ORLANDO—Three parenteral iron formulations were found to be very safe, with no anaphylactic reactions observed, in a single-center study presented at the 2010 American Society of Hematology Annual Meeting & Exposition.
The study was presented by Maureen Okam, MD, MPH, and Elyse Mandell, MSN, RNCS, of Brigham and Women’s Hospital and Dana-Farber Cancer Institute, Boston.
Anemia is a common problem in hematology practice. Oral iron is the first-line treatment, although parenteral iron often is used as well. Before the 1990s, the only US Food and Drug Administration–approved intravenous (IV) product was iron dextran, which was associated, though rarely, with fatal anaphylactic reactions. Since then, 3 new and “safer” iron formulations were approved: iron sucrose, sodium ferric gluconate, and most recently ferumoxytol.
“Randomized clinical trials examining the effectiveness of oral iron repletion compared to IV iron have yielded contradictory results, nevertheless there are clear indications for parenteral iron use,” said Okam. ”It remains unclear which of the available iron formulations used in the US is safest.”
The study therefore compared, by chart review, the adverse reaction rates of 3 formulations of parenteral iron used by 510 patients between 2008 and 2010 at Dana-Farber. Investigators documented that 59% of patients received ferric gluconate, 23% received iron dextran, and 18% received iron sucrose. The comparison did not include the newest drug, ferumoxytol, which is not used at her center.
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The overall adverse reaction rate was just 2.8%, Okam reported. By product, adverse events were observed in 2.3% of patients given ferric gluconate, 1.7% given iron dextran, and 5.4% given iron sucrose. The specific reactions are shown in the Table.
“Based on our single-center experience, we found IV iron to be safe, and determined that iron dextran was just as safe as the other products,” she said.
On one hand the average wholesale price of the products is comparable, but fewer visits are required for treatment with iron dextran (1 dose) and iron sucrose (3 doses), compared with ferric gluconate (8 doses). The total cost of treatment, therefore, is less with these 2 agents, she added.
“On the other hand, ferric gluconate was particularly well tolerated in our study,” she pointed out.
Too few events occurred to show a difference in reaction severity, although a larger study might elucidate potential differences, she said.