Report says less favorable Pradaxa data withheld from FDA

| | Cardiovascular Business | Heart Rhythm

Bloomberg News reported that Boehringer Ingelheim provided the FDA with one analysis showing a lower rate of fatal bleeding events in patients treated with dabigatran (Pradaxa) than was found in a second analysis that the company chose not to share.

The drug maker disclosed earlier that it faces more than 2,000 lawsuits in the U.S. from patients or their families over safety issues related to the anticoagulant. 

Boehringer kept Pradaxa analysis from FDA, records show

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