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Article

Risks Associated with the Use of Intranasal Corticosteroids: An Analysis of Adverse Reactions Reported to EudraVigilance

by
Luís Martins
1,
Samuel Silvestre
2 and
Cristina Monteiro
2,3,4,*
1
Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
2
CICS-UBI-Health Sciences Research Centre, Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
3
UFBI-Pharmacovigilance Unit of Beira Interior, Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
4
Academic Clinical Center of Beiras, Faculdade de Ciências da Saúde, Universidade da Beira Interior, 6200-506 Covilhã, Portugal
*
Author to whom correspondence should be addressed.
Healthcare 2024, 12(19), 1923; https://doi.org/10.3390/healthcare12191923
Submission received: 30 July 2024 / Revised: 9 September 2024 / Accepted: 23 September 2024 / Published: 25 September 2024

Abstract

Background: Intranasal corticosteroids (INCS) are used for several conditions, including allergic rhinitis and sinusitis. Consequently, their safety profile needs continuous monitoring. This study aimed to analyse the adverse drug reactions (ADRs) of the INCS with market authorisation in Europe. Methods: A retrospective analysis of the ADR data from EudraVigilance in the period between the 1 January 2011 and 12 June 2023 was performed, with 2641 reports selected for analysis. ADRs were categorised by seriousness and evolution, with a focus on the most prevalent ADRs and their alignment with the Summary of Product Characteristics (SmPC). Results: The 18–64 age group, particularly females, was most affected. Mometasone was the most reported INCS, with predominantly non-serious ADRs, evolving towards resolution, which often were not listed in the SmPC. From the reported ADRs that were not described in the SmPC of the INCS studied, “Anosmia” and “Ageusia” were highlighted. Regarding the ADRs described in the SmPC, the most frequently reported were “Epistaxis” and “Headache”. The ADRs belonging to the Designated Medical Event list were also analysed, with “Angioedema” as the most reported ADR, which was mainly associated with budesonide. Conclusions: These findings underscore the importance of continuous INCS monitoring to mitigate ADRs and safeguard public health. Further research is warranted to explore potential novel signs for safety arising from previously unreported ADRs.
Keywords: intranasal corticosteroids; pharmacovigilance; adverse drug reactions; EudraVigilance intranasal corticosteroids; pharmacovigilance; adverse drug reactions; EudraVigilance

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MDPI and ACS Style

Martins, L.; Silvestre, S.; Monteiro, C. Risks Associated with the Use of Intranasal Corticosteroids: An Analysis of Adverse Reactions Reported to EudraVigilance. Healthcare 2024, 12, 1923. https://doi.org/10.3390/healthcare12191923

AMA Style

Martins L, Silvestre S, Monteiro C. Risks Associated with the Use of Intranasal Corticosteroids: An Analysis of Adverse Reactions Reported to EudraVigilance. Healthcare. 2024; 12(19):1923. https://doi.org/10.3390/healthcare12191923

Chicago/Turabian Style

Martins, Luís, Samuel Silvestre, and Cristina Monteiro. 2024. "Risks Associated with the Use of Intranasal Corticosteroids: An Analysis of Adverse Reactions Reported to EudraVigilance" Healthcare 12, no. 19: 1923. https://doi.org/10.3390/healthcare12191923

APA Style

Martins, L., Silvestre, S., & Monteiro, C. (2024). Risks Associated with the Use of Intranasal Corticosteroids: An Analysis of Adverse Reactions Reported to EudraVigilance. Healthcare, 12(19), 1923. https://doi.org/10.3390/healthcare12191923

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