Tagged Articles

Bayer 143 articles

Judge nixes Bayer’s plan to reinstate whistleblower


An Arkansas federal judge who ordered the reinstatement of a whistleblower terminated after implicating Bayer Corp. in a Medicare fraud scheme rebuked the pharmaceutical giant for attempting to reinstate the former employee to a job 500 miles away. Bayer fired sales representative Mike Townsend in 2010 after he blew the whistle on a scheme by a major Bayer customer to defraud Medicaid by illicitly billing the program for intrauterine contraceptives. Mr. Townsend had worked as a Bayer sales rep for six years when he caught on to a Medicaid scam he alleges was orchestrated by Arkansas physician Kelly Dean Shrum, ... Read More

Pradaxa antidote granted breakthrough designation


The Food and Drug Administration (FDA) has granted breakthrough designation for Boehringer Ingelheim’s idarucizumab, a reversal agent to its blockbuster blood thinner Pradaxa. The accelerated review process will cut about four months off the review process for the medication. Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA can grant breakthrough designation to specific drugs that meet set criteria such as therapies that are used individually or in combination with other drugs to treat a serious or life threatening disease or condition, or those in which preliminary data shows evidence that the medication may provide ... Read More

California man sues Xarelto makers over bleeding risks


Makers of the blood thinner Xarelto overstated the effectiveness of the drug, failed to fully research the medication to better understand the risks, and knowingly concealed problems associated with the drug, according to a lawsuit filed by a California man. Kenneth Niemeier claims he suffered injuries after being treated with Xarelto, resulting in physical pain, mental anguish, diminished enjoyment of life, loss of earnings and medical expenses. His lawsuit names Janssen Research & Development, a subsidiary of Johnson & Johnson, and Bayer Healthcare Pharmaceuticals, alleging product liability. Xarelto is an anticoagulant used to prevent or treat blood clots in patients ... Read More

IUD side effects may outweigh benefits

mirena IUD

Women who used an intrauterine device, or IUD, were less likely to develop preeclampsia in subsequent pregnancies, but the protective effect was only found in women who had never been pregnant before getting the IUD, according to a new study. Intrauterine devices, such as the Mirena IUD, are T-shaped devices that are inserted into the cervix to prevent pregnancy. IUDs are considered highly effective but they are not 100 percent effective. The risk of becoming pregnant while implanted with an IUD are greatest during the first year, and women who become pregnant with an IUD in place are at greater risk of ... Read More

Bayer banks on sales of blood thinner Xarelto


Bayer announced it plans to increase sales for its main Healthcare division by 6 percent on average through 2017 to more than $26.7 billion by hanging its hat on new drugs, such as the blood thinner Xarelto. The company says rising sales of these newer drugs have helped offset declines of its birth control pill and multiple sclerosis treatment in the face of competition. Bayer teamed up with Johnson & Johnson subsidiary Janssen Pharmaceuticals to produce Xarelto, which became the second drug in a new class of blood thinners called Xa inhibitors. The anticoagulant is used to prevent or treat blood ... Read More

FDA approves new IUD

mirena IUD

A new intrauterine device (IUD) for birth control has been approved by the Food and Drug Administration (FDA). Liletta, which is already approved in Europe, is similar to Bayer’s Mirena and Skyla IUDs, which work by releasing a small amount of the hormone levonorgestrel. The approval is based on a comprehensive study of 1,751 women during which the device was found to be 99.45 percent effective at preventing pregnancy over a three-year period. The device showed effectiveness in women regardless of age, body mass index, or whether they had previously given birth. The study participants will continue to be followed ... Read More

European drug regulators expand indication for blood thinner Xarelto


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


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


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


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