Safety of Ferric Citrate Hydrate in Pregnant Women With Iron Deficiency Anemia, Fetuses, and Newborns: A Real-World, Observational, Post-Marketing Surveillance Study.

AIM: This post-marketing surveillance study determined the real-world use and safety of ferric citrate hydrate (FC) in fetuses and pregnant women with iron deficiency anemia (IDA).

METHODS

Pregnant women with IDA were registered centrally and followed prospectively from the first FC administration until the end of pregnancy or at treatment discontinuation. Demographic characteristics, FC administration, and levels of iron- and anemia-related parameters were collected. Newborns were followed for 7 days after birth.

RESULTS

Registration was from October 2021 to March 2023, and 149 women and 129 newborns were included for analysis. The mean (standard deviation; SD) age of the women was 32.1 (5.1) years, and 75.8% were at ≥ 28 weeks of gestational age at the first FC administration. The mean (SD) daily dose of FC was 494.2 (36.3) mg. FC treatment was continued until the end of pregnancy in 53 of 149 women (35.6%). The most frequent reason for the discontinuation of FC (96/149 women, 64.4%) was an improvement in IDA (68/149 women, 45.6%). Adverse drug reactions (ADRs) led to discontinuation in 4 of 149 women (2.7%). In 7 of 149 women (4.7%), 9 ADRs were found, including constipation (3/149, 2.0%), nausea (2/149, 1.3%), abdominal pain upper (1/149, 0.7%), diarrhea (1/149, 0.7%), hand dermatitis (1/149, 0.7%), and fetal death (1/149, 0.7%). No ADRs were found in newborns. Hemoglobin and serum ferritin levels were increased with FC treatment, but no signs of iron overload were reported.

CONCLUSIONS

No previously unknown safety concerns were detected in women, fetuses, or newborns by FC treatment during pregnancy.

TRIAL REGISTRATION: jRCT2031210322.