European Regulator Probes Injectable Iron Drugs for Bone Disorder Risk

The European Medicines Agency (EMA) has opened a formal review of all injectable iron-containing medicines following concerns that they may lead to abnormally low phosphate levels in the blood and related bone disorders, including osteomalacia, or softening of the bones.

The review was triggered by reports of serious cases of hypophosphataemia and bone softening in patients who had received only one or two doses of medicines containing the active substance ferric carboxymaltose. These reports suggested that existing risk-minimisation measures may not be sufficiently effective.

Injectable iron is typically reserved for patients with iron deficiency or iron-deficiency anaemia when oral supplements are ineffective, cannot be tolerated, or when a rapid restoration of iron levels is clinically required.

The EMA's safety committee will now assess whether the reported risks alter the overall benefit-risk balance of these products and whether changes to their marketing authorisations are necessary. The scope of the review extends beyond ferric carboxymaltose, as similar cases have been observed with other injectable iron products.

The review does not cover oral iron medicines. According to the regulator, oral formulations deliver considerably lower amounts of iron over a longer period and are considered far less likely to cause hypophosphataemia.

The move follows action earlier this week by the U.S. Food and Drug Administration, which added a boxed warning to labels of ferric carboxymaltose injections regarding the risk of low phosphate levels.