DOI: http://dx.doi.org/10.18203/2320-1770.ijrcog20211497

Safety and efficacy of ferric carboxymaltose in anaemic antenatal women: a prospective study

Supriya Jamkhandi, Rajesh Tile

Abstract


Background: Anemia is one of the most common nutritional deficiency disorders affecting the pregnant women, and is a worldwide problem. In India, prevalence ranges from 23.6%-61.4% and contributes to 80% of maternal mortality as a direct or indirect cause. This study aims to assess the efficacy and safety of intravenous ferric carboxymaltose in antenatal women with moderate anemia in the second and third trimester of pregnancy.

Methods: Prospective clinical study; total of 100 antenatal women with moderate anemia in second and third trimester were included in the study from January 2019 to September 2019 and given 1000mg of intravenous ferric carboxymaltose injection. Efficacy was assessed by rate of improvement in hemoglobin at 3 and 6 weeks post infusion. Safety analysis was done by assessing the adverse drug reactions and fetal heart monitoring during the infusion.

Results: A total 100 antenatal women with median gestational age of 28week at presentation received 1000mg of intravenous ferric carboxymaltose. There was rise in hemoglobin from 8.3gm% before injection to 11.12gm% 6 weeks post infusion, showing a mean rise of 2.8gm%. There were no reports of drug related major adverse effects in the mother or the fetus.

Conclusions: From this study, ferric carboxymaltose is found to be safe and effective treatment option for anemia in pregnancy.


Keywords


Anemia, Antenatal, Ferric carboxymaltose, Parenteral iron

Full Text:

PDF

References


WHO. The Global Prevalence of Anaemia in 2011. Geneva: World Health Organization; 2015.

Ezzati M, Lopus AD, Dogers A, Vander HS, Murray C. Selected major risk factors and global and regional burden of disease. Lancet. 2002;360:1347-60.

Indian council of medical research evaluation of nutritional anaemia prophylaxis program task force study New Delhi; 1989. Available at; https://www.icmr.nic.in/sites/default/files/icmr_bulletins/bufeb00.pdf. Accessed on 3 February 2021.

Centre for disease control (CDC), criteria for anaemia in children and child bearing age women MMWR. 1989;38:400-4; Available at https://www.cdc.gov/MMWR/preview/mmwrhtml/0 0051880.htm. Accessed on 3 February 2021.

FOGSI General Clinical Practice Recommendations. Management of Iron Deficiency Anemia in Pregnancy. Available at; www.fogsi.org/ wpcontent/uploads/2017/07/gcpr-recommend ationida.pdf. Accessed on 3 February 2021.

Guidelines for Prevention of Maternal Anaemia. Available at; http://www.nrhmtn.gov.in/ guideline/RGPMA.pdf.

Lone FW, Qureshi RN, Emanuel F. Maternal anaemia and its impact on perinatal outcome. Trop Med Int Health. 2004;9(4):486-90.

Longo SA, Moore RC, Canzoneri BJ, Robichaux A. Gastrointestinal Conditions during Pregnancy. Clin Colon Rectal Surg. 2010;23(2):80-9

Milman N. “Prepartum anaemia: prevention and treatment,” Annals Hemat. 2008;87(12):949-59.

Joshi SD, Chikkagowdra S, Kumar VCM. Comparative study of efficacy and safety of intravenous ferric carboxy maltose versus iron sucrose in treatment of postpartum iron deficiency anemia. Int J Reprod Contracept Obstet Gynecol. 2016;5.

Seid MH, Derman RJ, Baker JB, Banach W, Goldberg C, Rogers R. “Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial,”. Am J Obstet and Gyneco, 2008;199(4):435-7.

VanWyck DB, Martens MG, Seid MH, Baker JB, Mangione A. “Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial,” Obstet and Gynec. 2007;110(2): 267-78, part 1.

Breymann C, Gliga F, Bejenariu C, Strizhova N, “Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia,” Int J Gynec and Obstet. 2008;101(1):67-73.

A. Pfenniger, C. Schuller, P. Christoph, and D. Surbek, “Safety and efficacy of high-dose intravenous iron carboxymaltose vs. iron sucrose for treatment of postpartum anemia,” J Perin Medi. 2012;40(4):397-402.

Froessler B, Collingwood J, Hodyl NA, Dekker G. Intravenous ferric carboxymaltose for anaemia in pregnancy. BMC pregnancy and Childbirth. 2014;14(1):11.

Christoph P, Schuller C, Studer H, Irion O, De Tejada BM, Surbek D. Intravenous iron treatment in pregnancy: comparison of high-dose ferric carboxymaltose vs. iron sucrose. J Perinat Med. 2012;40(5):469-74.

B. Myers, O. Myers, and J. Moore, “Comparative efficacy and safety of intravenous ferric carboxymaltose (Ferinject) and iron(III) hydroxide dextran (Cosmofer) in pregnancy,” Obstetr Medici. 2012;5(3):105-7.

B. Froessler, G. Dekker, and G. McAuliffe, “To the rescue: the role of intravenous iron in the management of severe anaemia in the peri-partum setting,” Blood Transfusion. 2015;13(1):150-2.

Ezzati M, Lopez AD, Rodgers AA, Murray CJ. Comparative quantification of health risks: Global and regional burden of disease attributable to selected major risk factors. Geneva: World Health Organization. 2004.

National Family Health Survey 2016. Available from: http://rchiips.org/NFHS/NFHS4/manual/ NFHS4%20Biomarker%20Field%20M anual.pdf. Accessed on 3 February 2021.

IIPS National Family Health Survey 1998-99 (NFHS-2): Available from http://www.nfhsindia. org/india2.html. Accessed on 3 February 2021.

IIPS. National Family Health Survey 2005-06 (NFHS3): Available at: http://mohfw.nic.in/nfhs factsheet.htm. Accessed on 3 February 2021.

National Nutrition Monitoring Bureau (NNMB). 2002. NNMB Micronutrient survey. Hyderabad:National Institute of Nutrition.

Toteja GS, Singh P. Micronutrient profile of Indian population. New Delhi: Ind C Med Res. 2004.

Mahajan A, Bhagat BR, Gupta S, Mahajan B, Verma M. A comparative study of efficacy and safety of intravenous ferric carboxymaltose versus iron sucrose in the treatment of iron deficiency anaemia of pregnancy in a tertiary care hospital. Int J Reprod Contracept Obstet Gynecol. 2018;7(5):1938-42

Agrawal D. Masand DL. A study for efficacy and safety of ferric carboxymaltose versus iron sucrose in iron deficiency anemia among pregnant women in tertiary care hospital. Int J Reprod Contracept Obstet Gynecol. 2019;8(6):2280-5.

Jose, Mahey R, Sharma JB, Bhatla N, Saxena R, Kalaivani M., et al. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial BMC Preg and Childbirth. 2019;19:54.