Use of parenteral iron products and serious anaphylactic-type reactions.
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.
Wysowski
Diane K
DK
Office of Surveillance and Epidemiology, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. diane.wysowski@fda.hhs.gov
Swartz
Lynette
L
Borders-Hemphill
B Vicky
BV
Goulding
Margie R
MR
Dormitzer
Catherine
C
D000707:Anaphylaxis / Q000139:chemically induced* / Q000401:mortality*; D004342:Drug Hypersensitivity / Q000401:mortality*; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D006397:Hematinics / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D012189:Retrospective Studies; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
D005290:Ferric Compounds; D006397:Hematinics