Andexxa Blood Clot Risks Lead to FDA Questions Regarding Safety of the Reversal Agent for Xarelto, Eliquis
Xarelto Side Effects More Likely to Result in Death than Warfarin for Afib Patients with Heart Disease: Study
Side Effects of Blood Thinners, Diabetes Drugs Are Leading Causes of ER Visits Due to Medications: Study
Sports Betting Addiction Lawsuit Sports betting addiction lawsuits are being investigated for college students and young adults who developed gambling problems after using apps like FanDuel and DraftKings, alleging that the platforms failed to warn about the addictive nature of their features and marketing practices.
Nitrous Oxide Lawsuit Individuals who suffered harm, or families who lost a loved one after using nitrous oxide products may be eligible for financial compensation through a nitrous oxide lawsuit.
Hair Relaxer Lawsuit Regular exposure to chemicals in hair relaxer may cause uterine cancer, ovarian cancer and other injuries. Women diagnosed with cancer may be eligible for settlement benefits.
Depo-Provera Lawsuit Depo-Provera lawsuits are being investigated for women who developed meningioma brain tumors after receiving Depo-Provera birth control shots, claiming that Pfizer failed to adequately disclose side effects.
Ozempic Lawsuit Lawyers are pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits over gastroparesis or stomach paralysis, which can leave users with long-term gastrointestinal side effects
Suboxone Tooth Decay Lawsuit Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.
Change Healthcare Lawsuit Lawyers are reviewing Change Healthcare class action lawsuits for individuals who had their personal information stolen due to the data breach.
Bard PowerPort Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
AngioDynamics Port Catheter Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Processed Food Lawsuit Lawsuits are being pursued against the food industry over their manufacturing and advertising of ultra-processed foods, which have caused a generation of children to face an increased risk of developing childhood diabetes and other chronic illnesses.
Approval of New Blood Thinner May Require Restrictions on Use October 30, 2014 Irvin Jackson Add Your Comments Federal drug regulators are considering approval of a new blood thinner by Daiichi Sankyo, but some indications suggest that the drug may only be good for those who suffer significant kidney problems, as it appears to work worse than existing drugs among individuals whose kidneys are healthy. The FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet today to discuss whether to recommend that the FDA approve the blood thinner Savaysa (edoxaban), a Factor Xa inhibitor that is similar to other new-generation blood thinners like Xarelto, Pradaxa and Eliquis. In briefing materials (PDF) provided ahead of the meeting, FDA reviewers warn that it looks like the drug may only work better to treat patients with atrial fibrillation when given to those with bad kidneys. The review compared the proposed drug to warfarin; the go-to atrial fibrillation blood thinner that has been on the market since the 1950s. Learn More About Xarelto Lawsuits Side Effects of Xarelto May Increase Risk of Uncontrollable Bleeding. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Xarelto Lawsuits Side Effects of Xarelto May Increase Risk of Uncontrollable Bleeding. Learn More SEE IF YOU QUALIFY FOR COMPENSATION According to the review, Savaysa, the proposed brand name of the new blood thinner, only outperforms warfarin in patients with poor renal function. Kidney function is an important metric in the use of blood thinners because the healthier the kidneys are, the better they are at filtering out the blood thinning drug, meaning that there will be less of a chance for dangerous bleeding events. In many cases, patients need to have the levels of blood thinners monitored through regular testing. The reviewers note that they see little need for the drug since it does not appear to outperform Xarelto, Pradaxa and Eliquis, which are all part of a new-class of anticoagulants designed to be easier to take than warfarin, since the manufacturers claim that patients do not require regular blood monitoring. However, the new generation of blood thinners have been linked to concerns about uncontrollable bleeding problems, since they lack a safe and effective reversal agent like warfarin has, which doctors can use to stop the blood thinning effects of the drug. “Edoxaban has no proven advantages over any of the 3 direct-acting anticoagulants approved for stroke prevention in patients with atrial fibrillation,” the reviewers wrote. While the advisory committee’s recommendations to the FDA are not binding, the agency usually weighs those recommendations considerably when making final decisions. Bleeding Concerns with Xarelto, Pradaxa, Other New Blood Thinners The anticoagulant warfarin, which is sold under the brand name Coumadin, has been the go-to blood thinner for prevention of stroke among individuals with atrial fibrillation for decades. In recent years, factor xa inhibitors like Pradaxa, Xarelto and Eliquis have been introduced by drug makers attempting to capture the lucrative anticoagulant market. However, serious concerns have emerged about the safety of the drugs, and it is unclear whether the bleeding risk with this latest proposed member of the class will be considered by the panel in determining whether to provide approval for Savaysa. While all anticoagulants carry a risk of bleeds, doctors are able to quickly reverse the blood thinning effects of warfarin with a dose of vitamin K-based prothormbin complex concentrates (PCCs) and fresh frozen plasma (FFP), which acts as an antidote to reverse the medication if bleeding problems develop. However, no such reversal agent is available for Xarelto and other members of this new class, leading to a number of reports involving serious injury or death associated with uncontrollable bleeding. Pradaxa was the first member of this new generation of drugs to be approved by the FDA in late 2010. However, shortly after it was introduced by the drug maker Boehringer Ingelheim, it quickly earned the dubious distinction as one of the most commonly cited medications in adverse event reports submitted to the FDA, often involving problems with uncontrollable hemorrhages and death. Boehringer Ingelheim subsequently faced more than 9,000 Pradaxa lawsuits filed on behalf of individuals who alleged that the drug makers failed to adequately warn about the lack of a reversal agent. Earlier this year, the drug maker agreed to pay $650 million in Pradaxa settlements to resolve the litigation, averaging about $150,000 per case. Amid concerns about the safety of Pradaxa, the second member of this class, Xarelto, increased in popularity. However, reports of bleeding complications with Xarelto have also begun to emerge, leading to a number of similar Xarelto lawsuits being filed against Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary. Many of the complaints allege that the drug makers should issue a Xarelto recall until a reversal agent can be developed, arguing that the bleeding risks outweigh any benefits provided over warfarin, which has been the go-to anticoagulation treatment for decades. All of the manufacturers of factor xa inhibitors are currently working to identify and obtain approval for an effective reversal agent, which may help increase popularity of their medication and reduce the risk of bleeding injuries and deaths. Boehringer Ingelheim recently announced that the FDA has granted “breakthrough status” to fast-track the approval process for a possible antidote to the blood thinner Pradaxa, and Bayer and Johnson & Johnson indicated last year that they are working with a company called Portola Pharmaceuticals to develop an Xarelto reversal agent. Tags: Atrial Fibrillation, Bleeding, Blood Thinners, Coumadin, Daiichi Sankyo, Eliquis, Pradaxa, Stroke, Warfarin, Xarelto More Xarelto Lawsuit Stories Andexxa Blood Clot Risks Lead to FDA Questions Regarding Safety of the Reversal Agent for Xarelto, Eliquis November 21, 2024 Xarelto Side Effects More Likely to Result in Death than Warfarin for Afib Patients with Heart Disease: Study September 1, 2022 Side Effects of Blood Thinners, Diabetes Drugs Are Leading Causes of ER Visits Due to Medications: Study October 15, 2021 0 Comments Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermEmailThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Breast Cancer Survivors File BioZorb Tissue Marker Lawsuit After Implant Fails (Posted: today) Six women have filed a joint, multiplaintiff BioZorb tissue marker lawsuit, all indicating that they suffered injuries and complications due to the recalled device’s defective design. 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Andexxa Blood Clot Risks Lead to FDA Questions Regarding Safety of the Reversal Agent for Xarelto, Eliquis November 21, 2024
Xarelto Side Effects More Likely to Result in Death than Warfarin for Afib Patients with Heart Disease: Study September 1, 2022
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Breast Cancer Survivors File BioZorb Tissue Marker Lawsuit After Implant Fails (Posted: today) Six women have filed a joint, multiplaintiff BioZorb tissue marker lawsuit, all indicating that they suffered injuries and complications due to the recalled device’s defective design. MORE ABOUT: BIOZORB LAWSUITBioZorb Implant Lawsuit Alleges Tissue Marker Caused Swelling, Fluid Buildup and Chronic Pain (05/14/2025)Four Women File BioZorb Lawsuit Over Breast Tissue Marker Failures and Injuries (05/05/2025)Lawsuit Claims BioZorb Marker Caused Chronic Pain, Multiple Surgeries After Lumpectomy (04/14/2025)
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