Therapeutics

Review: IV iron does not increase serious adverse events compared with other forms of iron Clinical impact ratings:

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Question

Avni T, Bieber A, Grossman A, et al. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015;90:12-23.

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Are IV iron preparations safe compared with other forms of iron?

For correspondence: Dr. T. Avni, Rabin Medical Center, Petah Tikva, Israel. E-mail [email protected]. 

Review scope

Commentary

Included studies compared IV iron with no iron, placebo, oral iron, intramuscular (IM) iron, or other treatment for any indication and reported adverse events (AEs). Comparisons of different IV iron preparations, dosages, and administration schedules were excluded. The primary outcome was serious adverse events (SAEs) (Common Terminology Criteria for Adverse Events grades 3 to 5), including infections; infusion; and cardiovascular, neurologic, respiratory, gastrointestinal, thromboembolic, and constitutional severe reactions. Secondary outcomes included any AE, all-cause mortality, and AEs requiring discontinuation of treatment.

Review methods MEDLINE, LILACS, KOREAMED, and NLM gateway (all to Dec 2013); Cochrane Library (to Mar 2013); American Society of Hematology, European Haematology Association, American Society of Nephrology, European Renal Association, European Dialysis and Transplant Association, and American Heart Association conference proceedings (2008 to 2013); clinical trials databases; and reference lists were searched for randomized controlled trials (RCTs). 103 RCTs (n = 19 253, median follow-up 8 wk) met selection criteria. IV iron was compared with no iron (14 RCTs), placebo (20 RCTs), oral iron (56 RCTs), IM iron (4 RCTs), or other (9 RCTs). Types of iron included ferric carboxymaltose (15 RCTs), iron sucrose (57 RCTs), ferric gluconate (7 RCTs), iron dextran (14 RCTs), ferumoxytol (4 RCTs), iron polymaltose (3 RCTs), iron isomaltoside (2 RCTs), and ferric carboxymaltose plus iron sucrose (1 RCT). Randomization was adequate in 61 RCTs, concealment was adequate in 52 RCTs, and 20 RCTs were double-blind.

Main results IV iron did not differ from other forms of iron for SAEs or AEs overall (Table). IV iron did not differ from other forms of iron for serious infections or gastrointestinal events but did increase infusion reactions (Table).

The safety of IV iron therapy is recognized by physicians who prescribe it regularly, particularly hematologists, oncologists, and nephrologists. In other specialties and particularly primary care, concerns about adverse effects limit use (1). The systematic review and meta-analysis by Avni and colleagues concludes that IV iron does not increase SAEs overall or mortality, with fairly tight confidence intervals around risk estimates. The review had some limitations. It merged a wide range of indications for iron therapy, including iron deficiency, particularly for obstetric and gynecologic indications; hematopoietic support for such conditions as chronic renal failure or chemotherapyinduced anemia; management of the restless leg syndrome; or as a component of total parenteral nutrition. Total doses of IV iron ranged from 70 to 3200 mg administered on a variety of schedules, and several different therapeutic iron agents were used. Controls included no iron, oral iron, IM iron, and placebo. The included studies were published over a range of > 40 years. Given these sources of variation, it is surprising that little heterogeneity was found in many analyses. The findings of the review show that IV iron therapy had increased rates of infusion reactions and other adverse reactions not rated as serious (e.g., neurologic effects, hypotension). Although these reactions are not categorized as “serious” in the context of clinical trials, they are certainly of concern to the patients who experience them and their clinicians. The conclusion for the clinician is that IV iron can be safely used but, like chemotherapy and similar therapeutic modalities, it requires understanding of the frequency and management of adverse effects and well-informed patients when treatment decisions are made. This review provides useful information for this purpose. Robert T. Means Jr, MD James H. Quillen College of Medicine East Tennessee State University Johnson City, Tennessee, USA

Conclusion IV iron does not increase risk for serious adverse events compared with other forms of iron but does increase risk for infusion reactions.

Reference 1. Auerbach M, Coyne D, Ballard H. Intravenous iron: from anathema to standard of care. Am J Hematol. 2008;83:580-8.

Source of funding: Not stated.

IV iron vs no iron, placebo, oral iron, intramuscular iron, or other treatment* Outcomes

At a median 8 wk RRR/RRI (95% CI)

NNH (CI)

RRI 4% (⫺7 to 17)

Not significant

Infections

RRR 4% (⫺46 to 37)

Not significant

Adverse gastrointestinal events

RRI 3% (⫺36 to 66)

Not significant

RRI 147% (43 to 328)

292 (164 to 1316)

Any serious adverse event

Infusion reaction

RRI 4% (⫺1 to 8)

Not significant

Mortality

Any adverse event

RRI 6% (⫺19 to 39)

Not significant

Adverse event requiring discontinuation of treatment

RRR 8% (⫺12 to 24)

Not significant

*Abbreviations defined in Glossary. RRR, RRI, NNH, and CI calculated from relative risks in article using a fixed-effect model.

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ACP Journal Club

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Annals of Internal Medicine

19 May 2015

ACP Journal Club. Review: I.v. iron does not increase serious adverse events compared with other forms of iron.

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