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anticoagulant 48 articles

Study shows Pradaxa puts users at increased risk for heart attacks, bleeds


The new blockbuster blood thinner Pradaxa may present serious risks of heart attacks and spontaneous bleeding events, according to a study published by the Archives of Internal Medicine. Pradaxa was approved by the Food and Drug Administration (FDA) in October 2010 for the prevention of strokes in patients with a type of irregular heartbeat known as atrial fibrillation (AF). It was the first anticoagulant approved for such use since warfarin (Coumadin) more than 50 years ago. What had members of the health care community so in favor of the new drug was that patients on warfarin have to be monitored ... Read More

Drug company enjoys rising profits from controversial blood thinner Pradaxa

Boehringer Ingelheim Chief Executive Andreas Barner says he expects the drug company’s profits to rise by a “high-single-digit percentage” this year and to continue to climb in 2013 thanks to new blockbuster drugs, including the blood thinner Pradaxa. Blockbuster status is defined as generating annual sales of $1 billion or more. Pradaxa (dabigatran) is the first anticoagulant in more than five decades to be approved by the Food and Drug Administration (FDA) since warfarin (Coumadin). It is indicated for the prevention of strokes in patients with atrial fibrillation, a type of irregular heartbeat that can cause strokes. Pradaxa was presented ... Read More

Pradaxa linked to ‘serious harmful cardiovascular effects,’ study finds


A new study published by the Archives of Internal Medicine warns that patients taking the anticoagulant drug Pradaxa (dabigatran) face greater risks of heart attack and other harmful cardiovascular events than patients taking more conventional blood thinners. Pradaxa, which has been available in the United States since March 2008, came as a highly anticipated alternative to warfarin (Coumadin), a blood-thinning drug that has been around for nearly 60 years and is notoriously tricky to regulate within a patient’s body. The drugs are usually given to older patients with atrial fibrillation, an irregular heartbeat that decreases blood flow and increases the ... Read More

Pradaxa safety issues cause delay in new blood thinner approval

Safety issues following the October 2010 approval by the Food and Drug Administration (FDA) of the blood thinner Pradaxa are being blamed for the three-month delay in the decision on a new blood thinner. Apixaban (Eliquis), made by Pfizer and Bristol-Myers Squibb, was set for FDA review in March but regulators opted to extend the deadline. The FDA had previously granted the application of a six-month priority review, which would have resulted in a decision by March 28. The new decision date is June 28. Eliquis is an anticoagulant indicated for the prevention of stroke in patients with a type ... Read More

Pradaxa may not be best blood thinner to use with ablation therapy


The blood thinner Pradaxa (dabigatran) is approved for the prevention of strokes in patients with an abnormal heart rhythm known as atrial fibrillation, but experts say because of the bleeding risk, it may not be the best anticoagulant to use in patients undergoing ablation therapy. Ablation therapy is a procedure used to treat atrial fibrillation. During ablation therapy, a thin wire, or catheter, is positioned inside the heart near the pulmonary veins. Radio energy is applied to the tip of the catheter and is used to cauterize, or abate, the heart tissue around each pulmonary vein. This electrically “disconnects” the ... Read More

NZ coroner investigates deaths with blood thinner Pradaxa


New Zealand drug authorities are investigating cases of stomach and brain bleeds from blood thinners used to treat heart conditions. Authorities say the bleeding rates with the medications seen in the country mirror those in other parts of the world. The investigation is being conducted by Medsafe, New Zealand Medicines and Medical Device Safety Authority, a business unit of the Ministry of Health and the authority responsible for the regulation of medicines and medical devices in New Zealand. The agency says it has received 301 reports associated with serious bleeding events in the past year which are related to the ... Read More

More Pradaxa adverse events reported to FDA


The new blood thinner Pradaxa (dabigatran) continues to rack up more complaints to the Food and Drug Administration (FDA) than any other regularly monitored drug, with 931 incidents reported to the FDA in the first quarter of 2011, and an additional 856 reported in the second quarter. The data on suspect drugs is gathered by the Institute for Safe Medication Practices (ISMP) and its findings released in its quarterly newsletter. ISMP is a nonprofit organization devoted entirely to medication error prevention and safe medication use. The organization is known worldwide as the premier resource for impartial, timely, and accurate medication ... Read More

Drug company lowers price of controversial blood thinner Pradaxa

Boehringer Ingelheim has announced it is reducing the cost of its oral blood thinner, Pradaxa (dabigatran etexilate), in the UK by 13 percent, a move that the company hopes will encourage the National Health Service (NHS) to make sure the medicine is available to all eligible patients. Pradaxa was recently approved in the UK for the prevention of strokes and systemic embolism in adult patients with non-valvular atrial fibrillation (AF), a type of abnormal heart rhythm, with one or more risk factors. It was approved in the US in October 2010. Pradaxa is in a class of blood thinners known ... Read More