Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026

4 syyskuu 2026

PRAC starts safety review of injectable iron-containing medicines

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 when iron levels need to be restored quickly.

Hypophosphataemia and hypophosphataemic osteomalacia (softening of the bones caused by low blood phosphate levels) are known side effects of injectable iron medicines containing the active substance ferric carboxymaltose. Hypophosphataemia is listed as a common side effect in the product information, meaning it affects up to 1 in 10 people taking the medicine. However, the frequency of hypophosphataemic osteomalacia is unknown because the available data do not allow an estimate of how often it occurs. The product information also includes measures to reduce the risk of hypophosphataemic osteomalacia including recommendations to monitor blood phosphate levels in people receiving high doses or long-term treatment and those with known risk factors. 

The review was triggered following reports that raised concerns about the effectiveness of the current measures to reduce this risk for medicines containing ferric carboxymaltose. These included serious cases of hypophosphataemia, some of which resulted in osteomalacia, including in people who had received only one or two doses of ferric carboxymaltose and who did not have recognised risk factors. Furthermore, in some cases there were delays in diagnosing hypophosphataemia. This could be because symptoms of hypophosphataemia such as tiredness, muscle pain and bone pain may overlap with those of iron deficiency. In addition, the bone problems reported in these cases, such as osteomalacia, may not always be visible on X-rays. 

As similar cases have also been reported with other injectable iron-containing medicines, the scope of the review covers all of these medicines rather than only those containing ferric carboxymaltose.

Iron-containing medicines taken by mouth are not included in the review because they provide considerably lower amounts of iron over time than injectable medicines and are therefore less likely to cause hypophosphataemia. PRAC will now review the risk of hypophosphataemia and related bone disorders associated with injectable iron-containing medicines, as well as the effectiveness of existing measures to reduce these risks. The Committee will assess whether these risks affect the overall benefit-risk balance of the medicines and determine whether any changes to their marketing authorisations are needed. 

More information is available in EMA’s start of referral communication.

Information on all topics discussed by the PRAC is available in the agenda.

Agenda

Agenda of the PRAC meeting 31 August - 3 September 2026

Draft Reference Number: EMA/PRAC/164465/2026

PRAC statistics: September 2026

Monthly figures for PRAC outcomes based on the draft agenda.

@ European Medicines Agency

PRAC statistics: Text version

September 2026 statistics:

• 10 safety signals: 9 started, 1 ongoing
• 86 periodic safety update reports (PSURs) single assessments: 59 recommendations for centrally authorised medicines only, 23 recommendations for nationally authorised medicines only, 4 recommendations for PSURs including both centrally and nationally authorised medicines
• 73 risk management plans (RMPs) for centrally authorised medicines: 16 RMPs reviewed for new medicines, 57 RMPs reviewed for authorised medicines
• 25 post-authorisation safety studies (PASSs): 17 protocols for imposed and non-imposed studies reviewed, 8 results from imposed and non-imposed studies reviewed
• 1 referrals: 1 started, 0 ongoing or concluding

Ongoing referrals

Procedure: Injectable medicines containing iron

Glossary

• Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under 'Signal management'.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under 'Periodic safety update reports: questions and answers'.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans'.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under 'Post-authorisation safety studies'.
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.