Post-authorization safety study (PASS) on the risk of severe hypersensitivity reactions in patients treated with intravenous iron


Intravenous iron preparations (IV iron) are used for the treatment of moderate and severe anemia when oral preparations cannot be used or were not effective. Anemia can be related to numerous conditions such as chronic kidney disease, heavy uterine bleeding, pregnancy and postpartum anemia, chemotherapy-induced anemia, elective surgery, and chronic heart failure.
Reports of adverse events in two large cohort studies suggested an association between IV iron preparations and severe hypersensitivity reactions.
Thus, to assess the risk of severe hypersensitivity reactions, a post-authorization safety study (PASS) based on claims data from the German Pharmacoepidemiological Research Database (GePaRD) has been requested by the European Medicines Agency (EMA).
The study aims to investigate the incidence of severe hypersensitivity reactions, in new users of IV iron preparations, applying a cohort design that will cover the years 2005 to 2015. Additionally, incidence of severe hypersensitivity reactions in new users of intravenous penicillin will be calculated to provide context for interpreting the results. The study will also be conducted in the Netherlands, Denmark, France and Sweden.

Funding period

Begin:   April 2017
End:   December 2020


  • RTI Health Solutions


 Jonas Reinold

Selected project-related publications

    Posters at scientific meetings/conferences

  • Gutierrez L, Blin P, Dress J, Droz-Perroteau C, Ehrenstein V, Forstner M, Franzoni C, Lassalle R, Linder M, Moore N, Odsbu I, Overbeek J, Perez-Gutthan S, Pisa F, Rascher K, Rasouliyan L, Reinold J, Rothman K, Saigi-Morgui N, Schaller M, Smits L, Timmer A, Toft G, von Gersdorff G, Fortuny J. Challenges in conducting a multinational European study of severe hypersensitivity reactions among recipients of intravenous iron. 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), 24-28 August 2019, Philadelphia, USA. (Abstract published in: Pharmacoepidemiology & Drug Safety. 2019;28(S2):640)