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Steve Thomas
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Two Sides to Pradaxa’s Empirical Coin

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Since January 2012, the FDA-approved warnings and precautions for the blood thinner Pradaxa have included the following:

“Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.”

The drug’s manufacturer, Boehringer Ingelheim Pharmaceuticals Inc., as it defends itself from Pradaxa lawsuits, cannot readily debunk the warning. But it can point to new science that shows another anticoagulant is not better.

Such was the case Dec. 8 at the American Society of Hematology’s annual meeting in Atlanta, where research was presented that compared Pradaxa to warfarin, an older anticoagulant.

Studying what happened to Pradaxa patients and warfarin patients worldwide who experienced “major bleeding,” the study showed that fewer Pradaxa patients required surgery, Pradaxa patients “were more frequently treated with blood transfusions,” and they spent fewer nights in intensive care and coronary care units.

On the other hand, under Pradaxa’s “adverse reactions” precautions, there is something from the other side of the empirical coin:

“In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events. PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin.”

Even the latter finding seems like small potatoes compared to the following excerpt from the executive summary of a May 2012 analysis of serious adverse drug reactions reported to the FDA.

The nonprofit Institute for Safe Medication Practices wrote,

“Dabigatran (PRADAXA), approved in 2010 for the prevention of stroke in patients with atrial fibrillation, accounted for so many reports of serious adverse drug events that [were] prominent in several different categories. It accounted for 3,781 domestic, serious adverse events overall in 2011 (both manufacturer and direct reports), including 542 patient deaths. It surpassed all other regularly monitored drugs in reports of hemorrhage (2,367 cases), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure.”

What makes Pradaxa bleeding so dangerous is that there is no antidote for it.

Someone who experienced serious injury while being exposed to Pradaxa’s increased bleeding risk could read between the lines of the study that the manufacturer touts. Surely, someone who lost a family member to Pradaxa bleeding could explain the grim side of the rosy perspective.

A surviving spouse, for instance, could pluck a portrait of the deceased off of a living room shelf, put it close to the face of a researcher and say, “Do a study on this.”

To many juries in Pradaxa lawsuits, that beacon of irreversibly tormented humanity shines through the fog of dueling studies. And there are cases in which juries just plain get it.

Someone challenging a speeding ticket in court would have a hard time convincing the judge that he or she should not be penalized because other drivers were driving fast; this is analogous to some of the drug-efficacy comparisons. Similarly juries have awarded compensation to Pradaxa victims who were seriously harmed because of an unreasonable, and at one point carelessly uninformed, danger.