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Volumn 8, Issue 2, 2002, Pages 83-90

Safety of factor VIII inhibitor bypass activity (FEIBA®): 10-year compilation of thrombotic adverse events

Author keywords

Adverse drug reaction reporting systems; Blood coagulation factor inhibitors; Factor VIII; Product surveillance; Safety; Thrombosis

Indexed keywords

ACTIVATED PROTHROMBIN COMPLEX; BLOOD CLOTTING FACTOR; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; LIPID;

EID: 0036489638     PISSN: 13518216     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-2516.2002.00532.x     Document Type: Article
Times cited : (203)

References (36)
  • 1
    • 0031984019 scopus 로고    scopus 로고
    • Comparison of high responder inhibitor frequency in recent studies of previously untreated patients with hemophilia A
    • Ehrlich HJ, Bray GL, Gomperts ED. Comparison of high responder inhibitor frequency in recent studies of previously untreated patients with hemophilia A. Thromb Haemost 1998; 79: 242-3.
    • (1998) Thromb. Haemost , vol.79 , pp. 242-243
    • Ehrlich, H.J.1    Bray, G.L.2    Gomperts, E.D.3
  • 2
    • 0032836392 scopus 로고    scopus 로고
    • Epidemiology of inhibitor development in haemophilia A patients treated with virus-inactivated plasma-derived clotting factor concentrates
    • Kreuz W, Escuriola-Ettingshausen C, Martinez-Saguer I, Kaiml M, Kornhuber B. Epidemiology of inhibitor development in haemophilia A patients treated with virus-inactivated plasma-derived clotting factor concentrates. Vox Sang 1999; 77: 3-8.
    • (1999) Vox Sang , vol.77 , pp. 3-8
    • Kreuz, W.1    Escuriola-Ettingshausen, C.2    Martinez-Saguer, I.3    Kaiml, M.4    Kornhuber, B.5
  • 3
    • 0032730866 scopus 로고    scopus 로고
    • Management of haemophilia in patients with high-titre inhibitors: Focus on the evolution of activated prothrombin complex concentrate AUTOPLEX T
    • Penner JA. Management of haemophilia in patients with high-titre inhibitors: focus on the evolution of activated prothrombin complex concentrate AUTOPLEX T. Haemophilia 1999; 5 (Suppl. 3): 1-9.
    • (1999) Haemophilia , vol.5 , pp. 1-9
    • Penner, J.A.1
  • 4
    • 0020662181 scopus 로고
    • The use of factor eight inhibitor by-passing activity (FEIBA Immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors
    • FEIBA Study Group
    • Hilgartner MW, Knatterud GL, FEIBA Study Group. The use of factor eight inhibitor by-passing activity (FEIBA Immuno) product for treatment of bleeding episodes in hemophiliacs with inhibitors. Blood 1983; 61: 36-40.
    • (1983) Blood , vol.61 , pp. 36-40
    • Hilgartner, M.W.1    Knatterud, G.L.2
  • 5
    • 0025180213 scopus 로고
    • Efficacy and safety of vapor-heated anti-inhibitor coagulant complex in hemophilia patients
    • FEIBA Study Group
    • Hilgartner M, Aledort L, Andes A, Gill J, FEIBA Study Group. Efficacy and safety of vapor-heated anti-inhibitor coagulant complex in hemophilia patients. Transfusion 1990; 30: 626-30.
    • (1990) Transfusion , vol.30 , pp. 626-630
    • Hilgartner, M.1    Aledort, L.2    Andes, A.3    Gill, J.4
  • 6
    • 0027985567 scopus 로고
    • Inhibitors in hemophilia patients: Current status and management
    • Aledort L. Inhibitors in hemophilia patients: current status and management. Am J Hematol 1994; 47: 208-17.
    • (1994) Am. J. Hematol , vol.47 , pp. 208-217
    • Aledort, L.1
  • 7
    • 0030837755 scopus 로고    scopus 로고
    • Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors
    • French FEIBA Study Group
    • Negrier C, Goudemand J, Sultan Y, Bertrand M, Rothschild C, Lauroua P, French FEIBA Study Group. Multicenter retrospective study on the utilization of FEIBA in France in patients with factor VIII and factor IX inhibitors. Thromb Haemost 1997; 77: 1113-9.
    • (1997) Thromb. Haemost , vol.77 , pp. 1113-1119
    • Negrier, C.1    Goudemand, J.2    Sultan, Y.3    Bertrand, M.4    Rothschild, C.5    Lauroua, P.6
  • 8
    • 0032729979 scopus 로고    scopus 로고
    • Complications associated with the treatment of haemophiliacs with inhibitors
    • Green D. Complications associated with the treatment of haemophiliacs with inhibitors. Haemophilia 1999; 5 (Suppl. 3): 11-7.
    • (1999) Haemophilia , vol.5 , pp. 11-17
    • Green, D.1
  • 9
    • 4244028468 scopus 로고    scopus 로고
    • Perioperative treatment with recombinant factor VIIa in haemophilic patient with massive intraabdominal bleeding
    • Zupancic-Salek S, Radman I, Labar B. Perioperative treatment with recombinant factor VIIa in haemophilic patient with massive intraabdominal bleeding. Thromb Haemost 1997; 77 (Suppl.): PS-203.
    • (1997) Thromb. Haemost , vol.77 , pp. PS-203
    • Zupancic-Salek, S.1    Radman, I.2    Labar, B.3
  • 11
    • 85007274098 scopus 로고    scopus 로고
    • Baxter BioScience Pharmacovigilance Database (data on file)
    • Baxter BioScience Pharmacovigilance Database (data on file).
  • 12
    • 0026734071 scopus 로고
    • Myocardial infarction after FEIBA therapy in a hemophilia-B patient with a factor IX inhibitor
    • Mizon P, Goudemand J, Jude B, Marey A. Myocardial infarction after FEIBA therapy in a hemophilia-B patient with a factor IX inhibitor. Ann Hematol 1992; 64: 309-11.
    • (1992) Ann. Hematol , vol.64 , pp. 309-311
    • Mizon, P.1    Goudemand, J.2    Jude, B.3    Marey, A.4
  • 13
    • 0027492895 scopus 로고
    • Acute myocardial infarction complicating prothrombin complex concentrate therapy in an 8-year-old boy with hemophilia A and factor VIII inhibitor
    • Karayalcin G, Goldberg B, Cherrick I, Kurer C, Bierman F, Lanzkowsky P. Acute myocardial infarction complicating prothrombin complex concentrate therapy in an 8-year-old boy with hemophilia A and factor VIII inhibitor. Am J Pediatr Hematol Oncol 1993; 15: 416-9.
    • (1993) Am. J. Pediatr. Hematol. Oncol , vol.15 , pp. 416-419
    • Karayalcin, G.1    Goldberg, B.2    Cherrick, I.3    Kurer, C.4    Bierman, F.5    Lanzkowsky, P.6
  • 15
    • 0030897438 scopus 로고    scopus 로고
    • Magnetic resonance imaging of myocardial infarction during prothrombin complex concentrate therapy of hemophilia A
    • Gruen DR, Winchester PH, Brill PW, Ramirez E. Magnetic resonance imaging of myocardial infarction during prothrombin complex concentrate therapy of hemophilia A. Pediatr Radiol 1997; 27: 271-2.
    • (1997) Pediatr. Radiol , vol.27 , pp. 271-272
    • Gruen, D.R.1    Winchester, P.H.2    Brill, P.W.3    Ramirez, E.4
  • 17
    • 0022472091 scopus 로고
    • Management of anterior compartment syndrome in two high responder factor VIII inhibitor patients with activated prothrombin complex concentrate
    • Christiansen SE, Ingerslev J, Wallevik K, Farso F, Helmig O, Stenbjerg S. Management of anterior compartment syndrome in two high responder factor VIII inhibitor patients with activated prothrombin complex concentrate. Thromb Res 1986; 42: 707-12.
    • (1986) Thromb. Res , vol.42 , pp. 707-712
    • Christiansen, S.E.1    Ingerslev, J.2    Wallevik, K.3    Farso, F.4    Helmig, O.5    Stenbjerg, S.6
  • 19
    • 0031970658 scopus 로고    scopus 로고
    • Pharmacovigilance in the pharmaceutical industry
    • Talbot JC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol 1998; 45: 427-31.
    • (1998) Br. J. Clin. Pharmacol , vol.45 , pp. 427-431
    • Talbot, J.C.1    Nilsson, B.S.2
  • 20
    • 0034660472 scopus 로고    scopus 로고
    • Thrombotic thrombocytopenic purpura associated with clopidogrel
    • Bennett CL, Connors JM, Carwile JM et al. Thrombotic thrombocytopenic purpura associated with clopidogrel. N Engl J Med 2000; 342: 1773-7.
    • (2000) N. Engl. J. Med , vol.342 , pp. 1773-1777
    • Bennett, C.L.1    Connors, J.M.2    Carwile, J.M.3
  • 21
    • 0019426632 scopus 로고
    • The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial
    • Sjamsoedin LJ, Heijnen L, Mauser-Bunschoten EP et al. The effect of activated prothrombin-complex concentrate (FEIBA) on joint and muscle bleeding in patients with hemophilia A and antibodies to factor VIII. A double-blind clinical trial. N Engl J Med 1981; 305: 717-21.
    • (1981) N. Engl. J. Med , vol.305 , pp. 717-721
    • Sjamsoedin, L.J.1    Heijnen, L.2    Mauser-Bunschoten, E.P.3
  • 22
    • 0031709470 scopus 로고    scopus 로고
    • Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system
    • Alvarez-Requejo A, Carvajal A, Begaud B, Moride Y, Vega T, Arias LH. Under-reporting of adverse drug reactions. Estimate based on a spontaneous reporting scheme and a sentinel system. Eur J Clin Pharmacol 1998; 54: 483-8.
    • (1998) Eur. J. Clin. Pharmacol , vol.54 , pp. 483-488
    • Alvarez-Requejo, A.1    Carvajal, A.2    Begaud, B.3    Moride, Y.4    Vega, T.5    Arias, L.H.6
  • 23
    • 0031984680 scopus 로고    scopus 로고
    • Adverse events after protamine administration in patients undergoing cardiopulmonary bypass: Risks and predictors of under-reporting
    • Kimmel SE, Sekeres MA, Berlin JA, Goldberg LR, Strom BL. Adverse events after protamine administration in patients undergoing cardiopulmonary bypass: risks and predictors of under-reporting. J Clin Epidemiol 1998; 51: 1-10.
    • (1998) J. Clin. Epidemiol , vol.51 , pp. 1-10
    • Kimmel, S.E.1    Sekeres, M.A.2    Berlin, J.A.3    Goldberg, L.R.4    Strom, B.L.5
  • 24
    • 0035651985 scopus 로고    scopus 로고
    • Prescription-event monitoring and reporting of adverse drug reactions
    • Heeley E, Riley J, Layton D, Wilton LV, Shakir SA. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358: 1872-3.
    • (2001) Lancet , vol.358 , pp. 1872-1873
    • Heeley, E.1    Riley, J.2    Layton, D.3    Wilton, L.V.4    Shakir, S.A.5
  • 25
    • 0034019122 scopus 로고    scopus 로고
    • Recombinant factor VIIa is a pan-hemostatic agent?
    • Aledort LM. Recombinant factor VIIa is a pan-hemostatic agent? Thromb Haemost 2000; 83: 637-8.
    • (2000) Thromb. Haemost , vol.83 , pp. 637-638
    • Aledort, L.M.1
  • 26
    • 0000910214 scopus 로고
    • Disseminated intravascular coagulation (DIC) in a hemophiliac treated with recombinant factor VIIa
    • Stein SF, Duncan A, Cutler D, Glazer S. Disseminated intravascular coagulation (DIC) in a hemophiliac treated with recombinant factor VIIa. Blood 1990; 76 (Suppl. 1): 438.
    • (1990) Blood , vol.76 , pp. 438
    • Stein, S.F.1    Duncan, A.2    Cutler, D.3    Glazer, S.4
  • 27
    • 0027522777 scopus 로고
    • Recombinant activated factor VII in the treatment of bleeding episodes in patients with inherited and acquired bleeding disorders
    • Hedner U, Glazer S, Falch J. Recombinant activated factor VII in the treatment of bleeding episodes in patients with inherited and acquired bleeding disorders. Transfus Med Rev 1993; 7: 78-83.
    • (1993) Transfus. Med. Rev , vol.7 , pp. 78-83
    • Hedner, U.1    Glazer, S.2    Falch, J.3
  • 28
    • 0027406324 scopus 로고
    • Treatment of factor VIII inhibitors: Products and strategies
    • Macik BG. Treatment of factor VIII inhibitors: products and strategies. Semin Thromb Hemost 1993; 19: 13-24.
    • (1993) Semin. Thromb. Hemost , vol.19 , pp. 13-24
    • Macik, B.G.1
  • 29
    • 0028037631 scopus 로고
    • Recombinant activated factor VII (rFVIIa) therapy for intracranial hemorrhage in hemophilia A patients with inhibitors
    • Schmidt ML, Gamerman S, Smith HE, Scott JP, DiMichele DM. Recombinant activated factor VII (rFVIIa) therapy for intracranial hemorrhage in hemophilia A patients with inhibitors. Am J Hematol 1994; 47: 36-40.
    • (1994) Am. J. Hematol , vol.47 , pp. 36-40
    • Schmidt, M.L.1    Gamerman, S.2    Smith, H.E.3    Scott, J.P.4    DiMichele, D.M.5
  • 30
    • 0000832790 scopus 로고    scopus 로고
    • The treatment of bleeding in acquired haemophilia with recombinant factor VIIa
    • Hay CRM, Ludlam CA. The treatment of bleeding in acquired haemophilia with recombinant factor VIIa. Haemophilia 1996; 2 (Suppl. 1): 157.
    • (1996) Haemophilia , vol.2 , pp. 157
    • Hay, C.R.M.1    Ludlam, C.A.2
  • 31
    • 0030700329 scopus 로고    scopus 로고
    • The treatment of bleeding in acquired haemophilia with recombinant factor VIIa: A multicentre study
    • Hay CR, Negrier C, Ludlam CA. The treatment of bleeding in acquired haemophilia with recombinant factor VIIa: a multicentre study. Thromb Haemost 1997; 78: 1463-7.
    • (1997) Thromb. Haemost , vol.78 , pp. 1463-1467
    • Hay, C.R.1    Negrier, C.2    Ludlam, C.A.3
  • 32
    • 0001816364 scopus 로고    scopus 로고
    • Failure of recombinant factor VIIa to control surgical bleeding in a severe hemophilia A patient with an inhibitor and possible DIC
    • Stielties N, Ounnoughhene N, Vassilieff D, Sultan Y. Failure of recombinant factor VIIa to control surgical bleeding in a severe hemophilia A patient with an inhibitor and possible DIC. Thromb Haemost 1997; 77 (Suppl.): PS-202.
    • (1997) Thromb. Haemost , vol.77 , pp. PS-202
    • Stielties, N.1    Ounnoughhene, N.2    Vassilieff, D.3    Sultan, Y.4
  • 33
    • 0000350372 scopus 로고    scopus 로고
    • Acute myocardial infarction complicating therapy with FVIII followed by APCC and rFVIIa in a 26-year-old man with haemophilia A and FVIII inhibitor
    • Juvonen E, Kolho E, Anttila VJ, Lommi J, Nissinen M, Rasi V. Acute myocardial infarction complicating therapy with FVIII followed by APCC and rFVIIa in a 26-year-old man with haemophilia A and FVIII inhibitor. Haemophilia 1998; 4: 338.
    • (1998) Haemophilia , vol.4 , pp. 338
    • Juvonen, E.1    Kolho, E.2    Anttila, V.J.3    Lommi, J.4    Nissinen, M.5    Rasi, V.6
  • 34
    • 0031858822 scopus 로고    scopus 로고
    • Safety, efficacy and lessons from continuous infusion with rFVIIa
    • rFVIIa-CI Group
    • Schulman S. rFVIIa-CI Group. Safety, efficacy and lessons from continuous infusion with rFVIIa. Haemophilia 1998; 4: 564-7.
    • (1998) Haemophilia , vol.4 , pp. 564-567
    • Schulman, S.1
  • 35
    • 0032730115 scopus 로고    scopus 로고
    • Acute myocardial infarction following administration of recombinant activated factor VII (NovoSeven) in a patient with haemophilia A and inhibitor
    • Peerlinck K, Vermylen J. Acute myocardial infarction following administration of recombinant activated factor VII (NovoSeven) in a patient with haemophilia A and inhibitor. Thromb Haemost 1999; 82: 1775-6.
    • (1999) Thromb. Haemost , vol.82 , pp. 1775-1776
    • Peerlinck, K.1    Vermylen, J.2
  • 36
    • 0033995709 scopus 로고    scopus 로고
    • Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII
    • Liebman HA, Chediak J, Fink KI, Galvez AG, Shah PC Sham RL. Activated recombinant human coagulation factor VII (rFVIIa) therapy for abdominal bleeding in patients with inhibitory antibodies to factor VIII. Am J Hematol 2000; 63: 109-13.
    • (2000) Am. J. Hematol , vol.63 , pp. 109-113
    • Liebman, H.A.1    Chediak, J.2    Fink, K.I.3    Galvez, A.G.4    Shah, P.C.5    Sham, R.L.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.