The Comparative Safety of Intravenous Iron Dextran, Iron Saccharate, and Sodium Ferric Gluconate

Fishbane, Steven; Kowalski, E

doi:10.1046/j.1525-139x.2000.00104.x

Cited by 98 publications

(80 citation statements)

References 26 publications

(27 reference statements)

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“…[28] Given the rarity of true allergic events, the utility of a test dose especially for non-dextran molecules like the SFGC is debatable. [3,30] In the present study, a one-time test dose was given to patients receiving ID or SFGC as per the latest EBPG guidelines. [3] In the present study, a history of prior drug allergy, iron dextran use, and prior reaction to i.v.…”

Section: Discussionmentioning

confidence: 99%

The Comparative Safety of Various Intravenous Iron Preparations in Chronic Kidney Disease Patients

et al. 2008

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The relative safety of parenteral iron preparations is a controversial issue in the management of anemia in chronic kidney disease (CKD), as direct head-to-head comparative trials are lacking. In this study, patients of CKD were randomized to receive intravenous low molecular weight iron dextran (ID), sodium ferrigluconate complex (SFGC), and iron sucrose (IS) at doses and infusion rates recommended by the product manufacturer. One time test dose was used only for ID and SFGC. A total of 2,980 injections (n = 339) of i.v. iron was given, and 49 patients (14.45% per patient) and a total of 56 adverse events (1.88% per infusion) were noted. Odds ratios (OR) of serious adverse drug events (ADE; i.e., death, anaphylaxis, or suspected immuno-allergic events) per patient was not significant between ID vs. SFGC (3.566) and SFGC vs. IS (2.129), whereas that between ID vs. IS (7.594) was highly significant (p = 0.034). OR of serious ADE exposure was significantly higher in ID vs. SFGC (OR = 5.670, p = 0.0147) and ID vs. IS (OR = 7.799, p < 0.001). No significant difference was seen between the three groups in terms of non-serious ADEs. Drug discontinuation occurred significantly more often with ID. One patient who developed anaphylactoid reaction with SFGC and ID tolerated iron sucrose well.

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Section: Discussionmentioning

confidence: 99%

The Comparative Safety of Various Intravenous Iron Preparations in Chronic Kidney Disease Patients

et al. 2008

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“…Iron is usually substituted by intravenous iron (iv.Fe), because oral supplementation is inefficient (3)(4)(5)(6). Despite the acknowledged safety of iv.Fe preparations such as ferric saccharate (7)(8)(9), the occurrence of non-transferrin-bound iron (NTBI) in the plasma of patients has been reported, either directly (10 -14) or indirectly, by detection of enhanced symptoms of oxidative stress (15)(16)(17)(18), of neutrophil damage (19), of support of bacterial growth (11), or increased incidence of infectious diseases (20,21).…”

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confidence: 99%

Non–Transferrin-Bound Iron in the Serum of Hemodialysis Patients Who Receive Ferric Saccharate

Scheiber-Mojdehkar

Lutzky²,

Schaufler³

et al. 2004

Journal of the American Society of Nephrology

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Abstract. Intravenous iron (iv.Fe) is used to optimize response to recombinant human erythropoietin (r-HuEPO) in ESRD, but no consensus exists with respect to the best regimen to avoid transferrin "oversaturation," oxidative stress, and the occurrence of non-transferrin-bound iron (NTBI). Iv.Fe was stopped for 1 wk in 35 hemodialysis (HD) patients who were routinely receiving iv.Fe and r-HuEPO. The iv.Fe group received 100 mg of ferric saccharate (Venofer) at the end of the first HD session, whereas the time-control group was treated under the same conditions but received no iv.Fe. Serum samples were taken before the first HD session, immediately and 60 min after iv.Fe administration, and before the next HD session. Sera were analyzed for NTBI and peroxides; transferrin saturation was analyzed by urea-PAGE and Western blot. In an in vitro model system with HepG2 cells, the effects of ESRD serum on the labile iron pool (LIP) were assayed using the fluorescence calcein assay. NTBI significantly increased after iv.Fe-administration and returned to baseline values before the next HDsession. There was a shift from apo-to monoferric transferrin, but no "oversaturation" of transferrin after iv.Fe-treatment. Peroxides increased in both groups after HD. Hemodialysis decreased bioavailable iron for the LIP in HepG2-cells, whereas serum of iv.Fe-treated HD patients highly increased the LIP in these cells. A total of 100 mg of iv.Fe led to NTBI generation but not to an oversaturation of transferrin. Peroxide concentrations significantly increased during HD but were not correlated to iv.Fe administration and seemed to result from other sources of oxidative stress related to HD. NTBI can enter liver cells and increase the potentially harmful LIP.

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“…3 Other studies have reported similar high rates of allergic reactions for iron dextran. [4][5][6] As a result, several authors have advocated the use of iron gluconate over iron dextran, in order to avoid serious reactions. For example, The University of Iowa Health Care Center uses only iron gluconate despite the need for multiple dosing.…”

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confidence: 99%

Is iron gluconate really safer than iron dextran?

Eichbaum

Foran

Dzik

2003

Blood

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References1. Kristiansen M, Graversen JH, Jacobsen C, et al. Identification of the haemoglobin scavenger receptor. Nature. 2001;409:198-201 To the editor: Is iron gluconate really safer than iron dextran?Parenteral supplementation of iron is required in some patients with iron deficiency, including those with oral iron intolerance, chronic uncorrected bleeding, malabsorption, gastrointestinal inflammatory disease, dialysis dependence, or failure to take prescribed oral iron. A more rapid increase in hemoglobin production occurs after intravenous administration, which may be valuable in anemic patients and chronic bleeding patients. Unlike oral iron, the full dose of intravenous iron is delivered to the bone marrow and saturates tissue stores. 1,2 The 2 popular forms of available parenteral iron in the United States are iron dextran and iron gluconate. Despite their value, intravenous iron therapy carries the potential for serious allergic reactions. In 1980, Hamstra et al examined over 2000 infusions of iron dextran among 481 patients and reported that 26% of patients experienced side effects, of which the majority were mild and self-limited. Of the reactions, 2% were considered "severe" allergic and 0.6% were classified as anaphylactoid. Most reactions were reported to occur immediately during the infusion of a test dose. As a result, administration of a test dose is now recommended to monitor patients for reactions. 1 In contrast, iron gluconate is considered to have a lower reaction rate and a test dose is not recommended by the manufacturer. During the years of 1992 to 1996, Faich and Strobos reported 3.3 allergic events per million doses per year with iron gluconate and 8.7 allergic events per million doses per year with iron dextran. 3 No fatalities were associated with iron gluconate between 1976 to 1996. However, 31 fatalities among 196 allergy/anaphylactic cases were recorded between 1976 to 1996 for iron dextran, translating into a case fatality rate of 15.8% for iron dextran. 3 Other studies have reported similar high rates of allergic reactions for iron dextran. [4][5][6] As a result, several authors have advocated the use of iron gluconate over iron dextran, in order to avoid serious reactions. For example, The University of Iowa Health Care Center uses only iron gluconate despite the need for multiple dosing. 7 We report here a chart review of recorded reactions over the past 3 years (1999)(2000)(2001)(2002) to intravenous infusions of iron dextran and iron gluconate administered in the outpatient Blood Transfusion Center at Massachusetts General Hospital, Boston. A total of 65 infusions of either iron dextran (INFeD, Schein) or iron gluconate (Ferrlecit, Schein, Morristown, NJ) were performed among 35 patients over the 3-year period. All patients were directly observed for allergic reactions and reactions were recorded.We grouped the resulting reactions into 3 categories: severe (reactions such as anaphylactoid, shock, and cardiovascular collapse); moderate (reactions such as dyspnea, severe urt...

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The Comparative Safety of Intravenous Iron Dextran, Iron Saccharate, and Sodium Ferric Gluconate

Cited by 98 publications

References 26 publications

The Comparative Safety of Various Intravenous Iron Preparations in Chronic Kidney Disease Patients

The Comparative Safety of Various Intravenous Iron Preparations in Chronic Kidney Disease Patients

Non–Transferrin-Bound Iron in the Serum of Hemodialysis Patients Who Receive Ferric Saccharate

Is iron gluconate really safer than iron dextran?

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