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Pradaxa 80 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

FDA likely to approve medical device designed to prevent strokes in atrial fibrillation patients

A Food and Drug Administration (FDA) advisory panel specializing on circulatory system devices has voted overwhelmingly to recommend approval to Boston Scientific’s Watchman left atrial appendage closure device designed to prevent strokes in patients who suffer from a common irregular heart rhythm condition known as atrial fibrillation. The panel agreed in three separate 13-1 votes that the device was effective, safe, and that the benefits out weighed the risks. The FDA is not required to follow the advice of its expert panels, however it usually does. And, the agency is expect to approve the device. The big question is whether ... Read More

Boehringer Ingelheim fined for bad faith conduct in Pradaxa lawsuits


German drug company Boehringer Ingelheim was fined nearly $1 million for failing to preserve and produce critical documents in a multidistrict litigation over its blood thinner Pradaxa when the company knew it was facing numerous product liability lawsuits. Company executives were also ordered to be immediately available for depositions in New York or another convenient location for plaintiffs’ counsel. U.S. District Judge David R. Herndon noted that the court has had to referee disputes in the case related to lost, accidentally destroyed or recently discovered evidence, and found these discovery abuses amounted to bad faith conduct. Discovery documents and communications ... Read More

Researchers receive funding for innovative new blood thinner

Researchers have received financial support to develop a new kind of blood thinner they believe may prevent life threatening blood clots without causing major bleeding events, a dangerous side effect to currently marketed anticoagulants. Index Ventures is teaming up with GlaxoSmithKline and Johnson & Johnson to create X01, a new company formed to develop experimental drugs. The new $11 million venture early-stage biotech fund will help fund research into the innovative blood thinner ichorcumab. The drug is still in the very early stages of development with clinical trials not expected for at least another two years. However, financial analysts say ... 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

FDA approves new reversal agent for blood thinner warfarin

The Food and Drug Administration (FDA) has approved Kcentra (Prothrombin Complex Concentrate, Human) for patients who need an immediate reversal of the anti-clotting effects of the blood thinner warfarin. Until now, plasma was the only product approved in the United States to counter acute major bleeding events in patients using warfarin. Warfarin is in a class of blood thinners known as vitamin K antagonists, or VKA. The drug has been on the market for decades comes in both of brand name and generic versions. One of the most common uses for warfarin is to prevent strokes in patients with a ... 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