|
FERIDEX I.V.® (ferumoxides injectable solution)
Anaphylactic-like reactions and hypotension have been noted in some patients receiving FERIDEX I.V., other iron and dextran containing formulations, or radiographic contrast media. In clinical trials, anaphylactic and allergic adverse events occurred in 11/2240 (0.5%) of the patients who received FERIDEX I.V. These events included dyspnea, other respiratory symptoms, angioedema, generalized urticaria, and hypotension; and required treatment.
There is not sufficient evidence to support differentiation of lesions as benign or malignant with FERIDEX I.V. Based on clinical studies, the mean number of lesions seen before and after FERIDEX I.V. were comparable.
|
