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 .
Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran.
BACKGROUND Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores . Until recently , the only available form of intravenous iron was iron dextran , which is associated with significant adverse reactions , including anaphylaxis and death . Sodium ferric gluconate complex ( SFGC ) was recently approved for use in the U.S. under FDA 's priority drug review . This Phase IV study was design ed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control . METHODS This multicenter , crossover , r and omized , double blind , placebo-controlled prospect i ve comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron . The historical control was obtained from a meta- analysis of four publications examining outcomes in patients exposed to iron dextran . SFGC naïve patients were administered SFGC without a test dose , undiluted , at a rate of 125 mg over 10 minutes , and compared to placebo comprising bacteriostatic saline . RESULTS A total of 2534 patients were enrolled . The incidence of drug intolerance ( an adverse event precluding re-exposure ) was significantly less [ 0.44 % , confidence interval ( CI ) 0.21 to 0.71 % ] after SFGC as compared to the iron dextran control ( 2.47 % , CI 1.87 to 3.07 % , P < 0.0001 ) , but higher than after placebo ( 0.1 % , P = 0.02 ) . There was no difference found between SFGC and placebo in serious adverse events . A single life-threatening event occurred after SFGC ( 0.04 % , CI 0.00 to 0.22 % ) , which was significantly less than following iron dextran ( 0.61 % , CI 0.36 to 0.86 % ) , P = 0.0001 . CONCLUSION SFGC is well tolerated when given by intravenous push without a test dose . SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran . The routine use of iron dextran in hemodialysis patients should be discontinued
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 .