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Pradaxa - A Flawed Drug

Steve Wagner

Pradaxa is an anticoagulant or blood-thinner that is prescribed for patients suffering from atrial fibrillation, a heart condition that affects more than 2 million Americans. It was first approved by the F.D.A in October 2010 to prevent strokes. Prior to the approval of Pradaxa, the drug of choice for patients with atrial fibrillation was warfarin, which has been used since the 1950’s. Warfarin is a difficult drug to use, needing constant patient monitoring and routine blood tests to check its effectiveness. Pradaxa, on the other hand, requires no monitoring and is reportedly better at preventing strokes. As a result, when it was approved, it was hailed as the next mainstay in the treatment of atrial fibrillation and in less than a year, more than 1 million prescriptions were filled out for Pradaxa. Sales of Pradaxa took off reaching more than $200 million in the beginning of 2012.

Studies and patient experiences have proved, however, that all that glitters is not gold. Almost since the inception of its use, there have been a number of adverse reactions attributed to the drug. The most commonly reported side effect is bleeding. Bleeding is seen in more than 1 in 10 patients using Pradaxa. There have been many cases of people bleeding to death after a minor fall. In fact, there were more than 500 deaths associated with Pradaxa in 2011. The ISMP’s (Institute For Safe Medication Practices) 2011 report on drug risks ranked Pradaxa as the drug with the highest associated risk. It accounted for more than 3500 adverse events and surpassed all other drugs in reports of hemorrhage, acute renal failure, and stroke.

While warfarin too causes bleeding in patients, this bleeding can be stopped as Warfarin’s anticoagulant properties can be reversed by prescribing vitamin K and other substances. Pradaxa, however, has no antidote. In other words, once the bleeding starts, there is little that can be done to stop it. Research also shows that patients using Pradaxa had more than a 30% increased risk of having a heart attack when compared to warfarin. The risk of bleeding is especially higher in elderly patients with kidney or gastrointestinal problems.

Amidst the rising chorus of complaints against Pradaxa from doctors and patients, authorities in Europe, Australia, and Japan have issued safety warnings against this drug. Pradaxa’s manufacturer, Boehringer Ingelheim, says they are working on an antidote, but until then they are putting the lives of thousands at risk. As it is, more than 700,000 patients have already been prescribed Pradaxa in the U.S. to date and since it is still approved by the FDA, that number is set to go higher.

Pradaxa may be a premier anticoagulant, but its risks far outweigh the benefits. If you or any of your loved ones have experienced severe side effects or even death due to Pradaxa use, contact one of our Indiana defective drug attorneys to learn more about your legal rights. We will provide you with a free evaluation of your case and inform you about any compensation that you may be entitled to.


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