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dabigatran 28 articles

Pradaxa associated with more severe bleeding events than warfarin

The blood thinner Pradaxa (dabigatran) causes more major bleeding events including gastrointestinal bleeding than the commonly used warfarin, but fewer brain bleeds occurred in Pradaxa users compared to warfarin users, according to a new study. Pradaxa was approved in 2010 by the Food and Drug Administration (FDA) to prevent strokes and blood clots in patients with a common type of abnormal heart rhythm known as atrial fibrillation, a condition that can cause strokes. Pradaxa was the first in a new class of anticoagulants, and the first to go head-to-head against the long-prescribed warfarin for stroke prevention in atrial fibrillation patients. ... Read More

Did Boehringer Ingelheim withhold safety information about blood thinner Pradaxa?

When Pradaxa (dabigatran) hit the market in 2010 to prevent strokes in patients with atrial fibrillation, it became the first alternative treatment to the long-used warfarin for patients with the condition. What made Pradaxa so attractive compared to warfarin (Coumadin) is that patients taking Pradaxa did not have to have their blood monitored on a regular basis in order to prevent potentially deadly bleeding events. However, a British Medical Journal investigation has found that Boehringer Ingelheim, maker of Pradaxa, withheld information that showed patients taking Pradaxa who underwent routine drug level monitoring and dose adjustment could cut bleeding risk by ... Read More

Boehringer Ingelheim to pay $650 million to resolve Pradaxa lawsuits

Boehringer Ingelheim announced it will pay $650 million to resolve about 4,000 state and federal lawsuits alleging the company’s blood thinner Pradaxa caused patients to suffer serious bleeding events. Boehringer Ingelheim denied any wrongdoing and said the settlement is being offered to avoid lengthy litigation. The drug company said it expects most, if not all, the plaintiffs to accept the terms of the settlement, and it will vigorously defend itself against those who do not. Pradaxa (dabigatran) was the first drug to be approved from a new class of blood thinners. The drug has been plagued with reports of excessive ... Read More

Blood thinner Pradaxa linked to greater risk of major gastrointestinal bleeding events

The blood thinner Pradaxa (dabigatran) can help prevent strokes and death better than the long-used warfarin, however it puts users at greater risk for dangerous gastrointestinal bleeding events, according to a Food and Drug Administration (FDA) Drug Safety Communication. Both Pradaxa and warfarin are used to reduce the risk blood clots that can lead to strokes in patients with a common type of heart rhythm abnormality called non-valvular atrial fibrillation. Warfarin has been used for more than 50 years, but patients require regular monitoring due to the bleeding risks. Pradaxa was approved in 2010 and became the first anticoagulant alternative ... Read More

New black box warning added to blood thinner Pradaxa


Stopping treatment of the blood thinner Pradaxa (dabigatran) increases the risk of stroke, according to a new black box warning placed on the drug’s label. Pradaxa is an anticoagulant that was approved in 2010 for the prevention of strokes in patients with a type of heart rhythm abnormality known as atrial fibrillation. Patients with atrial fibrillation, a common irregular heartbeat, are at risk for pooling of the blood in the chambers of the heart, which can form a clot. If the clot breaks off and travels to the brain it can cause a life-threatening stroke. To prevent the clotting of ... Read More

Blood thinner Pradaxa may increase risk of flu, other viral infections


The blood thinner Pradaxa may increase the risk and severity of certain viral infections including the flu and myocarditis, an infection that attacks the heart and causes sudden death, a new study suggests. Pradaxa, also known as dabigatran etexilate, was approved by the Food and Drug Administration (FDA) in 2010 to prevent strokes in patients with a type of heart rhythm abnormality known as atrial fibrillation. The drug works by inhibiting thrombin, the body’s central coagulation activator. This process, however, disturbs the protease cascade of molecular events that normally occur in coagulation, which can reduce the innate immune response to ... Read More

Officials offer theories why Pradaxa associated with so many bleeding events


Theories abound as to why bleeding risks with the blood thinner Pradaxa (dabigatran) appear greater than the long-used Coumadin (warfarin). In a perspective published online in the New England Journal of Medicine, Food and Drug Administration (FDA) officials speculate the concern may be due to the heightened sensitivity and vigilance that generally accompany new drugs. Pradaxa is a new class of blood thinner that was approved by the FDA in 2010 to prevent strokes in patients with a common but life-threatening type of abnormal heart rhythm known as atrial fibrillation. It became one of the first alternatives to warfarin, and ... Read More

Atrial fibrillation patients should be aware of risks associated with Pradaxa vs. Warfarin


Anticoagulants are often given to patients with a type of heart rhythm abnormality known as atrial fibrillation to prevent strokes. The reasoning is that in people with atrial fibrillation, the upper chambers of the heart pump abnormally causing blood to pool in the atria. When that happens, blood clots are more likely to form. If a blood clot gets pumped out of the heart and lodges in a blood vessel in the brain, it can cause a stroke. Anticoagulants thin the blood and help prevent clots from forming, which, in turn, help prevent strokes from occurring in patients with atrial ... Read More

Clinical trial on blood thinner Pradaxa terminated due to safety concerns


A clinical trial studying the stroke and blood clot preventative effects of the blood thinner Pradaxa (dabigatran) in patients with mechanical heart valves was terminated after an interim review of the data by the trial’s Data Safety Monitoring Board. Boehringer Ingelheim’s Pradaxa was approved by the Food and Drug Administration (FDA) in 2010 for the prevention of strokes in patients with a common heart rhythm abnormality known as atrial fibrillation. It is the only indication for Pradaxa approved by the FDA; however, a recent study in the journal Circulation: Cardiovascular Quality and Outcomes indicated that the drug has increasing off-label ... Read More

FDA’s latest Pradaxa advisory doesn’t mention the drug’s fatal flaw


In its most recent safety review of Pradaxa (dabigatrin), the U.S. Food and Drug Administration (FDA) says that the risk of serious bleeding associated with the new anticlotting drug appears to be no higher than the bleeding rates associated with warfarin (Coumadin), the decades-old anticoagulant drug Pradaxa was largely designed to replace. Although FDA regulators haven’t changed their recommendations for Pradaxa, they advised health care professionals prescribing the drug to carefully follow dosing recommendations on the drug’s label, especially when using it to treat patients with renal (kidney) impairment. However, the FDA fails to mention what is perhaps the drug’s ... Read More