PMID- 15456478
OWN - NLM
STAT- MEDLINE
DCOM- 20050721
LR  - 20230829
IS  - 1538-7933 (Print)
IS  - 1538-7836 (Linking)
VI  - 2
IP  - 10
DP  - 2004 Oct
TI  - Comparative thrombotic event incidence after infusion of recombinant factor VIIa 
      versus factor VIII inhibitor bypass activity.
PG  - 1700-8
AB  - Thrombosis is a rare but well-recognized potential complication of Factor VIII 
      Inhibitor Bypass Activity (FEIBA) infusion. Recombinant factor VIIa (rFVIIa) is 
      increasingly used as an alternative to FEIBA; however, the thrombotic safety 
      profile of rFVIIa remains incompletely characterized. To determine the incidence 
      rates of thrombotic adverse events (AEs) after infusion of rFVIIa and FEIBA. Data 
      from the MedWatch pharmacovigilance program of the US Food and Drug 
      Administration, as supplemented by published case reports, were used in 
      conjunction with estimated numbers of infusions available from manufacturers to 
      assess comparative incidence of thrombotic AEs in patients receiving rFVIIa or 
      FEIBA in the period from April 1999 through June 2002. Reported thrombotic AEs 
      were rare, with incidence rates of 24.6 per 10(5) infusions (CI, 19.1-31.2 per 
      10(5) infusions) for rFVIIa and 8.24 per 10(5) infusions (CI, 4.71-13.4 per 10(5) 
      infusions) for FEIBA. Thrombotic AEs were significantly more frequent in rFVIIa 
      than FEIBA recipients (incidence rate ratio, 2.98; CI, 1.71-5.52). The most 
      commonly documented single type of thrombotic AE after rFVIIa infusion was 
      cerebrovascular thrombosis, while myocardial infarction was the most frequent 
      type in patients receiving FEIBA. Contrasting AE reporting patterns between 
      rFVIIa and FEIBA may have contributed to the observed difference in thrombotic 
      event incidence. Nevertheless, this comprehensive pharmacovigilance assessment 
      does not support superior thrombotic safety of rFVIIa and suggests that 
      thrombotic AE risk may be higher in rFVIIa than FEIBA recipients.
FAU - Aledort, L M
AU  - Aledort LM
AD  - Mount Sinai School of Medicine, New York, New York 10029-6574, USA. 
      louis.aledort@mssm.edu
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - England
TA  - J Thromb Haemost
JT  - Journal of thrombosis and haemostasis : JTH
JID - 101170508
RN  - 0 (Blood Coagulation Factors)
RN  - 0 (Recombinant Proteins)
RN  - 9001-25-6 (Factor VII)
RN  - AC71R787OV (recombinant FVIIa)
RN  - CS849DUN3M (anti-inhibitor coagulant complex)
RN  - EC 3.4.21.21 (Factor VIIa)
SB  - IM
CIN - J Thromb Haemost. 2004 Oct;2(10):1698-9. PMID: 15456477
CIN - J Thromb Haemost. 2005 Apr;3(4):818-9; author reply 819. PMID: 15842387
CIN - J Thromb Haemost. 2005 Apr;3(4):820-2; author reply 822. PMID: 15842389
CIN - J Thromb Haemost. 2006 Jul;4(7):1637. PMID: 16839372
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Coagulation Factors/*adverse effects
MH  - Child
MH  - Data Collection
MH  - Factor VII/administration & dosage/*adverse effects
MH  - Factor VIIa
MH  - Humans
MH  - Incidence
MH  - Intracranial Thrombosis/chemically induced
MH  - Middle Aged
MH  - Myocardial Infarction/chemically induced
MH  - Recombinant Proteins/administration & dosage/*adverse effects
MH  - Thrombosis/*chemically induced/epidemiology
EDAT- 2004/10/01 05:00
MHDA- 2005/07/22 09:00
CRDT- 2004/10/01 05:00
PHST- 2004/10/01 05:00 [pubmed]
PHST- 2005/07/22 09:00 [medline]
PHST- 2004/10/01 05:00 [entrez]
AID - S1538-7836(22)18116-X [pii]
AID - 10.1111/j.1538-7836.2004.00944.x [doi]
PST - ppublish
SO  - J Thromb Haemost. 2004 Oct;2(10):1700-8. doi: 10.1111/j.1538-7836.2004.00944.x.