Use of intravenous iron and risk of anaphylaxis: A multinational observational post‐authorisation safety study in Europe

Author:

Fortuny Joan1ORCID,Gersdorff Gero2ORCID,Lassalle Régis3ORCID,Linder Marie4ORCID,Overbeek Jetty5ORCID,Reinold Jonas6ORCID,Toft Gunnar7ORCID,Timmer Antje8ORCID,Dress Jochen9,Blin Patrick3ORCID,Droz‐Perroteau Cécile3ORCID,Ehrenstein Vera7ORCID,Franzoni Carla1,Herings Ron510ORCID,Kollhorst Bianca6ORCID,Moore Nicholas3ORCID,Odsbu Ingvild4ORCID,Perez‐Gutthann Susana1ORCID,Schink Tania6ORCID,Rascher Katherine2,Rasouliyan Lawrence1ORCID,Rothman Kenneth J.11ORCID,Saigi‐Morgui Nuria1ORCID,Schaller Mathias2,Smits Elisabeth5,Forstner Michael12ORCID,Bénichou Jacques13ORCID,Bircher Andreas J.1415ORCID,Garbe Edeltraut6ORCID,Rampton David S.16,Gutierrez Lia1ORCID,

Affiliation:

1. Pharmacoepidemiology and Risk Management RTI Health Solutions Barcelona Spain

2. Department of Internal Medicine–QiN‐group University of Cologne, Faculty of Medicine and University Hospital Cologne Cologne Germany

3. Bordeaux PharmacoEpi INSERM CIC1401, University of Bordeaux Bordeaux France

4. Centre for Pharmacoepidemiology Karolinska Institutet Stockholm Sweden

5. Department Research PHARMO Institute for Drug Outcomes Research Utrecht The Netherlands

6. Clinical Epidemiology Group Leibniz Institute for Prevention Research and Epidemiology–BIPS Bremen Germany

7. Department of Clinical Epidemiology Aarhus University Aarhus Denmark

8. Epidemiology and Biometry Group Carl von Ossietzky University Oldenburg Oldenburg Germany

9. Research Data Center (DaTraV) Federal Institute for Drugs and Medical Devices–BfArM Bonn Germany

10. Amsterdam UMC Vrije Universiteit Amsterdam, Epidemiology and Biostatistics Amsterdam The Netherlands

11. Pharmacoepidemiology and Risk Management RTI Health Solutions Waltham Massachusetts USA

12. Mesama Consulting Solothurn Switzerland

13. Department of Biostatistics Rouen University Hospital and Inserm U 1018, University of Rouen Rouen France

14. Allergy Unit Dermatology Clinic University Hospital Basel Basel Switzerland

15. Faculty of Biomedicine Università della Svizzera italiana Lugano Switzerland

16. Department of Gastroenterology Royal London Hospital London UK

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference18 articles.

1. Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety

2. Differences in the reporting rates of serious allergic adverse events from intravenous iron by country and population;Bailie GR;Clin Adv Hematol Oncol,2012

3. WalshK AndradeS CocorosN et al.Sentinel assessment report: parenteral iron and anaphylactoid reactions.US Food and Drug Administration; 22 July2016.https://www.sentinelinitiative.org/sites/default/files/surveillance‐tools/routine‐querying/Sentinel_Parenteral‐Iron‐and‐Anaphylactoid‐Reactions_Report.pdf. Accessed 6 October 2020.

4. Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products

5. On the relative safety of parenteral iron formulations

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