PharmacovigilanceOfficial

PRAC reviews injectable iron medicines over low phosphate and bone disorder risk

🇪🇺 EMA · Thu 12 Nov 2026

EMA's safety committee has opened an Article 31 review of all injectable iron products, assessing hypophosphataemia, osteomalacia and whether current risk-minimisation measures work.

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing injectable iron-containing medicines because of concerns about hypophosphataemia (low blood phosphate) and related bone problems, including osteomalacia. The procedure started on 3 September 2026, and the EMA page was updated on 12 November 2026, when Annex I was revised.

The trigger was reports questioning whether existing risk-reduction measures for ferric carboxymaltose are effective. According to EMA, these included serious cases of hypophosphataemia, some leading to osteomalacia, in patients who had received only one or two doses and had no recognised risk factors. Some diagnoses were also delayed, possibly because symptoms such as tiredness, muscle pain and bone pain overlap with those of iron deficiency, and because osteomalacia may not always show on X-rays.

Hypophosphataemia and hypophosphataemic osteomalacia are already known side effects of ferric carboxymaltose products. The product information lists hypophosphataemia as common, affecting up to 1 in 10 people, while the frequency of osteomalacia is unknown. It also advises monitoring phosphate levels in patients on high doses or long-term treatment, and in those with known risk factors. Because similar cases have been reported with other injectables, the review covers ferric carboxymaltose, ferric derisomaltose, ferric gluconate, ferric hydroxide polymaltose complex, iron dextran and iron sucrose. Oral iron products are excluded, as they supply considerably less iron over time and are less likely to cause the problem.

The Austrian medicines agency requested the review under Article 31 of Directive 2001/83/EC. PRAC will assess whether the risks change the benefit-risk balance and whether marketing authorisations need to change. As the products are nationally authorised, its recommendations will go to the CMDh, which will adopt a position. The EMA page lists a PRAC list of questions and a timetable for the procedure, but the source gives no dates for outcomes.

What it means for your team

  • Marketing authorisation holders of any parenteral iron product in the EU should check the Annex I product list, the PRAC list of questions and the timetable for the procedure, and prepare for possible requests for data.
  • Pharmacovigilance teams may wish to review case data on hypophosphataemia and osteomalacia, including cases after few doses, without known risk factors, or with delayed diagnosis.
  • Possible outcomes include changes to national marketing authorisations, as the PRAC recommendation will pass to the CMDh; regulatory and market-access teams should monitor for any product information or risk-minimisation changes.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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