COVID-19 Update - This is to inform you that the Government of India has announced a complete lockdown in India 22nd March 2020 to 3rd May 2020. As a result, our offices will now be closed till 3rd May 2020 and all our employees will be working from home. Office telephones will not be answered, and therefore you are requested to direct all your queries related to manuscript submission, review process, publication etc. at below mentioned details.,, Mob. 8826373757, 8826859373, 9910947804

Article view: 553

Article download: 232

Indian Journal of Obstetrics and Gynecology Research

Ferric Carboxymaltose Injection in Postpartum Iron Deficiency Anemia: Results from the prescription-event monitoring study

Full Text PDF Share on Facebook Share on Twitter

Author Details : Manish Pandya, Pankaj Patil, Swati Naik, Shahu Ingole, Rishi Jain

Volume : 4, Issue : 1, Year : 2017

Article Page : 92-95

Suggest article by email


Introduction: Ferric Carboxymaltose (FCM), a dextran free iron formulation can be administered in large doses without the risk of severe anaphylactic reactions in postpartum anemia (PPA). Evidence suggest that FCM is highly effective in correcting anemia and restoring iron stores faster.
Aims & Objective: To gather real-world clinical practice events on safety and efficacy of FCM injection in Indian patients with PPA.
Materials and Methods: This was a prospective, observational, non-comparative, non-interventional, prescription event monitoring study. Data were collected from 535 postpartum iron deficiency anemia patients treated with FCM injection. Safety was assessed from adverse events reported within 1 week post FCM administration. Treatment efficacy was assessed by change in Hb from baseline, at 1 week after treatment.
Results: There were no serious adverse events (AE) reported. Only 4 patients (<1%) reported AE (mild nausea, n=1; shivering, n=1; palpitation, n=1; pruritus and breathlessness, n=1). Mean change in Hb evaluated in 498 patients showed significant increase from baseline of 8.5 ± 1.2 gm/dl to 10.5 ± 1.0 gm/dl (difference = 2 ± 1.03 gm/dl; p < 0.001) at 1 week post-treatment. Increase in Hb was maximum (2.95 ± 1.08 gm/dl) in severely anemic patients with baseline Hb ≤7 gm/dl (n = 87). Safety and efficacy of FCM was rated by physicians as ‘very good and good’ in 99% patients.
Conclusion: Intravenous FCM was safe with AE profile similar to earlier reports. Clinical utility of FCM in the treatment of PPA was demonstrated with significant improvement in Hb in 1 week.

Ferric Carboxymaltose, Postpartum anemia

How to cite : Pandya M, Patil P, Naik S, Ingole S, Jain R, Ferric Carboxymaltose Injection in Postpartum Iron Deficiency Anemia: Results from the prescription-event monitoring study. Indian J Obstet Gynecol Res 2017;4(1):92-95

Copyright © 2017 by author(s) and Indian J Obstet Gynecol Res. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (