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Bayer 309 articles

GI bleeds more common with Xarelto than Eliquis or Pradaxa


In a study pitting three of the newer anticoagulants for stroke prevention in patients with the common heart rhythm abnormality atrial fibrillation, gastrointestinal (GI) bleeds appeared to occur less often in the newest of the three. The blood thinners – Pradaxa, Xarelto and Eliquis – were the first novel anticoagulants (NOACs) to receive Food and Drug Administration (FDA) approval, in 2010, 2011 and 2012, respectively. Pradaxa, manufactured by Boehringer Ingelheim, contains the drug ingredient dabigatran. Xarelto, made by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, contains rivaroxaban. Eliquis, produced jointly by Bristol-Myers Squibb and Pfizer, contains the active ingredient apixaban. ... Read More

Will Xarelto makers settle lawsuits before first bleeding side effects trial?


The first of about 17,000 Xarelto lawsuits over alleged bleeding risks is scheduled to go to trial later this month, but if Xarelto’s manufacturers follow the same path as Pradaxa’s two years ago, a settlement may be in the making. Pradax and Xarelto were approved by the Food and Drug Administration (FDA) in 2010 and 2011, respectively. The novel class of blood thinners is used to prevent strokes in patients with atrial fibrillation. The medication is also used to prevent or treat other blood clot-related conditions. The drugs were designed to be a more convenient alternative to the long-used warfarin, which has ... Read More

Xarelto makers look to expand indication despite bleeding risks


A recent Phase 3 clinical trial testing the blood thinner Xarelto to prevent heart attacks, strokes and other cardiac events in patients with coronary artery disease (CAD) or peripheral arty disease (PAD) was recently stopped prematurely because the results were overwhelmingly positive, putting Xarelto one step closer to winning approval for expanding its indication. But the benefits come with significant risks. Patients with CAD or PAD have atherosclerosis, or narrowed and blocked arteries in various regions of their bodies. These narrowed arteries can cause the formation of blood clots, which can break free and cause a heart attack or stroke. ... Read More

Study: Heart attack risk greater with Xarelto, Pradaxa compared to warfarin

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Patients newly diagnosed with the common heart rhythm abnormality called atrial fibrillation and treated with the newer blood thinners Xarelto or Pradaxa over the long-used warfarin may be at greater risk of having a heart attack, according to a retrospective study published in the British Journal of Clinical Pharmacology. Warfarin, a vitamin K antagonist (VKA), reduces blood clotting by reducing the action of vitamin K. Non-VKA, or novel, oral anticoagulants (NOAC), work differently. Both Xarelto and Pradaxa are direct thrombin inhibitors, which work by blocking thrombin, the blood’s central clotting agent. Researchers compared data on atrial fibrillation patients starting either ... Read More

Xarelto possibly linked to menorrhagia


Female patients treated with warfarin or newer oral anticoagulants may experience unusually heavy or prolonged menstruation, a condition called menorrhagia. The issue was identified with warfarin, Eliquis, Pradaxa, Savaysa, and Xarelto in the Food and Drug Administration (FDA) quarterly report of Potential Signals of Serious Risks/New Safety Information identified by the FDA’s Adverse Event Reporting System (FAERS). The blood thinners are already linked to an increased risk of major bleeding events including gastrointestinal bleeds and brain bleeds, some of which can be fatal. But the drugs can make patients more susceptible to any forms of bleeding, including from cuts or ... Read More

MiraLAX laxitive associated with serious side effects in pediatric patients


Children’s Hospital of Philadelphia (CHOP) is leading a study into reports of devastating side effects in children who were treated for constipation with the over-the-counter laxative MiraLAX. The Food and Drug Administration (FDA) awarded CHOP with a grant to conduct the research in early 2014, during which the agency disclosed that MiraLAX powder contains a small amount of Polyethylene glycol 3350 (PEG 3350). Under certain conditions, PEG 3350 can degrade into ethylene glycol or diethylene glycol – toxic ingredients that can be found in antifreeze. The FDA disclosed in the grant that it had received a number of reports of ... Read More

Olympic swimmer Katie Hoff featured in Xarelto ads


World Class swimmer Katie Hoff, who took home three medals in the 2008 Summer Olympics, was forced to retire from swimming in December 2015 after suffering from a pulmonary embolism. Now she is a spokesperson for the blood thinner Xarelto. Hoff made her Olympic debut in 2004 at the age of 15. Four years later she returned to snag the silver in the 400 free, bronze in the 400 IM, and bronze in the 800 free. She missed the 2012 Olympic Team then took a year off in 2013 to focus on her studies at the University of Miami. But ... Read More

Xarelto bellwethers in MDL could offer insight for cases pending in PA mass tort


Trials alleging bleeding risks with the blood thinner Xarelto are scheduled to begin this month in a Louisiana federal court, which may serve as a guide to determine how similar cases pending in Philadelphia will play out. Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana has set the date for the first Xarelto bellwether trial in a massive multidistrict litigation (MDL) for April. The federal Xarelto MDL names as defendants Xarelto manufacturers Johnson & Johnson, Janssen Pharmaceuticals, and Bayer. Plaintiffs accuse the drug companies of failing to warn patients that by taking Xarelto once ... Read More

Study: Significantly greater risk of major bleeding with Xarelto


Real world data pitting three rival blood thinners against each other as well as the long-used warfarin has identified a clear winner when it comes to safety and efficacy, and it isn’t the one with the highest sales. The data, from a study of U.S. Medicare patient records, compared newer blood thinners, Xarelto, Pradaxa and Eliquis with warfarin. The new class of blood thinners are used to prevent strokes in patients with atrial fibrillation, to treat and prevent deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. ... Read More

Xarelto lawsuits allege bleeding risks with no antidote


Joseph Boudreaux Jr. suffers from a common heart rhythm abnormality called atrial fibrillation. It causes blood to pool in the chambers of the heart, where it is prone to form clots. If a clot in the heart breaks free and travels to the brain, it can create a blockage and result in stroke. To prevent strokes in patients with atrial fibrillation, blood thinners are prescribed. Warfarin was the go-to blood thinner for more than 50 years and has been widely prescribed in that time. While effective at preventing blood clots and strokes, it interacted with other drugs and foods that ... Read More