title: Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile.
abstract: BACKGROUND
  In recent years, the hemostatic agent recombinant factor VIIa (rFVIIa) has emerged as a potentially new therapeutic agent for management of coagulopathy in patients with cirrhosis or following severe traumatic injury, a complex problem for clinicians in which standard treatment strategies are not always effective. As with other hemostatic agents, a primary safety concern of rFVIIa therapy is the theoretical possibility that systemic administration could confer an increased risk of thrombotic complications. So far, clinical experience indicates rFVIIa to be a safe treatment for currently approved indications within hemophilia. Little information is available, however, for patient populations outside this clinical setting.
  
  
  METHODS
  This article reviews critical safety data obtained from 13 Novo Nordisk-sponsored clinical trials of rFVIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury.
  
  
  RESULTS
  Thrombotic adverse events were reported for 5.3 percent (23/430) of placebo-treated patients and 6.0 percent (45/748) of patients on active treatment. No significant difference was found between placebo-treated and rFVIIa-treated patients with respect to the incidence of thrombotic AEs, either on an individual trial basis or for these trial populations combined (p=0.57).
  
  
  CONCLUSIONS
  An important determinant for the safety profile reported here is likely to be the specific mechanism of action of rFVIIa, shown in experimental studies to be localized to the site of vascular injury where tissue factor is exposed.
authors.affiliation: Department of Anesthesiology, Emory University Hospital, Atlanta, Georgia, USA.
authors.forename: Jerrold H
authors.initials: JH
authors.lastname: Levy
authors.forename: Abe
authors.initials: A
authors.lastname: Fingerhut
authors.forename: Thomas
authors.initials: T
authors.lastname: Brott
authors.forename: Irene H
authors.initials: IH
authors.lastname: Langbakke
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Erhardtsen
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Porte
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects*; D001778:Blood Coagulation Disorders / Q000188:drug therapy* / Q000209:etiology; D002986:Clinical Trials as Topic; D005167:Factor VII / Q000009:adverse effects / Q000627:therapeutic use*; D015942:Factor VIIa; D005355:Fibrosis / Q000097:blood / Q000150:complications*; D006801:Humans; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D013927:Thrombosis / Q000209:etiology; D014947:Wounds and Injuries / Q000097:blood / Q000150:complications*
chemical_list: D000925:Anticoagulants; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa