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

Autor: Stefan Wohlfeil, Lennart Nathell, Annegret Gohlke
Rok vydání: 2019
Předmět:
Adult
medicine.medical_specialty
Adolescent
Drug-Related Side Effects and Adverse Reactions
Iron
MedDRA
Pharmacology toxicology
MEDLINE
Intravenous iron
Toxicology
Iron sucrose
Ferric Compounds
030226 pharmacology & pharmacy
Drug Hypersensitivity
Young Adult
03 medical and health sciences
0302 clinical medicine
Hypersensitivity
medicine
Adverse Drug Reaction Reporting Systems
Humans
media_common.cataloged_instance
Pharmacology (medical)
Original Research Article
European Union
030212 general & internal medicine
European union
Intensive care medicine
Infusions
Intravenous
Adverse effect
Letter to the Editor
Retrospective Studies
media_common
Ferric Oxide
Saccharated
Pharmacology
business.industry
Pharmacoepidemiology
Retrospective cohort study
Middle Aged
medicine.disease
Europe
Emergency medicine
Female
business
Administration (government)
Iron Compounds
Anaphylaxis
medicine.drug
Zdroj: Drug Safety
ISSN: 1179-1942
0114-5916
DOI: 10.1007/s40264-019-00868-5
Popis: Introduction Severe hypersensitivity reactions (HSRs) such as anaphylaxis are of great clinical concern because of their life-threatening potential. The adverse events attributable to intravenous iron products include HSRs. An investigation by the European Medicines Agency presented in late 2013 resulted in the implementation of risk minimization measures (RMMs). Objective This study evaluated the number of severe HSRs reported for intravenous iron substances related to exposure for the 4-year periods before and after this implementation. Methods This was a retrospective pharmacoepidemiologic study with a case-population design. We obtained information from the safety surveillance database EudraVigilance on spontaneously reported severe HSRs using the Medical Dictionary for Regulatory Activities preferred terms “anaphylactic reaction/shock” and “anaphylactoid reaction/shock”. Exposure was estimated using IQVIA MIDAS sales data in European economic area countries. Results Reporting rates for individual products were heterogenous, and the implementation of RMMs appeared to have no clear impact. Reporting rates remained low for the full study period for iron sucrose (0.03–0.20) and ferric gluconate (0.02–0.14) and were higher at the beginning and lower at the end of the study period for ferric carboxymaltose (1.47–0.18). No clear trend was detected for iron dextran (range 0.22–2.80) and iron (III) isomaltoside 1000 (range 0–7.94). Conclusions Future research is needed to investigate whether the wide variability in reporting rates for severe HSRs associated with these intravenous iron products are due to potential differences in the safety profiles of these substances. Electronic supplementary material The online version of this article (10.1007/s40264-019-00868-5) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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