Sodium ferric gluconate complex in hemodialysis patients. Ii. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients

Daniel W. Coyne, N. Franklin Adkinson, Allen R. Nissenson, Steven Fishbane, Rajiv Agarwal, Joseph W. Eschbach, Beckie Michael, Vaughn Wesley Folkert, Daniel Batlle, J. Richard Trout, Naomi Dahl, Pamela Myirski, Jur Strobos, David G. Warnock

Research output: Contribution to journalArticle

78 Citations (Scopus)

Abstract

Background. Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron, sodium ferric gluconate in sucrose (SFGC). Methods. In a 69 center, prospective, double-blind, controlled trial of safety and tolerability of SFGC, the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations. Serum tryptase levels, a marker of mast cell degranulation, also were measured. Results. Among 143 iron dextran-sensitive patients exposed to SFGC, three (2.1%) were intolerant. All three had suspected allergic events to SFGC, including one patient with a serious reaction (0.7%). One dextran-sensitive patient (0.7%) had a suspected allergic reaction after placebo. In contrast, among 2194 iron dextran-tolerant patients, reactions to SFGC were significantly less common, with SFGC intolerance seen in seven patients (0.3%; P = 0.020), including five (0.2%) who had suspected allergic events (P = 0.010), but none who had serious events (0.0%; P = 0.061). Two iron dextran-tolerant patients (0.09%) had allergic-like reactions following placebo injections. Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100% increase in serum tryptase, while there were no confirmed allergic events in the iron dextran-tolerant group. Long-term exposure to SFGC in iron dextran-sensitive patients resulted in intolerance in only one additional patient and no serious adverse events. Conclusions. Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.

Original languageEnglish (US)
Pages (from-to)217-224
Number of pages8
JournalKidney International
Volume63
Issue number1
DOIs
StatePublished - 2003

Fingerprint

Dextrans
Renal Dialysis
Iron
Sucrose
Placebos
Tryptases
saccharated ferric oxide
ferric gluconate
gluconic acid
Mast Cells
Hypersensitivity
Cell Degranulation
Anaphylaxis
Serum
Allergens
Logistic Models
Regression Analysis

Keywords

  • Allergy
  • Anemia
  • Drug safety
  • Hemoglobin
  • Intravenous iron
  • Parenteral iron
  • Renal failure
  • Tryptase

ASJC Scopus subject areas

  • Nephrology

Cite this

Coyne, D. W., Adkinson, N. F., Nissenson, A. R., Fishbane, S., Agarwal, R., Eschbach, J. W., ... Warnock, D. G. (2003). Sodium ferric gluconate complex in hemodialysis patients. Ii. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Kidney International, 63(1), 217-224. https://doi.org/10.1046/j.1523-1755.2003.00703.x

Sodium ferric gluconate complex in hemodialysis patients. Ii. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. / Coyne, Daniel W.; Adkinson, N. Franklin; Nissenson, Allen R.; Fishbane, Steven; Agarwal, Rajiv; Eschbach, Joseph W.; Michael, Beckie; Folkert, Vaughn Wesley; Batlle, Daniel; Trout, J. Richard; Dahl, Naomi; Myirski, Pamela; Strobos, Jur; Warnock, David G.

In: Kidney International, Vol. 63, No. 1, 2003, p. 217-224.

Research output: Contribution to journalArticle

Coyne, DW, Adkinson, NF, Nissenson, AR, Fishbane, S, Agarwal, R, Eschbach, JW, Michael, B, Folkert, VW, Batlle, D, Trout, JR, Dahl, N, Myirski, P, Strobos, J & Warnock, DG 2003, 'Sodium ferric gluconate complex in hemodialysis patients. Ii. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients', Kidney International, vol. 63, no. 1, pp. 217-224. https://doi.org/10.1046/j.1523-1755.2003.00703.x
Coyne, Daniel W. ; Adkinson, N. Franklin ; Nissenson, Allen R. ; Fishbane, Steven ; Agarwal, Rajiv ; Eschbach, Joseph W. ; Michael, Beckie ; Folkert, Vaughn Wesley ; Batlle, Daniel ; Trout, J. Richard ; Dahl, Naomi ; Myirski, Pamela ; Strobos, Jur ; Warnock, David G. / Sodium ferric gluconate complex in hemodialysis patients. Ii. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. In: Kidney International. 2003 ; Vol. 63, No. 1. pp. 217-224.
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abstract = "Background. Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron, sodium ferric gluconate in sucrose (SFGC). Methods. In a 69 center, prospective, double-blind, controlled trial of safety and tolerability of SFGC, the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations. Serum tryptase levels, a marker of mast cell degranulation, also were measured. Results. Among 143 iron dextran-sensitive patients exposed to SFGC, three (2.1{\%}) were intolerant. All three had suspected allergic events to SFGC, including one patient with a serious reaction (0.7{\%}). One dextran-sensitive patient (0.7{\%}) had a suspected allergic reaction after placebo. In contrast, among 2194 iron dextran-tolerant patients, reactions to SFGC were significantly less common, with SFGC intolerance seen in seven patients (0.3{\%}; P = 0.020), including five (0.2{\%}) who had suspected allergic events (P = 0.010), but none who had serious events (0.0{\%}; P = 0.061). Two iron dextran-tolerant patients (0.09{\%}) had allergic-like reactions following placebo injections. Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100{\%} increase in serum tryptase, while there were no confirmed allergic events in the iron dextran-tolerant group. Long-term exposure to SFGC in iron dextran-sensitive patients resulted in intolerance in only one additional patient and no serious adverse events. Conclusions. Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.",
keywords = "Allergy, Anemia, Drug safety, Hemoglobin, Intravenous iron, Parenteral iron, Renal failure, Tryptase",
author = "Coyne, {Daniel W.} and Adkinson, {N. Franklin} and Nissenson, {Allen R.} and Steven Fishbane and Rajiv Agarwal and Eschbach, {Joseph W.} and Beckie Michael and Folkert, {Vaughn Wesley} and Daniel Batlle and Trout, {J. Richard} and Naomi Dahl and Pamela Myirski and Jur Strobos and Warnock, {David G.}",
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T1 - Sodium ferric gluconate complex in hemodialysis patients. Ii. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients

AU - Coyne, Daniel W.

AU - Adkinson, N. Franklin

AU - Nissenson, Allen R.

AU - Fishbane, Steven

AU - Agarwal, Rajiv

AU - Eschbach, Joseph W.

AU - Michael, Beckie

AU - Folkert, Vaughn Wesley

AU - Batlle, Daniel

AU - Trout, J. Richard

AU - Dahl, Naomi

AU - Myirski, Pamela

AU - Strobos, Jur

AU - Warnock, David G.

PY - 2003

Y1 - 2003

N2 - Background. Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron, sodium ferric gluconate in sucrose (SFGC). Methods. In a 69 center, prospective, double-blind, controlled trial of safety and tolerability of SFGC, the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations. Serum tryptase levels, a marker of mast cell degranulation, also were measured. Results. Among 143 iron dextran-sensitive patients exposed to SFGC, three (2.1%) were intolerant. All three had suspected allergic events to SFGC, including one patient with a serious reaction (0.7%). One dextran-sensitive patient (0.7%) had a suspected allergic reaction after placebo. In contrast, among 2194 iron dextran-tolerant patients, reactions to SFGC were significantly less common, with SFGC intolerance seen in seven patients (0.3%; P = 0.020), including five (0.2%) who had suspected allergic events (P = 0.010), but none who had serious events (0.0%; P = 0.061). Two iron dextran-tolerant patients (0.09%) had allergic-like reactions following placebo injections. Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100% increase in serum tryptase, while there were no confirmed allergic events in the iron dextran-tolerant group. Long-term exposure to SFGC in iron dextran-sensitive patients resulted in intolerance in only one additional patient and no serious adverse events. Conclusions. Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.

AB - Background. Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death. Although dextran, rather than iron, is believed to be the cause of these reactions, it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron, sodium ferric gluconate in sucrose (SFGC). Methods. In a 69 center, prospective, double-blind, controlled trial of safety and tolerability of SFGC, the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations. Serum tryptase levels, a marker of mast cell degranulation, also were measured. Results. Among 143 iron dextran-sensitive patients exposed to SFGC, three (2.1%) were intolerant. All three had suspected allergic events to SFGC, including one patient with a serious reaction (0.7%). One dextran-sensitive patient (0.7%) had a suspected allergic reaction after placebo. In contrast, among 2194 iron dextran-tolerant patients, reactions to SFGC were significantly less common, with SFGC intolerance seen in seven patients (0.3%; P = 0.020), including five (0.2%) who had suspected allergic events (P = 0.010), but none who had serious events (0.0%; P = 0.061). Two iron dextran-tolerant patients (0.09%) had allergic-like reactions following placebo injections. Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100% increase in serum tryptase, while there were no confirmed allergic events in the iron dextran-tolerant group. Long-term exposure to SFGC in iron dextran-sensitive patients resulted in intolerance in only one additional patient and no serious adverse events. Conclusions. Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients. However, logistic regression analysis, performed to account for the higher reaction rate to placebo, suggests that this increased reactivity was not drug-specific nor immunologically mediated, but represented host idiosyncrasy. These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy, and that SFGC is not a true allergen.

KW - Allergy

KW - Anemia

KW - Drug safety

KW - Hemoglobin

KW - Intravenous iron

KW - Parenteral iron

KW - Renal failure

KW - Tryptase

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