Clinical experience with activated factor VII: focus on safety aspects.

Recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk, Bagsvaerd, Denmark) has been used extensively worldwide for the treatment of haemophilic patients who have inhibitors to either factor VIII (FVIII) or FIX as well as other miscellaneous conditions. Over 1500 bleeding episodes have been treated with rFVIIa, and various surgical procedures have also been carried out under cover of this product. With the exception of one patient who had FVII deficiency, no antibodies to FVII have been detected. Serious adverse events in patients have been minimal: it is estimated that less than 1% of patients have had a serious adverse event that was possibly related to infusion of rFVIIa. Analysis of these events on a case-by-case basis suggests that rFVIIa is a very safe product with very few side effects. In particular, thromboembolic complications have occurred rarely, if at all.