Iron deficiency anemia is the most common cause of anemia in postpartum women, and is caused primarily by inadequate iron intake and blood loss during pregnancy. Postpartum anemia is associated with longer hospital stays, depression, anxiety, and delayed infant development. Although oral iron therapy is the most common treatment for postpartum iron deficiency anemia, its efficacy is limited by adverse gastrointestinal events and patient nonadherence. In addition, current intravenous iron therapies can provoke hypersensitivity and anaphylactoid reactions. However, recent studies have focused on ferric carboxymaltose as an intravenous iron replacement therapy because the risk of anaphylaxis or hypersensitivity reactions is very low. Specifically, the trial by Seid et al evaluated the efficacy, safety, and tolerability of intravenous ferric carboxymaltose therapy compared to that of oral ferrous sulfate administration in postpartum women.

This open-label, randomized controlled study included 291 women with postpartum iron deficiency anemia (hemoglobin (Hb) ≤10 g/dL) from multiple clinical centers in the United States. The patients received intravenous ferric carboxymaltose (n=143) weekly for 15 minutes until a calculated cumulative dose had been reached or oral ferrous sulfate (n=148) three times daily for six weeks. The study’s primary efficacy endpoint was the percentage of subjects who achieved a Hb level >12 g/dL between baseline and the end of the study. Also, secondary endpoints included improved changes from baseline in Hb, serum transferrin saturation, and ferritin.

The study’s results revealed significantly greater percentages of patients meeting the primary efficacy endpoint in the intravenous ferric carboxymaltose group compared with the oral ferrous sulfate group (91.4% vs. 66.7%, respectively). Achievement of secondary endpoints also favored the intravenous group. Finally, very few adverse events were reported in either group, nor were any significant changes observed in calcium and magnesium levels, or vital signs.

The efficacy, safety, and tolerability of intravenous ferric carboxymaltose suggest a superior treatment option to oral iron. Because this intravenous therapy can be administered more quickly and efficiently than oral therapies, it may provide new treatment options that circumvent the problems of adverse effects and patient nonadherence. Since the replenishment of iron stores is such a critical factor in preventing reoccurrence of iron deficiency anemia, more studies need to address sustained benefits of this intravenous therapy, as well as cost utilization differences between other iron therapies.

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 Gynecol. 2008 Oct;199(4):435.e1-7.

NAAC Expert Summary:
In this study, the efficacy, safety, and tolerability of intravenous carboxymaltose given in 1000 mg doses was compared to oral ferrous sulfate in women with postpartum anemia, a group highly susceptible to this condition. Seid et al found the intravenous drug to be more efficient in correcting this condition, compared to the standard oral preparation. Compared to the oral iron group, patients on the study drug achieved the target Hb level seven days faster (14 vs. 21), achieved the target level more often (91.4% vs. 66.7%), and replenished iron stores much more effectively and with fewer adverse events.

Previous research has shown the utility of intravenous iron in treating iron deficiency anemia in pregnancy and the postpartum period, either when oral iron has failed or as primary therapy. Yet parenteral therapy in these women has failed to become a standard of treatment, largely because of (1) safety concerns associated with high molecular weight dextran formulations; and (2) the inconvenience of repeated small intravenous dosing, required for most other iron preparations.

The current study demonstrates similar benefits of intravenous ferric carboxymaltose to other parental forms of iron. In addition, its apparent safety and the ability to provide high dose (1000 mg/dose) therapy in a single 15-minute administration make it an attractive agent when intravenous iron is warranted. Furthermore, the availability of this drug and others with similar safety and efficacy profiles may widen the indications for parenteral iron therapy.

Last Updated: February 4, 2009