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 .
Ferumoxytol for treating iron deficiency anemia in CKD.
Iron deficiency is an important cause of anemia in patients with chronic kidney disease ( CKD ) , but intravenous iron is infrequently used among patients who are not on dialysis .  Ferumoxytol is a novel intravenous iron product that can be administered as a rapid injection . This Phase III trial r and omly assigned 304 patients with CKD in a 3:1 ratio to two 510-mg doses of intravenous ferumoxytol within 5 + /- 3 d or 200 mg of elemental oral iron daily for 21 d. The increase in hemoglobin at day 35 , the primary efficacy end point , was 0.82 + /- 1.24 g/dl with ferumoxytol and 0.16 + /- 1.02 g/dl with oral iron ( P < 0.0001 ) . Among patients who were not receiving erythropoiesis-stimulating agents , hemoglobin increased 0.62 + /- 1.02 g/dl with ferumoxytol and 0.13 + /- 0.93 g/dl with oral iron . Among patients who were receiving erythropoiesis-stimulating agents , hemoglobin increased 1.16 + /- 1.49 g/dl with ferumoxytol and 0.19 + /- 1.14 g/dl with oral iron .  Treatment-related adverse events occurred in 10.6 % of patients who were treated with ferumoxytol and 24.0 % of those who were treated with oral iron ; none was serious . In summary , a regimen of two doses of 510 mg of intravenous ferumoxytol administered rapidly within 5 + /- 3 d was well tolerated and had the intended therapeutic effect . This regimen may offer a new , efficient option to treat iron deficiency anemia in patients with CKD
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 .