Retrospective cohort study comparing the adverse reactions and efficacy of intravenous iron polymaltose with ferric carboxymaltose for iron deficiency anemia.

ABSTRACT

OBJECTIVE: To examine the adverse drug reactions (ADRs) and the efficacy of intravenous iron polymaltose and ferric carboxymaltose (FCM) among gynecology/obstetric patients with anemia. METHODS: The present retrospective observational study examined data from anemic obstetrics and gynecology patients who received either iron polymaltose or FCM between January 1, 2011, and April 30, 2015, at The Royal Women's Hospital, Victoria, Australia. Patient demographic data, dosage, ADR documentation, and hemoglobin levels were collected from medical records and compared. RESULTS: The study included 221 patients; 111 and 110 received iron polymaltose and FCM, respectively. ADRs were documented for 18 (16.2%) patients in the iron polymaltose group and 2 (1.8%) in the FCM group (P<0.001), with no incidences of anaphylaxis. Both formulations achieved increased hemoglobin levels within 12 weeks (P<0.001 for both). Mean hemoglobin level increases were similar in both groups among non-pregnant patients (P=0.186), but were greater in the iron polymaltose cohort among pregnant patients (P=0.005). FCM dose compliance was suboptimal, with 8 of 57 (14%) patients who required second visits for doses greater than 1000 mg returning for the infusion. CONCLUSION: FCM was associated with a lower incidence of ADRs than iron polymaltose. Patients receiving FCM infusions were less likely to receive their total required iron dose. Further randomized prospective studies are required to compare clinical efficacy of iron polymaltose versus FCM.