Tagged Articles

stroke prevention 34 articles

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

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

Statins help lower stroke risk in diabetics, but can increase risk of diabetes in others

Cholesterol-lowering statin medications reduce the risk of recurrent stroke in patients who have diabetes or metabolic syndrome, a group of risk factors that occur together and increase the risk for coronary artery disease, stroke and type 2 diabetes, a new analysis indicates. The study, conducted by researchers at Vanderbilt University, is the first that focuses on the effect of statin treatment on secondary stroke prevention in people with type 2 diabetes or metabolic syndrome. The primary conclusion of the clinical trial found that the statin Lipitor (atorvastatin) reduced the risk of stroke in general. The secondary analysis assessed stroke risk ... 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

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