Dabigatran increases gastrointestinal bleed risk: FDA review

The study included information on more than 134,000 patients aged 65 years or older who were new users of the drug. 

The risk of myocaridal infarction was similar for warfarin and dabigatran. 

The FDA said the new study was based on a much larger and older patient population than those in its earlier review of post-market data. 

The study also “employed a more sophisticated analytical method to capture and analyse the events of concern.”

"The FDA still considers Pradaxa to have a favourable benefit to risk profile and has made no changes to the current label or recommendations for use," it said in a statement. 

The FDA's findings were mostly consistent with earlier clinical trial results from the pivotal RE-LY study, although an increased risk for MI found in RE-LY was not found in the new FDA study.