Andexxa Blood Clot Risks Lead to FDA Questions Regarding Safety of the Reversal Agent for Xarelto, Eliquis
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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.
Pradaxa Reversal Agent Gets Expedited FDA Review Process April 27, 2015 Irvin Jackson Add Your Comments Federal drug regulators have agreed to a fast-track review process for a potential reversal agent for the blood thinner Pradaxa, which has been linked to thousands of serious and sometimes fatal injuries due to uncontrollable bleeding events. Boehringer Ingelheim, the makers of Pradaxa, announced on April 23 that the FDA has granted Priority Review to an application for a drug called idarucizumab, which may be able to rapidly stop the blood thinning effects of the anticoagulant. The decision means that the drug’s review will be accelerated and, if approved, could get to patients faster than normal for new drugs. If approved, idarucizumab would be the first reversal agent to hit the market for a new generation of oral anticoagulants used to prevent strokes in patients with atrial fibrillation. The class, which includes the blockbuster drugs Pradaxa, Xarelto, and Eliquis, has been linked to uncontrollable bleeding events because they were released without antidotes that doctors can use in the event patients suffer hemorrhages or other bleeding events. 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 drugs have been promoted as superior replacements for warfarin, indicating that they are easier to use and require less frequent blood monitoring. However, unlike warfarin, which can be quickly reversed with a dose of vitamin K and fresh frozen plasma, there are no approved reversal agents for the medications. “The FDA’s decision to grant Priority Review to the idarucizumab application is an important milestone and a step toward bringing a new innovative option in anticoagulation care to physicians and patients,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc, in the press release. “If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option for PRADAXA patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabigatran.” The FDA grants a Priority Review in cases where a drug can significantly improve the safety or effectiveness of a treatment of serious conditions. The agency gave the drug “breakthrough status” in June 2014 while the drug was going through initial testing. The announcement comes just days after Portola Pharmaceuticals announced that testing indicated that its own reversal agent, andexanet alfa, had shown to be effective in reversing the blood thinning effects of both Eliquis and Xarelto. The manufacturer said the phase 3 trials had met both primary and secondary endpoint goals. It has also been granted breakthrough status for development. Race For A Reversal Agent As the popularity of the new generation of drugs has increased, concerns have emerged about the bleeding risk of Xarelto, Pradaxa and Eliquis. Pradaxa (dabigatran) was the first member of this class to hit the market, introduced by Boehringer Ingelheim in October 2010. As the medication rose in popularity, more than 4,000 Pradaxa lawsuits were filed on behalf of former users who alleged that inadequate warnings about the lack of a reversal agent were provided for consumers and the medical community. Following several years of litigation, a Pradaxa settlement agreement was announced last year, with Boehringer Ingelheim agreeing to pay $650 million to resolve the claims for an average of about $150,000 each. Xarelto (rivaroxoaban) was introduced in 2011, as the second member of this class, and it has since grown to become the best seller of the two. Bayer and Johnson & Johnson now face a growing number of Xarelto lawsuits, which raise nearly identical allegations from former users who suffered severe bleeding problems. Eliquis (apixaban) was approved by the FDA in early 2013, and Bristol-Myers Squibb has aggressively marketed the medication in direct-to-consumer advertisements to increase use, even though it also lacks a currently approved reversal agent. To date, Elquis has not been targeted by a large number of complaints or lawsuits, but that may change as its popularity increases. The FDA also recently announced the approval of a fourth member of this class, Savaysa (edoxaban), which will be marketed by Daiichi Sankyo. The first manufacturer to get a reversal agent approved may have a significant market advantage on its competitors. Tags: Bleeding, Blood Thinners, Boehringer Ingelheim, Eliquis, Pradaxa, 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 TermPhoneThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Lawsuit Alleges Depo-Provera DMPA Injection Increases Brain Tumor Risks (Posted: 2 days ago) A Depo-Provera lawsuit blames the active ingredient, DMPA, for an increased risk of the development of brain tumors. 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