Recombinant Factor VIIA in the Treatment of Bleeding

Madhu V. Midathada, MD; Paulette Mehta, MD; Milton Waner, MD; Louis M. Fink, MD


Am J Clin Pathol. 2004;121(1) 

In This Article

Side Effects

Laboratory, animal, and human studies have demonstrated the thrombogenicity of rFVIIa.[135,136] Several case reports already have been described in the preceding sections. Acute myocardial infarction was reported in a patient with hemophilia A and inhibitors after receiving rFVIIa for dental extraction, which shows that transfusion of rFVIIa might promote thrombotic complications, although the thrombogenic potential of rFVIIa is much less than that of activated PCCs.[137] Rosenfeld et al[138] described a patient with severe hemophilia A and factor VIII inhibitors in whom pulmonary embolism developed following sequential treatment with activated PCC and rFVIIa. As mentioned earlier, in 1 of 3 patients with Glanzmann thrombasthenia treated with rFVIIa, severe thromboembolic complication developed 5 days after discontinuing rFVIIa treatment.[65,139] A single institutional report on the use of rFVIIa in 16 patients during a 2-year period recorded 2 thrombotic events following the administration of rFVIIa.[140]

A study of 54 cases of retinal venous occlusion (RVO) showed that factor VIIa levels were significantly higher in the RVO group than in the control group. There was no significant difference in the factor VIIa levels between the central RVO group and the branched RVO group. Hypertension was highly prevalent in cases of branched RVO. These findings suggest that elevated levels of factor VIIa might have a role in the pathophysiology of central and branched RVO.[141]

When used in coagulation and platelet disorders, rFVIIa is associated with few side effects. As of November 2000, in an estimated 4,500 patients treated, 5 episodes of DIC, 7 episodes of myocardial infarction, 4 incidents of cerebrovascular ischemia or infarction, 5 episodes of deep vein thrombosis, and 1 episode of intestinal gangrene have been reported, and most of these cases had apparent comorbid or predisposing factors.[142]

Caution should be exercised when using rFVIIa in patients with underlying conditions that might predispose them to thrombosis and DIC, including crush injury, septicemia, atherosclerotic diseases, and advanced age.


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