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Research Paper | Biochemistry | India | Volume 12 Issue 10, October 2023

Evaluation of Hypersensitivity Reactions to Ferric Carboxymaltose in Iron - Deficiency Anemia Patients: A Multicenter Randomized Trial

Dr. Poulami Gupta Banerjee | Dr. Manoj Mukhopadhyay | Prabhu Shanmugam | Kumari Lily | Dr. Utpalendu Banerjee

Abstract: Iron deficiency anaemia is a widespread nutritional condition affecting physical and psychological well - being globally. While oral iron therapy is the standard treatment, its effectiveness can vary due to multiple factors. This has led to the emergence of intravenous iron therapies, such as Ferric Carboxymaltose (FCM), as an alternative for patients with inadequate responses to oral iron. Concerns regarding hypersensitivity reactions have arisen with intravenous iron, necessitating a detailed investigation. In this study, we evaluate the safety and efficacy of FCM compared to oral iron therapy in adult patients with iron deficiency anaemia and heart failure. Our research encompasses animal and human trials, with guinea pig tests revealing a 0% hypersensitivity rate for FCM. Additionally, a clinical trial involving 100 human subjects from various regions demonstrates no instances of hypersensitivity reactions. These findings suggest that FCM is a safe alternative for patients intolerant to oral iron formulations, with no evidence of hypersensitivity reactions. This study provides valuable insights into the utilization of FCM in managing iron deficiency anaemia, particularly in cases where oral iron is ineffective or not tolerated.

Keywords: Iron deficiency anaemia, Ferric Carboxymaltose, intravenous iron therapy, hypersensitivity reactions, efficacy, safety profile

Edition: Volume 12 Issue 10, October 2023,

Pages: 624 - 632