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Bayer 163 articles

AF patients should weigh stroke risk against bleeding risk with blood thinners


Atrial fibrillation, or AF, is the most common type of heart rhythm abnormality in which the heart beats too fast, too slow, or with an irregular rhythm. This causes blood to pool in the chambers of the heart, which can lead to blood clots that can break loose and travel to the brain, causing a stroke. Thus, patients with AF are at an increased risk of stroke. To reduce this risk, AF patients are often treated with blood thinners. But the decision to prescribe anticoagulants to AF patients is a gamble, says Dr. John Mandrola, in an editorial for Medscape. “The drugs ... Read More

Blood clot risk in patients who quit Pradaxa therapy prematurely


The Warnings and Precautions section on the labels of the blood thinner Pradaxa has been updated to include a warning that premature discontinuation of Pradaxa therapy can cause a thrombotic (blood clot) event. Pradaxa is a blood thinner that is prescribed to patients with a common heart rhythm abnormality known as atrial fibrillation. The drug helps prevent pooled blood in the heart chambers from clotting. These clots can travel to the brain and cause a stroke. The new warning states that if Pradaxa is discontinued for a reason other than pathological bleeding or completion of a course of therapy, treating ... Read More

Celebrity endorsements cannot hide bleeding risks with Xarelto


Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer are hoping a parade of celebrities will distract consumers from mounting lawsuits involving their blood thinner Xarelto. The companies have hired NBA player Chris Bosh, NASCAR driver Brian Vickers, golfing great Arnold Palmer, and former Saturday Night Live cast member Kevin Nealon to serve as spokesmen in commercials promoting Xarelto. The four celebrities move in widely different social and professional circles, but gather together as “old friends” for a friendly game of golf followed by lunch at the clubhouse to chat about how “treatment with Xarelto was the right move” for them. ... Read More

FDA approves emergency reversal agent for blood thinner Pradaxa


The Food and Drug Administration (FDA) has granted accelerated approval for Praxbind (idarucizumab), a drug designed to rapidly reverse the blood-thinning effects of the anticoagulant Pradaxa (dabigatran) in the event of a life threatening bleeding event. Pradaxa, which was introduced in 2010, was the first drug in a new class of blood thinners to gain FDA approval. It is used to prevent strokes in patients with atrial fibrillation. It was designed as a more convenient alternative to the long-used warfarin. However, unlike warfarin, there were no antidotes to reverse the blood thinning effects of Pradaxa in the event of a ... Read More

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


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


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