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Controversial Conclusions of Pradaxa Blood Test Study Concealed

Controversial Conclusions of Pradaxa Blood Test Study Concealed

February 11, 2014 — Federal judges unsealed documents indicating that Boehringer Ingelheim, the drug-maker behind the controversial anti-stroke drug Pradaxa (dabigatran), squashed conclusions from a study indicating that some patients may need routine blood tests.

Risk-factors for Pradaxa bleeding and stroke events:

  • Kidney dysfunction
  • Older age
  • Low body weight
  • Female sex
  • Previous stroke
  • Longer use of Pradaxa
  • Diabetes
  • Aspirin use

According to a report by the New York Times, the problem is that certain patients metabolize more of the drug, resulting in extremely high concentrations that increase their risk of bleeding. On the other end of the spectrum, certain patients do not fully metabolize Pradaxa, resulting in low concentrations that fail to protect against blood clot and stroke.

Paul A. Reilly, the author of the study, debated with co-authors and company leaders about how to present these findings. When the study was published earlier this month in the Journal of the American College of Cardiology, it omitted any indications about blood testing for high-risk patients.

Pradaxa is marketed as a “one size fits all” blood thinner, and a big selling point is that patients do not need routine blood testing. This is an advantage over warfarin, a 50 year-old blood thinner that requires frequent blood tests and dosage adjustments.

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