News
European Medicines Agency: PRAC starts safety review of injectable iron-containing medicines

4 September 2026

European Medicines Agency: PRAC starts safety review of injectable iron-containing medicines

Following its meeting of 31 August to 3 September 2026, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of injectable iron-containing medicines over concerns about the risk of hypophosphataemia (low blood phosphate levels) and related bone problems such as osteomalacia. Hypophosphataemia is a known, common side effect of medicines containing ferric carboxymaltose, but the review was triggered by reports questioning the effectiveness of existing risk-mitigation measures, including serious cases – some involving patients without recognised risk factors after only one or two doses – and delayed diagnoses. As similar cases have also been reported with other injectable iron-containing medicines, the review covers all such products; oral iron medicines are excluded, as they deliver considerably lower amounts of iron and are less likely to cause this effect.

The PRAC will assess the risk of hypophosphataemia and related bone disorders, the effectiveness of current risk-mitigation measures, and whether any changes to the marketing authorisations are needed.

For more information, see here.

More News

Subscribe to newsletter