Use of parenteral iron products and serious anaphylactic-type reactions Use of parenteral iron products and serious anaphylactic-type reactions
Editorial: Am. J. Hematol
Fecha: 01/09/2010
Diane K. Wysowski,* Lynette Swartz, B. Vicky Borders-Hemphill,Margie R. Goulding and Catherine Dormitzer
Controversy exists about the safety of the parenteral iron dextran products, Dexferrum and INFeD, which
have been associated with rare, serious anaphylactic-type reactions. In the United States, their product labels
carry boxed warnings of this adverse event; some have called for the withdrawal from marketing of the higher
molecular weight Dexferrum. Between 2002 and 2007, sales of Dexferrum, INFeD, and iron gluconate Ferrlecit
declined 32.5%, 21%, and 4.8%, respectively, while sales of iron sucrose Venofer increased 160%. Voluntary
reports submitted to the Food and Drug Administration show anaphylactic reactions and symptoms for the
four parenteral iron products. Because of underreporting, possible differential reporting, absence of iron dextran
brand names, and incomplete use (denominator) data, incidence rates and relative risk estimates cannot
be calculated. U.S. death certificate data show that for most years from 1979 through 2006, no more than 3
deaths per year were coded to ‘‘adverse events in therapeutic use of iron preparations;’’ brand names were
not consistently recorded. Emergency department data show small numbers of visits for treatment of allergic
reactions with intravenous iron preparations. The data presented herein show that allergic reactions are possible
with all four parenteral iron products, and it is difficult to determine which product has the largest risk
based on sales data, voluntarily submitted adverse event reports, death certificates, ED visits, and observational
studies performed to date. To help differentiate risk among the parenteral iron products, the brand
name of the product always should be provided on medical records, death certificates, and adverse drug
reaction reports.
have been associated with rare, serious anaphylactic-type reactions. In the United States, their product labels
carry boxed warnings of this adverse event; some have called for the withdrawal from marketing of the higher
molecular weight Dexferrum. Between 2002 and 2007, sales of Dexferrum, INFeD, and iron gluconate Ferrlecit
declined 32.5%, 21%, and 4.8%, respectively, while sales of iron sucrose Venofer increased 160%. Voluntary
reports submitted to the Food and Drug Administration show anaphylactic reactions and symptoms for the
four parenteral iron products. Because of underreporting, possible differential reporting, absence of iron dextran
brand names, and incomplete use (denominator) data, incidence rates and relative risk estimates cannot
be calculated. U.S. death certificate data show that for most years from 1979 through 2006, no more than 3
deaths per year were coded to ‘‘adverse events in therapeutic use of iron preparations;’’ brand names were
not consistently recorded. Emergency department data show small numbers of visits for treatment of allergic
reactions with intravenous iron preparations. The data presented herein show that allergic reactions are possible
with all four parenteral iron products, and it is difficult to determine which product has the largest risk
based on sales data, voluntarily submitted adverse event reports, death certificates, ED visits, and observational
studies performed to date. To help differentiate risk among the parenteral iron products, the brand
name of the product always should be provided on medical records, death certificates, and adverse drug
reaction reports.