title: Off-label use of recombinant factor VIIa in U.S. hospitals: analysis of hospital records.
abstract: BACKGROUND
  Recombinant factor VIIa (rFVIIa) is approved for treatment of bleeding in patients who have hemophilia with inhibitors but has been applied to a wide range of off-label indications.
  
  
  OBJECTIVE
  To estimate patterns of off-label rFVIIa use in U.S. hospitals.
  
  
  METHODS
  Retrospective database analysis.
  
  
  METHODS
  Data were extracted from the Premier Perspectives database (Premier, Charlotte, North Carolina), which contains discharge records from a sample of academic and nonacademic U.S. hospitals.
  
  
  METHODS
  12 644 hospitalizations for patients who received rFVIIa during a hospital stay.
  
  
  METHODS
  Hospital diagnoses and patient dispositions from 1 January 2000 to 31 December 2008. Statistical weights for each hospital were used to provide national estimates of rFVIIa use.
  
  
  RESULTS
  From 2000 to 2008, off-label use of rFVIIa in hospitals increased more than 140-fold, such that in 2008, 97% (95% CI, 96% to 98%) of 18 311 in-hospital uses were off-label. In contrast, in-hospital use for hemophilia increased less than 4-fold and accounted for 2.7% (CI, 1.9% to 3.5%) of use in 2008. Adult and pediatric cardiovascular surgery (29% [CI, 21% to 33%]), body and brain trauma (29% [CI, 19% to 38%]), and intracranial hemorrhage (11% [CI, 7.7% to 14%]) were the most common indications for rFVIIa use. Across all indications, in-hospital mortality was 27% (CI, 19% to 34%) and 43% (CI, 26% to 59%) of patients were discharged to home.
  
  
  CONCLUSIONS
  Accuracy and completeness of the discharge diagnoses and patient medication records in the database sample cannot be verified.
  
  
  CONCLUSIONS
  Off-label use of rFVIIa in the hospital setting far exceeds use for approved indications. These patterns raise concern about the application of rFVIIa to conditions for which strong supporting evidence is lacking.
authors.affiliation: Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Aaron C
authors.initials: AC
authors.lastname: Logan
authors.forename: Veronica
authors.initials: V
authors.lastname: Yank
authors.forename: Randall S
authors.initials: RS
authors.lastname: Stafford
mesh_terms: D000293:Adolescent; D000328:Adult; D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D015942:Factor VIIa / Q000627:therapeutic use*; D006467:Hemophilia A / Q000188:drug therapy; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006490:Hemostatics / Q000627:therapeutic use*; D017052:Hospital Mortality; D006753:Hospital Records; D006761:Hospitals; D006801:Humans; D020300:Intracranial Hemorrhages / Q000188:drug therapy; D008107:Liver Diseases / Q000150:complications / Q000601:surgery; D008875:Middle Aged; D056687:Off-Label Use; D012189:Retrospective Studies; D014481:United States; D014947:Wounds and Injuries / Q000150:complications; D055815:Young Adult
chemical_list: D006490:Hemostatics; D015942:Factor VIIa