18 Nov 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@).
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Wang: An anaphylaxis reaction can happen with any IV Iron product at first or subsequent exposure. Use IV Iron carefully according to its current label, when the patients are intolerant or don’t respond well to oral iron. The study provides information on the relative safety of currently approved IV Iron products on the US market up to 2013 (not including injectafer).
MedicalResearch: What recommendations do you have for future research as a result of this study?
Dr. Wang: There is another IV Iron product, injectafer, which was approved in July 2013 by the US FDA. The utilization was too low to study the risk of anaphylaxis associated with injectafer when this study was conducted. It will be interesting to consider future analysis of comparative safety of IV iron products that includes injectorfor. Also the anaphylaxis algorithm, based on ICD-9 code, CPT and HCPCS codes, used in this study may have low sensitivity, with the implementation of ICD-10 codes, additional efforts to improve the performance of anaphylaxis algorithm will be of interest in future research as well.
Cunlin Wang, MD, PhD; David J. Graham, MD, MPH; Robert C. Kane, MD; Diqiong Xie, PhD; Michael Wernecke, BA; Mark Levenson, PhD; Thomas E. MaCurdy, PhD; Monica Houstoun, PharmD; Qin Ryan, MD, PhD; Sarah Wong, MPH; Katrina Mott, MPH; Ting-Chang Sheu, MPH; Susan Limb, MD; Chris Worrall, BS; Jeffrey A. Kelman, MD, MSc; Marsha E. Reichman, PhD
Cunlin Wang, MD, PhD (2015). FDA Study Compares Anaphylactic Risk of IV Iron Products