WC500185968

Procedure scope: Evaluation of European databases for studies evaluating the risk of hypersensitivity
reactions in users of intravenous iron compounds (database feasibility evaluation report), literature
review of ferumoxytol and other IV iron containing medicinal products and hypersensitivity reactions,
annual cumulative reviews of hypersensitivity reactions for IV iron-containing medicinal products
MAH(s): various
Background
Intravenous (IV) iron containing products, nationally authorised medicinal products, are indicated in
the treatment of iron deficiency when the oral route is insufficient or poorly tolerated especially in CKD
patients (hemodialysis), but also in pre- or post-operative situations, or in case of intestinal absorption
disorders.
As part of the outcome of the Article 31 referral procedure on intravenous iron-containing medicinal
products (EMEA/H/A-31/1322), the MAHs were requested to conduct a post-authorisation safety study
(PASS) to further characterise the safety concerns relating to serious hypersensitivity reactions.
To address this request, a consortium of MAHs of IV iron compounds has been established with the
objective of assessing the feasibility of conducting a European multinational PASS on the utilisation of
IV iron compounds and the risk of serious hypersensitivity reactions among users of IV iron
compounds, to be conducted in several existing population-based automated health care data sources.
A common protocol synopsis for the PASS feasibility assessment was submitted to the National
Competent Authorities (NCAs) by each concerned MAH of each IV iron medicinal product within their
RMP submission.
France, who was Rapporteur for the Article 31 referral procedure on intravenous iron-containing
medicinal products (EMEA/H/A-31/1322), requested the advice of the PRAC on this feasibility study
report.
Summary of advice and conclusion(s)
Based on the review of the available information the PRAC agreed that whilst the MAHs are correct that
there are limitations when evaluating the risk of anaphylaxis in the databases identified, other
databases need to be considered as does the possibility to complement data from healthcare databases
with information to be obtained through other methods. The PRAC supported the Rapporteur’s view on
the feasibility of the study and supported the Rapporteur’s comments regarding the anticipated sample
size and ways to enhance it, the frequency of anaphylaxis / hypersensitivity reactions, as well as the
need for case verification in this particular study.
12. Organisational, regulatory and methodological matters
12.1. Mandate and organisation of the PRAC
Implementation of new Committee’s agenda template
The EMA Secretariat presented the new Committee’s agenda template. This initiative is to harmonise
the agenda templates for all the EMA committees. The new template will be used as of April 2015.
12.2. Pharmacovigilance audits and inspections
12.2.1. Pharmacovigilance Systems and their Quality Systems
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 54/89