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Bayer 183 articles

Blood thinner Brilinta performs poorly in stroke study


AstraZeneca’s blood thinner Brilinta posted dismal results in a large clinical study pitting the heart drug against aspirin in preventing recurrent heart attacks in the 90 days following a stroke. The benefit was so slight that researchers didn’t think it statistically significant, crushing the drug company’s hopes of racking up annual sales of $3.5 billion by 2023. AstraZeneca is also testing the drug in patients with peripheral artery disease, and hopes to have that data later this year. Brilinta is known as an anti-platelet, which prevents blood clots by preventing platelets in the blood from sticking together. It is used ... Read More

Antidote could boost sales of Xarelto, Eliquis


Drugs in a new class of anticoagulants could enjoy a hefty boost in sales if the Food and Drug Administration (FDA) approves an antidote that reverses the blood thinning qualities of the drugs, analysts say. The new class of blood thinners is known as Factor Xa inhibitors, and include Boehringer Ingelheim’s Pradaxa, Johnson & Johnson’s Janssen Pharmaceuticals and Bayer’s Xarelto, and Pfizer’s Eliquis. The drugs are designed to be a more convenient alternative to the long-used warfarin, which interacts poorly with several drugs and foods, requiring patients to be monitored regularly while taking the drug. Factor Xa inhibitors offered similar efficacy ... Read More

Did Xarelto makers withhold critical data from medical journal editors?


Questions are being raised whether Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer, makers of the blood thinner Xarelto, may have left out critical laboratory data when a peer reviewer at the New England Journal of Medicine requested it in order to confirm the accuracy of the data. The red flag was raised after a reporter with The New York Times found a footnote in a federal legal briefing that suggested that the two drug companies may have mislead editors in order to protect their profits. Xarelto raked in nearly $2 billion in U.S. sales last year. It is the ... Read More

British Medical Journal questions validity of Xarelto safety study


Medical professionals are raising questions about validity of clinical trials used to gain regulatory approval in the United States and Europe for the blood thinner Xarelto after a medical device that played a pivotal role in the study was found to be defective and was subsequently recalled. Xarelto, made and marketed by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, was approved by the Food and Drug Administration in 2011. It is now used to prevent strokes in patients with atrial fibrillation, treat and prevent deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently ... Read More

Approval of Xarelto antidote expected to relieve fears of uncontrolled bleeds


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


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


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


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