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Risks and Benefits of Iron

Anaemia affects 496 million non-pregnant women, 32 million pregnant women and 273 million pre-school children worldwide, especially in low and middle-income settings. Approximately half of this burden has been considered amenable to restitution of iron stores, although this proportion is smaller in malaria endemic settings. Putative effects of iron deficiency anaemia in children include impairment in cognitive development, while in women iron deficiency anaemia is considered to cause fatigue, impaired exercise performance and reduced economic productivity. In pregnancy, anaemia is associated with reduced birthweight. Public health strategies to restitute iron stores include distribution of iron supplementation (including multiple micronutrient powders in pre-school children), and the World Health Organization recommends universal distribution of these interventions in settings where anaemia is prevalent.  However, a critical recent concern has been the safety of iron supplementation to children living in settings where malaria and other infections are endemic, supported by large randomized controlled trials. Other risks, less commonly discussed, include the risk of fatal overdose from iron (especially in children), iron overload from chronic iron ingestion in individuals with a propensity to load iron, and potential impairments from iron on growth in children.

WHO guidelines recommend universal iron supplementation (or iron-containing micronutrient powders) where anaemia is prevalent. These guidelines are based on GRADE-based evaluations of evidence for pre-defined beneficial and harmful outcomes. However, these guidelines do not incorporate risk-benefit or economic analysis for these interventions. While economic analyses of iron supplementation programmes have been developed, these have not generally attempted to incorporate any assessment of the costs of potential harms associated with iron.

Formal assessment of the benefit-risk is required for implementation of new public health policies (for example, by NICE in the UK) and for licensing of new pharmaceuticals (for example, by the FDA in the US, TGA in Australia). Formal risk-benefit analysis can provide policy-makers and countries with a sophisticated quantification of the potential outcomes associated with an iron supplementation programme than is presently available within WHO guidelines. Together with economic analysis, this information can potentially guide programme managers and policy makers when selecting between various health priorities and public health interventions.

Taskforce Objectives

1. To evaluate the benefit-risk of iron supplementation as a public health intervention.

a. Sensitivities of assessments to age, intervention and context (e.g. malaria endemicity) will be incorporated.

b. If possible, an algorithm will be developed enabling re-evaluation of this assessment in different settings, with different interventions, or as evidence changes.

2. To undertake a health economic evaluation of iron supplementation as a public health intervention.

a. Sensitivities of assessments to age, intervention and context (e.g. malaria endemicity) will be incorporated.

b. If possible, an algorithm will be developed enabling re-evaluation of this assessment in different settings, with different interventions, or as evidence changes.

3. To identify the evidence gaps limiting benefit-risk and health economic analysis of iron supplementation interventions and make specific recommendations concerning the critical work needed.

The Risk and Benefits of Iron Task Force report for 2015 can be accessed here.

The Risk and Benefits of Iron Task Force Proposal can be accessed here.