Efficacy and safety of intravenous ferric carboxymaltose versus oral iron in pregnant women with anemia: a systematic review and meta-analysis.

OBJECTIVE

Intravenous (IV) ferric carboxymaltose represents an alternative to oral iron that enables rapid iron repletion through a single infusion, demonstrating promising efficacy and safety across diverse clinical settings. This study aims to evaluate the efficacy and safety of IV ferric carboxymaltose compared with oral iron in managing pregnancy-related anemia.

MATERIALS AND

METHODS

We systematically searched four databases for randomized controlled trials (RCTs) and observational cohorts comparing IV ferric carboxymaltose with oral iron in pregnant women with anemia. Randomized controlled trials and observational cohorts comparing intravenous ferric carboxymaltose with oral iron in pregnant women with anemia were included. Random-effects meta-analyses were performed using mean differences (MDs) for continuous outcomes and risk ratios (RRs) for dichotomous outcomes, each with 95% confidence intervals (CIs).

RESULTS

Twelve studies (Eight RCTs and four cohorts) were included. IV ferric carboxymaltose significantly improved Hb concentrations compared with oral iron (7 RCTs & 4 Cohorts; 6,495 patients; MD = + 0.91 g/dL; 95% CI 0.30-1.51; p = 0.0035) and increased serum ferritin (5 studies; 4,420 patients; MD = + 63.8 ng/mL; 95% CI 37.3-90.4; p < 0.001). The benefit of Hb was most evident at pre-delivery (8 studies; 1,575 patients; MD = 1.22 g/dL, 95% CI [0.55-1.89], p = 0.0003) but not in the postpartum period (4 Studies, 5,141 patients; MD = 0.74, 95% CI [ -0.50-1.98], p = 0.24). Safety analyses demonstrated lower risks of drug-related adverse events (3 studies; 471 patients; RR = 0.42, 95% CI [0.19-0.91], p = 0.02) and nausea ( 3 studies; 3,284 patients; RR = 0.27, 95% CI [0.09-0.75], p = 0.012) with IV ferric carboxymaltose.

CONCLUSIONS

Intravenous ferric carboxymaltose appears more effective than oral iron in improving hematologic indices in pregnant women with anemia and shows a favorable tolerability profile, including fewer drug-related adverse events and nausea. However, the findings should be interpreted cautiously, given the substantial heterogeneity across studies.