Allergies, Anemia, Author Interviews, FDA / 18.11.2015
FDA Study Compares Anaphylactic Risk of IV Iron Products
MedicalResearch.com Interview with:
Cunlin Wang, MD, PhD
Division of Epidemiology I,
Office of Surveillance and Epidemiology,
Center for Drug Evaluation and Research
US Food and Drug Administration
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Wang: IV Iron has been known for its risk of anaphylactic reaction, but there has been little research on the comparative safety of individual IV Iron products from a large population-based study. This study included 688,183 new users of IV iron not on dialysis from the U.S. Medicare program over a ten-year span (January 2003 to December 2013). The main findings of the study are: the risk for anaphylaxis at first exposure was higher for iron dextran than non-dextran IV iron products combined (iron sucrose, gluconate and ferumoxytol). When individual IV Iron products were compared, the data suggested that iron dextran has the highest risk of anaphylaxis and Iron sucrose has the lowest risk, estimated both at the first time exposure and after cumulative exposures. The low and high molecular weight dextran products could not be individually identified during most of study period. However, from January 2006 through March 2008, during which the use of two dextran products could be distinguished, there was very low use of high molecular weight dextran (Dexferrum@). This suggested that the study results likely represent the risk of the low molecular weight dextran (Infed@).
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