Alertă privind medicamentele injectabile cu fier: EMA declanșează o evaluare de siguranță în toată UE

The European Medicines Agency (EMA) is evaluating the safety of injectable iron medications in the EU due to severe cases of low phosphate levels in blood, some linked to osteomalacia. This assessment will determine if current risk mitigation measures are adequate or if changes to drug authorizations are needed. Injectable iron is used for treating iron deficiency and anemia, especially in patients unable to take oral supplements. The review includes various iron formulations administered via injection or infusion. The EMA's decision follows similar actions by the FDA in the U.S., which has issued warnings about symptomatic hypophosphatemia associated with these treatments. The evaluation aims to assess the risks and effectiveness of existing safety measures, with recommendations to follow after the analysis is complete.