Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comment
. 2020 May;43(5):503-505.
doi: 10.1007/s40264-020-00929-0.

Comment on 'Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures'

Philip Schaffalitzky de Muckadell  1 , Claes Christian Strom  2
Affiliations
Comment

Comment on 'Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures'

Philip Schaffalitzky de Muckadell et al. Drug Saf. 2020 May.
No abstract available

PubMed Disclaimer

Conflict of interest statement

Philip Schaffalitzky de Muckadell and Claes Christian Strom are employees of Pharmacosmos A/S.

Figures

Fig. 1
Fig. 1
Rate of reporting serious or severe HSRs, or serious ADRs, in head-to-head randomized clinical trials of IIM [–, –11]. aThe total number of patients was obtained from Auerbach et al. [10] and Bhandari et al. [11]. ADR adverse drug reaction, FCM ferric carboxymaltose, HSR hypersensitivity reaction, IIM iron isomaltoside
See this image and copyright information in PMC

Comment on

References

    1. Nathell L, Gohlke A, Wohlfeil S. Reported severe hypersensitivity reactions after intravenous iron administration in the European Economic Area (EEA) before and after implementation of risk minimization measures. Drug Saf. 2019 doi: 10.1007/s40264-019-00868-5. - DOI - PMC - PubMed
    1. Ehlken B, Nathell L, Gohlke A, Bocuk D, Toussi M, Wohlfeil S. Evaluation of the reported rates of severe hypersensitivity reactions associated with ferric carboxymaltose and iron (III) isomaltoside 1000 in Europe based on data from EudraVigilance and VigiBase™ between 2014 and 2017. Drug Saf. 2019;42(3):463–471. doi: 10.1007/s40264-018-0769-5. - DOI - PMC - PubMed
    1. Bhandari S, Thomsen LL. A single 1000 mg infusion of iron isomaltoside 1000 demonstrates a more rapid hemoglobin response and reduced risk of cardio-vascular adverse events compared to multiple doses of IV iron sucrose in the FERWON trials [Abstract SP342] Nephrol Dial Transplant. 2019;34(Suppl 1):i475–i486.
    1. Derman R, Roman E, Modiano MR, Achebe MM, Thomsen LL, Auerbach M. A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. Am J Hematol. 2017;92(3):286–291. doi: 10.1002/ajh.24633. - DOI - PMC - PubMed
    1. Bhandari S, Kalra PA, Kothari J, Ambühl PM, Christensen JH, Essaian AM, et al. A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients. Nephrol Dial Transplant. 2015;30(9):1577–1589. doi: 10.1093/ndt/gfv096. - DOI - PMC - PubMed