Pradaxa is a drug that is classified as a direct thrombin inhibitor.  Direct thrombin inhibitors slow or prevent the body’s production of thrombin, which is a protein that is essential to the formation of blood clots.  The formation of thrombins is the body’s first step in the process known scientifically as the coagulation cascade, through which the body quickly forms a network of tiny fibers that stem the flow of blood from an injured vessel.  This process is triggered by dabigatran etexilate mesylate, the active ingredient in Pradaxa.

Pradaxa was approved by the FDA in 2010 for the prevention of strokes in patients at high risk for such injuries.  By acting as a “blood thinner,” Pradaxa lowers the chance of blood clots forming in the patient’s body.  Most strokes are caused by blood clots that break loose from their point of origin, to be carried through the circulatory system until they lodge in a blood vessel of the brain, blocking blood flow to the brain.  By reducing or eliminating the presence of blood clots in the body, Pradaxa also reduces the chance of strokes.

However, this same thrombin-inhibiting action that makes the drug work can also create a deadly side-effect.  When the drug is too effective at stopping the formation of blood clots, the body is left defenseless if a high-blood loss injury occurs.  This phenomenon has led to the death of at least 260 patients on Pradaxa, who died from an uncontrollable loss of blood.

The history of Pradaxa problems has been consistent in several countries.  In Japan, regulators asked Boehringer Ingelheim to beef up its warnings regarding potentially deadly bleeding as early as August 19, 2011.  The Japan regulators also wanted the company to emphasize that there was no available antidote to counteract the bleeding once it has begun.

In Australia, where the drug was first approved for use in November 2009, the Australian equivalent of the FDA began to receive reports of “adverse events” almost immediately.  After less than two years of approved use, the Australian agency  had received 203 injury reports, 124 of which were categorized as “serious.”  Many of the injuries occurred quickly, as the patient was transitioning from other stroke-prevention medications to Pradaxa.  The Australian agency actually issued a new warning regarding these problems on October 7, 2011.

Despite these reported problems abroad, Boehringer Ingelheim did not revise its warnings in the United States to address this loss of the risk of blood loss until January 2012.

Pradaxa is made by Boehringer Ingelheim, a German pharmaceutical company.  It is distributed in the United States by a subsidiary named Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Connecticut.