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Bayer 137 articles

European drug regulators expand indication for blood thinner Xarelto

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European drug regulators have expanded the indication for Bayer’s blood thinner Xarelto allowing more types of patients to receive the drug. The National Institute for Health and Care Excellence (NICE) issued a final draft guidance allowing anticoagulant Xarelto to be used in combination with the antiplatelet drug clopidogrel and aspirin, or with aspirin alone, to prevent blood clots in patients who have had a heart attack. Xarelto, which contains the active ingredient rivaroxaban, is already approved to treat and prevent strokes in some heart patients and in patients with deep vein thrombosis or pulmonary embolism, and to prevent blood clots in patients ... Read More

New adverse events listed on safety label of Xarelto blood thinner

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The safety label for the new blood thinner Xarelto (rivaroxaban) has been updated to include a new adverse reaction for thrombocytopenia, a condition associated with abnormal bleeding, as well as hepatitis and other liver injuries. Xarelto blood thinner, made by Johnson & Johnson unit Janssen Pharmaceuticals and Bayer, is an anticoagulant used to treat or prevent blood clots in some heart patients and patients undergoing knee or hip replacement surgery. It is in a new class of blood thinners known as Xa Inhibitors, which also includes the brand name drugs Pradaxa and Eliquis. This class of drugs is the first ... Read More

Doctors paid millions to promote dangerous new blood thinners

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Pharmaceutical companies pushing novel new anticoagulants paid doctors nearly $20 million to promote their blood thinner drugs during the last five months of 2013, according to a Pro Publica analysis of Sunshine Act data. Pfizer and Bristol-Myers paid $8 million for doctors to market Eliquis – more than any other drug during that time period. Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer paid nearly $7 million to promote Xarelto, and Boehringer Ingelheim shelled out nearly $5 million to push Pradaxa. Pradaxa was the first to be approved in 2010, followed by Xarelto and then Eliquis. All three blood thinners ... Read More

Cardiologists raise concerns about bleeding risks with Pradaxa, Xarelto, Eliquis

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When a group of medical experts gathered last April for the Cardiac Safety Research Consortium (CSRC) at the Food and Drug Administration (FDA) headquarters in White Oak, Md., it was to discuss the best way to deal with bleeding events that occurred with a group of newer anticoagulants. The drugs, Pradaxa (dabigatran), Xarelto (rivaroxaban) and Eliquis (apixaban) hit the market within the past five years and have all but replaced the long-used warfarin for the treatment and prevention of blood clots and strokes in some heart patients and patients who have undergone knee or hip replacement surgery. However, the blood ... Read More

No antidote available for newer blood thinners Pradaxa, Xarelto, Eliquis

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The new blood thinners Pradaxa (dabigatran), Xarelto (rivaroxaban), and Eliquis (apixaban) may be more convenient for patients than the long-used anticoagulant warfarin because users do not have to be regularly monitored as they do with warfarin. However the newer medications are lacking a one thing that warfarin has – a lifesaving antidote that can reverse the bleeding effects of the drug. Blood thinners are designed to prevent or treat blood clots and strokes in some heart patients and in patients who have undergone knee or hip replacement surgery. Warfarin has been used for decades as a treatment but patients had to ... Read More

Woman files Xarelto side effects lawsuit

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Bernadette Fuller is suing Janssen, a subsidiary of Johnson & Johnson, and Bayer Healthcare Pharmaceuticals claiming the drug companies promoted their blood thinner Xarelto as a safe and effective treatment for the prevention of strokes in some patients but failed to warn that the drug could cause gastrointestinal bleeding and other serious bleeding events including ones that required transfusions. Xarelto was approved by the Food and Drug Administration (FDA) three years ago based on data from clinical trials that touted positive results. However, during those same trials the companies learned that the drug could cause bleeding events. The lawsuit claims that ... Read More

Study links Mirena IUD to increased risk of breast cancer

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Women who use intrauterine devices (IUDs) that release the hormone levonorgestrel, such as the Mirena IUD may be at an increased risk of breast cancer, according to a new study published in the journal Obstetrics and Gynecology. Levonorgestrel is a synthetic form of the hormone progesterone which is naturally produced in a woman’s body to regulate ovulation. Not only does it hinder conception, it also strengthens the uterine lining, which reduces heavy menstrual bleeding. Not only is the Mirena IUD approved by the Food and Drug Administration (FDA) to prevent pregnancy, it is also used to treat heavy periods, endometriosis ... Read More

Bleeding risks associated with new blood thinners Xarelto, Pradaxa

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Advertisements warning of bleeding risks with new blood thinners including Pradaxa and Xarelto leave many people asking if the drugs are worth the risk. Blood thinners, also called anticoagulants or antiplatelets, are often prescribed to patients with some heart or blood vessel diseases, or for people with poor blood flow to the brain. These drugs reduce the risk of heart attack and stroke by reducing the formation of blood clots in the arteries and veins. There are two main types of blood thinners – anticoagulants and antiplatelets. Anticoagulants include the drugs heparin and warfarin, which work on chemical reactions in ... Read More

Xarelto side effects lawsuits consolidated in multidistrict litigation

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The U.S. Judiciary Panel on Multidistrict Litigation has consolidated nearly two dozen lawsuits in Louisiana federal court filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp., alleging the drug companies failed to warn that the blood thinner Xarelto could cause serious bleeding events. Defendants fought centralizing the lawsuits, claiming discrepancies in dosage and patients’ medical history made the cases too dissimilar. But the panel found the Xarelto side effects lawsuits struck a similar chord in their claims that the drug companies withheld information from clinical trials that showed the drug could increase the risk for life-threatening bleeding events. ... Read More

Bayer faces mounting lawsuits over Mirena IUD side effects

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K. had only recently gotten the Mirena IUD following the birth of her son. The contraceptive works for up to five years, but K. asked her doctor to remove it. She was becoming increasingly convinced that her Mirena IUD had caused her weight gain, fatigue, moodiness, and her hair to fall out in clumps. However, when her doctor tried to remove the device, it was nowhere to be found. She had to undergo surgery, where her doctors discovered the device had perforated her uterus and migrated into her abdomen, lodging in her omentum, the tissue that protects and connects the ... Read More