EMA starts safety review of injectable iron medicines over hypophosphataemia risk

EMA’s Pharmacovigilance Risk Assessment Committee has begun reviewing injectable iron-containing medicines. The review will assess low blood phosphate levels and related bone problems; the supplied meeting highlights report no findings or prescribing changes.

PRAC has started a review of injectable iron-containing medicines.
Assessment focuses on hypophosphataemia and related bone problems.
No risk estimates or prescribing changes appear in the supplied text.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a safety review of injectable iron-containing medicines to assess the risk of low blood phosphate levels and related bone problems. The announcement appears in highlights from the committee’s 31 August–3 September 2026 meeting, published on 4 September 2026, and lists an ongoing referral for parenteral iron-containing medicinal products. The supplied text does not identify individual products, quantify the risks, or provide patient-level data. It also reports no conclusions or changes to prescribing recommendations. For clinicians using injectable iron, this is notification of an ongoing regulatory assessment rather than a completed evaluation of risk.

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Source

European Medicines Agency: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026 ↗

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