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Xarelto 217 articles

Xarelto trial halted early due to excessive harmful events

A phase III clinical trial, called GALILEO, comparing the blood thinner Xarelto to the antiplatelet Plavix with aspirin in patients who have undergone transcatheter aortic valve replacement, was stopped early after a preliminary analysis showed excesses in key adverse events in patients treated with Xarelto. Among patients in the Xarelto group, 11.4 percent suffered thromboembolic events compared to 8.8 percent of patients in the Plavix/aspirin group; and 4.2 percent of Xarelto patients experienced bleeding compared to 2.4 percent of patients in the Plavix/aspirin group. There was also a 6.8 all-cause mortality risk in Xarelto patients compared to 3.3 percent among ... Read More

Twitter users call Xarelto ad misleading

A series of tweets and retweets are questioning what Johnson & Johnson is up to with its latest Xarelto ad. “I saw this commercial for the novel anticoagulant Xarelto the other day and it seemed a bit misleading,” tweeted ProPublica Senior Editor Charles Ornstein. The ad featured a Xarelto user, Tiffany, donning a leather jacket and walking around motorcycles. The disclaimer on the bottom of the screen read, “As with any blood thinner, Tiffany had to stop riding her motorcycle while taking Xarelto.” That’s because if someone taking a blood thinner is in an accident they generally have more serious ... Read More

First trials on novel class of blood thinners to begin soon

The first human trial of a novel class of anticoagulants shown to be as effective as blood thinners like Xarelto and Eliquis but with much fewer adverse bleeding effects is scheduled to begin soon in Australia. The new class has successfully completed regulatory toxicology studies and was well-tolerated after a 28-day repeat dosing. VE-1902, developed by Verseon, is in a new class of drugs called PRecision Oral AntiCoagulants, or PROACs. If results of clinical trials are favorable, V-1902 could have a major impact on the treatment of cardiovascular diseases by becoming the first blood thinner suitable for long-term anticoagulation-antiplatelet combination ... Read More

Hundreds of new Xarelto cases filed in PA each month

Hundreds of new Xarelto side effects cases are being filed each month in Philadelphia’s Complex Litigation Center, where more than 1,700 cases are pending, and plaintiffs attorneys don’t appear to be slowing the trend. As many as 400 to 600 new cases are being filed each month by patients who blame Johnson & Johnson’s Janssen Pharmaceuticals and Bayer for not adequately warning about serious bleeding risks with their blood thinner Xarelto. Plaintiffs also claim that the drug companies also didn’t inform doctors to monitor patients to reduce their risk for life-threatening bleeds, including gastrointestinal bleeds and brain hemorrhages. Plaintiffs attorneys ... Read More

Tennessee man files Xarelto lawsuit

A Tennessee man is suing the makers of the blood thinner Xarelto alleging the companies filed to warn that the medication could cause serious and life-threatening bleeding events. John Lovier claims that he suffered a gastrointestinal bleed in June 2016 after being treated with Xarelto, which not only caused him physical pain, but left him with medical, hospital and surgical expenses. He filed his lawsuit in the U.S. District Court for the Eastern District of Louisiana and is seeking compensation from Janssen Research & Development LLC, Janssen Ortho LLC, Janssen Pharmaceuticals Inc., Johnson & Johnson, Bayer Healthcare LLC, Bayer Healthcare ... Read More

FDA approves Xarelto, Eliquis antidote AndexXa

After nearly two years rife with rejections and requests for more information, Portola Pharmaceuticals’ AndexXa has been approved by the Food and Drug Administration (FDA), as the only antidote to reverse the blood thinning effects of the Factor Xa inhibitor anticoagulants Xarelto and Eliquis, in cases of life-threatening or uncontrolled bleeding. Xarelto and Eliquis work by inhibiting a protein involved in the formation of blood clots. They are used to prevent strokes in patients with the common heart rhythm abnormality atrial fibrillation, to prevent and treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who ... Read More

Xarelto victims ask appeals court to vacate decisions of first three trials

Plaintiffs in three bellwether trials involving bleeding risks with the blood thinner Xarelto that resulted in wins for the defendants have asked an appeals court to vacate the decisions arguing that the judge overseeing the trials improperly excluded key evidence and gave jurors incorrect instructions, The National Law Journal reported. The cases were the first three to go to trial among more than 20,000 pending in a multidistrict litigation in the Eastern District of Louisiana. Plaintiffs accuse Johnson & Johnson’s Janssen Pharmaceuticals and Bayer of not adequately warning of the risks involved with using Xarelto, including bleeding risks like gastrointestinal ... Read More

Xarelto bleeding victim fights drugmakers’ motion to throw out case

A man suing Johnson & Johnson’s Janssen Pharmaceuticals and Bayer over Xarelto bleeding risks pushed back against the drug companies after they asked the judge overseeing the case in Philadelphia to drop the case because his prescribing doctor testified he did not read Xarelto’s safety label. Daniel Russell argued that the focus should not be on that doctor – Dr. Riple Hansalia – because he was simply continuing a prescription made by another physician – Dr. Ihab Girgis – the day before. Thus, Dr. Girgis should be considered the relevant prescriber under the law, Russell argued. Furthermore, Dr. Hansalia may ... Read More

J&J profits despite mounting Xarelto lawsuits

Johnson & Johnson told investors that it expects to rake in between $81 billion and $81.8 billion in profits for 2018, more than previously forecasted, and $20 billion in first-quarter sales – up 12.6 percent year-over-year, thanks in large part to its pharmaceutical unit. But one drug that fell under the company’s expectations was its blood thinner Xarelto. Xarelto posted a sales increase of 13 percent to $578 million, but missed the company’s estimate of $634 million. Johnson & Johnson blamed supply issues caused by Hurricane Maria and changes in access agreements with insurers. Despite these challenges, Xarelto gained 1.6 ... Read More

Janssen, Bayer ask judge to toss latest Xarelto side effects trial

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer asked a Philadelphia judge to toss a case currently in trial blaming the drug companies for not adequately warning about bleeding risks with their blood thinner Xarelto, arguing that there is no evidence that the prescribing physician in the case would have given the plaintiff a different medication if stronger warnings had been on the label, because he testified he didn’t even read the drug’s label. As a result, Janssen and Bayer argued, the plaintiff doesn’t have a case. The trial involves the case of Daniel Russell, who in April 2013 had a ... Read More