english.prescrire.org > Spotlight > Archives : 2014 > Intravenous iron: pretence on the part of the European authorities

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Intravenous iron: pretence on the part of the European authorities

The European Medicines Agency (EMA) has allowed iron dextran, the most dangerous alternative, to remain on the market. The French authorities have had to resort to stratagems to protect patients.

In iron-deficiency anaemia, intravenous iron-based drugs should be reserved for the rare cases where iron cannot be given orally. The efficacy of the different forms of intravenous iron is similar. The adverse effects are chiefly skin disorders, nausea, fever, muscle pain and sometimes severe or even fatal hypersensitivity reactions. It has been established that hypersensitivity reactions are more frequent and more severe with iron dextran than with other irons, especially iron sucrose.

The EMA Committee for Medicinal Products for Human Use (CHMP) suggested restrictions on the use of all medicines based on intravenous iron, with “additional monitoring” of hypersensitivity reactions, and the inclusion of a black triangle on patient leaflets to encourage patients and healthcare professionals to report any adverse effects of these drugs.

These measures are a step in the right direction but are insufficient when it comes to iron dextran. Given the additional risk of hypersensitivity and the fact that there are other options that are equally effective (iron sucrose in particular), it is unacceptable to have allowed this drug to remain on the European market. 

In France, patients will be protected against iron dextran since it is not authorised for use outside hospitals due to its insufficient medical benefits; iron dextran is effectively no longer obtainable.

©Prescrire 1 July 2014

"Intravenous iron-containing products: EMA procrastination" Prescrire Int 2014; 23 (151): 184-185. (Pdf, subscribers only).
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