A recent article published in the British Medical Journal asserts that Boehringer Ingelheim withheld from regulators important analyses regarding how to use its blockbuster anticoagulant stroke drug as safely and effectively as possible; Boehringer Ingelheim strongly objects.
Boehringer Ingelheim responded by issuing a press release and video statement to set the record straight following "recent misleading and inaccurate reports in the media" about Pradaxa and claiming that the allegations made by BMJ were reported months ago in the media and have been previously addressed by BI. In February, Bloomberg reported that court records showed that Boehringer Ingelheim failed to disclose a data analysis to the FDA that indicated a higher death rate due to fatal bleeding from Pradaxa
The FDA then launched an inquiry into Pradaxa's safety which concluded that - based on a review of 134,000 patients - Pradaxa has a "a favorable benefit to risk profile" and no changes to its labelling were warranted.
Boehringer Ingelheim maintains that regulators were provided with the “complete data set and analyses” of clinical evidence and that BMJ was also given this information but chose not to include the material in its article.
Read the WSJ blog
