The FDA just sent a release stating they are looking at results from a clinical trial that included 18,000 people to see if major bleeding events from Pradaxa (dabigatran) are occurring more frequently than first reported. What stimulated this action were post-marketing reports of major bleeding events. FDA will release information regarding their analysis when available. Here’s the FDA link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm
In the meantime, use Pradaxa with caution in older adults, not with NSAIDs and adjust the dose in those with renal impairment.