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Bayer 354 articles

New evidence could lead to Xarelto re-trial

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Attorneys for a woman who suffered a major bleeding event after taking the blood thinner Xarelto are seeking a new trial after discovering new evidence that questions the accuracy of statements made by the drug’s makers. Jurors found in favor of Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. During the trial, jurors were told by the drug companies that there was no effective test to determine whether patients were at an increased risk for internal bleeds while taking Xarelto, and dismissed plaintiff Dora Mingo’s expert witness’ testimony that a lab test called prothrombin time – or PT – would not ... Read More

Korea adds severe skin reaction warning to Xarelto

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Korea’s Ministry of Food and Drug Safety (MFDS) is requiring an update to the safety label of the blood thinner Xarelto to include new warnings regarding the risk of the serious and sometimes fatal skin reactions known as Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). The warning comes after the European Commission issued a public safety alert regarding serious skin conditions with Xarelto. Most side effects were reported within the first week of treatment. The ministry collected opinions and reviewed them last month and determined that the warnings should also come with a recommendation for doctors to discontinue ... Read More

Xarelto users should avoid grapefruit

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People who take the blood thinner Xarelto should limit their intake of grapefruit while taking the drug, cautions Joe Graedon and Teresa Graedon with the People’s Pharmacy published in myAJC. Xarelto hit the market in 2011 and was promoted as a novel oral anticoagulant that was just as effective but far more convenient than the long-used warfarin. For decades, warfarin had been the go-to treatment for the prevention of strokes in patients with the common heart rhythm abnormality called atrial fibrillation. But taking warfarin came at a price. The blood thinner can interact adversely with numerous medications or foods. For ... Read More

Whistleblower Lawsuit Against Bayer Revived by U.S. Appeals Court

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A whistleblower suing Bayer A.G. in connection to a statin drug that was pulled from the market in 2001 over health risks has had her case revived by a federal appeals court for the second time. According to Business Insurance, Laurie Simpson filed a whistleblower lawsuit against the Germany-based drug giant and its units under the False Claims Act, which authorizes private parties to sue on behalf of the U.S. government in cases of suspected fraud targeting taxpayer-funded programs and government agencies. Ms. Simpson’s whistleblower suit accuses Bayer of misrepresenting the efficacy of its cholesterol-lowering statin Baycol compared with competing ... Read More

Xarelto cases in state court start soon

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Drug maker Bayer asked the Philadelphia Court of Common Pleas to dismiss punitive damages from two of the first bellwether trials scheduled pending in state court involving Xarelto side effects. Meanwhile, attorneys representing people suing Xarelto’s makers filed two motions seeking to bar defense experts from testifying that attorney advertising affects the incidence of bleeding events, or that bleeding events can be beneficial if they lead to early diagnosis of other conditions. Bayer asked the court to apply either New Jersey law or German law to the cases, which would free the drug company from paying punitive damages. The motion ... Read More

Xarelto data: benefits don’t outweigh the harms

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Johnson & Johnson’s Janssen Pharmaceuticals and Bayer have been fast to tout the news that their blood thinner Xarelto in combination with aspirin cut the risk of cardiovascular death, heart attacks or strokes in patients with coronary artery disease and/or peripheral artery disease (PAD/CAD) – a population that’s at higher risk for cardiovascular events. But, while it’s a win for the drug companies, it’s not so much for patients, according to Dr. John Mandrola’s commentary in Medscape. If approved for the prevention of strokes and heart attacks in PAD/CAD patients based on COMPASS data, the drug would become a candidate ... Read More

Major bleeding reported in Xarelto-aspirin combo study

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Johnson & Johnson’s Janssen Pharmaceuticals and Bayer are touting new data that shows their blood thinner Xarelto when combined with aspirin significantly reduced the risk of heart attacks and strokes in patients with stable coronary or peripheral artery disease. However, the risk of major bleeding events was significantly higher in patients taking both meds at the same time. Data from the so-called COMPASS study, which was funded by Bayer, was presented at the ESC Congress in 2017 in August and published in The New England Journal of Medicine. It was the largest study involving Xarelto, with more than 27,000 patients enrolled. ... Read More

Fourth Xarelto trial could bring justice to victims

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A different set of circumstances in the fourth bellwether trial involving bleeding risks with the blood thinner Xarelto could break the winning streak enjoyed by drug makers Johnson & Johnson’s Janssen Pharmaceuticals and Bayer. Patients in the three previous Xarelto lawsuits to go to trial had failed to persuade jurors that Janssen and Bayer did not adequately warn patients that the blood thinner could cause gastrointestinal bleeds, brain hemorrhages and bleeding deaths. It is unusual for bellwether trials in pharmaceutical litigation to repeatedly fall in favor of the defendants, but those suing the drug companies refuse to give up the ... Read More

FDA to review Xarelto antidote

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The Food and Drug Administration (FDA) has accepted for review Portola Pharmaceuticals’ resubmitted Biologics License Application (BLA) for the Factor Xa inhibitor reversal agent AndexXa (andexanet alfa). The medication is designed to reverse the blood thinning effects of the blood thinners Xarelto and Eliquis in the event of a bleeding emergency. Last August, AndexXa first came under review by the FDA but the agency shocked analysts and drug makers when it refused to approve the medication without additional information primarily related to its manufacturing and analytics. The BLA resubmission includes the supplemental data relating to analytics and manufacturing that was ... Read More

Four new Xarelto lawsuits filed

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Four lawsuits were filed in the Madison County Circuit Court in Illinois against Johnson & Johnson, Janssen Pharmaceuticals and Bayer alleging the companies failed to adequately warn that their blood thinner Xarelto could cause life-threatening bleeding events. The lawsuits were filed by Brian Bruce, Deborah Diaby, Robert Taxacher, and Lori Williams, who all claim to have suffered a bleeding injury after taking Xarelto. Their lawsuits claim that the drug companies advertised the blood thinner as safe and effective in preventing strokes in patients with the heart rhythm abnormality atrial fibrillation. But studies show that Xarelto increases the risk of gastrointestinal bleeds ... Read More