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Higher risk for Adverse Events, especially serious type 1 reactions, with iron dextran therapy than and suggest that iron sucrose (Venofer) carries the lowest risk for hypersensitivity reactions.


Nephrol Dial Transplant. 2005 Jul;20(7):1443-9. Epub 2005 Apr 26.Click here to read Links
Hypersensitivity reactions and deaths associated with intravenous iron preparations.
Bailie GR, Clark JA, Lane CE, Lane PL.

Albany Nephrology Pharmacy (ANephRx) Group, Albany, NY, USA. bailieg@acp.edu



BACKGROUND:


Parenteral iron therapy is an accepted adjunctive management of anaemia in kidney disease.


Newer agents may have fewer severe hypersensitivity adverse events (AE) compared with iron dextrans (ID).


The rate of type 1 adverse events to iron sucrose (IS) and sodium ferric gluconate (SFG) relative to iron dextran is unclear.


We used the US Food and Drug Administration's Freedom of Information (FOI) surveillance database to compare the type 1 adverse events profiles for the three intravenous iron preparations available in the United States.


METHODS: We tabulated reports received by the FOI database between January 1997 and September 2002, and calculated 100 mg dose equivalents for the treated population for each agent.


We developed four clinical categories describing hypersensitivity adverse events (anaphylaxis, anaphylactoid reaction, urticaria and angioedema) and an algorithm describing anaphylaxis, for specific analyses.


RESULTS:


All-event reporting rates were

29.2, 10.5 and 4.2 reports/million 100 mg dose equivalents,

while all-fatal-event reporting rates were 1.4, 0.6 and 0.0 reports/million 100 mg dose equivalents

for Iron Dextran, sodium ferric gluconate (Ferrlecit) and Iron Sucrose (Venofer),

respectively.


Iron dextran had the highest reporting rates in all four clinical categories and the anaphylaxis algorithm.


Sodium ferric gluconate (Ferrlecit) had intermediate reporting rates for urticaria, anaphylactoid reaction and the anaphylaxis algorithm, and a zero reporting rate for the anaphylaxis clinical category.


Iron sucrose (Venofer) had either the lowest or a zero reporting rate in all clinical categories/algorithm.


CONCLUSIONS:


These findings confirm a higher risk for AE, especially serious type 1 reactions, with iron dextran therapy than with newer intravenous iron products and also suggest that iron sucrose (Venofer) carries the lowest risk for hypersensitivity reactions.

posted by DrR @ 11:30 AM