Efficacy and safety of ferric carboxymaltose in Indian pregnant women with iron deficiency anemia

Background: Ferric carboxymaltose (FCM) is a third-generation intravenous dextran-free, intravenous iron formulation that can be given in a single dose over a small duration. The study assessed hematological parameters before and after FCM administration in pregnant women for whole population and according to gestational age, severity of anemia and gravida status. Methods: This was a single centre, prospective, observational, open label, clinical study at real life scenario with 4 weeks follow up. Thirty pregnant women with IDA and visiting to the Pushpam Maternity Hospital, Ahmedabad for antenatal care were enrolled for the study. I.V. FCM was administered as a single dose of 1000 mg. Change in the haemoglobin (Hb), ferritin, other hematological parameters at baseline and after 4 weeks of completion of parenteral iron therapy was noted. Results: A significant increase in the haemoglobin (Hb) of 2.08 gm/dl and ferritin of 92.89 ng/ml was recorded at 4 weeks. There was also a significant rise in Hb, ferritin, MCV, MCH, RBC count, MCHC as compared to the baseline in patients with moderate anemia. There was significant increase in Hb, hematocrit, ferritin and MCV as compared to baseline in primi and multigravida women and also in gestational age ≤ and >28 weeks. No adverse effects were observed throughout the duration of the study. Conclusions: FCM infusion prior to delivery significantly increased hemoglobin levels and improved ferritin levels and other haematological parameters at 4 weeks in whole population and also in moderate anemia, primi and multigravida, gestational age ≤ and >28 weeks.