Pradaxa a flawed drug, according to experts

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As deaths linked to Pradaxa mount, many doctors are voicing concern over the pharmaceutical drug.  Dr. Bryan A. Cotton, a Houston trauma surgery, is one of those doctors.  According to Dr. Cotton, Pradaxa has contributed to the bleeding deaths of at least eight people at Memorial Hermann-Texas Medical Center.  He provided details on one particular case in which an elderly man arrived at the hospital for treatment after falling at home.  At the time of admission, the man was alert and able to speak, but declined rapidly. “We pretty much threw the whole kitchen sink at him. But he still bled to death on the table” said Dr. Cotton. “You feel helpless. And that’s a very bad feeling for us,” he continued.

Pradaxa differs from older pharmaceutical anticoagulants, such as warfarin, in that there is no antidote to counteract Pradaxa’s blood-thinning effects.  Many in the medical field believe that the approval process which allowed Pradaxa to be marketed was insufficient because it permitted the drug to be prescribed without an antidote.  Boehringer Ingelheim, the manufacturer, reported that they were formulating an antidote.

In the two years since Pradaxa hit the market, it has generated more than $1 billion in sales.  Some believe that doctors are not cautious enough about prescribing the drug, providing it to patients who have a higher risk of bleeding.

According to Dr. Mark L. Mosley, emergency room director at Wesley Medical Center in Kansas, the problem is that the medical professionals who prescribe Pradaxa, as a general rule, are cardiologists and family practitioners, while those who see the harm are E.R. and trauma doctors. Dr. Mosley said it was “shocking, just shocking” that Pradaxa was approved by the FDA without an available antidote.

Dr. Richard H. Schmidt, associate professor of neurology at the University of Utah, treated an 83-year old Pradaxa patient who bled to death. “The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin,” he said.

Boehringer Ingelheim has recommended dialysis to flush the medication from the body of patients who experience bleeding.  The company notes that “the amount of data supporting this approach is limited,” and Dr. Cotton believes that this is not a viable option. “People that are bleeding to death aren’t going to tolerate being put on dialysis,” he said.

The Food and Drug Administration reports that approximately 725,000 people in this country have been prescribed Pradaxa. The agency has received more reports of injury and death linked to Pradaxa than any of the other 800+ drugs monitored by the Institute for Safe Medication Practices.

Over 500 deaths have been associated with Pradaxa use in the United States. To date, more than 100 lawsuits have been filed and many more are anticipated.

For more information, please contact the Ohio Pradaxa lawyers at Clark, Perdue & List. 

Source: The New York Times, “A Promising Drug with a Flaw,” Katie Thomas, November 2, 2012.