EU opens injectable-iron review over hypophosphataemia and bone disorders

What changed

EMA’s safety committee, PRAC, opened an Article 31 safety review of injectable iron medicines on 3 September 2026. Regulatory-affairs teams should identify affected national authorisations and coordinate the response with pharmacovigilance colleagues. EMA has listed a procedure timetable and questions for marketing-authorisation holders. (ema.europa.eu)

The review concerns hypophosphataemia—low blood phosphate—and related bone disorders, including osteomalacia, or bone softening. AIFA confirms that concerns involving ferric carboxymaltose expanded to all injectable iron medicines after similar cases were reported with other products. Oral iron is excluded. (aifa.gov.it)

Why it matters

PRAC is testing whether existing safeguards work. Ferric-carboxymaltose product information already recommends phosphate monitoring for specified patients. Reports prompting the review included serious cases after only one or two doses and in people without recognised risk factors. (ema.europa.eu)

That gives teams a practical reason to reassess product-specific case evidence and current monitoring advice. A useful internal review would examine dose history, risk factors and delayed recognition of symptoms. This is an operational recommendation based on the concerns EMA describes. (ema.europa.eu)

Italy and Portugal published national notices on 4 September 2026. These communicate the same EU procedure. INFARMED says the assessment will consider the overall benefit-risk balance and whether authorisations should be maintained, varied, suspended or withdrawn. Those remain possible outcomes. (aifa.gov.it)

Who should pay attention

The affected portfolios contain ferric carboxymaltose, ferric derisomaltose, ferric gluconate, ferric hydroxide polymaltose complex, iron dextran or iron sucrose. Regulatory-affairs, pharmacovigilance and safety-labelling teams supporting these medicines should coordinate their work. Class-wide scope does not establish an equal level of risk for every complex. (ema.europa.eu)

What to watch next

Check the published PRAC questions and timetable for applicable response requirements. The medicines are nationally authorised, so PRAC’s recommendations will go to CMDh, the coordination group for national authorisation procedures, for a position. (ema.europa.eu)

As of 8 September 2026, EMA lists the procedure as started. Teams should track subsequent conclusions and implementation documents before treating any proposed product-information change as an adopted requirement. (ema.europa.eu)

Sources

• S3 — EMA: Referral record, scope, procedural status and published document list. (ema.europa.eu)
• S4 — EMA: Review announcement explaining the safety concerns. (ema.europa.eu)
• S2 — AIFA: September PRAC update confirming the class-wide review. (aifa.gov.it)
• S1 — INFARMED: National safety circular describing potential authorisation outcomes. (infarmed.pt)