pbleeds_-resized-600As discussed in our prior post below (here) PRADAXA or DABIGATRAN has become the subject of Mass Tort litigation with a coordinated Mulit-District Litigation.

The civil case against the manufacturer continues to be developed as coordinated proceedings in the MDL, as well as a number of State courts begin to unravel the tale of “What is DABIGATRAN“. Is it possible that one day we will search for the anti-coagulant in the past tense and ask “What was PRADAXA?“. In other words, could there eventually be a recall or market withdrawal of the increasingly controversial blood thinner? The short answer for now is maybe or the pills may eventually carry a “Black Box Warning”, the strongest available warning required by the FDA for drugs. Ironically, COUMADIN and WARFARIN already carry a “Black Box Warning” but PRADAXA (DABIGATRAN ETEXILATE) does not since the October 2010 launch of the pills.

A November 2, 2012, New York Times story, “A Promising Drug With A Flaw“, by K. Thomas, provides a timely review and upate on PRADAXA cases. The article explores the perspective of a trauma surgeon, Dr. Bryan A. Cotton, and at least 8 deaths he attributes to the drug at one Houston, Texas, area hospital. This coupled to the pill being linked to at least 542 U.S. deaths has contributed to growing concerns over the sudden popularity of the drug. As noted in this story, PRADAXA, or DABIGATRAN, was linked to more reports of injury or death than any other regularly monitored drug, as reported by the Institute for Safe Medication Practices.

The FDA released a statement on November 2, 2012, confirming that it continued to believe, and rely upon the manufacturer’s data, in finding that the drug did not show a higher risk of bleeding than WARFARIN or COUMADIN. However, this in no way addresses the following:

  • There is no quick reversal agent or antidote for the blood thinning effects of PRADAXA (DABIGATRAN ETEXILATE).
  • Claims that the drug can be taken out of the body in an emergency by way of dialysis are arguably an empty promise if the patient at issue is not a regular dialysis patient. There is no significant scientific study to support such claims by the manufacturer, BOEHRINGER INGELHEIM. Send us any and we will remove this statement.
  • Marketing materials emphasize the drug requiring little or no monitoring in contrast to WARFARIN or COUMDADIN. However, the trade off is the serious risk of bleeding out where no antidote exists, the increased risk of gastrointestinal bleeding which may or may not be controllable, and the lack of any established scientific record in comparison to the 50+ year history WARFARIN and COUMADIN have established.

Our office continues to evaluate cases invovling PRADAXA or DABIGATRAN  that involve uncontrollable bleeding, often originating as a gastrointestinal bleed, leading to transfusions, hospitalization and related complications. Unfortunately, some patients and clients have not survived an adverse event involving the anti-coagulant.

Interestingly, there have been 2 PRADAXA RECALLS that have gained little attention despite serious risks associated with the product. Whether the FDA or manufacturer will again RECALL PRADAXA remains to be seen.


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