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reversal agent 16 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

FDA delays vote on surgical drug due to concerns about allergic reactions

An advisory panel to the Food and Drug Administration (FDA) has delayed its decision whether to approve sugammadex, an injection to reverse the muscle relaxant effects of drugs used during surgery. The agency was scheduled to vote on the drug this week but tabled the vote without explanation. Merck, maker of the drug, says the FDA needed more time to assess the results of a recent inspection of a clinical trial site. That trial was to determine whether sugammadex increased the risk of allergic reactions. The drug was voted down in 2008 because of concerns over bleeding events and allergic ... 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

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

Multidistrict litigation against maker of blood thinner Pradaxa progressing


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

More than 100 lawsuits filed against makers of Pradaxa blood thinner


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

Reversal agent for blood thinner Pradaxa currently in development


A highly specific and selective antidote designed to reverse the blood thinning effects of Pradaxa (dibigatran) is currently in development, drug maker Boehringer Ingelheim announced at the 2012 American Heart Association Scientific Sessions in Los Angeles. The antidote, if approved, could be used during critical care situations or where existing reversal strategies may not be sufficient. 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 was one of the first drugs to be approved for the indication since the ... Read More

Authors say FDA approved Pradaxa before safety was established


An effort by the Food and Drug Administration (FDA) to expedite the approval of new drugs for serious medical conditions has allowed some medications to be cleared with inadequate testing to determine safety and efficacy, two drug safety experts claim in an article in the Journal of the American Medical Association. Thomas J. Moore, director of the drug safety publication QuatertWatch, and Curt D. Furberg, emeritus professor of medicine at Wake Forest University, say the FDA’s efforts to speed medications to patients have compromised prescription drug safety. One example they cite is the blood thinner Pradaxa, which was approved in ... Read More