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Bayer 169 articles

Bayer cited for minimizing risks of Mirena IUD at promotion parties

mirena IUD

When it comes to promoting a new drug or medical device, drug makers can get creative. But when they overstep the lines, the Food and Drug Administration (FDA) steps in to point out the error of their ways. Such is the case with drug maker Bayer. In 2009, the company partnered with the social media site Mom Central. The plan was to organize in-home events designed to promote the use of the company’s Mirena IUD. The small, flexible, T-shaped device is inserted into the cervix where it releases a small amount of hormone to prevent pregnancy as well as reduce ... Read More

Xarelto safety label updated to include details of major bleeds

xarelto

The ADVERSE REACTIONS section of the safety label for the blood thinner Xarelto (rivaroxaban) has been updated to include more detailed information about bleeding risks. Xarelto, made by Bayer and Johnson & Johnson unit Janssen Pharmaceuticals, was first approved by the Food and Drug Administration (FDA) in 2011. It is used to prevent strokes in patients with an irregular heart rhythm called atrial fibrillation, to treat and prevent blood clots of the deep veins and lungs, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. Xarelto was designed to go head-to-head with the ... Read More

NY new advertising campaign promotes IUD for birth control

mirena IUD

The New York Health Department is hoping a new advertising campaign will encourage women to consider getting intrauterine devices, or IUDs. The ads, which feature all five boroughs, are produced in English and Spanish. They feature bright colors with eye-catching designs. One of the ads reads, “You spent the night in Brooklyn. But you left your birth control in Staten Island. Maybe the IUD is right for you.” The ads will run for three months citywide, with 1,000 appearing on subway stations and 20 big posters at bus stations. They also feature the social-media hashtag, #MaybeTheIUD. IUDs are small devices ... Read More

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

xarelto

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

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

explosion

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

Essure

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

xarelto

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

xarelto

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