Tagged Articles

Xarelto 195 articles

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

Lawyer accuses Xarelto makers of ‘fake news’

An attorney for a woman suing the makers of the blood thinner Xarelto in the first case to reach trial among about 1,500 in a mass tort program in the Philadelphia County Court of Common Pleas cried “fake news” during closing arguments Friday to convey how false information is being increasingly disseminated. “We live in a world today where it’s getting harder every day to tell that which is fact from that which is fake. It’s getting harder and harder to keep all that straight, and it happened right here in this courtroom,” the attorney told jurors. “Bayer comes from ... Read More

Jurors to decide fate in fourth Xarelto side effects trial

The fourth bellwether trial alleging bleeding risks with the blood thinner Xarelto came to a close Friday in the case of an Indiana woman who claims the drug caused her a serious gastrointestinal bleed. A Philadelphia jury is left to decide whether Xarelto makers, Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, failed to adequately warn patients and their doctors about Xarelto side effects. The trial involves the case of Lynn Hartman, who was prescribed Xarelto to treat her heart condition called atrial fibrillation. Months later, in June 2014, she was hospitalized for a suspected gastrointestinal bleed, losing about 40 percent of ... Read More