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Bayer 163 articles

Bayer CropScience Will Pay $5.6 Million To Settle Deadly Plant Explosion Charges


Bayer CropScience has agreed to pay $5.6 million to resolve charges that it violated federal chemical accident prevention laws at its facility in Institute, W. Va., where an explosion killed two people in 2008. The terms of the settlement agreement require Bayer CropScience to commit $4.23 million for improvements in in emergency preparedness and response at its Institute, W. Va., plant and protections for the Kanawha River; pay a $975,000 penalty for safety violations; and spend $452,000 to implement safety measures at chemical storage facilities throughout the U.S. According to the U.S. Justice Department, Bayer CropScience agreed to make a ... Read More

FDA to review safety risks with Essure permanent birth control insert


The Food and Drug Administration (FDA) announced it will hold a safety review on the birth control implant Essure after receiving a “dramatic increase” in the number of complaints involving the device in the past two years. Essure was approved in 2002, and remains the only FDA-approved non-surgical permanent birth control method. It is a flexible coil that is permanently placed into each of the fallopian tubes. The inserts work with the body to form a natural barrier that keeps sperm from reaching the egg, thus preventing pregnancy. The FDA gathered about 20,000 complaints about the device from a closed ... Read More

Xarelto bleeding risks MDL fastest growing mass tort


Lawsuits alleging bleeding risks with the blood thinner Xarelto continue to mount, once again making it the fastest growing mass tort involving product liability claims, according to a monthly analysis of statistics from the U.S. Judicial Panel on Multidistrict Litigation. The latest analysis covers filings from Aug. 17 through Sept. 15. The lawsuits allege that the Xarelto makers, Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, failed to thoroughly test the drug’s safety and efficacy before marketing the medication, and did not adequately warn of Xarelto side effects, which includes major bleeding events including gastrointestinal bleeds, brain hemorrhages, and bleeding deaths. ... Read More

Billie Jean King raises awareness of common heart rhythm abnormality


Former tennis star Billie Jean King is teaming up with Johnson & Johnson unit Janssen Pharmaceuticals to raise awareness of stroke risk in patients who have a common heart rhythm abnormality called atrial fibrillation, or AFib. AFib is the most common type of arrhythmia. It occurs when the top two chambers of the heart beat at different rhythms than the bottom two chambers, which can cause blood to pool in the upper chambers of the heart. This can cause the blood to clot. If a clot breaks free and travels to the brain, it can block blood flow and cause ... Read More

Lawsuits target Xarelto bleeding risks


Bayer’s blood thinner Xarelto is the subject of a growing class action lawsuit alleging bleeding risks in people who used the drug. Xarelto was approved by the Food and Drug Administration in 2011, making it the second in a new class of anticoagulants designed as a more convenient alternative to the long-used warfarin. Xarelto is used to prevent strokes in patients with atrial fibrillation, as well as to prevent or treat blood clots in specific populations of patients. Xarelto and other drugs in its class are considered more convenient than warfarin because patients taking them do not have to be ... Read More

Woman sues doctors for improper placement of Mirena IUD

mirena IUD

A West Virginia woman is suing two doctors for improperly placing her Mirena intrauterine device (IUD), causing her to become pregnant and requiring her to undergo multiple surgeries. Melissa Cutter Johnson filed her lawsuit against Drs. Marcia A. Khalil and Gina Jereza-Harris. Her lawsuit also names Community Health Systems Inc. and Access Health-OB/GYN. According to her complaint, Johnson was implanted with the Mirena IUD at the medical center in September 2009, about three weeks after delivering a baby girl. The device helps prevent pregnancy for up to five years. However, Johnson became pregnant with twin daughters in September 2012. She ... Read More

Xarelto linked to major bleeding events


Gloria Glatz, 88, didn’t let her advancing age keep her from being active. She played Scrabble religiously, enjoyed vising the casino, and was known for whipping up a mean batch of potato salad. When she was diagnosed with a common heart rhythm abnormality known as atrial fibrillation, a condition that causes the blood to clot in the heart, increasing the risk for stroke, instead of treating her with the long-used blood thinner warfarin, her doctors opted for a newer treatment, Xarelto. Introduced in 2011, Xarelto was one of the first drugs in a new class of anticoagulants designed to be ... Read More

New blood thinner will struggle against Pradaxa, Xarelto


Lixiana, the fourth drug in the Factor Xa inhibitor class of blood thinners to hit the market, has won market approval for the prevention of strokes in patients with non-valvular atrial fibrillation who have one or more other risk factors, such as congestive heart failure, high blood pressure, or a prior stroke. But it is unlikely the anticoagulant will be able to step out of the shadow of its forefathers in the class. Lixiana joins the blood thinners Pradaxa, Xarelto and Eliquis for the treatment of atrial fibrillation. Some of the other medications – Xarelto and Eliquis – have a ... Read More

Blood thinner Eliquis taking a bite out of Xarelto sales


Bayer and Johnson & Johnson unit Janssen Pharmaceuticals’ blood thinner Xarelto may be enjoying billion-dollar sales, but investors say that Bristol-Myers Squibb and Pfizer’s competitor anticoagulant Eliquis could give Xarelto a run for its money. The anticoagulant market has long been dominated by warfarin, but blood thinners from a new class of drugs known as factor Xa have been rising in popularity because studies show they are more effective, are easier to dose, and have fewer side effects. Xarelto has been the top contender against Eliquis.The drug was approved in 2011 as a treatment for deep vein thrombosis in patients ... Read More

Blood thinners linked to serious bleeding risks


Physicians at two Texas hospitals are concerned that a two-part investigative report published by the Milwaukee Journal Sentinel and MedPage Today warning consumers about life threatening bleeding risks with newer anticoagulants may prompt some people to abruptly discontinue taking the drugs. Suddenly discontinuing the therapy without first discussing it with a doctor could put one at risk of new or worsening blood clots. It’s a tricky conundrum. Blood thinners can save lives by preventing and treating blood clots. Left untreated, clots can travel to the lungs and cause pulmonary embolism, or to the brain and cause strokes. For decades, patients ... Read More