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Bayer 339 articles

Bleeding most reported drug-related adverse event


There are unacceptably high risks associated with oral blood thinners, most of which involve life threatening bleeding events, according to the Food and Drug Administration (FDA) Adverse Events database and a new systematic study by the Centers for Disease Control and Prevention (CDC). The issue was identified by the Institute for Safe Medication Practices (ISMP) in its fourth quarter QuarterWatch report. ISMP’s annual report focused on drugs and specific adverse reactions that affect large patient populations and involve substantial numbers of serious injuries. There were nearly 22,000 serious adverse events reports linked to use of anticoagulants, and in particular Xarelto, ... Read More

Xarelto mass tort grows in first half of 2017


Lawsuits alleging bleeding risks with the blood thinner Xarelto pending in the Philadelphia Court of Common Pleas increased by 210 cases – or 17 percent – from Jan. 1 to June 14, 2017, according to Law.com. The number of cases jumped from 1,214 to 1,424. The Xarelto mass tort is one of nine pending in the Philadelphia. There are also about 1,600 Xarelto lawsuits that have been consolidated in a multidistrict litigation (MDL) in the Eastern District of Louisiana under Judge Eldon E. Fallon. Two Xarelto cases in the MDL have been heard, with the third scheduled for August. A total ... Read More

Pradaxa antidote effective in new study

blood cells

Praxbind, a drug that reverses the blood thinning properties of the anticoagulant Pradaxa in the event of a bleeding emergency, was found to be safe and effective enough for urgent use even if patients later prove not to have little or no Pradaxa in their bloodstream, researchers concluded in a study published in the New England Journal of Medicine. Dr. Charles Pollack, Jr., with Thomas Jefferson University in Philadelphia, and colleagues, conducted a full cohort analysis of the reversal effects of Praxbind, which contains the active ingredient idarucizumab. Praxbind and was approved by the Food and Drug Administration (FDA) in ... Read More

Xarelto makers hit with two new lawsuits


Two new lawsuits have been filed in New York state court against Johnson & Johnson’s Janssen Pharmaceuticals and Bayer alleging the drug companies downplayed risks with their blood thinner Xarelto, Law360 reports. The lawsuits were filed by Thomas Walsh and Joseph Roman, and on behalf of their wives. The men claim they suffered “life-threatening bleeding” and “other severe and personal injuries” after taking the medication, and that Bayer and Janssen knew of its “serious and dangerous side effects” but failed to adequately warn doctors or their patients. Furthermore, their lawsuits state, the drug companies did not perform adequate human tests ... Read More

Eliquis bleeding risks case filed in NY

blood cells

Bristol-Myers Squibb Co. and Pfizer Inc. skimped on pre-approval testing and withheld information about bleeding risks with their blood thinner Eliquis, loved ones of a man who died after taking the drug told a New York state court, Law360 reports. Raymond Warme, father of Dawn Dunn and partner of Orla Troy, was prescribed Eliquis in April 2014 to prevent strokes associated with his heart rhythm irregularity called atrial fibrillation. About two months later, Warme started bleeding internally and soon after died from his injuries. Dunn and Troy claim that the drug makers conducted clinical trials in China using “incompetent and ... Read More

Class action sought in blood monitoring suit

blood cells

Patients who purchased Alere Inc.-brand home blood-clot testing kits asked a California federal judge to certify Colorado, Florida, Georgia, Maryland, New York, Pennsylvania and nationwide classes of people who purchased the company’s INRatio testing kits since 2009, according to Law360. The consumers say that the Alere’s INRatio Monitor for tracking the speed of blood clotting and the INRatio test strips used with the device were inaccurate. The company asked consumers to return the products for destruction, but never offered refunds to consumers. “Believing that the results produced by a testing product like the INRatio products are accurate, as any reasonable ... Read More

FDA considers new indication for Xarelto


The Food and Drug Administration (FDA) has agreed to a priority review of a supplemental new drug application for the blood thinner Xarelto to include a 10-milligram, once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. VTE includes deep vein thrombosis (DVT), a blood clot in the deep veins and often in the legs. It also includes pulmonary embolism (PE), a blood clot that travels to the lung. Blood thinners are often prescribed to treat and prevent these conditions. Once anticoagulant therapy is stopped, up to 10 percent of people ... Read More

Patient requests new Xarelto trial


The man who lost the first bellwether trial in a mulstidistrict litigation alleging the blood thinner Xarelto causes uncontrolled bleeding asked a Louisiana federal court for a new trial, arguing that a pretrial order prevented him from fully arguing his case to jurors, according to Law360. Joseph Boudreaux’s attorneys told the jury that Boudreaux should have been monitored with a blood clotting test called Neoplastin PT to determine the level of Xarelto in his system. But the court prevented them from providing information on how the test works. Yet, Xarelto’s manufacturers, Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, were able ... Read More

Mirena poses risk of adverse pregnancy outcomes

mirena IUD

The Food and Drug Administration (FDA) has approved updates to the safety label for the intrauterine device Mirena to include new risks regarding pregnancy or suspected pregnancy. Mirena is a contraceptive device made by Bayer to prevent pregnancy for up to five years. It is also used to treat heavy menstrual cycles. Mirena is a T-shaped device that is inserted into the cervix where it releases a small amount of the hormone levonorgestrel. The birth control has been linked to risks such as migration of the device, perforation of organs and tissue damage, a well as a ectopic pregnancy. The update states ... Read More

Janssen, Bayer face thousands more Xarelto lawsuits


Johnson & Johnson’s Janssen Pharmaceuticals and Bayer prevailed in a trial involving bleeding side effects with its blood thinner Xarelto, but the drug companies face more litigation in the estimated 18,500 other lawsuits pending. The latest trial involved the case of Sharyn Orr, a 67-year-old woman who was prescribed Xarelto to prevent strokes associated with her heart ailment, atrial fibrillation. She had been taking the medication for more than a year when she suffered a severe headache with vomiting. She was rushed to the hospital where a CT scan was performed, revealing a major brain bleed. An operation could increase ... Read More