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Several Canadian women sue Bayer over Mirena IUD side effects

mirena IUD

Several Canadian women have filed lawsuits against Bayer alleging the company did not adequately warn that its Mirena intrauterine device could cause serious injuries. The lawsuits mirror concerns of hundreds of other plaintiffs in the United States. In 2013, Health Canada, the country’s drug regulator, received 52 reports of uterine perforations involving the Mirena IUD. Perforations have caused tissue or organ damage. There were also reports that the device migrated from its intended position in the cervix to other parts of the abdomen. Surgery is often required to remove the renegade Mirena IUDs. In some cases women have had to ... Read More

Doctors waiting on real-world safety data from new blood thinners


Drugs from a new class of blood thinners are gaining traction in sales, but analysts say they have a lot to prove before doctors push aside the long-used warfarin for the new drugs. The new blood thinners are from a class known as factor Xa inhibitors and include the brand names Pradaxa, Xarelto and Eliquis. They have been approved sometime within the past five years and are used to prevent strokes caused by blood clots in patients with a common heart rhythm abnormality called atrial fibrillation. Xarelto and Eliquis are also used to treat and prevent blood clots in various ... Read More

Japan expands indication for blood thinner Xarelto


The controversial blood thinner Xarelto has been granted clearance by Japanese drug regulators for expansion of the drug’s usage to include the treatment and secondary prevention of pulmonary thromboembolism (PE) and deep vein thrombosis (DVT). DVT is a condition in which blood clots form in one of the large, deep veins, generally in the legs. PE is a condition that occurs when a blood clot travels to the lungs and partially or completely block a branch of a pulmonary artery. PE can be fatal if the blood clot is large, there are multiple clots, or if the patient has heart or ... Read More

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