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Comment
. 2019 May;42(5):689-691.
doi: 10.1007/s40264-019-00814-5.

Comment on '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'

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

Comment on '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'

Philip Schaffalitzky de Muckadell et al. Drug Saf. 2019 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 anaphylactic reactions with FCM compared with the rate of anaphylactic or anaphylactoid reactions with iron isomaltoside at similar stages in the lifecycles of the products. FCM data were derived from the Swissmedic report [3] and from IQVIA MIDAS sales data for Switzerland, during the period between 1 January 2010 and 1 October 2013 (3‒6 years post-launch). Monofer data were derived from the Ehlken et al. analysis [1] (4‒7 years post-launch). DDD defined daily dose, EEA European Economic Area, FCM ferric carboxymaltose
See this image and copyright information in PMC

Comment in

Comment on

References

    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 doi: 10.1007/s40264-018-0769-5. - DOI - PMC - PubMed
    1. European Medicines Agency. Rapid response to BMJ. Re: Pandemrix vaccine: why was the public not told of early warning signs? (EMA/659264/2018). 2018. https://www.ema.europa.eu/documents/other/european-medicines-agency-rapi.... Accessed 18 Jan 2019.
    1. Swissmedic. Vigilance-news. Edition no. 11. 2013.
    1. Center for Drug Evaluation and Research. Medical review of ferric carboxymaltose (application number: 203565Orig1s000). 2013. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000M.... Accessed 17 Jan 2019.
    1. Uppsala Monitoring Centre. VigiBase. https://www.who-umc.org/vigibase/vigibase/. Accessed 1 Nov 2018.