Recently, the British Medical Journal (BMJ) published a report regarding a clinical trial that resulted in FDA approval of the anticoagulant medication Xarelto.
Allegations that Johnson & Johnson and Bayer Hid KnowledgeBellwether trials began in late April against the makers of anticoagulant Xarelto, charging failure to warn of its side effects and lack of an antidote.Michigan Xarelto Lawyer: Reports about the accuracy of a blood-testing device used during clinical trials have fueled concerns about Xarelto safety.FDA investigators find evidence of misconduct in Xarelto clinical trials, as more patients continue to file lawsuits over Xarelto bleeding problems.
Xarelto Lawsuit Plaintiffs Await Results Of Investigation
Xarelto Lawsuit - Xarelto Lawyers and Free Lawsuit Evaluations
Perceived shortcomings of clinical data used to approve the blood thinner Xarelto could take center stage in bellwether trials scheduled for early 2017.It is most commonly prescribed to reduce the risk of blood clots and strokes among patients with atrial fibrillation or following hip or knee replacement surgery.
Xarelto Clinical Trial Mishap Could Sway Jury in
J&J/Bayer’s Xarelto Prevents Blood Clotting Better than
Xarelto Clinical Trial Data Questioned Due to Use of Faulty Device.
Validity of Xarelto Clinical Trials as a Point of ContentionDecember 1, 2015 — Concerns have been raised about the integrity of data from the ROCKET-AF clinical trial, which compared Xarelto to warfarin, after investigators.However, in December 2014 there was an INRatio recall after it was discovered that some of the devices could return results that were falsely low.Validity of Xarelto Clinical Trials as a Point of Contention Aug 31, 2016 Currently, there are more than 800 Xarelto lawsuits pending in Philadelphia.
Xarelto cited in clinical trial 'misconduct' report
Problems with Xarelto, Pradaxa and Eliquis have been reported due to the lack of an antidote for any of the medications at the times they were released, often leaving doctors helpless to stop bleeds that may develop among users of the blood thinners.U.K. Health Agency Echoes FDA Warning of Amputation Risk with Invokana.A report on clinical trial misconduct suggests Xarelto bleeding complications may have been falsified, as an early study on the drug had major issues.Plaintiffs allegedly suffered gastrointestinal bleeding among other side effects.A third member of this new class is Eliquis, and all three medications have been aggressively promoted in direct-to-consumer advertisements in recent years.Xarelto Clinical Trial Issue May Lead To Dosage Level Testing For All New Oral Anticogaulant Drugs.
Xarelto promised fewer restrictions than the older blood thinner warfarin.The Duke researchers told a peer reviewer that comparative data did not exist, though they later explained that they answered this way because of how the question was worded.
The New York Times reports that control data collected at an independent laboratory could potentially have shown the inaccuracy of the device, but this information was not shared with the NEJM.Because of the faulty testing device, patients taking warfarin, the comparison drug, may have gotten an incorrect dose, making warfarin seem less effective than Xarelto.Side Effects of Xarelto May Increase Risk of Uncontrollable Bleeding.
Andexanet alfa: FXa Inhibitor Antidote - PortolaIn a report published in The BMJ (subscription required) on December 3, researchers warns that a defective device used during the clinical trials may have led to an underestimation of the rate of Xarelto bleeding complications.
Did A Faulty Blood Monitor Affect The Outcome of theFDA Launches Investigation into Xarelto Clinical Trials After Reports that Blood-Detecting Device Malfunctioned During Tests.Other types of bleeding events reported among XARELTO users in clinical trials are: Intraocular (eye) Pericardial (tissue surrounding the heart).
However, additional cases continue to be filed by individuals who have suffered injuries since the date of the settlement.The widely used oral blood thinner, Xarelto (rivaroxaban) showed its potential in cutting down the risk of recurrence of severe life-risking blood clots. Xarelto.Xarelto (rivaroxaban) was approved as a treatment to prevent blood clots in people with pulmonary embolisms, deep vein thrombosis, and in patients at risk for clots after hip and knee replacement surgeries.
Researchers hid clinical trial evidence of Xarelto sideOriginal Article from The New England Journal of Medicine — Oral Rivaroxaban for Symptomatic Venous Thromboembolism.Portola Pharmaceuticals has said it expects to present a Xarelto reversal agent for approval this month.
Xarelto Trials Suspected of Using Faulty Blood Clot
New findings reveal potential defects in the Xarelto clinical trials.