Abnormal uterine bleeding: The well-known and the hidden face.

Abnormal uterine bleeding (AUB) is a bleeding from the uterine corpus that is abnormal in regularity, volume, frequency or duration. It encompasses heavy menstrual bleeding, irregular menstrual bleeding and intermenstrual bleeding, which are common symptoms among women of reproductive age, impacting their overall well-being. Menstruation involves interactions between endometrial epithelial and stromal cells, immune cell influx, and changes in endometrial vasculature. These events resemble an inflammatory response with increased vessel permeability, tissue breakdown, and the arrival of innate immune cells. However, the mechanisms of menstrual cessation are poorly understood. AUB can be related to structural causes (polyp, adenomyosis, leiomyoma, malignancy/hyperplasia) and nonstructural conditions (coagulopathy, ovulatory dysfunction, endometrial, iatrogenic). While transvaginal ultrasound is the primary method for the screening of intracavitary lesions, saline infusion sonohysterography is more accurate to detect endometrial polyps and submucous leiomyomas, while hysteroscopy with biopsy remains the reference method for a definitive diagnosis. The main goals in managing AUB are addressing and correcting the underlying primary cause, if possible, and establishing a regular bleeding pattern or amenorrhea, which can be done with antifibrinolytic agents, progestins, gonadotropin-releasing hormone agonists and antagonists, or surgical interventions, each one with specific indications and limitations. Further research is necessary to assess the effectiveness and the long-term effects of various medical and surgical treatments. Meanwhile, the availability of diagnostic methods such as transvaginal ultrasound and hysteroscopy and the universal distribution of medical treatments for AUB should be prioritized by policymakers to minimize the diagnostic and treatment delay and thus reduce the risk of AUB-related anemia and the need of hysterectomy.

The HOPE study: evaluating the impact of an online educational resource for heavy menstrual bleeding on the patient-physician dynamic.

The Heavy menstrual bleeding: Evidence-based Learning for best Practice (HELP) Group developed an educational website about heavy menstrual bleeding (HMB). The "HMB improving Outcomes with Patient counseling and Education" (HOPE) project examined the website's impact on women's knowledge, confidence, and consultations with healthcare providers (HCPs). HOPE was a quantitative online survey of gynecologists and women with HMB in Brazil. After an initial consultation, patients had unlimited access to the website and completed a survey. HCPs also completed a survey about the sconsultation. After a second consultation, HCPs and patients completed another survey. HCP surveys assessed their perception of patients' awareness, understanding, and willingness to discuss HMB. Patient surveys assessed their knowledge, experience, and confidence in discussing HMB. Forty HCPs recruited 400 women with HMB. Based on HCP perceptions at the first consultation, 18 percent of patients had "good knowledge" or "very good knowledge" of HMB, increasing to 69 percent after patients had visited the website. Before and after visiting the website, 34 percent and 69 percent of patients, respectively, regarded their HMB knowledge as "goo.d" Additionally, 17 percent of women reported their anxiety as "highest" during the first consultation; this decreased to 7 percent during the second consultation. After visiting the HELP website, patients' knowledge of HMB improved and they were less anxious.

Interaction predictors of self-perception menstrual symptoms and influence of the menstrual cycle on physical performance of physically active women.

OBJECTIVE: To analyze the physical performance, self-perception menstrual symptoms, of physically active eumenorrheic women with endogenous ovarian cycle in two phases of the menstrual cycle. METHODS: Twenty-six women participated in the study (age 25.8 ± 3.9 years; height 1.64 ± 0.58 m; mass 64 ± 12.32 kg; menarche 11.69 ± 1.28 years). Assessments were performed in two phases of the menstrual cycle (MC), Early-Follicular Phase (FP) and Mid-Luteal Phase (LP), performance was assessed through total time to exhaustion (TTE), complete stages (CE), and final speed (FE), through a graded exercise test (GXT). Information on the participants' menstrual symptoms and their perceptions of the influence of MC on their performance were also collected. Data normality was assessed using the Shapiro-Wilk test. Paired analyses were conducted (t test or Wilcoxon) to examine the responses between the menstrual phases. The interaction analysis of symptom predictors was performed by multiple linear regression, with a significance level of p ≤ 0.05. RESULTS: There was no significant difference in physical performance between the phases during the GXT in TTE (mean difference 8.50; 95% CI - 11.99 to 42; p = 0.36). During FP, women with heavy flow had shorter performance in the GXT (t = - 2.5; p = 0.01), demonstrating an r2 = 0.32. In LP, for the women who reported not having the perception of the influence of the menstrual cycle on exercise, the total test time was longer (t = 2.55; p = 0.01), with an r2 = 0.45. CONCLUSION: There was no difference in physical performance between FP and LP. However, menstrual flow intensity and perception of cycle interference demonstrated a decrease in TTE.

Uterine volume, menstrual patterns, and contraceptive outcomes in users of the levonorgestrel-releasing intrauterine system: A cohort study with a five-year follow-up.

OBJECTIVE: The aim of our study was to evaluate the effects of the LNG-IUS on uterine volume, bleeding patterns, and LNG-IUS-related outcomes among women using the device to treat abnormal uterine bleeding caused by fibroids, adenomyosis, HMB (without structural cause), or contraception. STUDY DESIGN: This was a 5-year cohort study with LNG-IUS users. We selected 147 women, who were allocated to four groups: a) control (contraception indication); b) fibroids; c) adenomyosis; d) HMB. The visits for clinical and ultrasound evaluations were made at baseline and at 3, 6, 12, 24, 36, 48, and 60 months postinsertion. All data are expressed as mean and standard deviation (SD) or absolute and relative (%) frequency. Differences among groups were established by using the χ2 (chi-square) test and Fisher's exact tests for categorical outcomes, as well as the Mann-Whitney and the Kruskal-Wallis tests and Friedman's ANOVA for continuous variables. We used the 5% significance level as an indication of statistical significance. Logistic regression analyses were performed to study the association between predictors and outcomes. Results are expressed as odds ratios (ORs) with a 95% confidence interval (CI 95%). RESULTS: Although all groups had real rates of bleeding patterns, troublesome bleeding appeared to be more frequent in the fibroid group (∼15%). Also, along the 60 months of follow-up, uterine volume slightly decreased in the groups of HMB, adenomyosis, and fibroids, but not in the contraception group. However, the isolated volume of fibroids remained unchanged. In this cohort, we observed high continuation rates among LNG-IUS users. The uterine volume ≥200 cm3 was the main predictor of hysterectomy or IUS expulsion in the adenomyosis and fibroid groups. CONCLUSION: The LNG-IUS may control uterine menstrual bleeding as well as uterine volume in adenomyosis, fibroids, and HMB. An initial uterine volume smaller than 200 cm3 is an important predictor of adherence to treatment and better outcomes.

Expulsion rates of the levonorgestrel 52 mg intrauterine system are similar among women with heavy menstrual bleeding and users for contraception.

OBJECTIVE: To compare the expulsion rates of the levonorgestrel (LNG) 52 mg intrauterine system (IUS) among women with heavy menstrual bleeding versus women using solely for contraception. STUDY DESIGN: We conducted an audit study of 548 (8.8%) women with heavy menstrual bleeding and 5655 (91.2%) users for contraception (comparison group) for 4 years in Campinas, Brazil. We retrieved sociodemographic data, expulsion rates, and variables associated to device placement. Among women with heavy menstrual bleeding, we placed the devices after the cessation of bleeding or after the reduction of menstrual flow. RESULTS: Thirty-one of 548 (5.6%) women with heavy menstrual bleeding and 315 of 5655 (5.6%) from the comparison group expelled the device. This constituted 7.8 expulsions/100 women-years in women with heavy menstrual bleeding and 10.3 expulsions/100 women-years from the comparison group (p = 0.94). Expulsion risk was associated with previous cesarean delivery in both groups (OR 1.93, 95% CI 1.36;2.74). CONCLUSIONS: Expulsion rates of the LNG IUS among women with heavy menstrual bleeding whose IUS was placed after the cessation or reduction of bleeding were similar to expulsion rates among users for contraception. Previous cesarean delivery was a risk factor for expulsion. IMPLICATIONS: We recommend the 52 mg LNG IUS placement after the cessation of bleeding or a reduction of menstrual flow among women with heavy menstrual bleeding because this strategy was associated with similar risk of expulsion when compared to users for contraception.

The difficult journey to treatment for women suffering from heavy menstrual bleeding: a multi-national survey.

PURPOSE: Up to 30% of women of reproductive age experience HMB, which has a substantial impact on their quality of life. A clinical care pathway for women with HMB is an unmet need, but its development requires better understanding of the factors that characterise current diagnosis and management of the condition. MATERIALS AND METHODS: This observational, survey-based study assessed the burden, personal experiences, and path through clinical management of women with HMB in Canada, the USA, Brazil, France and Russia using a detailed, semi-structured online questionnaire. After excluding those reporting relevant organic pathology, responses to the questionnaire from 200 women per country were analysed. RESULTS: Around 75% of women with HMB had actively sought information about heavy periods, mostly through internet research. The mean time from first symptoms until seeking help was 2.9 (Standard deviation, 3.1) years. However, 40% of women had not seen a health care professional about the condition. Furthermore, 54% had never been diagnosed or treated. Only 20% had been diagnosed and received appropriate treatment. Treatment was successful in 69% of those patients currently receiving treatment. Oral contraceptives were the treatment most commonly prescribed for HMB, although the highly effective levonorgestrel-intrauterine system was used by only a small proportion of women. CONCLUSIONS: This study provides insight into the typical journey of a woman with HMB which may help patients and health care professionals improve the path to diagnosis and treatment, although further research with long-term outcomes is needed.

Safety and bleeding patterns of the levonorgestrel 52-mg intrauterine system among women with thrombosis or coagulopathy.

OBJECTIVE: To assess the safety of the levonorgestrel 52-mg intrauterine system (LNG-IUS) in women with a history of thrombosis or coagulopathy and to evaluate bleeding patterns. METHODS: A retrospective chart review was conducted of 117 women attending a clinic between 2007 and 2019. Their sociodemographic characteristics, hematologic status, reasons for using LNG-IUS, duration of use, use of oral anticoagulants, complications, and bleeding patterns were analyzed. RESULTS: Ninety-nine women had a history of thrombosis (71.7% in use of oral anticoagulants) and 18 had coagulopathies. No bleeding or any other complications occurred during placement of the LNG-IUS. Around two-thirds of the women reported amenorrhea or oligomenorrhea at 12, 24, and 54 months of follow-up, with no difference between the groups using the IUS for contraception or to treat heavy menstrual bleeding (HMB) (P=0.07), those with a history of thrombosis or coagulopathy (P=0.53), and users or non-users of oral anticoagulants (P=0.59). CONCLUSION: The LNG-IUS is safe for women with hematologic disorders. It was associated with amenorrhea or oligomenorrhea in a large proportion of users up to 54 months of follow-up regardless of use of oral anticoagulants, reason for use of LNG-IUS (contraception or HMB), or history of coagulopathy or thrombosis.

Trastornos hereditarios de la coagulación en adolescentes con sangrado menstrual excesivo, ¿debemos evaluar la vía fibrinolítica? / Inherited bleeding disorders in adolescents with excessive menstrual bleeding: should we evaluate the fibrinolytic pathway?

Resumen: Introducción: El Sangrado Menstrual Excesivo (SME) es un problema frecuente en la adolescencia. La prevalencia de trastornos hereditarios de la coagulación (THC) como causa del SME no está bien establecida y la participación de defectos de la vía fibrinolítica ha sido poco explorada. Objetivo: Determinar la prevalencia de THC y defectos de la fibrinólisis en adolescentes con SME. Pacientes y Método: Se incluyeron 93 adolescentes, edad 11 a 18 años. Los antecedentes personales y familiares de sangra do se obtuvieron con un cuestionario estandarizado. Se controló exámenes: tiempo de protrom- bina (TP), tiempo de tromboplastina parcial activada (TTPa), estudio del factor Von Willebrand, recuento y función plaquetaria. Los pacientes que no fueron diagnosticados como THC, se evaluaron adicionalmente con el tiempo de lisis del coágulo. Resultados: 41 pacientes (44%) fueron diagnos ticados como THC: Enfermedad de Von Willebrand n = 28, defectos de la función plaquetaria n = 8, hemofilia leve n = 5. Se confirmó disminución del tiempo de lisis del coágulo en 31 pacientes. El 54% de pacientes diagnosticado como THC, tuvo SME como la primera manifestación hemorrágica. Conclusión: Estos resultados apoyan la necesidad de evaluación de la coagulación, incluyendo la vía fibrinolítica, en el estudio de adolescentes con SME.

Abstract: Introduction: Heavy Menstrual Bleeding (EMB) is a frequent problem in adolescence. The prevalence of inherited bleeding disorders (IBD) as a cause of EMB is not well established and the involvement of fibri nolytic pathway defects has been poorly explored. Objective: To determine the prevalence of IBD and fibrinolysis defects in adolescents with EMBs. Patients and Method: 93 adolescents (11 to 18 years old) were included. Personal and family history of bleeding were obtained through a standard ized questionnaire. The following lab tests were performed: prothrombin time (PT), activated partial thromboplastin time (aPTT), von Willebrand factor quantification, and platelet count and function. Those patients who were not diagnosed with IBD were further evaluated with clot lysis time assay. Results: 41 patients (44%) were diagnosed as IBD (Von Willebrand disease n = 28, platelet func tion defects n=8, mild hemophilia n = 5. Decreased clot lysis time was found in 31 patients. 54% of patients diagnosed with IBD had EMB as the first hemorrhagic manifestation. Conclusion: These results support the need to evaluate the coagulation process, including the fibrinolytic pathway in the study of adolescents with EMB.

Bleeding changes after levonorgestrel 52-mg intrauterine system insertion for contraception in women with self-reported heavy menstrual bleeding.

BACKGROUND: The levonorgestrel 52-mg intrauterine system has proven efficacy for heavy menstrual bleeding treatment in clinical trials, but few data exist to demonstrate how rapidly the effects occur and the effects in women with self-reported heavy bleeding, as seen commonly in clinical practice. OBJECTIVE: Evaluate changes in bleeding patterns in women with self-reported heavy menstrual bleeding before levonorgestrel 52-mg intrauterine system insertion. STUDY DESIGN: A total of 1714 women aged 16-45 years old received a levonorgestrel 52-mg intrauterine system in a multicenter trial evaluating contraceptive efficacy and safety for up to 10 years. At screening, participants described their baseline menstrual bleeding patterns for the previous 3 months. Participants completed daily diaries with subjective evaluation of bleeding information for the first 2 years. For this analysis, we included women with at least 1 complete 28-day cycle of intrauterine system use and excluded women using a hormonal or copper intrauterine contraception in the month prior to study enrollment. We evaluated changes in menstrual bleeding and discontinuation for bleeding complaints per 28-day cycle over 26 cycles (2 years) in women who self-reported their baseline pattern as heavy. We also compared rates of amenorrhea, defined as no bleeding or spotting, within the entire study population in women with subjective heavy menstrual bleeding at baseline compared with those who did not complain of heavy menstrual bleeding. RESULTS: Of the 1513 women in this analysis, 150 (9.9%) reported baseline heavy menstrual bleeding. The majority of women reported no longer experiencing heavy menstrual bleeding by the end of cycle 1 (112/150, 74.7%) with even greater rates by cycle 2 (124/148, 83.8%). At the end of cycles 6, 13, and 26, 129 of 140 (92.1%; 95% confidence interval, 87.7%-96.6%), 114 of 123 (92.7%; 95% confidence interval, 88.1%-97.3%), and 100 of 103 (97.1%; 95% confidence interval, 93.8%-100%) women reported no heavy menstrual bleeding, respectively. After cycles 13 and 26, 63 of 123 (51.2%; 95% confidence interval, 42.4%-60.1%) and 66 of 103 (64.1%; 95% confidence interval, 54.8%-73.3%), respectively, reported their bleeding as amenorrhea or spotting only. A lower proportion of women with baseline self-reported heavy menstrual bleeding reported amenorrhea as compared with women in the overall study cohort without heavy menstrual bleeding at the end of 6 cycles (319 [25.5%] vs 21 [15.0%], P=.005) and 13 cycles (382 [34.4%] vs 26 [21.1%], P=.003); differences were not significant after 19 cycles (367 [37.2%] vs 36 [31.0%], P=.022) and 26 cycles (383 [43.5%] vs 38 [36.9%], P=.21). Only 4 (2.7%) women with baseline heavy menstrual bleeding discontinued for bleeding complaints (2 for heavy menstrual bleeding and 2 for irregular bleeding), all within the first year. CONCLUSION: Most women who self-report heavy menstrual bleeding experience significant improvement quickly after levonorgestrel 52-mg intrauterine system insertion. Discontinuation for bleeding complaints among women with baseline heavy menstrual bleeding is very low.

Heavy menstrual bleeding: a global survey of health care practitioners' perceptions.

OBJECTIVES: This study sought to assess the perceptions of health care practitioners (HCPs) regarding heavy menstrual bleeding (HMB). METHODS: We developed an online survey for HCPs administered in 10 countries (Brazil, Canada, China, France, Germany, Korea, Russia, Spain, UK and USA), in order to assess their perceptions regarding HMB. RESULTS: We received 1032 responses. Most HCPs considered more than 7 days of bleeding abnormal. There was a significant difference in the definition of HMB between countries (p < .001). Most HCPs measured menstrual blood loss by the number of sanitary pads or tampons needed, followed by the impact on patients' daily activities. The majority of HMB patients (61%) were diagnosed as having a non-structural disorder with no causative identifiable coagulopathy. Patient acceptance and compliance were each relevant for the treatment decisions of half of the HCPs. Treatment options for idiopathic HMB featured mainly oral contraceptives and the levonorgestrel-releasing intrauterine system. Surgery was mentioned as a treatment option for idiopathic HMB by 44% of HCPs. CONCLUSION: The definition of HMB and HCP perceptions of HMB regarding diagnostic and therapeutic issues varied between countries. Surgery was mentioned as a treatment for idiopathic HMB by nearly half of HCPs. Clinician education is greatly needed to improve the management of women with HMB.

El sangrado menstrual excesivo afecta la calidad de vida en adolescentes / Heavy menstrual bleeding affects quality of life in adolescents

Resumen Introducción: El sangrado menstrual excesivo (SME) se presenta aproximadamente en 37% de las adolescentes y afecta en distinto grado su calidad de vida. Objetivo: Medir la magnitud del impacto del SME en la calidad de vida en adolescentes. Pacientes y Método: Se entrevistó a adolescentes con diagnóstico de SME entre 10 y 18 años y a uno de sus tutores. Se aplicó el cuestionario de calidad de vida PedsQL 4.0 escala genérica, su versión Proxy PedsQL 4.0 al tutor, más 3 preguntas sobre limitación de actividades diarias. La concordancia entre la percepción de calidad de vida del tutor y adolescente se evaluó con el gráfico de Bland y Altman. Resultados: 46 adolescentes y tutores fueron evaluados. El puntaje total promedio PedsQL 4.0 para las adolescentes fue 64,48 (DS 14,54), con un rango de 18,48 a 88,04 con mayor compromiso en la dimensión emocional. Un 50% de las adoles centes falta al colegio, 80,4% a educación física y 65,2% a actividades al aire libre o fiestas. No hubo concordancia entre la percepción de las adolescentes y sus tutores. Conclusiones: Se evidenció un deterioro de la calidad de vida de las adolescentes encuestadas, siendo la dimensión emocional la más afectada. El desempeño en el cuestionario fue incluso más bajo que en patologías crónicas publicadas con esta misma herramienta.

Abstract Introduction: Heavy menstrual bleeding (HMB) occurs in 37% of adolescents and compromise their quality of life. Objective: To measure the magnitude of the impact of the SME on the quality of life in adolescents. Patients and Method: We interviewed adolescents diagnosed with HMB between 10 and 18 years old and one of their guardians. PedsQL 4.0 generic core scale was applied to measure quality of life, its Proxy PedsQL 4.0 version was applied to the guardian and 3 more questions to adolescents about limitation of daily activities. The concordance between the guardian's perception of the adolescent quality of life and the adolescent's perception was evaluated with the Bland and Altman graph. Results: 46 adolescents and guardians were evaluated. The total average PedsQL 4.0 score for adolescents was 64.48 (SD 14.54), with a range of 18.48 to 88.04 with a greater involvement in the emotional dimension. 50% of adolescents missed school, 80.4% physical education and 65.2% outdoor activities or parties. There was no agreement between the perception of the girls and guar dians. Conclusions: We evidence a deterioration in the quality of life of the surveyed adolescents, being the emotional dimension most affected. The performance in the questionnaire was also lower than in samples of chronic diseases published with this same tool.

Abnormal Uterine Bleeding / Sangramento uterino anormal

Abstract Abnormal uterine bleeding is a frequent condition in Gynecology. It may impact physical, emotional sexual and professional aspects of the lives of women, impairing their quality of life. In cases of acute and severe bleeding, women may need urgent treatment with volumetric replacement and prescription of hemostatic substances. In some specific cases with more intense and prolonged bleeding, surgical treatment may be necessary. The objective of this chapter is to describe the main evidence on the treatment of women with abnormaluterinebleeding, both acuteand chronic.Didactically,thetreatmentoptions were based on the current International Federation of Gynecology and Obstetrics (FIGO) classification system (PALM-COEIN). The etiologies of PALM-COEIN are: uterine Polyp (P), Adenomyosis (A), Leiomyoma (L), precursor and Malignant lesions of the uterine body (M), Coagulopathies (C), Ovulatory dysfunction (O), Endometrial dysfunction (E), Iatrogenic (I), and Not yet classified (N). The articles were selected according to the recommendation grades of the PubMed, Cochrane and Embase databases, and those in which the main objective was the reduction of uterine menstrual bleeding were included. Only studies written in English were included. All editorial or complete papers that were not consistent with abnormal uterine bleeding, or studies in animal models, were excluded. The main objective of the treatment is the reduction of menstrual flow and morbidity and the improvement of quality of life. It is important to emphasize that the treatment in the acute phase aims to hemodynamically stabilize the patient and stop excessive bleeding, while the treatment in the chronic phase is based on correcting menstrual dysfunction according to its etiology and clinical manifestations. The treatment may be surgical or pharmacological, and thelatterisbasedmainlyonhormonaltherapy,anti-inflammatorydrugsandantifibrinolytics.

Resumo O sangramento uterino anormal é uma afecção frequente que pode afetar negativamente aspectos físicos, emocionais, sexuais e profissionais, piorando a qualidade de vida das mulheres. Nos casos de sangramento intenso e agudo, as mulheres podem necessitar de tratamento de urgência, com reposição volumétrica e substâncias hemostáticas. Há situações que necessitam de tratamento prolongado, e ainda situações em que o tratamento cirúrgico pode ser necessário. O objetivo deste estudo é descrever as principais evidências sobre o tratamento das mulheres com sangramento uterino anormal, tanto na fase aguda quanto na crônica. A apresentação do tratamento foi baseada no sistema de classificação (PALM-COEIN, na sigla em inglês) da Federação Internacional de Ginecologia e Obstetrícia (FIGO). As etiologias do PALMCOEIN são: Pólipo uterino (P), Adenomiose (A), Leiomiomia (L), lesões precursoras e Malignas do corpo uterino (M), Coagulopatias (C), distúrbios da Ovulação (O), disfunção Endometrial (E), Iatrogênicas (I), e não classificadas nos itens anteriores (N). Os artigos foram selecionados conforme os graus de recomendação das bases de dados PubMed, Cochrane e Embase que tivessem como objetivo o tratamento do sangramento uterino anormal em mulheres. Somente artigos escritos em inglês foram incluídos. Todos os editoriais ou papers completos que não tratassem de sangramento uterino anormal, ou estudos baseados em modelos animais, foram excluídos. O tratamento tem como objetivo a redução do fluxo menstrual, reduzindo morbidade e melhorando a qualidade de vida. O tratamento na fase aguda visa estabilizar hemodinamicamente a paciente e estancar o sangramento excessivo, enquanto a terapia da fase crônica é baseada na correção da disfunção menstrual, conforme sua etiologia ou conforme a manifestação clínica. O tratamento pode ser cirúrgico ou medicamentoso, sendo o segundo baseado principalmente em fármacos hormonais, anti-inflamatórios ou antifibrinolíticos.

Intravenous Ferric Carboxymaltose in Children with Iron Deficiency Anemia Who Respond Poorly to Oral Iron.

OBJECTIVE: To assess the benefits and risks of intravenous (IV) ferric carboxymaltose (FCM) in children with iron deficiency anemia (IDA). STUDY DESIGN: In a retrospective cohort study of patients seen at our center, we identified all FCM infusions in children with IDA over a 12-month period through a query of pharmacy records. Clinical data, including hematologic response and adverse effects, were extracted from the electronic medical record. RESULTS: A total of 116 IV FCM infusions were administered to 72 patients with IDA refractory to oral iron treatment (median age, 13.7 years; range, 9 months to 18 years). Median preinfusion and postinfusion hemoglobin values were 9.1 g/dL and 12.3 g/dL, respectively (at 4-12 weeks after the initial infusion; n = 53). Sixty-five patients (84%) experienced no adverse effects. Minor transient complications were encountered during or immediately after 7 infusions. CONCLUSION: FCM administered as a short IV infusion without a test dose proved to be safe and highly effective in a small yet diverse population of infants, children, and adolescents with IDA refractory to oral iron therapy.