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Bayer 283 articles

First Xarelto bleeding risks trial scheduled for March 2017


The first trial in a massive multidistrict litigation of nearly 14,000 cases involving bleeding risks allegedly caused by the blood thinner Xarelto is scheduled for March, with other trials, each serving as bellwethers, slated for April and May. The first case to be tried involves that of Joseph Boudreaux, who claims he began taking Xarelto in January 2014 as a treatment for his heart condition called atrial fibrillation. About a month later, he was hospitalized for internal bleeding, resulting in multiple blood transfusions. Like the thousands of other lawsuits, Boudreaux claims that Xarelto’s makers, Johnson & Johnson’s Janssen Pharmaceuticals and ... Read More

Eliquis sales poised to top Xarelto in blood thinner market


Bristol-Myers Squibb (BMS) and Pfizer’s blood thinner Eliquis is poised to edge ahead of Johnson & Johnson’s Janssen Pharmaceuticals and Bayer’s Xarelto in 2017 and become the market leader. BMS CEO Giovanni Caforio added, “We think we are relatively close to achieving that.” Eliquis has already nabbed the top spot in the institutional setting, such as in hospitals and cardiologists’ offices, beating out long-used warfarin, and is making ground among primary care physicians. “We are beginning to see very, very strong momentum,” Caforio added. Xarelto and Eliquis were approved by the Food and Drug Administration (FDA) in 2011 and 2012, ... Read More

Bayer recalls administration sets used with infusion system


Bayer is recalling more than 86,000 Source Administration Sets used with the Medrad Intego PET Infusion System because they may produce a particulate matter in the medicine vials created when the tip of the needle pushes through the rubber top of the vial. If this occurs, the particulate matter could enter into the patient and cause serious adverse health consequences including infection, tissue damage, and death. Medrad Intego PET Infusion Systems control and deliver medications from a chamber to patients through a needle inserted into a vein during nuclear medicine procedures. These procedures are used to diagnose and treat diseases ... Read More

Blood thinner sales expected to grow through 2021


Sales of blood thinners are expected to surge through 2021, thanks in part to a popular novel new class of anticoagulants, according to an analysis by Persistence Market Research. Blood thinners are life-saving medications that are used to prevent or treat blood clots in the blood vessels, which can block blood circulation leading to serious health consequences. They are commonly used to treat deep vein thrombosis (blood clots in the deep veins, often in the legs), pulmonary embolism (blood clots in the lungs), atrial fibrillation (an irregular heart rhythm that can cause blood clots to develop in the chambers of ... Read More

Xarelto makers face 15,000 bleeding risks lawsuits


Johnson & Johnson, its subsidiary Janssen Pharmaceuticals, and Bayer will come into the New Year gearing up for a series of trials alleging life-threatening bleeding risks with their blood thinner Xarelto. The lawsuits claim the drug companies did not adequately warn consumers that the drug could cause gastrointestinal bleeds, brain hemorrhages and bleeding deaths, and that the drug was poorly designed and marketed because there is no antidote to reverse the bleeding effects of Xarelto. Xarelto was approved by the Food and Drug Administration (FDA) in 2011, and is now the top-selling blood thinner in a new class of drugs called ... Read More

Be aware of Xarelto bleeding risks warning signs


Johnson & Johnson, Janssen Pharamceuticals and Bayer’s blood thinner Xarelto is the top selling anticoagulant in its class. The drug companies have spent millions to help keep it that way. The drug is used to prevent strokes in patients with atrial fibrillation, treat or prevent deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. It is marketed as a more convenient alternative to the long-used warfarin, which requires patients to be monitored on a regular basis. As with warfarin, patients taking Xarelto are at increased risk of ... Read More

2016 year-end review of FDA medical device safety alerts

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The Food and Drug Administration (FDA) issued about 60 Safety Alerts involving medical devices in 2016. Here is a sampling of safety issues that the agency alerted the public about: Olympus and Pentax updated the reprocessing instructions for their specialized endoscopes, called duodenoscopes, in an effort to cut down on the risk of patient-to-patient spread of bacteria that can lead to drug-resistant infections. The devices, which are fed down patients’ throats to treat or diagnose conditions of the pancreas, have crevasses that can harbor bacteria even after the devices have been cleaned and disinfected. The FDA ordered manufacturers to provide ... Read More

Xarelto, Eliquis antidote up for FDA approval again in 2017


AndexXa, a universal antidote to the new breed of blood thinners Xarelto and Eliquis was surprisingly shot down by drug regulators last August due to manufacturing issues, but its manufacturer Portela Pharmaceutials says it expects the reversal agent to gain approval sometime in 2017. Xarelto and Eliquis were approved in 2013 and 2014, respectively, and are used to prevent strokes in patients with the heart rhythm abnormality atrial fibrillation, to prevent or treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. They were designed to be ... Read More

First Xarelto lawsuits over bleeding risks to be tried in 2017


The multidistrict litigation (MDL) against Johnson & Johnson’s Janssen Pharmaceuticals and Bayer Corp. involving bleeding injuries with the blood thinner Xarelto was originally consolidated in December 2014, and has since swelled to nearly 14,000 cases pending before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana. Additional lawsuits have also been filed in state court. Xarelto was first approved by the Food and Drug Administration (FDA) in 2011 and used to prevent strokes in patients with atrial fibrillation, to prevent and treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently ... Read More

J&J spent $28.4M for docs to promote blood thinner Xarelto


Johnson & Johnson spent a whopping $28.4 million in 2015 for fees, meals, travel, gifts and royalties – but not research – to health care providers for promotional speeches or consultation involving its top selling anticoagulant Xarelto, according to Propublicae’s updated Dollars for Docs database. It was the highest amount paid by a drug company in 2015 for so-called “general payments” to doctors to promote their meds. Pfizer and Bristol-Myers Squibb’s similar blood thinner, Eliquis, is poised to steal Xarelto’s large share of the blood thinner market. Its makers shelled out $18.8 million in general payments to doctors to help ... Read More