The main adverse effects to be expected from the use of rFVIIa is the occurrence of thromboembolic complications. This study reviews the occurrence of adverse effects reported to the FDA over a period of more than 5 and a half years. A total of 431 reports were found including 185 thromboembolic events in 168 patients. However, relating those to therapy with rFVIIa is hindered by the concomitant medications and existing medical condition, added to the inherent limitations of passive surveillance. The safety and efficacy of rFVIIa can best be assessed in the context of randomized clinical trials.

– Maadh Aldouri