Boehringer Withheld Pradaxa Analysis from FDA
As reported by Bloomberg, court records show that Boehringer Ingelheim failed to disclose a data analysis to the FDA that indicated a higher death rate due to fatal bleeding from anticoagulant Pradaxa.
While the German drugmaker provided the FDA with all of the underlying data, the only analysis that was provided was the one that indicated that the number of people who died from bleeding was less than expected.
Approved in 2010 as the first alternative to warfarin, Pradaxa is currently involved in over 2,000 lawsuits - a figure which Boehringer recently confirmed a few weeks ago after it appeared in a German newspaper.
Read the Bloomberg press release