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 .
Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron
Although oral iron is the initial treatment approach for iron deficiency anemia ( IDA ) , some patients fail to respond to or can not tolerate oral iron . This double‐blind safety and efficacy study of the intravenous ( IV ) iron , ferumoxytol , r and omized patients with a history of unsatisfactory oral iron therapy , or in whom oral iron could not be used ,  to ferumoxytol ( n = 609 ) or placebo ( n = 203 ) . The proportion of patients achieving the primary endpoint ( hemoglobin increase ≥2.0 g/dL at Week 5 ) was 81.1 % with ferumoxytol versus 5.5 % with placebo ( P < 0.0001 ) . The mean increase in hemoglobin from Baseline to Week 5 , a secondary endpoint ( also the alternative preplanned primary efficacy endpoint for other health authorities ) , was 2.7 versus 0.1 g/dL ( P < 0.0001 ) . Achievement of a hemoglobin ≥12 g/dL , time to a hemoglobin increase ≥2.0 g/dL , and improvement in the Functional Assessment of Chronic Illness Therapy Fatigue score also significantly favored ferumoxytol over placebo at Week 5 (  P < 0.0001 ) . Ferumoxytol treatment‐emergent adverse events were mainly mild to moderate . Ferumoxytol was effective and well tolerated in patients with IDA of any underlying cause in whom oral iron was ineffective or could not be used . This trial was registered at www . clinical trials.gov as # NCT01114139 . Am . J. Hematol . 89:7–12 , 2014 . © 2013 Wiley Periodicals ,
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 .