XARELTO BLEEDING RISKS AND POTENTIALLY FATAL SIDE EFFECTS 1
In 2011, a new anticoagulant drug was approved by the U.S. Food and Drug Administration (FDA). The new drug Xarelto was marketed as a more convenient alternative to blood thinning medications that were already available. Patients with atrial fibrillation, those who recently had knee or hip replacement surgery, or those who otherwise could benefit from a blood thinner may have been prescribed this medication with the promise that they could take Xarelto without monthly blood testing and with no dietary restrictions. However, as the years have passed, Xarelto has been associated with serious risks that far outweigh the potential benefits of the drug. In just four years, the FDA has issued numerous safety label updates, many individuals have been injured or killed, and many people have taken legal action against Bayer Healthcare and the Johnson & Johnson Janssen subsidiary for the harm that has been done. If you or a loved one has been harmed by Xarelto, then we encourage you to read this report. As a patient, it can be hard to get access to relevant information about your medication, but at Gray & White we believe that you have the right to have as much information as possible. Knowledge is power. We want you to know the truth about Xarelto and about your legal options. If you have questions, need immediate assistance, or if you would like to find out more about your possible Xarelto injury lawsuit, call our defective drug attorneys today at 888-450-4456. FDA Approval and History The first FDA approval of Xarelto came on July 1, 2011, when the agency approved the drug to prevent deep vein thrombosis in patients undergoing knee or hip replacement surgery. Over the next two years, the FDA also approved Xarelto for the following uses: To prevent stroke in people with atrial fibrillation (November 2011). To treat and reduce the recurrence of blood clots (November 2012). To reduce the risk of stent thrombosis in patients with acute coronary syndrome (June 2013). 1
However, during the same period the FDA also changed the safety label warnings for Xarelto numerous times. The safety label of Xarelto was amended in August 2013, January 2014, February 2014, March 2014 and December 2014. It was in January 2014 that the FDA added to the warning and precautions section of the label. The edited version warned that: There is an increased risk of bleeding for patients taking Xarelto. Any signs of bleeding should be promptly evaluated. There is no known antidote for bleeding from Xarelto. A black box warning about this risk has not been added to the Xarelto label as of May 2015. Side Effects of Xarelto Most medications have some known side effects. As an informed patient, you have to weigh the potential benefits of the medication against the potential risks. When you were first prescribed Xarelto as a blood thinner, you may have been told about the drug s benefits. Specifically, you may have been told that you would not need monthly blood monitoring and that you would not have to watch your diet. But you may not have been told about the risks. Your doctor may not have been keeping this information from you. Instead, Bayer the maker of Xarelto and Janssen the distributor of Xarelto may not have provided information about the risks to the FDA, to doctors, or to you. Yet, over the past few years as millions of patients have taken Xarelto, the following risks have been identified: Death. Stroke. Brain hemorrhage. Retinal damage and blindness. Internal bleeding. 2
These serious, and sometimes fatal, medical conditions develop when the patient taking Xarelto begins to bleed uncontrollably. If uncontrolled bleeding occurs because of Xarelto, then there is no known way to stop it. Unlike other anticoagulant medications such as warfarin, there is no antidote for uncontrolled bleeding caused by Xarelto. A patient who is bleeding uncontrollably while on warfarin, for example, may receive vitamin K to stop the bleeding. However, vitamin K is not an antidote for Xarelto and there is currently no way to stop the bleeding or prevent the harm that can result from the bleeding. Convenience Can Be Deadly Despite these risks, Xarelto is marketed as a drug of convenience. Its website promises that if you take Xarelto that you can say goodbye to warfarin s blood monitoring routine. Bayer and Janssen maintain that with Xarelto you can get the benefits of a blood thinning drug with: No regular blood monitoring. No known dietary restrictions. No frequent dosage adjustments. Many patients contend that while Bayer and Janssen told them of the potential benefits they failed to adequately warn them of the risks. Once you know of or experience the risks the benefits are negligible. True Stories of People Harmed by Xarelto In late 2014, 21 Xarelto injury cases pending in federal courts were ordered to be coordinated or consolidated as multidistrict litigation (MDL) in the Eastern District of Louisiana. The panel on multidistrict litigation found that there were facts that were individually important to each person hurt, but that certain facts about the development, manufacturing, regulatory approval, 3
labeling, and marketing of Xarelto were common to all of the Xarelto injury cases. Specifically, at issue in each case was whether Xarelto s warning label adequately informed patients and healthcare providers about: The risk of severe bleeding and other injuries. The results of certain clinical studies. The alleged need for blood monitoring. The lack of an antidote or reversal agent to counteract the effect of Xarelto. While the cases have been consolidated, it is the individuals who were harmed by Xarelto who remain important. Here are some of their stories: Cheryl Butler. Ms. Butler allegedly began taking Xarelto in 2013. In April of that year, she suffered a life-threatening gastrointestinal bleed for which there was no antidote. Ms. Butler survived the bleed, but reportedly has lasting effects from her medical emergency. She contends that she never would have taken Xarelto had she been properly warned about the potential for uncontrolled bleeds. The family of Thomas C. Dunkley. Mr. Dunkley s family alleges that he had been taking Xarelto for 10 days when he suffered a fatal brain bleed for which there was no antidote. Mr. Dunkley died on August 1, 2012. The family of William N. Packard, Jr. Mr. Packard s family alleges that he was taking Xarelto for atrial fibrillation when he suffered a subdural hemorrhage. Mr. Packard was reportedly admitted to the hospital on June 23, 2012, where doctors tried to save his life. However, his hemorrhage reportedly resulted in his death on June 28, 2012. In their legal complaint, the family alleged that his death was due to the failure to warn, a design defect, negligence, and other counts. You too have an individual story to tell. It is your life, or that of your loved one, that has been forever changed by the side effects of Xarelto. 4
What to Do If You Are Hurt by Xarelto If you have been hurt or if a loved one has died from a Xarelto side effect, then we encourage you to: Get immediate medical attention. While there is no known antidote, uncontrolled bleeding is a medical emergency for which you should seek immediate medical care. Make sure the hospital knows that you are taking Xarelto. Doctors may be able to switch your medication and to do what they can to help you during this difficult time. Educate yourself so you can make your own informed decisions. Learn about your rights, about what Bayer and Janssen could have done to prevent your injury and about what you can do now to recover from the harm done by the companies failure to adequately warn you about the side effects of Xarelto. Keep all evidence and records. This includes but is not limited to your medical records. Other records may include how long you were out of work, bills that you were unable to pay, and evidence of emotional suffering. Speak with a Xarelto injury lawyer. You are the one who suffered the physical consequences of Xarelto or the one who is suffering the devastating emotional loss of a loved one from Xarelto. However, you do not have to handle your legal recovery on your own. You have the right to get help. Talk to a Lawyer About Xarelto You may have never needed a lawyer before at least for something as important as the physical consequences you or a loved one suffered because of Xarelto. Accordingly, you may have some questions about what you should talk about with your lawyer. 5
Nothing is off limits; nothing is too embarrassing to talk about; and nothing should stop you from being honest with the attorney who wants to help you recover. We are on your side and we invite you to talk to us honestly and openly about: Side effects and physical problems. We want to know exactly how you suffered from the uncontrolled bleeding you experienced while on Xarelto. Talk to us about what it felt like and what medical care you required. Let us know exactly what your recovery period was like or how your loved one suffered physically prior to his death. The effect on your life and your family. How has your life changed since you or your loved one was hurt by Xarelto? What things can you no longer do? What emotional pain have you suffered? What you ve done to seek help. Tell us about your doctors appointments, about the friends and relatives who have come to your aid, and about the assistance you ve needed since you were hurt. Your questions. We are ready to answer all of them. We will explain how a mass tort case works, what you can expect from litigation, what you can expect from us, and what could happen at the end of your case. Our goal is to help you, and we can do that best by fully understanding the harm you ve suffered. Our No-Fee Guarantee You ve been harmed by an FDA-approved drug that you should have been able to trust. You should not have to worry about coming up with the money to pay an attorney to seek justice. At Gray & White Law, we do not get paid unless you do. Our no-fee guarantee means that we will provide you with legal services at no cost until you receive compensation for your injuries. Ready to reach out to us? Here s how: Call us toll-free: 888-450-4456. 6
Visit our website: GrayAndWhiteLaw.com Fill out the electronic quick contact form located on our website. Chat in real time with a real person by using the live chat option on our website. Stop by our law office in person, located at 713 E. Market Street in Louisville. We are ready to provide you with the free consultation you deserve and are committed to helping you recover from your injuries. 7