Abstract

FERROUS ASCORBATE IN PREGNANCY: INSIGHTS FROM A REAL-WORLD PRESCRIPTION EVENT MONITORING (PEM) STUDY

Rajvee A. Soni*, Dr. Ashok D. Agrawal, Dr. Mayur R. Bhurat, Aishwarya M. Agale, Puja R. Khodpe, Premjit G. Pawar, Dr. Ashish Wagh, Dimpal D. Maurya

ABSTRACT

Background: Iron deficiency anemia (IDA) is a common and significant public health concern during pregnancy, contributing to adverse maternal and fetal outcomes. Ferrous ascorbate, a combination of ferrous iron and ascorbic acid, offers enhanced bioavailability and improved gastrointestinal tolerability compared with conventional iron salts. This prescription-event monitoring (PEM) study aimed to generate real-world evidence on the safety and effectiveness of ferrous ascorbate in pregnant Indian women with IDA. Methods:This prospective, observational, non-interventional study included 126 pregnant women diagnosed with IDA who received ferrous ascorbate (Furr CR/Furr XT) according to the treating physician’s discretion. Baseline demographic data, clinical characteristics, dosing details, and hemoglobin (Hb) values were recorded. Hb levels were reassessed after 4 weeks to determine treatment efficacy. Safety was evaluated through adverse events (AEs) reported during the same period. Data analysis included descriptive statistics and paired t-tests to compare pre- and post-treatment Hb values. Results: Participants had a mean age of 27.92 ± 4.71 years and a mean weight of 53.76 ± 8.89 kg. The baseline Hb was 9.14 ± 0.95 g/dL. Following 4 weeks of ferrous ascorbate therapy, Hb increased significantly to 10.20 ± 0.98 g/dL, with a mean rise of 1.06 ± 0.03 g/dL (p < 0.001). Consistent improvements were observed across all trimesters. The treatment was well tolerated; only 7 patients (5.5%) experienced mild AEs—constipation, nausea, vomiting, diarrhea, or insomnia. No serious AEs were reported. Conclusion: Ferrous ascorbate (Furr CR/Furr XT of Corona Remedies Ltd., Ahmedabad) demonstrated significant improvement in Hb levels within 4 weeks and exhibited a favorable safety profile. These real-world findings support its effectiveness and tolerability as an oral iron therapy for managing IDA in pregnancy.

Keywords: Iron deficiency anemia, Pregnancy, Ferrous ascorbate, Prescription-event monitoring (PEM).