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 double-blind, placebo-controlled trial of intravenous iron dextran therapy in patients with ESRD and restless legs syndrome.
BACKGROUND Restless legs syndrome ( RLS ) is a common disorder in patients with end-stage renal disease ( ESRD ) that causes motor agitation and insomnia . Because RLS has been associated with iron deficiency , we sought to investigate the effects of intravenous ( IV ) iron dextran on symptoms of RLS in a double-blind placebo-controlled trial . METHODS Patients determined to have RLS by International RLS Study Group criteria were administered either iron dextran , 1,000 mg , or normal saline IV in a blinded fashion . Patient demographic data were collected , and blood chemistry tests , liver function studies , serum iron levels , ferritin levels , and total iron-binding capacity were obtained at baseline and 1 , 2 , and 4 weeks postinfusion . Side effects or adverse events to interventions were monitored , and RLS symptoms were assessed by a rating scale at the same intervals . RESULTS Eleven patients were r and omly assigned to the administration of iron dextran , and 14 patients to the administration of saline .  RLS severity scores were slightly higher in the placebo group at baseline , but hemoglobin levels , iron stores , and other biochemical parameters did not differ . Although no change in symptoms were seen in the placebo-treated group , significant improvement in RLS symptom scores in response to iron dextran was seen 1 week after infusion ( -2 ; interquartile range [ IQR ] , -6 to -1 ; P = 0.03 , Wilcoxon 's rank sums ) , but was greatest at 2 weeks ( -3 ; IQR , -5 to -2 compared with -1 to 0 ; P = 0.01 ) . Salutary effects of iron persisted at 4 weeks , but were no longer statistically significant . The significant increase in serum ferritin levels and iron saturation observed in the iron dextran-treated group was not seen in the placebo-treated group . No differences in adverse events were noted between groups . CONCLUSION High-dose iron dextran infusion is associated with a significant , but transient , reduction in symptoms of RLS in patients with ESRD
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 .