Intravenous iron-containing medicinal products

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview

On 27 June 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) completed its review of intravenous iron-containing medicines used to treat iron deficiency and anaemia (low red-blood-cell counts) associated with low iron levels. The CHMP concluded that the benefits of these medicines are greater than their risks, provided that adequate measures are taken to minimise the risk of allergic reactions.

Intravenous iron medicines are used when iron supplements given by mouth cannot be used or do not work. All intravenous iron medicines have a small risk of causing allergic reactions, which can be life-threatening if not treated promptly. The Committee therefore concluded that measures should be put in place to ensure the early detection and effective management of allergic reactions that may occur. Iron preparations should only be given in an environment where resuscitation facilities are available, so that patients who develop an allergic reaction can be treated immediately. In addition, the CHMP considered that the current practice of first giving the patient a small test dose is not a reliable way to predict how the patient will respond when the full dose is given. A test dose is therefore no longer recommended but instead caution is warranted with every dose of intravenous iron that is given, even if previous administrations have been well tolerated.

The CHMP also considered that, during pregnancy, allergic reactions are of particular concern as they can put both the mother and unborn child at risk. Intravenous iron medicines should therefore not be used during pregnancy unless clearly necessary. Treatment should be confined to the second or third trimester, provided the benefits of treatment clearly outweigh the risks to the unborn baby. The Committee also recommended further activities, including yearly reviews of allergic reaction reports and a study to confirm the safety of intravenous iron medicines.

The review of intravenous iron medicines was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following a national review in 2010. The review highlighted the risk of serious allergic reactions, especially in pregnant women who had received intravenous iron medicines. The CHMP recommendation was sent to the European Commission, which endorsed it on 13 September 2013 and adopted a final decision that is legally binding throughout the European Union (EU).

Key facts

About this medicine
Approved name
Intravenous iron-containing medicinal products
International non-proprietary name (INN) or common name
  • ferric carboxymaltose
  • iron dextran
  • sodium ferric gluconate
  • iron isomaltoside
  • iron sucrose
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1322
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
CHMP-EC
Key dates and outcomes
CHMP opinion date
27/06/2013
EC decision date
13/09/2013

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Intravenous iron-containing medicinal products Article-31 referral - New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines (PDF/97.58 KB)

    Adopted

    First published: 01/10/2013
    Last updated: 14/11/2013
    EMA/579491/2013

  • List item

    Intravenous iron-containing medicinal products Article-31 referral - Assessment report (PDF/382.38 KB)


    First published: 01/10/2013
    Last updated: 01/10/2013
    EMA/549569/2013

  • List item

    Intravenous iron-containing medicinal products Article-31 referral - Annex I (PDF/478.96 KB)


    First published: 01/10/2013
    Last updated: 28/07/2021

  • List item

    Intravenous iron-containing medicinal products Article-31 referral - Annex II (PDF/125.49 KB)


    First published: 01/10/2013
    Last updated: 01/10/2013

  • List item

    Intravenous iron-containing medicinal products Article-31 referral - Annex III (PDF/56.97 KB)


    First published: 01/10/2013
    Last updated: 14/11/2013

  • List item

    Intravenous iron-containing medicinal products Article-31 referral - Annex IV (PDF/29.14 KB)


    First published: 01/10/2013
    Last updated: 01/10/2013

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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