Safety and Efficacy of High-Dose Intravenous Ferric Carboxymaltose for the Management of Iron Deficiency Anemia in Pregnancy: A Retrospective Study at a Tertiary Care Center in Japan

Background Ferric carboxymaltose (FCM) is a novel intravenous iron formulation that allows high-dose administration in a single infusion, enabling rapid iron replenishment. Within the framework of Patient Blood Management, including perioperative strategies such as autologous blood donation, FCM represents a key strategy for correcting iron deficiency anemia during pregnancy. Although international evidence supports the use of FCM during pregnancy, clinical data from Japan remain scarce, and no systematic studies in pregnant women have been reported. Thus, we aimed to evaluate the efficacy and safety of FCM use during pregnancy in a Japanese tertiary perinatal center. Methods We retrospectively analyzed pregnant women who received intravenous FCM at least once at Niigata University Medical and Dental Hospital, which managed a total of 1,116 deliveries during the 3-year study period from January 2022 through December 2024. Clinical data were extracted from the medical records, including underlying diagnoses, total administered dose, estimated blood loss at delivery, and changes in hemoglobin (Hb) and mean corpuscular volume (MCV), as well as information on autologous blood donation. Results During the study period, 16 pregnant women received FCM. The median Hb level at the first administration was 8.4 (range: 7.1–11.1) g/dL, which increased to 10.3 g/dL at delivery (range: 8.5–12.2 g/dL). The median MCV increased from 84.5 (range: 64.3–102.4) fL to 91.0 (range: 67.8–103.8) fL. When limited to the 10 women who did not undergo autologous blood donation, both changes were statistically significant (p = 0.002, Wilcoxon signed-rank test). No maternal or neonatal adverse events related to FCM administration were observed. In a secondary analysis, among the six women who underwent autologous blood donation, five received FCM on the same day as the donation, and in three of them, donation was successfully performed twice. Notably, none of the five women had Hb levels below 10 g/dL at cesarean section. Conclusions FCM administration was effective and well tolerated in Japanese pregnant women, particularly among those with moderate to severe anemia. Combining FCM with autologous blood storage may be useful to maintain adequate Hb levels and enable multiple donations before cesarean delivery in high-risk pregnancies.