Update on adverse drug events associated with parenteral iron

Chertow, Glenn M.; Mason, Phillip D.; Vaage-Nilsen, Odd; Ahlmén, J

doi:10.1093/ndt/gfi253

Cited by 412 publications

(296 citation statements)

References 17 publications

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“…The large majority of serious adverse events (SAEs) with iron dextran were due to the HMW formulations, Dexferrum and Imferon. The authors concluded that when HMW iron dextran is avoided, the other formulations are safe with a SAE rate of less than 1:200,000 administrations [43]. This is supported by two published prospective studies and a meta-analysis comparing LMW iron dextran and IS [44][45][46], two prospective comparisons of ferumoxytol and IS [47,48], and a retrospective observational analysis [49], all of which found no significant difference in adverse events among the various formulations.…”

Section: Safety Issuesmentioning

confidence: 86%

How we diagnose and treat iron deficiency anemia

2015

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It is estimated that one‐third of the world's population is anemic, the majority being due to iron deficiency (ID). In adults, ID is associated with fatigue in the absence of anemia, restless legs syndrome, pica and, in neonates, delayed growth and development. In adolescents, ID is associated with decrements in learning and behavioral abnormalities. In the absence of a clear cause, search for a source of bleeding is indicated. No single test is diagnostic of ID unless the serum ferritin is low or the percent transferrin saturation is low with an elevated total iron binding capacity. Oral iron is considered front line therapy except for conditions such as gastric bypass, heavy uterine bleeding, inflammatory bowel disease, and hereditary hemorrhagic telangiectasia. Oral iron has many unpleasant side effects, resulting in low patient adherence. For patients intolerant of, or unresponsive to, oral iron, intravenous (IV) administration is the preferred route. While early formulations were associated with a high incidence of serious adverse events (SAEs), newer formulations are much safer with SAEs occurring very infrequently. Full replacement doses can be administered in a matter of minutes to a few hours. Nevertheless, there remains a reluctance to use IV iron due to a misunderstanding of the safety of the available formulations. IV iron is safe and effective in all clinical circumstances including pregnancy. The preponderance of published evidence suggests IV iron therapy is underutilized and we believe that IV iron should be moved forward in the treatment of ID and iron deficiency anemia (IDA). Am. J. Hematol. 91:31–38, 2016. © 2015 Wiley Periodicals, Inc.

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Section: Safety Issuesmentioning

confidence: 86%

How we diagnose and treat iron deficiency anemia

2015

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“…In facts, the medical community experienced a long lasting generalized prejudice against IV iron, whatever the preparation used. Only relatively recently, it was realized that severe and potentially lethal reactions were almost exclusively due to HMWD-iron [99], which, in the meantime, was no longer produced since 1992 [100] and replaced by other preparations (Fig. 3a).…”

Section: Historical Considerationsmentioning

confidence: 99%

Modern iron replacement therapy: clinical and pathophysiological insights

et al. 2017

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Iron deficiency, with or without anemia, is extremely frequent worldwide, representing a major public health problem. Iron replacement therapy dates back to the seventeenth century, and has progressed relatively slowly until recently. Both oral and intravenous traditional iron formulations are known to be far from ideal, mainly because of tolerability and safety issues, respectively. At the beginning of this century, the discovery of hepcidin/ferroportin axis has represented a turning point in the knowledge of the pathophysiology of iron metabolism disorders, ushering a new era. In the meantime, advances in the pharmaceutical technologies are producing newer iron formulations aimed at minimizing the problems inherent with traditional approaches. The pharmacokinetic of oral and parenteral iron is substantially different, and diversities have become even clearer in light of the hepcidin master role in regulating systemic iron homeostasis. Here we review how iron therapy is changing because of such important advances in both pathophysiology and pharmacology.

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“…19 The high-molecular-weight iron dextran formulation most frequently were responsible for these side effects seen in 2.3% of the patients. 20,21 However, the availability of new preparations like iron sucrose, with much better safety profiles, are more useful in day to day clinical practice. 17,22 The present study was done to evaluate the safety and the effectiveness of IV iron sucrose for pre-op patients waiting for fitness prior to surgery.…”

Section: Discussionmentioning

confidence: 99%

Intravenous iron sucrose for treatment of anemia in gynecology patients awaiting surgery

Gandhi

Satia

2016

Int J Reprod Contracept Obstet Gynecol

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Background: Anemia refers to reduction in the total circulatory erythrocyte mass which results in decrease in the oxygen carrying capacity of the blood. Patients who require a surgical intervention as regards their complaints are many a times denied fitness because of anemia. Current anesthetic and surgical practice ideally recommend a hemoglobin level of > 10 g/dl or a hematocrit of >30 % for any surgical intervention. Surgery is postponed until cause of anemia is identified and the anemia corrected without resorting to blood transfusions. The current study evaluates other alternatives to increase the hemoglobin as early as possible without resorting to blood transfusion. The efficacy and safety of intravenous iron sucrose along with the achievement of the desired hemoglobin values for patients posted for elective gynecological surgeries within the next menstrual cycle was evaluated. Methods: This study was an open label, single arm, and prospective study of women with iron deficiency anemia in gynecological disorders. 100 patients attending Gynecology OPD of Seth G. S. Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, India requiring surgical intervention but not given fitness due to anaemia were the subjects of this study. All patients with surgically treatable conditions with hemoglobin level >7g/dL but < 10 g/dl were the inclusion criteria Selected subjects received intravenous iron sucrose. Maximum dose 200mg/weekX3 weeks initially. At the end of three weeks of starting therapy Hb estimation was done and compared with the baseline levels as regarding the hemoglobin rise. The results were statistically analyzed using the "paired t" test. Results: The requirement of iron-sucrose for the individual patient was calculated based on the weight of the patient. The analysis of iron requirement-sucrose combination showed a mean of 481.7 mg with standard deviation (SD) of 62.72 mg and a range of 378.85 mg. The minimum iron-sucrose requirement was 361.55 mg and the maximum was 740.40 mg The mean Hb (gm%) value before intervention was 8.43 with a standard deviation of 0.56, whereas, the mean Hb (gm %) value after intervention was higher, 10.41 with standard deviation (SD) of .56 the mean Hb (gm %) Increase in 2 weeks was 1.60 with standard deviation (SD) of 0.31, whereas, in 3 weeks was 2.03 with standard deviation (SD) of 0.51. The mean Hb (gm %) increase was higher in participants with 3 weeks, which was statistically significant (p<0.05). Conclusions: Parenteral iron therapy was not safe in the past but iron sucrose has made it the safest and effective therapy. Parenteral iron therapy can be used for patients with Hb level between 6-8mg/dl It is highly efficacious and reliable way to achieve the desired Hb level patient compliance is assured with intravenous iron sucrose patient can be satisfactorily posted for surgery within a period of 3 weeks i.e. within her next menstrual period by reliably and effectively correcting her anemia with intravenous iron sucrose.

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Update on adverse drug events associated with parenteral iron

Cited by 412 publications

References 17 publications

How we diagnose and treat iron deficiency anemia

How we diagnose and treat iron deficiency anemia

Modern iron replacement therapy: clinical and pathophysiological insights

Intravenous iron sucrose for treatment of anemia in gynecology patients awaiting surgery

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