title: Bleeding incidence and real-life prescribing practices with dabigatran use in an acute care setting.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  We included all adult patients administered dabigatran from January 1, 2011, to December 31, 2011, while admitted to a large university-affiliated medical center.
  
  
  METHODS
  Dabigatran is available on formulary with a dosing and monitoring policy developed by a multidisciplinary subcommittee of the formulary and therapeutics committee.
  
  
  METHODS
  This is an institutional review board-approved retrospective chart review of 172 patients administered dabigatran during hospitalization.
  
  
  METHODS
  Incidence of gastrointestinal bleeds and minor bleeds with the use of dabigatran.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Our results demonstrate that the incidence of bleeds experienced with dabigatran was relatively low despite the reports received by FDA.
authors.affiliation: St. John's University College of Pharmacy and Health Sciences, Queens, New York, USA.
authors.forename: Tran H
authors.initials: TH
authors.lastname: Tran
authors.forename: Caroline
authors.initials: C
authors.lastname: Nguyen
authors.forename: Timothy
authors.initials: T
authors.lastname: Lam
authors.forename: Peter
authors.initials: P
authors.lastname: Campbell
mesh_terms: D000328:Adult; D000991:Antithrombins / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000188:drug therapy; D000069604:Dabigatran / Q000009:adverse effects*; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced*; D006801:Humans; D015994:Incidence; D012189:Retrospective Studies
chemical_list: D000991:Antithrombins; D000069604:Dabigatran