During its September 2026 meeting, the PRAC started a review of the safety of injectable iron-containing medicines and the risk of hypophosphataemia and bone complications.

The review will assess the risk of hypophosphataemia (low blood phosphate levels) and related bone disorders, including hypophosphataemic osteomalacia, as well as the effectiveness of the measures currently in place to minimise these risks and whether further regulatory action may be needed.

The review was initiated following reports of serious hypophosphataemia, in some cases associated with osteomalacia, in patients treated with medicines containing ferric carboxymaltose. As similar cases have also been reported with other injectable iron-containing medicines, the review has been extended to all medicines in this category.

Oral iron-containing medicines are not included in the review, as only a very small number of cases of hypophosphataemia have been reported with them despite their widespread use. 

Further information is provided in the communication available under “Related Documents”.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure the continuous monitoring of the safety of medicinal products and the protection of patient health.