EMA launches safety review of injectable iron medicines

The European Medicines Agency (EMA), through its Pharmacovigilance Risk Assessment Committee (PRAC), has launched a safety review of all injectable iron-based medicines available in the European Union. This action follows reports of severe cases of hypophosphatemia—low phosphate levels in the blood—which have been linked to bone complications such as osteomalacia.

While the review was initially prompted by reports involving ferric carboxymaltose, the scope has been extended to include all injectable iron products, including ferric derisimaltose, ferric gluconate, ferric hydroxide polymaltose complex, iron dextran, and iron sucrose. These treatments are typically used for patients with iron deficiency or anemia when oral administration is ineffective or insufficient, such as patients undergoing dialysis, those with heart failure, or individuals with severe deficiencies during pregnancy.

The evaluation aims to determine if current risk-minimization measures are adequate and whether regulatory changes to medicinal authorizations are necessary. Oral iron preparations are not included in this review, as they provide lower amounts of iron over time and carry a lower risk of causing hypophosphatemia.