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, double-blind, placebo controlled, multi-center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome.
Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome ( RLS ) . We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit . Sixty patients with primary RLS ( seven males , age 46 ( 9 ) years , S-ferritin < or = 45 microg/L ) recruited from a cohort of 231 patients were r and omly assigned in a 12-months double-blind , multi-centre study of iron sucrose 1000 mg ( n = 29 ) or saline ( n = 31 ) . The primary efficacy variable was the RLS severity scale ( IRLS ) score at week 11 . Median IRLS score decreased from 24 to 7 ( week 11 ) after iron sucrose and from 26 to 17 after placebo ( P = 0.123 , N.S. for between treatment comparison ) . The corresponding scores at week 7 were 12 and 20 in the two groups ( P = 0.017 ) . Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose ( Kaplan-Meier estimate , log rank test P = 0.0006 ) suggesting an iron induced superior long term RLS symptom control . Iron sucrose was well tolerated . This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase ( 7 weeks ) and during long-term follow up in patients with variable degree of iron deficiency . Further studies on target patient groups , dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS
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 .