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Xarelto 217 articles

Judge pushes for resolution in massive Xarelto MDL

U.S. District Court Judge Eldon Fallon, overseeing the Xarelto multidistrict litigation, appears to be pushing both sides toward a resolution, stating in the Jan. 30, 2018, monthly status conference hearing that “I need to devise an end game.” The nationwide MDL involves more than 21,000 lawsuits alleging Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer did not adequately warn about the bleeding risks with its top selling blood thinner. The MDL was created in 2014 in New Orleans, and since then, hundreds of new cases have been filed each month. Cases in state courts in Philadelphia and Los Angeles ... Read More

More major bleeding with Xarelto compared to Pradaxa, Eliquis

The blood thinner Xarelto is associated with more bleeding events than Pradaxa or Eliquis, according to a retrospective, observational real-world study comparing the three drugs in patients with non-valvular atrial fibrillation. The results were presented at the International Stroke Conference 2018. The study involved patients with atrial fibrillation from the U.S. Department of Defense Military Health System who had started treatment with either Pradaxa, Xarelto or Eliquis. The analysis compared 12,763 patients who were either taking Pradaxa or Xarelto, and 4,802 patients treated with either Pradaxa or Eliquis. In the first arm comparing Pradaxa to Xarelto, reserachers found that patients ... Read More

Xarelto, Eliquis antidote review postponed

The Food and Drug Administration (FDA) has postponed its decision whether to approve an antidote to the blood thinners Xarelto and Eliquis, pushing the action date from early February to early May in order to consider additional information it had requested from the manufacturer. The news came as a blow not only to Portola Pharmaceuticals, maker of the antidote called AndexXa, but also to Eliquis’ Pfizer and Bristol-Myers Squibb, and Xarelto’s Johnson & Johnson and Bayer. “The agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company ... Read More

Bayer tries to skirt $28M Xarelto verdict

Bayer AG is trying to wiggle out of a $28 million verdict involving Xarelto side effects by saying the plaintiff’s legal team made xenophobic and offensive statements and tried associate the German company with Nazis in the minds of jurors. Bayer Healthcare Pharmaceuticals Inc., and Johnson & Johnson unit Janssen Pharmaceuticals cited an Instagram post by plaintiff Lynn Hartman’s legal team that used the hashtag “killinnazis,” and referenced “multiple inflammatory and xenophobic references” made during closing arguments. Hartman’s case is the latest to go to trial in the Xarelto mass tort program in Philadelphia County Court of Common Pleas where ... Read More

New guidance on controlling bleeding events with blood thinners

The American College of Cardiology (ACC) issued new guidance for managing major and minor bleeding events in patients taking oral blood thinners. The document is published in the Journal of the American College of Cardiology and compliments the 2017 ACC expert consensus decision pathway for management of anticoagulation in patients with atrial fibrillation. Atrial fibrillation is a common heart rhythm abnormality that increases the risk for strokes due to blood clots. Patients are generally treated with an oral anticoagulant such as the long-used warfarin, as well as newer blood thinners Pradaxa, Xarelto, Eliquis and Savaysa. These medications are designed to ... Read More

PA Xarelto trials focus on US bleeding risks

The first Xarelto side effects bellwether trial in a pool of about 1,500 pending in Philadelphia County Court of Common Pleas resulted in a $28 million verdict in favor of Lynn Hartman, who sued Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer alleging Xarelto caused her to bleed internally. The next trials in Philadelphia are scheduled for March, April, May and June. Apart from the cases pending in the Philadelphia mass tort program, another 18,000 lawsuits consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana are pending. Three have been tried and fell in favor of ... Read More

Janssen seeks approval for Xarelto in CAD/PAD patients

Johnson & Johnson is looking to expand the use of its blood thinner Xarelto. The company announced that its subsidiary Janssen Research & Development LLC has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for two new indications for Xarelto – reducing the risk of major cardiovascular events such as cardiovascular death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease (CAD/PAD), and for reducing the risk of limb ischemia (severe blockage in the arteries of the lower extremities) in patients with PAD. CAD and PAD are conditions in which ... Read More

$28M Xarelto verdict gives hope to others suing over side effects

The $28 million verdict against the makers of the blood thinner Xarelto for not adequately warning about bleeding risks is a reassuring sign to the near-20,000 cases pending across the country that they will see justice. But attorneys for drug makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer are expected to put up a fight as they try to worm their way out of the verdict during post-trial motions and a possible appeal to the Pennsylvania Superior Court. The case involved Lynn Hartman, who claimed she suffered gastrointestinal bleeding after taking Xarelto to treat atrial fibrillation. She was hospitalized for ... Read More

Plaintiff awarded $29M in latest Xarelto trial

A Philadelphia jury awarded an Indiana woman $29 million after finding that Johnson & Johnson’s Janssen Pharmaceuticals and Bayer did not adequately warn about bleeding risks with their blood thinner Xarelto. The case was brought by Lynn Hartman, who was prescribed Xarelto to treat a common heart rhythm abnormality called atrial fibrillation. In June 2014, she was hospitalized for suspected gastrointestinal bleeding. During her four-day hospital stay, she underwent multiple blood transfusions and was taken off Xarelto. Hartman’s attorneys presented studies showing the rate of major bleeding in U.S. patients taking Xarelto is 8.1 per year. The rate of major ... Read More

Xarelto linked to greater bleeding risks

In a study pitting newer blood thinners in the direct acting oral anticoagulants (DOAC) class against each other as well as the long-used warfarin for safety and efficacy, Xarelto was associated with a greater risk of major bleeding compared to Eliquis and Savaysa. The systematic meta-analysis, published in The British Medical Journal, involved a search of data from 23 published randomized trials involving nearly 95,000 patients assessing the use of DOAC and other blood thinners for the prevention of stroke in patients with the common heart rhythm abnormality called atrial fibrillation. Thirteen of the studies compared DOACs with warfarin. In ... Read More