Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicines EMA’s safety committee, PRAC, has started a review of injectable iron-containing medicines following concerns about the risk of hypophosphataemia (low blood phosphate levels) and related bone problems, including osteomalacia (softening of the bones). Phosphate is important for keeping bones healthy. When phosphate levels become too low, osteomalacia can occur causing symptoms such as bone pain. In some cases, it can result in fractures. Injectable iron-containing medicines are used to treat iron deficiency and iron deficiency anaemia (low red blood cell levels) when iron taken by mouth does not work well enough, cannot be used, or
EMA - European Medicines Agency · March 30, 2023
PRAC meeting highlights: 31 August – 3 September 2026
Original title: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026
PRAC initiated a safety review of injectable iron-containing medicines for risk of hypophosphataemia and related bone problems.
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