Effectiveness and safety of ferric carboxymaltose treatment in children and adolescents with inflammatory bowel disease and other gastrointestinal diseases

Abstract

BackgroundThe treatment of iron deficiency anemia in children with inflammatory bowel disease is a particular challenge and often insufficient. Absorption of orally given iron may be impaired by intestinal inflammation and treatment with oral iron may aggravate intestinal inflammation. This retrospective study is the first to describe the use of intravenous ferric carboxymaltose (FCM) in the pediatric setting.MethodsAll subjects who had received at least one dose of FCM intravenously in the observation period were included in this analysis with data collected for up to 3 months post last FCM dose.ResultsIn total, 72 children between 0 and 18 years with underlying gastrointestinal disorders had been treated for concomitant iron deficiency anemia. The majority of patients had Crohn’s disease (40.3%) or ulcerative colitis (30.5%). The total number of FCM administrations was 147, the mean number per patient was 2.0 and the mean cumulative dose 821 mg iron (median single dose: 500 mg; max. 1000 mg). Post administration of FCM, correction of iron deficiency anemia was observed with improved mean hemoglobin levels from 9.5 g/dL at baseline to 11.9 g/dL within 5–12 weeks. Decreases in white cell count, platelets and C-reactive protein were observed post FCM, potentially suggesting reduced inflammation with iron repletion. Three subjects reported mild adverse drug reactions related to FCM; two of these were considered to be potentially related to long duration of administration and to high volume of saline solution for dilution. As such, the method of administration was amended to have a maximum infusion time of 60 minutes and dilution with less than or equal to 100 mL saline solution.ConclusionsOverall FCM was well tolerated in this pediatric population and appeared to be effective in correcting iron deficiency anemia. We cannot exclude that the correction of iron deficiency anaemia is in some part due to the treatment of the underlying disease and not related to the iron supplementation only.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-230X-14-184) contains supplementary material, which is available to authorized users.

Prevalence of iron deficiency anemia and iron deficiency in a pediatric population with inflammatory bowel disease

“…Indeed, these patients not only tend to have a diet poor in many nutrients, including iron but also, present impaired absorption and increased intestinal blood loss, especially those with UC. All of these associated with increased requirements during growth explains a tendency to iron deficiency [2,8,11,21]. Also we believe that in some cases IDA/ID could be underdiagnosed.…”

“…The true prevalence of iron deficiency (ID) and IDA in the pediatric population is unknown. In recent studies, Goodhand et al and later Danko estimated it to be up to 70% at diagnosis and even after two years of follow-up prevalence can be as high as 30% [2,[4][5][6][7][8][9][10].…”

“…Therefore, it is important to carefully evaluate iron status of all patients so that ID and IDA can be diagnosed and treated timely [7,8].…”

“…In context of IBD, interpreting serum ferritin relative to C-reactive protein has been proposed as a method to detect iron deficiency [2,8,9].…”

“…Recently, its gastrointestinal side-effects, slow onset of action and negative impact on disease activity gave rise to the use of intravenous formulations [2,5,6,9,[13][14][15]. There have been some concerns regarding the safety of these preparations in the pediatric population, mainly with dextran formulations which carry increased risk of anaphylaxis [6,8,9,15,16]. But, now, the new formulas such as iron sucrose and ferric carboxymaltose (FCM), the last one still only approved for patients over 14 years, have better safety profiles and are now the first line treatment for IDA and ID in IBD patients [3,4,8,9,[16][17][18].…”