PMID- 11952842
OWN - NLM
STAT- MEDLINE
DCOM- 20030723
LR  - 20191105
IS  - 1351-8216 (Print)
IS  - 1351-8216 (Linking)
VI  - 8
IP  - 2
DP  - 2002 Mar
TI  - Safety of factor VIII inhibitor bypass activity (FEIBA): 10-year compilation of 
      thrombotic adverse events.
PG  - 83-90
AB  - Published and unpublished spontaneously reported thrombotic adverse events (AEs) 
      in factor VIII inhibitor bypass activity (FEIBA(R)) recipients were compiled for 
      the most recent 10-year period during which FEIBA(R) units equivalent to 3.95 x 
      105 typical infusions were distributed worldwide. A total of 16 thrombotic AEs 
      were documented over the 10-year period, corresponding to an incidence of 4.05 
      per 105 infusions (95% CI, 2.32-6.58 per 105 infusions). Disseminated 
      intravascular coagulation (n=7) and myocardial infarction (n=5) were the most 
      frequent thrombotic AEs. One fatality occurred in an 87-year-old metastatic 
      cancer patient. In 13/16 (81%) patients known risk factors were present, most 
      commonly FEIBA(R) overdose in 8/16 (50%), obesity in 3/16 (19%) and serum lipid 
      abnormalities in 2/16 (12%). These findings indicate that thrombotic AEs in 
      FEIBA(R) recipients are very rare. Recognition of risk factors and avoidance of 
      FEIBA(R) overdosage may avert thrombotic AEs.
FAU - Ehrlich, H J
AU  - Ehrlich HJ
AD  - Baxter BioScience, Vienna, Austria, Baxter BioScience, Glendale, California, USA. 
      hartmut.ehrlich@baxter.com
FAU - Henzl, M J
AU  - Henzl MJ
FAU - Gomperts, E D
AU  - Gomperts ED
LA  - eng
PT  - Journal Article
PL  - England
TA  - Haemophilia
JT  - Haemophilia : the official journal of the World Federation of Hemophilia
JID - 9442916
RN  - 0 (Blood Coagulation Factors)
RN  - 9001-27-8 (Factor VIII)
RN  - CS849DUN3M (anti-inhibitor coagulant complex)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Coagulation Factors/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Disseminated Intravascular Coagulation/chemically induced
MH  - Drug Overdose
MH  - Factor VIII/antagonists & inhibitors
MH  - Female
MH  - Hemophilia A/drug therapy
MH  - Hemophilia B/drug therapy
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Myocardial Infarction/chemically induced
MH  - Risk Factors
MH  - Thrombosis/*chemically induced/epidemiology
EDAT- 2002/04/16 10:00
MHDA- 2003/07/24 05:00
CRDT- 2002/04/16 10:00
PHST- 2002/04/16 10:00 [pubmed]
PHST- 2003/07/24 05:00 [medline]
PHST- 2002/04/16 10:00 [entrez]
AID - 532 [pii]
AID - 10.1046/j.1365-2516.2002.00532.x [doi]
PST - ppublish
SO  - Haemophilia. 2002 Mar;8(2):83-90. doi: 10.1046/j.1365-2516.2002.00532.x.