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FDA’s stance on Pradaxa based on flawed data

Filed November 9th, 2012 Joshua Sophy

The Food and Drug Administration’s recent announcement that the rate of severe bleeding episodes suffered by people prescribed the blood thinner drug Pradaxa is about the same as any other drug on the market has come under scrutiny.

According to a Forbes.com report, the Observational Medical Outcomes Project believes the FDA’s methods for reaching that conclusion may be lacking. The non-profit group established in part by the FDA itself found that the agency’s method of using “unadjusted incidence rate ratios” does not account for all of the dangers posed by the relatively new blood thinner drug, Pradaxa.

Pradaxa has been blamed for more than 500 deaths worldwide but the FDA believes the company’s maker, Germany-based Boehringer Ingelheim, that this rate of death is expected and about the same as people taking other drugs for the same purpose, such as warfarin (Coumadin).

For instance, the non-profit found in a statement released this week, the FDA does not account for the fact that Pradaxa has no known antidote, meaning that when patients taking the drug suffer a severe bleeding episode, health care professionals are rendered powerless to stop it. This often has fatal consequences, resulting in life-threatening bouts of cerebral and gastrointestinal hemorrhaging.

OMOP suggests the FDA revise its methodology before addressing the risk factors of drugs in the future and that it do so by updating its stance on Pradaxa.

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