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

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Abstract
Published and unpublished spontaneously reported thrombotic adverse events (AEs) in factor VIII inhibitor bypass activity (FEIBA®) recipients were compiled for the most recent 10-year period during which FEIBA® units equivalent to 3.95 × 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® 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® recipients are very rare. Recognition of risk factors and avoidance of FEIBA® overdosage may avert thrombotic AEs.