There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .
A randomized controlled study of iron supplementation in patients treated with erythropoietin.
In view of current uncertainty regarding the optimum route for iron supplementation in patients receiving recombinant human erythropoietin ( EPO )  , a prospect i ve r and omized controlled study was design ed to investigate this issue . All iron-replete renal failure patients commencing EPO who had a hemoglobin concentration < 8.5 g/dl and an initial serum ferritin level of 100 to 800 micrograms/liter were r and omized into three groups with different iron supplementation : Group 1 , i.v . iron dextran 5 ml every 2 weeks ; Group 2 , oral ferrous sulphate 200 mg tds ; Group 3 , no iron . All patients were treated with 25 U/kg of EPO thrice weekly subcutaneously . The hemoglobin concentration , reticulocyte count , serum ferritin , transferrin saturation , and EPO dose were monitored every two weeks for the first four months . Thirty-seven patients entered the study ( 12 i.v . , 13 oral , 12 no iron ) . The three groups were equivalent with regard to age , sex , and other demographic details . Even allowing for dosage adjustments , the hemoglobin response in the group receiving i.v . iron ( 7.3 + /- 0.8 to 11.9 + /- 1.2 g/dl ) was significantly greater than that for the other two groups ( 7.2 + /- 1.1 to 10.2 + /- 1.4 g/dl and 7.3 + /- 0.8 to 9.9 + /- 1.6 g/dl for Groups 2 and 3 , respectively ; P < 0.005 for both groups vs. Group 1 at 16 weeks ) . There was no difference between the groups supplemented with oral iron and no iron . Serum ferritin levels remained constant in those receiving i.v . iron ( 345 + /- 273 to 359 + /- 140 micrograms/liter ) , in contrast to the other two groups in which ferritin levels fell significantly ( 309 + /- 218 to 116 + /- 87 micrograms/liter and 458 + /- 206 to 131 + /- 121 micrograms/liter for Groups 2 and 3 , respectively ; P < 0.0005 for Group 1 vs. Group 2 , and P < 0.005 for Group 1 vs. Group 3 at 16 weeks ) . Dosage requirements of EPO  were less in Group 1 ( 1202 + /- 229 U/kg/16 weeks ) than in Group 2 ( 1294 + /- 314 U/kg/16 weeks ) or Group 3 ( 1475 + /- 311 U/kg/16 weeks ; P < 0.05 vs. Group 1 ) . The results of this study suggest that , even in iron-replete patients , those supplemented with i.v . iron have an enhanced hemoglobin response to EPO with better maintenance of iron stores and lower dosage requirements of EPO , compared with those patients receiving oral iron and no iron supplementation
There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .