There is a lack of reliable evidence of the effectiveness of rFVIIa for non-hemophilic indications. Levi and colleagues (2005) performed a systematic review on the safety and effectiveness of rFVIIa in patients with or without coagulation disorders. They concluded that more randomized controlled clinical trials are needed to evaluate the safety and effectiveness of rFVIIa for patients without a pre-existent coagulation disorder and with severe bleeding. In the meantime, off-labeled use of rFVIIa may be considered in patients with life-threatening bleeding. This is in agreement with the observations of Lam et al (2005) who stated that until further prospective controlled data are available, it is recommended that conventional intervention for prevention and control of hemorrhage in non-hemophiliac patients should remain the standard of care. More recently, O’Connell and colleagues (2006) reported that the use of rFVIIa is associated with severe adcerse events (AEs) especially when it is used for off-labeled indications. They analyzed 431 incidents of AEs reported to the FDA during the first 5 years after the approval of NovoSeven. They noted that most reported thromboembolic AEs followed the use of the drug for off-labeled indications (n = 151) and occurred in the arterial and venous systems, often resulting in serious morbidity and mortality. The majority of complications occurred within 24 hours of taking the drug. These investigators concluded that randomized controlled studies are needed to ascertain the safety and effectiveness of rFVIIa in patients without hemophilia.