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Bayer 368 articles

Former FDA chief: Xarelto makers did not adequately warn of bleeding risks

Former Food and Drug Administration (FDA) Commissioner David Kessler told a Philadelphia jury that the warning labels on the blood thinner Xarelto did not give consumers or their doctors enough information about the risk of significant bleeding events using the drug posed. “They did not adequately notify physicians that some patients are at higher risk than other,” he said. “That’s what I believe.” Kessler testified for plaintiff Lynn Hartman during the first bellwether involving Xarelto side effects to go to trial in Philadelphia. Hartman sued Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer claiming the drug caused her to ... Read More

Judge orders deposition of Xarelto sales rep

A sales representatives for Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, were ordered to undergo a midtrial deposition by a Pennsylvania state judge to determine whether she tried to sway a doctor’s testimony in an upcoming trial alleging Janssen’s blood thinner Xarelto caused a man’s internal bleeding. Attorneys for plaintiff Lynn Hartman asked the judge for the deposition after they became suspicious over the timing of the drug rep’s visit to the doctor before his deposition in April, and the fact that Janssen failed to disclose the contact until just weeks before the trial was to begin on ... Read More

Xarelto trial delayed over possible witness tampering

Opening statements in the first Xarelto side effects bellwether trial to be heard in the Philadelphia Court of Common Pleas were set to begin Monday, but were delayed due to a tussle between parties over the significance of a meeting between the plaintiff’s treating physician and a sales representative for Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, maker of Xarelto. Janssen’s attorneys said the meeting was a routine call between a drug rep and a doctor. But the plaintiff’s attorneys said it smelled more like the events that occurred with a witness in a bellwether trial involving DePuy Orthopedics’ hip implant, ... Read More

Xarelto trial begins this week in PA mass tort program

The first bellwether trial in a mass tort program in the Philadelphia County courts alleging the blood thinner Xarelto caused uncontrolled bleeding is scheduled to go to trial this week. The lawsuit was filed by Lynn Hartman of Indiana, who claimed she suffered gastrointestinal bleeding after taking Xarelto to prevent strokes related to her heart condition called paroxysmal atrial fibrillation. The bleeding injury landed her in the hospital for four days in June 2014, during which her doctors ordered her to stop taking Xarelto. Since then, she has suffered no additional internal bleeding. Hartman’s trial is one of 1,500 pending ... Read More

Lower dosage of Xarelto approved for prevention of recurrent VTE

The Food and Drug Administration (FDA) has approved a new lower dosage of Xarelto for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. The new 10-milligram, once-daily dose was approved based on a review of data from the EINSTEIN CHOICE study, a Phase 3, double-blind study that showed that both the 10mg and 20mg doses of Xarelto worked better than 100mg of aspirin at reducing the risk of VTE after six months of standard anticoagulation. The study showed that the 10mg dose reduced VTE risk by 74 percent, and the 20mg dose ... Read More

FDA to decide on lower dose of Xarelto for VTE prevention

The Food and Drug Administration (FDA) is expected to decide this week whether it should include a 10-milligram, once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy for the blood thinner Xarelto. Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer were granted priority review for a supplemental New Drug Application for the new dosage earlier this year, which includes data from EINSTEIN CHOICE study, a Phase 3, double-blind, superiority study that showed that both 10mg and 20mg doses of Xarelto worked better than 100mg of aspirin at reducing the ... Read More

Xarelto side effects victims appeal to Fifth Circuit

Two men who lost bellwether trials blaming the blood thinner Xarelto for uncontrolled bleeding events told a Louisiana federal court that they are appealing some orders and the final judgments to the Fifth Circuit. Plaintiffs Jospeh Boudreaux and Joseph Orr, both of whom had sued Xarelto makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, filed notices of appeal on a collective nine court decisions, including requests for new trials. Both plaintiffs are appealing an April 13 order in which Judge Eldon E. Fallon rejected their attempts to stop speculative testimony and opinions by the drug companies’ expert. A total of ... Read More

Xarelto’s ‘unacceptably high risks’ highlighted by monitoring program

There are “unacceptably high risks” with oral anticoagulants including the blood thinner Xarelto that highlight the need for steps to be taken to improve the safety of these high-risk drugs, the Institute for Safe Medication Practices (ISMP) stated in its QuarterWatch Annual Report. The newsletter monitors Food and Drug Administration (FDA) MedWatch reports. ISMP reviewed new results from two data sources, including reports made to the FDA Adverse Event Reporting System (FAERS) and data from a new systematic study by the Centers for Disease Control and Prevention (CDC). Researchers found that newer blood thinners, led by Xarelto, accounted for 21,996 reports ... Read More

Nixed Xarelto case highlights importance of early filing

A Louisiana federal judge kicked Herbert Louiviere’s failure-to-warn case out of a massive multi district litigation against the makers of the blood thinner Xarelto, saying he waited too long to file a lawsuit alleging the drug caused his internal bleeding. The ruling highlights the importance of not delaying to file a lawsuit. Louiviere was prescribed Xarelto in January 2013. The drug is used to prevent strokes in people with the common heart rhythm abnormality atrial fibrillation, as well as to prevent and treat some blood clot conditions. On March 6, 2013, Louiviere was hospitalized for a gastrointestinal bleed, at which ... Read More

More major bleeding with Xarelto than aspirin

When Bayer announced it was pulling the plug on a late-stage clinical trial that showed its blood thinner Xarelto was no better than low-dose aspirin at preventing strokes and blood clots in patients who have had a recent stroke, the company also revealed that the blood thinner caused more major bleeding events than aspirin. The bleeding rates were relatively low overall, which normally may have gone under the radar if Bayer and Johnson & Johnson’s Janssen Pharmaceuticals were not facing nearly 20,000 lawsuits over Xarelto bleeding risks. Xarelto used to be the top selling novel oral anticoagulant (NOAC) on the ... Read More