title: A review of the off-label use of recombinant activated factor VII in a developing country tertiary care center.
abstract: Recombinant activated factor VII (rFVIIa) was first approved for treatment of congenital hemophilia. It could, however, also have a role in management of patients without pre-existing coagulopathies who undergo surgical procedures, have life-threatening hemorrhages, or sustain traumas associated with major blood loss. A retrospective chart review was performed for all cases given rFVIIa at American University of Beirut Medical Center (AUB MC). Patients with a previous medical history of thrombophilia were excluded. There were four pediatric patients with a mean age younger than 1 year. Adult patients' mean age was 64.5 +/- 17.4 years. The most common off-label uses for rFVIIa are control of hemorrhage during the repair of aortic dissection (4/17 cases) or following intracerebral hemorrhage (4/17 case). One trauma patient received the medication. Complications included cerebral ischemia in one patient. Three of the patients died but their death was not related to the bleeding or the medication. Based on the prognostic score proposed by Biss and Hanley, seven patients were low risk, four intermediate risk, and six high risk. Although off-label use of rFVIIa at AUB MC was supported by published reports, and associated with few complications, guidelines are required to control use of this medication.
authors.affiliation: American University of Beirut Medical Center, Beirut, Lebanon.
authors.forename: Ramzi
authors.initials: R
authors.lastname: El Accaoui
authors.forename: Hussain
authors.initials: H
authors.lastname: Isma'eel
authors.forename: Pierre Bou
authors.initials: PB
authors.lastname: Khalil
authors.forename: Ali
authors.initials: A
authors.lastname: Taher
mesh_terms: D000046:Academic Medical Centers / Q000706:statistics & numerical data; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D003029:Coagulants / Q000627:therapeutic use*; D003906:Developing Countries; D004348:Drug Labeling; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006489:Hemostatic Techniques; D006801:Humans; D007223:Infant; D007861:Lebanon; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011379:Prognosis; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D016019:Survival Analysis
chemical_list: D003029:Coagulants; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa