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.
Savaysa, New Factor Xa Blood Thinner, To Hit Market With Black Box Warning February 9, 2015 Irvin Jackson Add Your Comments The latest in a new generation of novel anticoaguants will be introduced this month by Daiichi Sankyo, with the brand name Savaysa. However, the drug may have difficulty competing with previously introduced members of this new class, such as Xarelto, Pradaxa and Eliquis, because it will contain a “black box” warning that patients with normal kidney functioning may filter the drug out too quickly, resulting in an increased risk of stroke. Last month the FDA approved U.S. use of Daiichi Sankyo’s oral tablet blood thinner Savaysa, which has been on the market for several years overseas under the brand name Lixiana. However, the agency is requiring a black box warning on Savaysa, which is the strongest label warning possible, indicating that the drug should not be used on patients with high functioning kidneys. The new blood thinner joins a crop of similar drugs, known as Factor Xa inhibitors, which seek to replace warfarin as the go-to drug for preventing strokes in patients with atrial fibrillation. The drugs, which include Xarelto, Pradaxa and Eliquis, are also being broadly used for other blood thinner applications, and have become a very lucrative class of medications. 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 The FDA approved Savaysa for the treatment of patients with deep vein thrombosis, pulmonary embolism and other blood clot-related problems as well. However, the FDA’s warning could significantly restrict the use of Savaysa, warning that it is inappropriate for some patient groups. “Savaysa has a Boxed Warning that provides important dosing and safety information for health care professionals about specific patient groups, including a warning that Savaysa is less effective in atrial fibrillation patients with a creatinine clearance greater than 95 milliliters per minute,” the FDA warned when it approved the drug. “Patients with creatinine clearance greater than 95 milliliters per minute have an increased risk of stroke compared to similar patients given warfarin. Savaysa should not be used in nonvalvular atrial fibrillation patients with a higher creatinine clearance. Another anticoagulant should be used instead.” Creatinine clearance levels indicate how well the kidneys are performing at filtering drugs out of the blood. It can affect both a drug’s potency and how long it stays in the body. Health experts have warned that the other blood thinners, like Xarelto and Pradaxa, may be dangerous when kidney functioning is low, resulting in a build-up in the body and an increased risk of bleeding events. Factor Xa Bleeding Concerns Concerns 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 risk of uncontrollable bleeding with the drugs, since the currently available medications have no approved reversal agents. It is unclear whether the bleeding risk also applies to Savaysa, given its lower efficacy in patients with normal kidney functions. 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 Sayasa and other members of this new class, leading to a number of reports involving serious injury or death associated with uncontrollable bleeding with those already on U.S. markets. In a press release announcing the drug’s approval, Daiichi Sankyo claims that Savaysa was associated with a 19% reduction in the risk of major bleeding events when compared to warfarin. 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. Last 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. Tags: Atrial Fibrillation, Bleeding, Blood Thinners, Daiichi Sankyo, Eliquis, Lixiana, Pradaxa, Savaysa, 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 TermNameThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Link Between Hair Relaxers and Cancer To Be Examined by Court During “Science Day” (Posted: 3 days ago) A federal judge has called for Science Day presentations to explain to the court the theories and evidence linking hair relaxer to increased cancer risks. MORE ABOUT: HAIR RELAXER LAWSUITHair Relaxer Cancer Lawsuits Continue To Be Filed as Lawyers Prepare First Cases for Trial (06/24/2025)Replacement Hair Relaxer Lawsuit To Be Selected for MDL Bellwether Pool (06/12/2025)Hair Relaxer Lawsuits and Talcum Powder Lawsuits Designated as New Mass Torts in Philadelphia (05/30/2025) Lawyers Ordered To Engage in Talcum Powder Settlement Talks in MDL (Posted: 3 days ago) A special mediator has been appointed to oversee negotiations between Johnson & Johnson and tens of thousands of women who say its talcum powder products caused them to develop reproductive system cancers. MORE ABOUT: TALCUM POWDER LAWSUITSTalcum Powder Ovarian Cancer Lawsuit Selected for First Federal Bellwether Trial (07/01/2025)Retired Talcum Powder Judge May Be Appointed To Address Renewed Expert Motions (06/20/2025)Talc Safety To Be Subject of New Independent Scientific Expert Panel Led by FDA (05/22/2025) Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (Posted: 4 days ago) A wrongful death lawsuit claims a woman’s sister died of a Depo-Provera brain tumor which was not discovered until after her death. MORE ABOUT: DEPO-PROVERA LAWSUITLawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)Ortho-Cept, Similar Birth Control Pills Linked to Intracranial Meningioma Risks, Study Warns (06/17/2025)Status of Depo-Provera Shot Lawsuits Outlined by MDL Judge (06/13/2025)
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
Link Between Hair Relaxers and Cancer To Be Examined by Court During “Science Day” (Posted: 3 days ago) A federal judge has called for Science Day presentations to explain to the court the theories and evidence linking hair relaxer to increased cancer risks. MORE ABOUT: HAIR RELAXER LAWSUITHair Relaxer Cancer Lawsuits Continue To Be Filed as Lawyers Prepare First Cases for Trial (06/24/2025)Replacement Hair Relaxer Lawsuit To Be Selected for MDL Bellwether Pool (06/12/2025)Hair Relaxer Lawsuits and Talcum Powder Lawsuits Designated as New Mass Torts in Philadelphia (05/30/2025)
Lawyers Ordered To Engage in Talcum Powder Settlement Talks in MDL (Posted: 3 days ago) A special mediator has been appointed to oversee negotiations between Johnson & Johnson and tens of thousands of women who say its talcum powder products caused them to develop reproductive system cancers. MORE ABOUT: TALCUM POWDER LAWSUITSTalcum Powder Ovarian Cancer Lawsuit Selected for First Federal Bellwether Trial (07/01/2025)Retired Talcum Powder Judge May Be Appointed To Address Renewed Expert Motions (06/20/2025)Talc Safety To Be Subject of New Independent Scientific Expert Panel Led by FDA (05/22/2025)
Depo-Provera Wrongful Death Lawsuit Blames Injections for Fatal Brain Tumor (Posted: 4 days ago) A wrongful death lawsuit claims a woman’s sister died of a Depo-Provera brain tumor which was not discovered until after her death. MORE ABOUT: DEPO-PROVERA LAWSUITLawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (06/20/2025)Ortho-Cept, Similar Birth Control Pills Linked to Intracranial Meningioma Risks, Study Warns (06/17/2025)Status of Depo-Provera Shot Lawsuits Outlined by MDL Judge (06/13/2025)