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New Investigation Questions Whether Pradaxa Should Have Been Approved

Who Knew What, and When Did They Know It?

If you have been hurt by the blood thinning drug Pradaxa, then the answer to this question is an important one for you to know. Did you suffer an unfortunate side effect that could not have been reasonably foreseen or was there information about the risk that was available before the drug ever entered the U.S. market?

A New Investigation Seeks to Answer the Question

Recently, the BMJ (formerly the British Medical Journal) released information about its investigation into Pradaxa. Here is what the investigators found:

  • Boehringer Ingelheim, the manufacturer of Pradaxa, may have failed to share important information with the FDA. There was allegedly research available that showed the benefit of regularly monitoring a patient’s anticoagulant activity while on Pradaxa and adjusting the dosage of the drug so as to avoid dangerous bleeding. Boehringer Ingelheim reportedly alleges that the research was withheld because it was unreliable.
  • As early as 2011, Boehringer Ingelheim was concerned about fatal bleeds and whether they could be prevented by adjusting the dosage of the drug based on test results. These concerns were reportedly not shared with the public.
  • The drug manufacturer and the FDA continue to maintain that regular monitoring is not required for patients taking Pradaxa. Some scientists are concerned about this, however.

If you have suffered a significant bleeding incident while on Pradaxa, then you deserve to know whether your injury could have been prevented. Please follow us on Facebook to stay up to date on important developments regarding Pradaxa, and please speak to your doctor in Des Moines, Cedar Rapids, or elsewhere in Iowa about what you can do to protect your health.

Jason F. Abraham
Managing Partner, Hupy and Abraham
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