Safety of intravenous iron isomaltoside for iron deficiency and iron deficiency anemia in pregnancy

Jan Wesström, Jan Wesström

Abstract

Purpose: To evaluate the efficacy and safety for mother and child of using intravenous iron isomaltoside (IV-IIM) during pregnancy.

Methods: Using an appointment register, we retrospectively identified all pregnant women who received a single dose of 1000 or 1500 mg IV-IIM in the maternity ward of Falu Hospital and subsequently gave birth between August 6, 2013 and July 31, 2018. Women who received IV-IIM (case group) were individually matched with pregnant women who did not receive IV-IIM (control group) by delivery date, maternal age (± 2 years), and parity. Adverse drug reactions (ADRs), demographic characteristics, hemoglobin and s-ferritin counts, pregnancy and delivery complications, and infant data (APGAR score, pH at umbilical artery, birthweight, birth length, intrauterine growth restriction and neonatal ward admission). Data were obtained from electronic patient charts. SPSS was used for descriptive statistics.

Results: During the 5-year period, 213 women each received a single administration of IV-IIM. Ten (4.7%) ADRs occurred during IV-IIM administration. All ADRs were mild hypersensitivity reactions, abated spontaneously within a few minutes, and did not recur on rechallenge. No association between IIM dose and ADR frequency was noted. Maternal and fetal outcomes, including hemoglobin counts at delivery and postpartum, were similar in the case and control groups.

Conclusion: These results support the convenience, safety, and efficacy of a single high-dose (up to 1500 mg) infusion of IV-IIM for iron deficiency or iron deficiency anemia during pregnancy.

Keywords: Intravenous iron; Iron deficiency; Iron isomaltoside; Pregnancy; Safety.

Conflict of interest statement

No competing interests exist.

References

    1. Rahman MM, et al. Maternal anemia and risk of adverse birth and health outcomes in low- and middle-income countries: systematic review and meta-analysis. Am J Clin Nutr. 2016;103(2):495–504. doi: 10.3945/ajcn.115.107896.
    1. Maguire JL, et al. Association between total duration of breastfeeding and iron deficiency. Pediatrics. 2013;131(5):e1530–e1537. doi: 10.1542/peds.2012-2465.
    1. Wassef A, Nguyen QD, St-Andre M. Anaemia and depletion of iron stores as risk factors for postpartum depression: a literature review. J Psychosom Obstet Gynaecol. 2018;40:1–10.
    1. Eckerdal P, et al. Delineating the association between heavy postpartum haemorrhage and postpartum depression. PLoS ONE. 2016;11(1):e0144274. doi: 10.1371/journal.pone.0144274.
    1. Congdon EL, et al. Iron deficiency in infancy is associated with altered neural correlates of recognition memory at 10 years. J Pediatr. 2012;160(6):1027–1033. doi: 10.1016/j.jpeds.2011.12.011.
    1. Cusick SE, Georgieff MK, Rao R. Approaches for Reducing the Risk of Early-Life Iron Deficiency-Induced Brain Dysfunction in Children. Nutrients. 2018;10(2):227. doi: 10.3390/nu10020227.
    1. Janbek J, Sarki M, Specht IO, Heitmann BL. A systematic literature review of the relation between iron status/anemia in pregnancy and offspring neurodevelopment. Eur J Clin Nutr. 2019;73(12):1561–1578. doi: 10.1038/s41430-019-0400-6.
    1. Pena-Rosas JP, et al. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015;7:Cd004736.
    1. Tolkien Z, et al. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS ONE. 2015;10(2):e0117383. doi: 10.1371/journal.pone.0117383.
    1. Auerbach M. Commentary: Iron deficiency of pregnancy—a new approach involving intravenous iron. Reprod Health. 2018;15(Suppl 1):96. doi: 10.1186/s12978-018-0536-1.
    1. Achebe MM, Gafter-Gvili A. How I treat anemia in pregnancy: iron, cobalamin, and folate. Blood. 2017;129(8):940–949. doi: 10.1182/blood-2016-08-672246.
    1. Auerbach M, Deloughery T. Single-dose intravenous iron for iron deficiency: a new paradigm. Hematology Am Soc Hematol Educ Program. 2016;2016(1):57–66. doi: 10.1182/asheducation-2016.1.57.
    1. Bircher AJ, Auerbach M. Hypersensitivity from intravenous iron products. Immunol Allergy Clin North Am. 2014;34(3):707–723. doi: 10.1016/j.iac.2014.04.013.
    1. Szebeni J, et al. Hypersensitivity to intravenous iron: classification, terminology, mechanisms and management. Br J Pharmacol. 2015;172(21):5025–5036. doi: 10.1111/bph.13268.
    1. Fishbane S, et al. The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis. 1996;28(4):529–534. doi: 10.1016/S0272-6386(96)90463-1.
    1. Kalra PA, Bhandari S. Efficacy and safety of iron isomaltoside (Monofer((R))) in the management of patients with iron deficiency anemia. Int J Nephrol Renovasc Dis. 2016;9:53–64. doi: 10.2147/IJNRD.S89704.
    1. Kalra PA, Bhandari S. Safety of intravenous iron use in chronic kidney disease. Curr Opin Nephrol Hypertens. 2016;25(6):529–535. doi: 10.1097/MNH.0000000000000263.
    1. Manconi M, et al. When gender matters: restless legs syndrome. Report of the "RLS and woman" workshop endorsed by the European RLS Study Group. Sleep Med Rev. 2012;16(4):297–307. doi: 10.1016/j.smrv.2011.08.006.
    1. Kalra PA, et al. A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrol Dial Transplant. 2016;31(4):646–655. doi: 10.1093/ndt/gfv293.
    1. Qassim A, et al. Safety and efficacy of intravenous iron polymaltose, iron sucrose and ferric carboxymaltose in pregnancy: a systematic review. Aust N Z J Obstet Gynaecol. 2018;58(1):22–39. doi: 10.1111/ajo.12695.
    1. Minogue A et al. (2017) Poster: consultant Haematologist Review of Intravenous Iron Service in Pregnant Women at Queen’s Hospital, Romford. Transfusion Practitioner and Consultant Haematologist, Queen’s Hospital, Romford, UK Aug 2017
    1. Runge VM. Safety of magnetic resonance contrast media. Top Magn Reson Imaging. 2001;12(4):309–314. doi: 10.1097/00002142-200108000-00007.
    1. Kang SY, Kim HB, Sunwoo S. Association between anemia and maternal depression: a systematic review and meta-analysis. J Psychiatr Res. 2020;122:88–96. doi: 10.1016/j.jpsychires.2020.01.001.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit