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

Published and unpublished spontaneously reported thrombotic adverse events (AEs) in factor VIII inhibitor bypass activity (FEIBA ® ) recipients were compiled for the most recent 10‐year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 × 10 5 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 10 5 infusions (95% CI, 2.32–6.58 per 10 5 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.