The anticoagulant drug Xarelto represents a new class of blood thinning medications meant to replace Coumadin and warfarin. With claims of fewer side effects and easier prescribing restrictions for patients, the joint effort from Bayer and Johnson & Johnson has already surpassed competitors Eliquis and Pradaxa with over $1 billion in sales.
However, the advent of these next-generation blood thinners hasn’t been all positive. Experts have weighed in with warnings that they may cause more serious internal bleeding risks than warfarin since there isn’t yet an antidote for severe hemorrhaging.
Consumer watchdog groups tracking adverse event reports to the FDA have noted thousands of patient complications, and several hundred deaths filed with the agency.
And now, with the number of lawsuits alleging internal bleeding hospitalization from Xarelto on the rise around the country, lawyers have asked that cases be moved to a special drug injury federal court.
Judicial Panel for Multidistrict Litigation reports over 13,700 Xarelto lawsuits pending in Louisiana federal court alleging internal bleeding.
American Medical Assoc. study finds patients taking Xarelto had higher rates of internal bleeding and death than those taking Pradaxa.
Patient-Centered Outcomes Research Institute announces $6.5 million study to compare the safety of Xarelto, Pradaxa, Eliquis and Coumadin.
Institute for Safe Medication Practices names Xarelto the most dangerous drug in the U.S., with over 10,000 complications reported to the FDA in 2015.
Cambridge, Massachusetts study suggests competitor Savaysa may be more cost effective than Xarelto.
New York Times report suggests Xarelto makers may have concealed data that measuring device used during clinical trials was defective.
Duke University study shows internal bleeding incidents among Xarelto patients rose with the number of medications taken.
Judicial Panel on Multidistrict Litigation reports 2,826 internal bleeding lawsuits now pending in Xarelto MDL court.
Philladelphia judge creates second mass tort court for victims suffering internal bleeding after using Xarelto.
U.S. based Portola Pharmaceuticals announces positive test results for its new drug andexanet alfa as a possible bleeding antidote for Xarelto.
Study finds doctors were paid nearly $20 million to promote blood thinner drugs like Xarelto in just the last 5 months of 2013.
JPML signs order consolidating Xarelto bleeding lawsuits to U.S. District Judge Eldon E. Fallon in the Eastern District Federal Court of Louisiana.
Researchers from the University of Tel Aviv confirm Xarelto may have greater risks for intestinal bleeding than warfarin.
Xarelto named among the top-5 fastest-growing drugs on the market
Johnson & Johnson fights the consolidation of Xarelto bleeding lawsuits, claiming it will lead to more cases.
Swiss researchers at the University of Basel establish a link between Xarelto use and liver damage.
13,500 bottles of Xarelto are recalled by Johnson & Johnson and the FDA due to microbial contamination concerns FDA Enforcement Report.
Sales of Xarelto top $1 billion for 2014. Johnson & Johnson Reports 2014 Third-Quarter Results.
Lawyers representing at least 21 patients and families in over 10 states file petition to consolidate growing Xarelto lawsuits into specialized federal pharmaceutical injury court in Southern District of Illinois.
Bayer admits it now faces at least 10 lawsuits in the United States alleging internal bleeding injury or death from Xarelto.
Boehringer Ingelheim, maker of Xarelto competitor Pradaxa, announces it will pay $650 million to settle over 3,500 lawsuits alleging internal bleeding.
First lawsuit filed by family of patient alleging bleeding death from Xarelto.
Journal of the American Medical Association reports study suggesting blood thinners like Xarelto can double the risk of bleeding when taken with a non-steroidal anti-inflammatory or aspirin for pain or headache.
The FDA votes unanimously against approving Xarelto for acute coronary syndrome (sudden blockage of blood to the heart).
Findings presented at the American Heart Association 2013 Scientific Sessions suggest Xarelto causes three times higher risk of internal bleeding in acutely ill patients and four times higher risk of internal bleeding in patients with acute coronary syndrome (ACS).
Anticoagulants including Xarelto ranked among the most dangerous drugs on the market by the Institute for Safe Medication Practices. Xarelto alone ranks 10th for side effects reported to FDA.
German newspaper Der Speigel reports that German health officials have received 968 reports of adverse events involving Xarelto in the first eight months of 2013, including 72 deaths.
Bayer and Johnson & Johnson report joint sales of Xarelto of $827 million for first half of 2013.
Report in GastroJournal suggests newer anticoagulants like rivaroxaban (Xarelto) carry a 48% higher risk of gastrointestinal bleeding than standard care.
FDA MedWatch adverse event recordings show 593 reports of bleeding linked to Xarelto by the end of 2012.
Reuters publishes report showing first sign doctors are concerned with Xarelto bleeding safety.
Xarelto approved by the FDA to prevent blood clots and resulting strokes in patients with the heart condition atrial fibrillation.
Report in AHA Circulation Journal shows researchers searching for antidote for Xarelto internal bleeding. Prothrombin found to be possible agent.
The FDA approves Xarelto for sale in the United States to prevent deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients that have undergone hip or knee replacement surgery.
Xarelto approved by Health Canada to prevent venous thromboembolism (blood clots) in patients who have undergone hip or knee replacement surgery.