Low Molecular Weight Iron Dextran Research Articles

Perinatal Outcomes Following Intravenous Iron for Treatment of Iron Deficiency With and Without Anemia.

To determine maternal and neonatal outcomes in individuals with iron deficiency receiving antepartum intravenous (IV) iron supplementation, stratified by the degree of anemia. Retrospective cohort study of iron-deficient pregnant patients who received at least one IV infusion of iron (iron sucrose, low molecular weight iron dextran [LMWID], or ferric carboxymaltose) during their pregnancy from January 1, 2011 through June 16, 2022. Our primary outcomes included both neonatal composite morbidity and maternal composite morbidity in the context of maternal anemia. Patients who received LMWID had fewer infusion visits, received higher total doses of iron and had a more substantial correction of hemoglobin compared to those who received iron sucrose (p < 0.01). Maternal anemia at the time of admission was not associated with neonatal composite morbidity. However, there was a significant association between anemia status and maternal composite outcome (p = 0.05). Anemia at time of delivery was associated with the likelihood of requiring a blood transfusion (p = 0.01). This study reinforces previous findings emphasizing the adverse effects of iron deficiency on maternal health and the role of IV iron in reducing these risks.

Correction of Anemia with Intravenous Iron Mitigates Adverse Maternal Outcomes in Pregnancy

Background and Aim: Iron deficiency anemia (IDA) is common in pregnancy and associated with both maternal and fetal morbidity. Despite its high prevalence and associated complications, there is a lack of consensus regarding the treatment of iron deficiency (ID) in pregnant individuals. In spite of the higher efficacy and tolerance of intravenous (IV) iron compared to oral formulations, obstetric guidelines reserve its use for IDA refractory to oral treatment, even in late gestation. This study sought to determine maternal and neonatal outcomes in individuals receiving IV iron supplementation antepartum, stratified by severity of IDA. Methods: We performed a cohort study of pregnant individuals (age ≥18 years) who received at least one IV infusion of an iron formulation (iron sucrose (IS), low molecular weight iron dextran (LMWID), or ferric carboxymaltose (FCM)) during their pregnancy at a single center from 2011-2022. Our primary outcomes included both neonatal and maternal composite morbidity.Maternal composite morbidity was defined as postpartum hemorrhage, hysterectomy, puerperal infection, preeclampsia/gestational hypertension, maternal ICU admission, and/or requiring blood transfusion. Neonatal composite morbidity was defined as having either preterm birth, 5-minute Apgar less than seven, NICU admission, and/or low birth weight. Secondary outcomes included the incidence of pregnancy morbidity by anemia severity, defined by the World Health Organization Critiera as non-anemic (Hgb &amp;gt;11 g/dL, mild (Hgb 10 to 10.9 g/dL), moderate (Hgb 7 to 9.9 g/dL), or severe (Hgb &amp;lt; 7 g/dL), type of IV iron preparation used, and total iron dose received. Demographics, clinical characteristics, and perinatal outcomes were compared using chi-square or Fisher Exact test and two-sample t-tests. Results: A total of 312 pregnant individuals were included. The majority were 20-34 years (65.1%), multiparous (69.2%), and self-identified as being of White or Hispanic race (42.3% and 37.2%, respectively). Mean ferritin nadir during pregnancy was 12.9 ± 26.7 μg/L, which did not significantly differ between those with and without anemia. A total of 67.3% of individuals were anemic with Hgb &amp;lt; 11g/dL at some time during their pregnancy, with only 22.1% of individuals on admission to labor and delivery (L&amp;D). In this cohort, most individuals (80.9%) received IV LMWID, 17.8% received IV IS, and only 1.0% received IV FCM. IV iron was well tolerated, with only 3 patients (0.96%) not completing their infusion due to reaction. More individuals with moderate anemia on admission received IV IS during pregnancy compared to those with mild and no anemia (50.0% vs 18.4% vs 15.0%, respectively, p&amp;lt;0.01). The mean number of infusions was 2.63±1.51 for IS compared to 1.20±0.40 for LMWID. Mean total iron dose received was 561±392 mg in those receiving IS compared to 979 ± 200 mg in those receiving LMWID. Only 23.4% of individuals received a total of 1,000mg or more of IS, compared to 91.3% of individuals who received LMWID. Anemia status was associated with the incidence of maternal composite morbidity, with more composite morbidity among anemic (25/69 (36.2%)) vs. non-anemic (59/243 (11.5%)) individuals (Table 1). In contrast, the incidence of neonatal composite morbidity did not significantly differ by anemia status. In those who were still anemic at the time of admission (N=69), the degree of anemia severity (mild vs moderate) was not significantly associated with maternal or neonatal composite morbidity (Table 2). Conclusions: Anemia status, regardless of severity, is associated with higher rates of maternal composite morbidity. Anemia on admission to L&amp;D was less likely in those who received IV LMWID compared to those who received IV IS. The total dose of iron received was lower, on average, in those prescribed IS (despite the need for more infusion visits). IV iron therapy was safe and effective in this cohort of pregnant individuals and decreased the incidence of anemia on admission to L&amp;D.

Ironing out the Wrinkles: Low Molecular Weight Iron Dextran and Premedications

Intravenous (IV) iron infusion increases hemoglobin levels and reduces the need for transfusions compared to oral iron in patients with iron deficiency. Low molecular weight iron dextran (LMW ID) has a boxed warning for anaphylactic-type infusion reactions and premedication is commonly given. However, a recent multi-institution cohort study showed similar rates of infusion-related adverse events (AEs) with iron sucrose (4.3%) and iron dextran (3.8%), and a 23-fold higher incidence of AEs among those who received premedication compared with those who did not (38.6% vs 1.7%). There is currently a national shortage of iron dextran. A study during a previous iron dextran shortage in 2016 showed that the increased use of newer IV iron formulations persisted even once the shortage ended. This may in part be due to the concern for infusion reactions, but the use of these formulations comes at a significant cost. An analysis of the US FDA database showed that, based on differences in the average price of iron sucrose and LMW ID, the cost to prevent one life-threatening AE related to the use of LMW ID was estimated to be 5.0-7.8 million dollars. The cost to prevent one LMW ID-related death was estimated to be 33 million dollars. To further evaluate the incidence of infusion reactions and the use of premedication at the University of Kansas Medical Center, we performed a retrospective analysis of all patients who received their first ever infusion of iron dextran between 1/1/2021-12/31/2022. Infusion reactions were characterized as severe if hypoxia (O2&amp;lt;90%), hypotension (&amp;lt;100/80) or hospital admission occurred. Ninety-six patients were identified. 17 (17.7%) were males and 79 (82.3%) were females. There were 49 (51%) Caucasian, 26 (27.1%) African Americans, 12 (12.5%) Hispanic, and 9 (9.4%) others. 8 patients had infusion reaction (8.3%; 95% CI 4.0-15.1%) as determined by review of nursing documentation. Serious infusion reactions with LMW ID were rare (n=2, 2.1%), and neither patient required epinephrine administration nor hospitalization. Patients with history of allergies (n=61, 63.5%) had a higher incidence of AEs compared to those who did not (13.1% [95% CI, 6.4-23.2%] vs 0.0%, P = 0.022). This was even higher in 27 (28.1%) patients with 3 or more allergies (18.5% [95% CI, 7.4-35.9%] vs 0.0%, P = 0.019). In 71 (80.2%) patients who received premedication, there was a lower incidence of AEs compared to those who did not (3.9% vs 26.3%; χ2 = 10.02; P =0.007). The incidence of AEs was compared with individual premedication, and lower incidences were seen in 64 (66.7%) patients with diphenhydramine (3.1% vs 18.8%, χ2 = 6.82; P =0.015), 50 (52.1%) with methylprednisolone (2.0% vs 15.2%, χ2 = 5.48; P =0.022), and 46 (47.9%) with acetaminophen (0.0% vs 16%, χ2 = 8.03; P =0.004). Notably, a variety of premedication combinations and doses were used, indicating a lack of standardization even within a single institution. No patient who received acetaminophen experienced an infusion reaction. By contrast, there was no significant difference in patients receiving famotidine, suggesting that while acetaminophen may be a useful premedication, famotidine may not be beneficial. Further, our data strongly suggests that patients without a history of drug allergies do not require premedication. Our retrospective study demonstrates significant benefit to receiving premedication, which is divergent when compared to previous studies. This may be due to several reasons: the previously mentioned multi-center study included multiple formulations of IV iron, had a much lower rate of premedication (6% vs. 80%), and used a different definition of infusion reaction. In the multi-center cohort study, administration of medications post-iron infusion was used as a surrogate marker of reaction, while in our study it was based on review of nursing documentation. Both our study and the prior multi-center study noted an increased incidence of infusion reactions in patients with a history of allergies, and both demonstrated the rarity of serious reactions. Based on these results and the prior studies indicating the increased cost of other IV iron formulations, consideration of reinstitution of LMW ID with de-escalation of premedication in those without history of drug allergies should be considered once the current drug shortage resolves.

Hematology Electronic Consultation As a Means for Effective Management of Iron Deficiency Anemia

Introduction: The use of non-visit electronic consultation (e-consult) can improve patient access to hematology care when an urgent in-person evaluation is not required. Prior studies have confirmed that e-consults have been rapidly adopted in certain settings, can resolve queries without the need for in-person follow-up, and, in turn, lead to an increase in total consult volume institutionally. Iron deficiency is a common reason for e-consult, however utilization trends, the efficacy and safety of iron repletion in this context, and the avoidance of face-to-face hematology consultation remain largely unknown. Methods: We performed a descriptive and retrospective electronic chart review of patients referred for iron deficiency or iron deficiency anemia from 1/2018 - 1/2020 at our single institution. Baseline patient demographics, underlying etiology of iron deficiency, pregnancy status, baseline and follow up laboratory values pre- and post-receipt of iron, type of iron formulation, and adverse events were obtained from detailed review of electronic medical records. Iron deficiency was defined as ferritin ≤ 50μg/L. The primary outcomes of interest included time to e-consult order placement to formal hematologist recommendation and time to intravenous (IV) iron infusion. Secondary outcomes included recurrence of iron deficiency, repeat e-consult, conversion to in-person evaluation, and whether the etiology of iron deficiency was appropriately assessed. We defined appropriate etiology assessment as either: 1) a determined etiology documented within the note of the requesting provider or by the hematology consultant, or 2) if evidence of workup to determine etiology had been recommended and initiated Results: A total of 180 e-consults for iron deficiency were reviewed over the 2-year study period. A summary of patient characteristics is included in Table 1. The median age of those referred was 40 years (interquartile range (IQR) 29-54). Sixty-eight percent of patients were Non-Hispanic White, 10% were Non-Hispanic Black, and there was a female predominance of 89%. Twenty-six percent lived outside the Portland metropolitan area. The most common attributed etiology of iron deficiency was uterine blood loss (27%), followed by gastrointestinal (17% blood loss, 13% malabsorption), and 7% of patients were pregnant at the time of e-consult placement. The most common IV iron formulations were low molecular weight iron dextran (43%) and ferumoxytol (30%), and adverse reactions were rare occurring in only 3.3% of patients. The median time from e-consult order placement to completion by hematology was 0.5 days (IQR 0-1) and from initial evaluation to IV iron infusion was 20 days (IQR 12-35) (Table 2). The median time of ferritin lab follow-up was 60 days when ordered by primary care provider and 37 days when ordered by hematology. Labs pre- and post-iron repletion rose from mean ferritin of 19.3 μg/L (standard deviation (SD) 33.1) to 166.9 μg/L (SD 127.2) and hemoglobin 11.7 g/dL (SD 1.8) to 12.7 g/dL (SD 1.6). Recurrence occurred in 58% of patients, and 13% of consults required in-person evaluation. The primary etiology was addressed in 45% of consults. Conclusion: The results from this analysis demonstrate that e-consults permit efficient and safe management of iron deficiency, improve access to hematology care, and generate cost savings for the healthcare system. With the growing utilization of e-consults for iron deficiency evaluation and management, wait times to initial hematology evaluation may improve while access to care is simultaneously increased. Future quality improvement efforts, such as standardizing note templates to document suspected etiology and automating follow-up labs at the time of iron infusion, should be considered to expedite appropriate workup, reduce risk of incomplete repletion and recurrence of iron deficiency, and optimize educational opportunities for ordering providers.

Role of single-dose intravenous iron therapy for the treatment of anaemia after orthopaedic trauma: protocol for a pilot randomised controlled trial

IntroductionOrthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this...

A Safe Effective and Resource Conscientious Protocol for Iron Dextran Desensitization

Intravenous (IV) iron is preferred for iron deficient patients who cannot tolerate or do not respond to oral iron. Severe reactions to IV iron are rare but can necessitate desensitization for future administration. Traditionally, iron dextran is avoided due to high reactions rates; however, reactions rates are lower with low-molecular-weight (LMW) formulations. We describe a case series of 3 patients who underwent successful LMW iron dextran desensitization.

Statement of Retraction: lactoferrin plus health education versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating iron deficiency anemia (IDA) in pregnancy: a randomized controlled trial

Statement of Retraction: lactoferrin plus health education versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating iron deficiency anemia (IDA) in pregnancy: a randomized controlled trial

MO523: The Differential Effect of Third-Generation Intravenous Iron Preparations (Ferric Carboxymaltose, Ferric Derisomaltose) on Hematinic and Renal Function Variables in Patients With Non-Dialysis Dependent CKD and Iron Deficiency Anemia

Abstract BACKGROUND AND AIMS Iron deficiency anemia is common in patients with non-dialysis dependent chronic kidney disease (CKD). Guidelines advocate the use of oral or intravenous (IV) iron, with IV iron offering a quicker and potentially more efficacious replenishment. The advent of third-generation IV iron products [such as ferric carboxymaltose (FCM) and ferric derisomaltose (FDI)] has allowed high doses of iron to be provided in a single sitting. Despite good evidence on their efficacy in replenishing iron stores and safety in terms of renal injury and inflammation when compared against placebo, oral iron or older iron compounds (such as iron sucrose and low molecular weight iron dextran), the two compounds have never before been compared head-to-head in CKD. METHOD As part of the single-center double-blinded exploratory randomized controlled trial ‘Iron and Phosphaturia—ExplorIRON-CKD’ that took place in a tertiary center in the UK, patients with iron deficiency with/without anemia and CKD stage 3a–5 but not on dialysis were recruited to receive FCM or FDI in two divided doses—1000 mg at baseline and 500–1000 mg in a 1-month interval to achieve replenishment. Iron deficiency was defined as serum ferritin (SF) &amp;lt;200 µg/L or transferrin saturation (TSAT) ≤20% and SF 200–299 µg/L. Markers of treatment response such as hemoglobin and iron parameters [serum ferritin (SF), transferrin saturation (TSAT)], renal function and injury [serum creatinine, estimated glomerular filtration rate (eGFR) and protein: creatinine ratio (PCR)] and inflammation (CRP) were monitored throughout the study. Hemoglobin, renal function and inflammation were monitored at baseline, 2 weeks, 1 month and 2 months following initial infusion. Iron response was assessed at baseline, 1–2 days, 2 weeks, 1 month post-initial infusion (and time of second infusion), 1–2 days after the second infusion and 2 months after initial administration. RESULTS A total of 26 patients were recruited; 14 were randomized to receive FDI and 12 to receive FCM. All patients received at least one iron dose (1000 mg), 10 patients received two FDI doses and 11 received two FCM doses. There was an increase in hemoglobin in both groups, with no significant difference between the groups at any given time point in the study [baseline: FDI: 99.2 (12.2) g/L versus FCM: 101.6 (15.3) g/L; P = .67; 2 months: FDI: 106.0 (13.3) g/L versus FCM: 109.1 (8.3) g/L; P = .526). Both groups had a median baseline SF &amp;lt;100 µg/L and TSAT &amp;lt;20%, and by the end of follow-up, iron repletion was similarly successful in both groups as indicated by a median SF &amp;gt; 400 µg/L and a TSAT &amp;gt;20% (Figure 1). A small numerical reduction was noted in median eGFR in the FCM group from baseline to the end of the study (baseline: 18.0 (11.3) mL/min/1.73 m2 versus 2 months: 16.5 (8.5) mL/min/1.73 m2); however, there was no significant difference between the two groups at any time point in the study (Figure 2). Urinary PCR, serum creatinine and CRP remained stable throughout the study and did not differ significantly between the two groups. CONCLUSION Third-generation IV iron preparations are efficacious in replenishing iron stores. There was no adverse short-term impact on renal function, injury or inflammation. In our cohort, the two compounds were equivocal for the parameters studied, with no significant difference identified in any of the areas examined. The population was small, therefore the results should be interpreted with caution; nonetheless, newer IV iron compounds appear to be equally efficacious in the treatment of iron deficiency anemia in non-dialysis-dependent CKD.

Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial.

Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. · IV iron decreases rates of anemia on admission for delivery compared with oral iron.. · In an unblinded randomized trial, a significant proportion of patients preferred alternate therapy.. · Future RCTs should incorporate double-blinded technique to reduce risk of patient crossover.. · Results from feasibility trial support a larger RCT comparing IV to oral iron for IDA in pregnancy..

A retrospective study of the safety and efficacy of low molecular weight iron dextran for children with iron deficiency anemia.

Iron deficiency anemia (IDA) affects millions of children worldwide. Oral iron replacement is effective but often poorly tolerated. Intravenous iron has been demonstrated to have utility in all ages, but pediatric use remains limited. Low molecular weight iron dextran (LMWID) has a dosing range capable of replacing iron deficits in a single infusion and has been evaluated in small pediatric cohorts, but additional safety and efficacy data are limited. Here, we evaluate the safety and efficacy of LMWID in association with an electronic medical record (EMR)-based effort to optimize dosing. A retrospective IRB-approved investigation of LMWID utilization at a tertiary pediatric hospital between January 1, 2016 and March 31, 2020 was undertaken to evaluate the therapeutic efficacy and frequency/severity of infusion-related adverse event (AE) in children and adolescents receiving LMWID. Patient demographics and LMWID dosing characteristics were collected, and primary outcome measures included laboratory response and the incidence/severity of any infusion-related events. The utilization of an EMR-based nomogram for LMWID dosing was also evaluated. A total of 254 infusions for 191 patients were included (ages 0.7-20.9years), most with IDA. LMWID replaced at least 75% of the estimated iron deficit in a single infusion for 76% of patients. The mean hemoglobin and ferritin increases were 2.1g/dl and >100ng/ml, respectively. Infusion-related AEs were rare, occurring in only 12/254 (4.7%) of infusions and 67% during the test dose; each rapidly resolved without long-term sequelae. No AEs occurred in those <10years of age. Premedication use markedly decreased with nomogram use without a change in AE rate. In a large institutional cohort, LMWID was well tolerated in children and adolescents, with most patients having their total iron deficits relieved in a single infusion. These data support expanded use of LMWID in the management of pediatric iron deficiency.

Safety and Efficacy of Intravenous Iron Sucrose versus Low Molecular Weight Iron Dextran for Treatment of Iron Deficiency Anemia in Pregnancy: A Randomized Controlled Trial.

ObjectiveThis study aimed to compare the efficacy, side effects, and clinical outcomes between parenteral iron sucrose complex (ISC) and low-molecular-weight iron dextran (LMWID) for iron deficiency anemia (IDA) in pregnancy.MethodsThe study was conducted in a Malaysian tertiary hospital for a period of 1 year. Forty pregnant women with IDA between 24 and 38 weeks of gestation were randomized into two groups receiving treatment with either ISC or LMWID.ResultsNo significant difference was found between the groups in terms of demographic data, parity, and mean gestational age. A mean total of 835 ± 150 mg doses of ISC and 656 ± 382 mg doses of LMWID were administered (P = 0.0001). Adverse events were reported in five patients who received LMWID and none in those treated with ISC (P = 0.024). The mean hemoglobin (Hb) level increment 2 weeks post treatment was higher among those who received ISC than in those who received LMWID. The ISC group demonstrated an increase of 1.91 ± 1.10 g/dL (from 8.43 ± 1.03 g/dL to 10.29 ± 0.90 g/dL) compared with the LMWID group at 1.39 ± 0.54 g/dL (from 8.61 ± 0.70 g/dL to 9.92 ± 0.88 g/dL, P = 0.023). All participants in both groups delivered at term. The estimated blood loss during delivery was significantly higher in the LMWID group (359 ± 247 mL) than in the ISC group (280 ± 100 mL, P = 0.026). Otherwise, no significant difference was observed in terms of Hb level during delivery and the perinatal outcomes for both groups.ConclusionParenteral ISC is more effective than LMWID in treating maternal IDA, and it is associated with fewer adverse events.

Efficacy and Safety of Low Molecular Weight Iron Dextran (LMWID) Vs. Ferumoxytol in Treating Iron Deficiency Anemia

Introduction: Iron deficiency anemia is the most common form of anemia and hematologic problem worldwide. Treatment options include oral or intravenous (IV) iron replacement. Although oral iron is commonly employed as first-line therapy, many studies suggest that IV iron more effective and associated with better quality of life when compared to oral iron. Yet, adverse infusion reactions are possible. Several forms of IV iron are used in clinical practice, including low molecular weight iron dextran (LMWID), ferumoxytol, ferric gluconate, iron sucrose, and ferric carboxymaltose. We sought to compare the efficacy and safety of LMWID and ferumoxytol, the two most frequently used products at our center. Methods: A retrospective cohort analysis was conducted using internal pharmacy records. Adults with an ICD-10 diagnosis of iron deficiency anemia treated with LMWID or ferumoxytol from 2018 to 2019 were identified. Records were reviewed for demographics, comorbidities, allergies, type and frequency of iron administered. Outcomes of interest were comparisons of baseline and post-treatment hemoglobin [Hgb] and ferritin levels and adverse events (AEs) following infusion. Results: In total 55 patients received one of the two included iron preparations. Of the 40 cases of iron deficiency treated with LMWID, only 4 patients (10%) received a second dose. Of the first LMWID infusions (dose of 1000 mg), all patients demonstrated an increase in Hgb from a mean of 12.21 to 13.15 within an average of 2.75 months. Mean ferritin levels went from 28.34 pre-treatment to 231.14 post-treatment, within an average of 3.26 months. 2 patients (5%) received premedication, one with diphenhydramine or promethazine, based on prior history of an AE. AEs were documented in 3 patients (7.5%) and included arm swelling, dysphagia with globus sensation, and nausea. No patients received premedication prior to ferumoxytol infusion. Those receiving ferumoxytol demonstrated an increase in hemoglobin from a mean of 10.25 to 12.17 within an average of 4.2 months. Ferritin increased from baseline 75.93 to 150.33 within 3 months. AE of diarrhea and nausea were reported in only one patient (6.67%) upon second infusion of ferumoxytol. No patient in either group experienced AEs requiring hospitalization, nor did any patient develop severe hypersensitivity reactions, hypotension, or hypophosphatemia. Discussion: In our retrospective cohort, LMWID or ferumoxytol for treatment of iron deficiency were well tolerated with minimal AEs, limited to arm swelling, dysphagia and nausea in 3 patients. Those treated with ferumoxytol experienced similarly few AEs, with only one patient developing transient diarrhea and nausea. Hesitancy to utilize IV iron has persisted due to concerns for potential side effects including anaphylaxis. Our encouraging results provide additional evidence for the efficacy and safety of LMWID and furomoxytol, and should help to assuage fears that IV iron might be poorly tolerated or ineffective. Disclosures Shatzel: Aronora, Inc.: Consultancy.

Desideromastica: Tactile Chew Cravings in Iron Deficiency Anemia

Introduction: The compulsive craving and consumption of non-food substances, known as pica, is a well-documented symptom associated with iron deficiency anemia (IDA). Olfactory cravings associated with IDA are a recently described phenomenon known as desiderosmia. In our practice we observed a subset of patients with IDA who report specific tactile cravings associated with mastication. Methods: This study included patients from the Mayo Clinic (Rochester, MN) and Ankara Training and Research Hospital (Ankara, Turkey) Hematology practices who self-reported tactile mastication cravings during initial evaluation for IDA between 1/1/18 and 6/30/19. Information including sociodemographics, substance craved, values of hemoglobin (Hgb), mean corpuscular volume (MCV), and ferritin before and after iron replacement therapy, and symptom resolution after treatment were recorded. Results: We observed 12 patients with IDA who self-reported chew cravings during initial evaluation. All patients were female and the median age was 41.5 years (33-59). Of these 12 patients, median baseline Hgb, MCV, and ferritin were 9.4 g/dL (6.6-12.9), 73.7 fL (59.1-95.1), and 6 µg/L (2-21), respectively. Tactile cravings included chewing gum (3), mastic gum (2), ginseng (1), dry oats (1), crackers (1), pickles (1), chips (1), sawdust (1), and knitting rope (1). Many patients reported the frequency and satisfaction of these cravings resulted in jaw pain as well as the persistence of cravings despite this discomfort. Only 16.7% (2/12) reported concurrent ice pica. In total, 9 patients proceeded with observed treatment of their IDA with clinical follow-up and laboratory confirmation of iron repletion. Oral (ferrous glyconate or ferrous fumarate) and intravenous (ferric carboxymaltose, iron sucrose, or low molecular weight iron dextran) iron replacement were used in 33.3% (3/9) and 66.7% (6/9) patients, respectively. Post-treatment median laboratory values include: Hgb 12.7 g/dL (10.8-14.7), MCV 80.1 fL (76.1-91.7), and ferritin 98 µg/L (24-398). Overall, 88.9% (8/9) reported resolution of chew cravings after iron repletion. The lone patient with persistent symptoms had a baseline ferritin of 10 µg/L, improved to 398 µg/L after replacement, and settled back at 42 µg/L three months later. Discussion: Our patient experience provides suggestive evidence that oral tactile craving symptoms, distinct from ice pica, exists in a subset of patients suffering from IDA. For this, we propose the term "desideromastica" derived from the Latin words "desiderare" for desire and "mastica" for chew. "Desidero" can also be indicative of a reduction in iron, which relates to iron deficiency. Our hope in naming this relatively unexplored symptom associated with IDA will encourage additional clinicians to share their experience and guide future investigation. Disclosures No relevant conflicts of interest to declare.

Donor Iron Deficiency Study (DIDS): protocol of a study to test whether iron deficiency in blood donors affects red blood cell recovery after transfusion.

Despite fulfilling all requirements for blood donation, a large proportion of regular blood donors are iron deficient. Red blood cells (RBC) from iron-deficient donors may be particularly susceptible to damage induced by standard refrigerated storage. Herein, we present a study protocol for testing whether correcting iron deficiency in donors with iron-deficient erythropoiesis will improve the quality of their refrigerator-stored RBC. This is a randomised, controlled, double-blind clinical trial. Sixty healthy regular donors who meet donation standards, while exhibiting iron-deficient erythropoiesis by laboratory testing criteria, will donate a single standard RBC unit that will be leucoreduced and stored in a refrigerator under standard conditions for 40-42 days. A 51Cr-radiolabelled 24-hour RBC recovery study will be performed and then these donors will be randomised to receive, in a double-blinded fashion, either intravenous saline, as a control, or low-molecular weight iron dextran (1 g), to provide total iron repletion. Four to six months later, they will donate a second RBC unit, which will be similarly stored, and autologous 51Cr-labelled 24-hour post-transfusion RBC recovery will again be determined. The primary endpoint will be the change in 24-hour post-transfusion recovery from the first to the second donation. The primary outcome will be the group mean difference in the primary endpoints between the group receiving intravenous saline and the group receiving intravenous iron dextran. Secondary outcomes will be quality of life, fatigue, and emotional health, assessed by surveys. This study will provide definitive evidence as to whether donor iron deficiency affects the quality of the blood supply and will assess the severity of symptoms affecting iron-deficient blood donors.

RETRACTED ARTICLE: Lactoferrin plus health education versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating iron deficiency anemia (IDA) in pregnancy: a randomized controlled trial

We, the Editor and Publisher of the Journal of Maternal-Fetal and Neonatal Medicine, have retracted the following article: A. M. Darwish, H. A. Fouly, W. H. Saied & E. Farah (2019) Lactoferrin plus health education versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating iron deficiency anemia (IDA) in pregnancy: a randomized controlled trial, The Journal of Maternal-Fetal & Neonatal Medicine, 32:13, 2214–2220, DOI: 10.1080/14767058.2018.1429396. Since publication, significant concerns have been raised about the integrity of the data and the reported results in the article. Concerns have also been raised about unexplained overlap between this article and another study published previously (online in 2017) by the same corresponding author: A. M. Darwish, E. E. Khalifa, E. Rashad & E. Farghally (2019) Total dose iron dextran infusion versus oral iron for treating iron deficiency anemia in pregnant women: a randomized controlled trial, The Journal of Maternal-Fetal & Neonatal Medicine, 32:3, 398–403, DOI: 10.1080/14767058.2017.1379988. Specifically, these two studies contain 27 identical values in the baseline table and 38 identical values in the outcome tables. Upon query, the authors have not provided responses to our concerns or supplied their original data for review. As significant concerns about the integrity of the article remain, we are therefore retracting the article. The authors have been notified of the retraction. We have been informed in our decision-making by our policy on publishing ethics and integrity and the COPE guidelines on retractions. The retracted article will remain online to maintain the scholarly record, but it will be digitally watermarked on each page as “Retracted”.

Intravenous iron treatments for iron deficiency anemia in inflammatory bowel disease: a budget impact analysis of iron isomaltoside 1000 (Monofer) in the UK

ABSTRACTIntroduction: Iron deficiency is the leading cause of anemia in patients with inflammatory bowel disease (IBD). Intravenous iron is the first-line treatment for clinically active IBD or previous oral iron intolerance. The aim of the present study was to develop a comparative model of iron deficiency and delivery for iron isomaltoside (IIM), ferric carboxymaltose (FCM), low molecular weight iron dextran (LMWID), and iron sucrose (IS) in the treatment of iron deficiency anemia associated with IBD.Areas covered: A model was developed to evaluate iron delivery characteristics, resource use and costs associated with IIM, FCM, LMWID and IS. Iron deficiency was modeled using dosing tables and retreatments were modeled based on a pooled retrospective analysis. The analyses were conducted over 5 years in patients with IBD with mean bodyweight of 75.4 kg and hemoglobin levels of 10.77 g/dL based on observational data.Expert opinion: The modeling analysis showed that using IIM required 1.2 infusions (per treatment) to correct the mean iron deficit, compared with 1.6, 1.2, and 7.1 with FCM, LMWID and IS, respectively. Costs were estimated to be 2,518 pounds sterling (GBP) per patient with IIM or LMWID, relative to GBP 3,309 with FCM or GBP 14,382 with IS.

Total dose iron dextran infusion versus oral iron for treating iron deficiency anemia in pregnant women: a randomized controlled trial

Study objective: To test safety, efficacy, and cost-effectiveness of total dose infusion (TDI) of low molecular weight (LMW) iron dextran for treatment of iron deficiency anemia (IDA) during pregnancy in comparison to oral ferrous fumarate.Design: Prospective interventional randomized controlled trial (RCT). Design classification. Canadian Task Force II3.Setting: Antenatal clinic and causality unit of a tertiary care referral facility and University Hospital.Patients: A total 66 anemic pregnant women (hemoglobin level between 7–10 g/dl).Intervention: Administration of a LMW iron dextran as a TDI (group A) or Oral iron ferrous fumarate 60 mg elemental iron three times daily (group B) followed by remeasurement of hemoglobin after 4 weeks.Measures and main results: The main outcome measure was clinical and laboratory improvement of anemia after 4 weeks of starting the therapy. Both groups showed a significant clinical improvement of anemia 4 weeks post-therapy. However, the first improvement of symptoms was significantly faster in group A. Complete blood count (CBC) as well as all iron indices were improved in both groups after 4 weeks of therapy, but were significantly better in group A than B. Side effects in group B were mainly gastrointestinal (GIT) while one case of mild hypersensitivity to TDI and another one case of local reaction at the site of injection were reported in group A.Conclusions: It is concluded that despite being equally effective in improving both clinical and laboratory evidence of IDA, TDI allows iron restoration with a single dose faster than oral iron therapy with a reasonable safety profile. It is a good example of office one-stop therapy. Nevertheless, noninvasive selfusage at home is a clear advantage of the cheaper oral iron therapy which makes it the first choice for treating IDA in the second and third trimesters of pregnancy in tolerable cases.Trial registration: ClinicalTrials.gov identifier: NCT03212781.

Intravenous Iron Treatments For Iron Deficiency Anemia In Inflammatory Bowel Disease: A Budget Impact Analysis Of Iron Isomaltoside 1000 In The UK

Iron deficiency (ID) is the leading cause of anemia in patients with inflammatory bowel disease (IBD). Intravenous iron should be considered the first-line iron-correction treatment in patients with clinically active IBD, hemoglobin <10g/dL, previous oral iron intolerance, or requiring erythropoiesis-stimulating agents. The study objective was to evaluate resource use and costs associated with using iron isomaltoside (Monofer; IIM) relative to other intravenous iron formulations in patients with iron deficiency anemia (IDA) associated with IBD. A budget impact model was developed to evaluate the cost of IIM relative to ferric carboxymaltose (Ferinject; FCM), low molecular weight iron dextran (Cosmofer; LMWID) and iron sucrose (Venofer; IS). Iron deficits were modeled using dosing tables and the need for retreatments was modeled using a pooled retrospective analysis of randomized trial data. The analysis was conducted over 5 years in patients with mean bodyweight of 75.4 kg (SD 17.4 kg) and hemoglobin levels of 10.8 g/dL (SD 1.4 g/dL) based on observational data from patients with IBD. Costs were modeled using healthcare resource groups. Using IIM required 1.29 infusions (per treatment) to correct the mean iron deficit, compared with 1.64, 1.29 and 7.14 with FCM, LMWID and IS, respectively. Patients using IIM required multiple infusions in 28.7% of cases, compared with, 64.3%, 28.7% and 100% with FCM, LMWID and IS, respectively. Total costs were estimated to be GBP 2,593 per patient with IIM or LMWID, relative to GBP 3,309 with FCM (savings of GBP 717 with IIM) or GBP 14,382 with IS (savings of GBP 11,789 with IIM). Using IIM in place of FCM or IS markedly reduced the number of infusions required to correct ID in patients with IBD and IDA. The reduction in infusions was accompanied by substantial reductions in cost relative to FCM and IS.

Markers of oxidative/nitrosative stress and inflammation in lung tissue of rats exposed to different intravenous iron compounds.

Iron deficiency anemia is a frequent complication in clinical conditions such as chronic kidney disease, chronic heart failure, inflammatory bowel disease, cancer, and excessive blood loss. Given the ability of iron to catalyze redox reactions, iron therapy can be associated with oxidative stress. The lung is uniquely susceptible to oxidative stress, and little is known about the effects of intravenous iron treatment in this organ. This study characterized changes in markers of oxidative/nitrosative stress and inflammation in the lung of non-iron deficient, non-anemic rats treated with five weekly doses (40 mg iron per kg body weight) of low molecular weight iron dextran (LMWID), iron sucrose (IS), ferric carboxymaltose (FCM), ferumoxytol (FMX), iron isomaltoside 1000 (IIM), or saline (control). Rats treated with LMWID, FMX, or IIM showed significant changes in most measures of oxidative/nitrosative stress, inflammation, and iron deposition compared to the saline-treated controls, with greatest changes in the LMWID treatment group. Increases in products of lipid peroxidation (thiobarbituric acid reactive substances) and protein nitrosation (nitrotyrosine) were consistent with increases in the activity of antioxidant enzymes (catalase, Cu,Zn-SOD, GPx), decreases in antioxidative capacity (reduced:oxidized GSH ratio), increased levels of transcription factors involved in the inflammatory pathway (NF-κB, HIF-1α), inflammatory cytokines (TNF-α, IL-6), adhesion molecules (VCAM-1), markers of macrophage infiltration (ED-1), and iron deposition (Prussian blue, ferritin). Since changes in measured parameters in FCM- or IS-treated rats were generally modest, the results suggest that FCM and IS have a low propensity to induce lung inflammation. The relevance of these findings to clinical safety profiles of the tested intravenous iron products requires further investigation.

A budget impact analysis of parenteral iron treatments for iron deficiency anemia in the UK: reduced resource utilization with iron isomaltoside 1000.

Background and aimsThe reported prevalence of iron deficiency anemia (IDA) varies widely but estimates suggest that 3% of men and 8% of women have IDA in the UK. Parenteral iron is indicated for patients intolerant or unresponsive to oral iron or requiring rapid iron replenishment. This study evaluated differences in the cost of treating these patients with iron isomaltoside (Monofer®, IIM) relative to other intravenous iron formulations.MethodsA budget impact model was developed to evaluate the cost of using IIM relative to ferric carboxymaltose (Ferinject®, FCM), low molecular weight iron dextran (Cosmofer®, LMWID), and iron sucrose (Venofer®, IS) in patients with IDA. To establish iron need, iron deficits were modeled using a simplified dosing table. The base case analysis was conducted over 1 year in patients with IDA with mean bodyweight of 82.4 kg (SD 22.5 kg) and hemoglobin levels of 9.99 g/dL (SD 1.03 g/dL) based on an analysis of patient characteristics in IDA trials. Costs were modeled using UK health care resource groups.ResultsUsing IIM required 1.3 infusions to correct the mean iron deficit, compared with 1.3, 1.8, and 7.7 with LMWID, FCM, and IS, respectively. Patients using IIM required multiple infusions in 35% of cases, compared with 35%, 77%, and 100% of patients with LMWID, FCM, and IS, respectively. Total costs were estimated to be GBP 451 per patient with IIM or LMWID, relative to GBP 594 with FCM (a GBP 143 or 24% saving with IIM) or GBP 2,600 with IS (a GBP 2,149 or 83% saving with IIM).ConclusionUsing IIM or LMWID in place of FCM or IS resulted in a marked reduction in the number of infusions required to correct iron deficits in patients with IDA. The reduction in infusions was accompanied by substantial reductions in cost relative to FCM and IS over 1 year.