The Janssen Pharmaceutical companies of J&J today announced findings from the FDA Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety.
XARELTO® remains the most studied oral Factor Xa inhibitor in the world today with more than five million U.S. patients |
[16-January-2018] |
TITUSVILLE, N.J., Jan. 16, 2018 /PRNewswire/ -- The Janssen Pharmaceutical companies of Johnson & Johnson today announced findings from the U.S. Food and Drug Administration’s (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm XARELTO®‘s safety and effectiveness across a wide range of patients. The FDA Mini-Sentinel report also notes a lower risk of ischemic stroke was associated with the use of XARELTO® compared to warfarin and lasted throughout the more than three-year analysis. The Sentinel Initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the safety of approved and FDA-regulated medical products using existing electronic healthcare data from multiple sources. The Initiative is FDA’s response to the Food and Drug Administration Amendments Act (FDAAA), and includes the Mini- Sentinel, a working pilot project to develop an active surveillance system and complement existing methods of safety surveillance. “We’re pleased to see the Sentinel Initiative in action and that FDA’s findings are consistent with results from other independent real-world and post-marketing studies,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen Pharmaceuticals, Inc. “These FDA results yet again confirm the positive benefit-risk profile of XARELTO® across a wide range of patients.” This FDA analysis evaluated the safety of XARELTO® in people with nonvalvular atrial fibrillation (AF) who initiated XARELTO® or warfarin from November 2011 to April 2015. To examine the safety of both products, methodologies included assessing ICD-9-CM codes from inpatient claims and evaluating rates of gastrointestinal (GI) bleeding, ischemic stroke and intracranial hemorrhage in patients with AF. In its report, FDA concludes this study, “demonstrates the capability of Sentinel to conduct prospective safety monitoring with sophisticated re-usable tools and does not raise any new safety concerns regarding use of rivaroxaban.” Nearly six million Americans are diagnosed with AF, an irregular heartbeat that can lead to blood clots, stroke, heart failure and other heart-related complications. It is the most common serious heart rhythm abnormality in people over the age of 65. When a clot forms in the heart due to AF, it can travel to the brain and cause a stroke. Click to Tweet: #FDA report confirms safety and effectiveness of XARELTO® (rivaroxaban). See full PI including BOXED WARNINGS https://ctt.ec/4P4uC+ WHAT IS XARELTO®? XARELTO® (rivaroxaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke. XARELTO® is also a prescription medicine used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months. XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery. IMPORTANT SAFETY INFORMATION What is the most important information I should know about XARELTO® (rivaroxaban)?
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
Do not take XARELTO® if you:
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:
Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?” How should I take XARELTO®?
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736). Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide. Trademarks are those of their respective owners. About the Janssen Pharmaceutical Companies We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at @JanssenUS. Janssen Pharmaceuticals, Inc. is part of the Janssen Pharmaceutical Companies. Media Contact: Christina Chan Investor Relations Contacts: Lesley Fishman View original content with multimedia:http://www.prnewswire.com/news-releases/fda-mini-sentinel-assessment-confirms-safety-and-effectiveness-of--xarelto-rivaroxaban-and-its-association-with-a-lower-risk-of-ischemic-stroke-vs-warfarin-300583085.html SOURCE Janssen Pharmaceutical Companies |