Safety of Ferric Carboxymaltose in Children: Report of a Case Series from Greece and Review of the Literature

Panagopoulou, Paraskevi; Alexiadou, Sonia; Ntoumpara, Maria; Papazoglou, Anna; Makis, Alexandros; Tragiannidis, Athanasios; Fotoulaki, Maria; Mantadakis, Elpis

doi:10.1007/s40272-022-00491-5

Cited by 7 publications

(10 citation statements)

References 54 publications

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“…Regarding third-generation IV iron formulations (i.e., ferumoxytol, ferric carboxymaltose (FCM) and iron isomaltoside), there is a paucity of safety data in children since they have not been approved for children <14 years old in Europe and <18 years old in the U.S. [ 15 ], apart from FCM, only recently approved for children >1 year old in the U.S. [ 16 ]. However, over the period 2014–2021, a systematic review found 11 studies with 866 children receiving 1231 FCM infusions [ 17 ]. AEs to FCM were reported in 52 (6%) children, with degrees of severity between I and III according to the “Common terminology Criteria for AE” [ 15 ].…”

Section: Frequency Of Hypersensitivity Reactions To Intravenous Iron ...mentioning

confidence: 99%

“…AEs to FCM were reported in 52 (6%) children, with degrees of severity between I and III according to the “Common terminology Criteria for AE” [ 15 ]. Reactions included skin rash, pruritus, mild urticaria, dizziness, mild fever, headache and extravasation injury and one case of mild anaphylactic reaction with a transient drop in oxygen saturation [ 17 ]. Interestingly, 147 children <6 years old had milder reactions (grade I and II) [ 17 ].…”

Section: Frequency Of Hypersensitivity Reactions To Intravenous Iron ...mentioning

confidence: 99%

“…Reactions included skin rash, pruritus, mild urticaria, dizziness, mild fever, headache and extravasation injury and one case of mild anaphylactic reaction with a transient drop in oxygen saturation [ 17 ]. Interestingly, 147 children <6 years old had milder reactions (grade I and II) [ 17 ]. A complete allergy work up was not performed.…”

Section: Frequency Of Hypersensitivity Reactions To Intravenous Iron ...mentioning

confidence: 99%

“…Stojanovic et al [ 25 ] reported that most reactions (184 out of 195; 94%) were immediate, while delayed reactions developed from 1 h to 5 days after the infusion in 11 children. Immediate HSRs include anaphylaxis and isolated immediate non-life-threatening symptoms, such as local irritation, rash, urticaria, angioedema, pruritus, nausea, vomiting, diarrhea, headache and myalgia [ 12 , 17 , 26 , 27 , 28 , 29 ].…”

Section: Clinical Manifestationsmentioning

confidence: 99%

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Hypersensitivity to Intravenous Iron Preparations

et al. 2022

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Intravenous iron is widely used for the treatment of iron deficiency anemia when adherence to oral iron replacement is poor. Acute hypersensitivity reactions during iron infusions are very rare but can be life threatening. Major risk factors for hypersensitivity reactions include a previous reaction to an iron infusion, a fast iron infusion rate, multiple drug allergies, atopic diseases, high serum tryptase levels, asthma, and urticaria. The management of iron infusions requires meticulous observation, and, in the event of an adverse reaction, prompt recognition and severity-related interventions by well-trained medical and nursing staff. Avoidance of IV iron products in patients with iron hypersensitivity reactions may not be considered as a standard practice.

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Section: Frequency Of Hypersensitivity Reactions To Intravenous Iron ...mentioning

confidence: 99%

Section: Frequency Of Hypersensitivity Reactions To Intravenous Iron ...mentioning

confidence: 99%

Section: Frequency Of Hypersensitivity Reactions To Intravenous Iron ...mentioning

confidence: 99%

Section: Clinical Manifestationsmentioning

confidence: 99%

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Hypersensitivity to Intravenous Iron Preparations

et al. 2022

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“…FCM has been studied in children mostly retrospectively [90][91][92][151][152][153], but also prospectively [154]. FCM appeared effective in correction of anemia, with an acceptable risk profile comparable with adults.…”

Section: Practical Guidelinesmentioning

confidence: 99%

High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment

Boots

Quax

2022

Drug Saf

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The intravenous iron formulations ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) offer the possibility of administering a large amount of iron in one infusion. This results in faster correction of anemia and the formulations being better tolerated than oral iron formulations. This triad of logistic advantages, improved patient convenience, and fast correction of anemia explains the fact that intravenous iron formulations nowadays are frequently prescribed worldwide in the treatment of iron deficiency anemia. However, these formulations may result in hypophosphatemia by inducing a strong increase in active fibroblast growth factor-23 (FGF-23), a hormone that stimulates renal phosphate excretion. This effect is much more pronounced with FCM than with FDI, and therefore the risk of developing hypophosphatemia is remarkably higher with FCM than with FDI. Repeated use of FCM may result in severe osteomalacia, which is characterized by bone pain, Looser zones (pseudofractures), and low-trauma fractures. Intravenous iron preparations are also associated with other adverse effects, of which hypersensitivity reactions are the most important and are usually the result of a non-allergic complement activation on nanoparticles of free labile iron—Complement Activation-Related Pseudo-Allergy (CARPA). The risk on these hypersensitivity reactions can be reduced by choosing a slow infusion rate. Severe hypersensitivity reactions were reported in < 1% of prospective trials and the incidence seems comparable between the two formulations. A practical guideline has been developed based on baseline serum phosphate concentrations and predisposing risk factors, derived from published cases and risk factor analyses from trials, in order to establish the safe use of these formulations.

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Intravenous Iron Therapy for Children With Iron Deficiency Anemia

Orhan¹,

Büyükavcı²

2022

Journal of Pediatric Hematology/Oncology

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Iron deficiency anemia in children is a public health problem. Although oral iron treatment is the first choice, common side effects and compliance problems can cause the treatment to be interrupted. This study retrospectively evaluated children treated with intravenous (IV) iron sucrose or ferric carboxymaltose (FCM) and compared the treatment processes and efficacy. The demographic characteristics and treatment details of the 44 children with iron deficiency anemia were retrospectively evaluated. Iron sucrose was administered to 25 patients and FCM was administered to 19 patients. The IV iron infusion was applied to 64% of the patients because of unresponsiveness to oral treatment, 25% of the patients because of compliance problems, and 11% of the patients because of severe anemia. IV iron therapy increased hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin, red-cell distribution width, and serum ferritin levels and decreased platelet count. The mean number of infusions per patient in the FCM group was lower, and the total treatment time was shorter. In conclusion, IV iron sucrose or FCM can be used in children with nonadherence to oral therapy and severe anemia in addition to specific indications.

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Safety of Ferric Carboxymaltose in Children: Report of a Case Series from Greece and Review of the Literature

Cited by 7 publications

References 54 publications

Hypersensitivity to Intravenous Iron Preparations

Hypersensitivity to Intravenous Iron Preparations

High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment

Intravenous Iron Therapy for Children With Iron Deficiency Anemia

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