Effectiveness and Safety of Ferric Carboxymaltose in Treating Iron Deficiency Anemia: A Prospective Study in Rural and Tribal India.

Introduction: More than half of Indian rural women (pregnant and non-pregnant) are anemic. Limited evidence exists on the effectiveness and tolerability of ferric carboxymaltose (FCM) in Indian rural and tribal women. Aims and Objectives: The primary objective was to assess the effectiveness of intravenous (IV) infusion of FCM in iron deficiency anemia (IDA) in rural and tribal women. Secondary objectives included evaluating changes in hematological parameters from baseline and assessing tolerability. Materials and Methods: A prospective, open-label, observational, real-world, single-center study was conducted at Getwell Multispecialty Hospital, Manchar, Pune. Female patients with IDA (Pregnant: Hb 6 to <11 g/dL, non-pregnant: Hb: 6 to <12 g/dl) were recruited. FCM was administered as an IV infusion, and patients were followed up at 6 weeks. Change in Hb, other haematological parameters from baseline were assessed. Adverse effects related to FCM were monitored. Results: Fifty-five patients completed the study; 7.27% were pregnant and 92.73% were nonpregnant. A significant increase in Hb of 3.64 g/dL was recorded at 6 weeks. All pregnant women achieved the target Hb of 11 g/dL, whereas 58.82% of nonpregnant women reached 12 g/dL; there was a significant increase in hematocrit, mean corpuscular volume, mean corpuscular hemoglobin (MCH), and MCH concentration (P < 0.05 for all) as compared to baseline. FCM infusion was well tolerated. Conclusions: FCM IV infusion significantly increased Hb levels and other hematological parameters at 6 weeks. FCM appears to be an effective and well-tolerated treatment for IDA in pregnant and non-pregnant women in rural and tribal area.