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Bayer 169 articles

Approval of Xarelto antidote expected to relieve fears of uncontrolled bleeds

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The approval of an antidote to reverse the blood thinning effects of the anticoagulant Xarelto is expected in 2016, and it should boost sales of the drug and help prevent serious injuries and deaths from major bleeding events. Xarelto, made by Bayer AG and Johnson & Johnson subsidiary Janssen Pharmaceuticals, was approved in 2011 to go head-to-head with the long-used warfarin in the prevention of strokes in patients with atrial fibrillation. It has since been approved to treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. ... Read More

A-fib patients taking multiple meds at greater risk of bleeds

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As many as two thirds of atrial fibrillation (A-fib) patients are taking at least five medications, and many are taking as many as nine, a new study reveals. While multiple medications do not appear to increase stroke risk in these patients, it does increase their risk of bleeding. Atrial fibrillation is a common heart rhythm abnormality that can cause blood to pool in the chambers of the heart and form blood clots. These clots can travel from the heart to the brain, causing strokes. Patients with atrial fibrillation are often treated with blood thinners to reduce their risk for stroke. For ... Read More

Oregon to offer birth control pills without prescription

Birth control pills

Women in Oregon will now be able to get birth control pills without a prescription, thanks to a groundbreaking state law that will take effect later this year. Women who wish to obtain birth control without a doctor’s orders will be required to fill out a health questionnaire that would be examined by pharmacists who will determine whether the women should receive the pills. Pharmacists must first undergo specific training before they will be allowed to give birth control pills to women without prescriptions. Lawmakers have argued that requiring women to see a doctor in order to get a prescription ... Read More

Authorities question blood clotting test used in studies to approve Xarelto

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European and U.S. drug regulators are investigating whether trial data used to gain marketing approval in both countries for the blood thinner Xarelto was affected by a defective blood clotting test. Xarelto, known chemically as rivaroxaban, is manufactured by Bayer and Johnson & Johnson unit Janssen Pharmaceuticals. Xarelto has become Bayer’s top-selling drug with more than $1.8 billion in sales for 2014 and even greater sales expected for 2015. It is used to prevent strokes in patients with a type of irregular heart rhythm called atrial fibrillation, as well as the prevention and treatment of deep vein thrombosis and pulmonary embolism, ... Read More

Illinois woman files Xarelto bleeding risks lawsuit

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Chezarea Jones lodged a 32-count complaint against Bayer and Johnson & Johnson’s Janssen Pharmaceuticals alleging the companies did not adequately warn about bleeding risks with their blood thinner Xarelto. The lawsuit was filed in St. Clair County (Illinois) Circuit Court on Oct. 13. Jones’ lawsuit is one of hundreds filed against Bayer, Johnson & Johnson and Janssen alleging the companies did not properly warn doctors and health care providers of the dangers associated with Xarelto while knowingly exaggerating the drug’s benefits and uses compared to other drugs. Xarelto was initially approved by the Food and Drug Administration (FDA) in 2011 ... Read More

FDA approves new indication for blood thinner Pradaxa

blood cells

The Food and Drug Administration (FDA) has expanded the use of the blood thinner Pradaxa, known chemically as dabigatran etexilate mesylate, for the prevention of blood clots in patients who have recently undergone hip replacement surgery. This is the fourth indication for Pradaxa since the drug was approved in 2010. Pradaxa, manufactured by Boehringer Ingelheim, was initially approved for the prevention of strokes in patients with a common heart rhythm abnormality called atrial fibrillation. It was the first drug in a new class of blood thinners known as factor Xa inhibitors. Since then, the FDA has approved three other blood ... Read More

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

xarelto

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

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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

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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

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