Effectiveness of Single-dose Ferric Carboxymaltose in Enhancing Hemoglobin Levels in Pregnant Women with Moderate-to-Severe Iron-deficiency Anemia

Abstract

Background: Anemia contributes to increased pregnancy-associated morbidity and mortality; hence warranting rapid correction. Parenteral ferric carboxymaltose (FCM) has FDA and DCGI approval for use in pregnancy-linked iron-deficiency anemia, with minimal and nonserious side effects. Ferric carboxymaltose is given as a single-dose administration, requiring lesser hospital visits and costs. FCM has been accepted for clinical use in the Indian population. However, there is limited evidence about its use for moderate or severe anemia among antenatal women. This study aims to analyze the efficacy and safety of single-dose intravenous ferric carboxy maltose among anemic pregnant females. Methods: Prospective observational study comprising 150 iron-deficiency anemic pregnant women between 16 and 32 weeks of gestation with hemoglobin between 5 and 9 gm/dL. Single dose of FCM (dose calculated by Ganzoni’s formula) was administered and treatment effectiveness was assessed by serial hemoglobin measurement at 2 weeks and 6 weeks after administration of FCM and then at the time of delivery. Safety was determined by analysis of adverse drug reactions and biochemical tests at the aforesaid time intervals. Results: The mean rise in hemoglobin at 2 weeks was 1.35 gm/dL, at 6 weeks was 3.08 gm/dL and at delivery was 4.80 gm/dL (p < 0.001). No serious adverse effects were found. Conclusions: The present study bolsters clinical use of intravenous FCM in anemic pregnant females in view of its efficacy and safety. Low-risk single dose dispensation and subsequent upsurge in hemoglobin levels should place FCM as a preferred alternative in moderate-to-severe anemia management during pregnancy.