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Volume 2013, Article ID 169107, 10 pages
Clinical Study

Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia

1Vital Prospects Clinical Research Institute, PC, Tulsa, OK 74136, USA
2Luitpold Pharmaceuticals, Inc., Norristown, PA 19403, USA
3Department of Pathology, Albert Einstein College of Medicine, Bronx, NY 10461, USA

Received 29 May 2013; Revised 25 July 2013; Accepted 26 July 2013

Academic Editor: Aurelio Maggio

Copyright © 2013 Iftikhar Hussain et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Several intravenous iron complexes are available for the treatment of iron deficiency anemia (IDA). Iron dextran (DEX) is associated with an elevated risk of potentially serious anaphylactic reactions, whereas others must be administered in several small infusions to avoid labile iron reactions. Ferric carboxymaltose (FCM) is a nondextran intravenous iron which can be administered in high single doses. A randomized, open label, and multicenter comparison of FCM to DEX in adults with IDA and baseline hemoglobin of ≤11.0 g/dL was conducted. A total of 160 patients were in the safety population (FCM ; DEX ). Adverse events, including immune system disorders (0% in FCM versus 10.3% in DEX, ) and skin disorders (7.3% in FCM versus 24.4% in DEX, ), were less frequently observed in the FCM group. A greater portion of patients in the FCM group experienced a transient, asymptomatic decrease in phosphate compared to patients in the DEX group (8.5% in FCM versus 0% in DEX, ). In the FCM arm, the change in hemoglobin from baseline to the highest observed level was 2.8 g/dL, whereas the DEX arm displayed a change of 2.4 g/dL ( ). Treatment of IDA with FCM resulted in fewer hypersensitivity-related reactions than DEX.