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anticoagulant 48 articles

New black box warning added to blood thinner Pradaxa

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

Pradaxa

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

Yoga helps reduce irregular heartbeat episodes in atrial fibrillation patients

The calming effects of yoga may help reduce the number of irregular heartbeat episodes in patients with a common heart rhythm abnormality known as atrial fibrillation, a new study suggests. Atrial fibrillation is a common problem that affects about 10 percent of the population age 75 and older. In people with atrial fibrillation, blood pools in the heart’s upper chambers, increasing the risk for blood to clot. If the blood clot breaks free it can travel to the brain and cause a stroke. Generally, patients with atrial fibrillation are given drugs to control the heart’s rhythm and rate. They are ... Read More

Multidistrict litigation against maker of blood thinner Pradaxa progressing

Pradaxa

Attorneys are well into the discovery phase with each side producing tens of thousands of documents, and depositions should begin soon for the multidistrict litigation (MDL) case against Boehringer Ingelheim, maker of the blood thinner Pradaxa. Defendants allege that the drug maker did not adequately warn users that the drug put them at greater risk for life threatening bleeding events. They say they were also not warned that no antidote has yet been produced to counter the effects of the drug. “We’re really starting now to get to the meat of the litigation. The pace is picking up more,” Chief ... Read More

FDA approves new safety label for blood thinner Pradaxa

Pradaxa

The Food and Drug Administration (FDA) has approved new language on the safety label of the blood thinner Pradaxa to include new warnings, precautions and contraindications informing patients not to take the drug if they have ever had or plan to have a valve in their hearts replaced. The updated safety label and medication guide comes after an interim analysis of results from a study showed  increased incidents of thromboembolic events (blood clots) and bleeding events in patients with mechanical prosthetic heart valve replacements who used the new anticoagulant. Pradaxa was approved by the FDA in 2010 to prevent strokes ... Read More

FDA warns against blood thinner Pradaxa use in patients with mechanical heart valves

Pradaxa

The blood thinner Pradaxa (dabigatran) should not be used in patients with mechanical heart valves because these patients are at greater risk for strokes, heart attacks and blood clots, and are more likely to bleed after valve surgery, the Food and Drug Administration (FDA) warns. Pradaxa is a new type of blood thinner that was approved by the FDA in 2010 for the prevention of strokes in patients with a common and life threatening heart rhythm abnormality known as atrial fibrillation. It is not approved for patients with atrial fibrillation caused by heart valve problems, but doctors have the discretion ... Read More

Clinical trial on blood thinner Pradaxa terminated due to safety concerns

Pradaxa

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

More than 100 lawsuits filed against makers of Pradaxa blood thinner

Pradaxa

More than 100 lawsuits have been filed in federal courts against Boehringer Ingelheim, the makers of the blood thinner Pradaxa, claiming the drug company failed to warn patients that the drug could cause serious bleeding problems and that there was no antidote to reverse the effects of the drug. Pradaxa was approved in late 2010 by the Food and Drug Administration (FDA) for the prevention of strokes in patients with a common heart rhythm irregularity known as atrial fibrillation. Pradaxa is one of the first anticoagulants since warfarin to be approved for atrial fibrillation patients. Warfarin also carries a bleeding ... Read More