Bleeding incidence and real-life prescribing practices with dabigatran use in an acute care setting.

Abstract

Since dabigatran's emergence in the United States market for use in preventing stroke and systemic embolism in nonvalvular atrial fibrillation, the Food and Drug Administration has issued two safety alerts for serious bleeding events. The postmarketing findings, along with anecdotal clinician concerns, prompted this drug utilization evaluation for dabigatran. We included all adult patients administered dabigatran from January 1, 2011, to December 31, 2011, while admitted to a large university-affiliated medical center. Dabigatran is available on formulary with a dosing and monitoring policy developed by a multidisciplinary subcommittee of the formulary and therapeutics committee. This is an institutional review board-approved retrospective chart review of 172 patients administered dabigatran during hospitalization. Incidence of gastrointestinal bleeds and minor bleeds with the use of dabigatran. The incidence of gastrointestinal bleeds in our study was 2.3% and minor bleeds was 2.3%. Doses outside of the manufacturer's recommendations were not associated with overt bleeds while in the hospital. Our results demonstrate that the incidence of bleeds experienced with dabigatran was relatively low despite the reports received by FDA.