May 7, 2014 – A wrongful death lawsuit was filed against Janseen Pharmaceuticals and Bayer involving the popular blood thinner Xarelto. The death suit was filed by Della Wise on behalf of her Aunt, Mattie Edgin who died after consuming Xarelto. She alleged that the manufacturer “fervently marketed” and “had no regard to the accuracy and misrepresentation of their misleading marketing” She also stressed in her lawsuit that unlike other blood thinners, Xarelto doesn’t have a cure to stop uncontrollable bleeding in emergency situations.
June 17, 2014 – Bayer announced that a small number of lawsuits have been filed regarding Xarelto alleging that the blood thinning drug has been linked to numerous severe bleeding events and deaths. Plaintiffs in these cases were alleging that the makers failed to adequately warn the public that the drug had no anecdote and in an emergency doctor’s will struggle to reverse the blood thinning effects.
June 26, 2014 – Another wrongful death lawsuit is filed against Janssen Pharmaceuticals by the wife of a man who bled to death after taking Xarelto. She is alleging that Johnson and Johnson failed to warn that this drug can cause uncontrollable bleeding and there is no cure. Nancy Packard filed this suit in Florida after her husband, William Packard, died. William had begun to take the blood thinner in January 2012 to treat atrial fibrillation. After taking the prescription for several months he developed uncontrollable bleeding in his brain, which contributed to his death.
July 29, 2014 – An additional wrongful death lawsuit is filed against the manufacturer of Xarelto. Ruth McGowan filed a lawsuit on behalf of her father Thomas Dunkley in Vermont. She is alleging that the makers of this medication concealed the safety risks and failed to properly test it before marketing it to the public. Dunkley was taking the blood thinner for about a month when he developed bleeding in the brain which ultimately contributed to his death.
Xarelto Compared to Pradaxa:
There were countless deaths and serious uncontrollable bleeding events linked to the popular and drug Pradaxa which is similar to Xarelto. Pradaxa is also a prescription blood thinner that has been linked to serious adverse side effects. Currently there are over 2000 pending Pradaxa lawsuits, and many victims have received compensation for their injuries after taking this medication. Xarelto may already be on the same treacherous path that Pradaxa has taken. There have already been many deaths and serious bleeding events linked to Xarelto. Just like in the Pradaxa cases, you could be entitled to compensation for your injuries.
Anyone who has been injured by Xeralto should talk to an experienced Xeralto attorney about filing a Xarelto lawsuit to receive compensation. Injuries are often caused by these types of medicines because the drug was defectively designed or the patient was not adequately warned about the drug’s dangers, like in the case of Pradaxa. The major concern with recent blood thinning medicines like Xarelto is that they have no antidote and the blood thinning effects of the drug are ultimately irreversible in emergency situations.
Do You Need Advice from a Xarelto Lawyer?
If you or a loved has been suffered serious bleeding injuries due to taking this medicine, then you should talk to an attorney about your legal options. You may be entitled to compensation for medical expenses, lost income, pain and suffering, or other losses. We work with some of the more experienced Xarelto Lawyers who handle these cases and there is no legal fee unless you receive a settlement or award. Feel free to call us toll-free anytime or submit a contact form online for a free (no obligation) case evaluation.
- (i) The New England Journal of Medicine, September 2011. http://www.nejm.org/doi/full/10.1056/NEJMoa1009638
- (ii) Institute for Safe Medication Practices, QuaterWatch, October 3, 2012. http://www.ismp.org/quarterwatch/pdfs/2012Q1.pdf
- (iii) The New England Journal of Medicine, February 2013. http://www.nejm.org/doi/full/10.1056/NEJMoa1111096