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bleeding deaths 23 articles

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

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

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

Sanofi under investigation for withholding information about Plavix side effects

Drug maker Sanofi is under investigation by the Department of Justice for not disclosing information about life threatening side effects with its blockbuster blood thinner Plavix. Plavix is an anticoagulant prescribed for heart disease patients to prevent blood clots that can cause heart attacks, strokes and death. The drug grew to be the second revenue-generating drug in the world with annual sales of about $9 billion in 2011 alone. In 2010, the Food and Drug Administration (FDA) added a black box warning to the drug’s safety label informing that certain patients with a genetic variation are unable to properly metabolize ... Read More

FDA to consider heart device to prevent strokes in atrial fibrillation patients

A heart device designed to prevent strokes in patients with the heart rhythm abnormality atrial fibrillation works just as well as a currently available and widely used drug, a key study found. Patients who have atrial fibrillation experience abnormal heart rhythms that can cause the blood in the chambers of the heart to pool. Clots can form in this pooled blood and travel to the brain, causing a stroke. Patients with the condition are typically given blood thinners to prevent strokes. Warfarin has been the long-used anticoagulant for atrial fibrillation patients, until 2010, when the Food and Drug Administration (FDA) ... 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