title: Safety of factor VIII inhibitor bypass activity (FEIBA): 10-year compilation of thrombotic adverse events.
abstract: Published and unpublished spontaneously reported thrombotic adverse events (AEs) in factor VIII inhibitor bypass activity (FEIBA(R)) recipients were compiled for the most recent 10-year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.
authors.affiliation: Baxter BioScience, Vienna, Austria, Baxter BioScience, Glendale, California, USA. hartmut.ehrlich@baxter.com
authors.forename: H J
authors.initials: HJ
authors.lastname: Ehrlich
authors.forename: M J
authors.initials: MJ
authors.lastname: Henzl
authors.forename: E D
authors.initials: ED
authors.lastname: Gomperts
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D001779:Blood Coagulation Factors / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004211:Disseminated Intravascular Coagulation / Q000139:chemically induced; D062787:Drug Overdose; D005169:Factor VIII / Q000037:antagonists & inhibitors; D005260:Female; D006467:Hemophilia A / Q000188:drug therapy; D002836:Hemophilia B / Q000188:drug therapy; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced; D012307:Risk Factors; D013927:Thrombosis / Q000139:chemically induced* / Q000453:epidemiology
chemical_list: D001779:Blood Coagulation Factors; D005169:Factor VIII; C065655:anti-inhibitor coagulant complex