Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria
| Autor: | Amy L Curry, Andrew H Schindzielorz, Chandrashekhar S Muganurmath |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Olfactory and gustatory dysfunction medicine.medical_specialty Population Review Causality assessment Allergic rhinitis Fluticasone propionate Olfaction Disorders Taste Disorders 03 medical and health sciences Nasal Polyps Intranasal fluticasone 0302 clinical medicine Anti-Allergic Agents Pharmacovigilance medicine Humans Pharmacology (medical) 030223 otorhinolaryngology education Adverse effect Administration Intranasal Nasal polyposis education.field_of_study business.industry General Medicine Rhinitis Allergic Causality Dermatology Causal inference Respiratory Fluticasone Female Bradford Hill criteria Nasal administration business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Advances in Therapy |
| ISSN: | 1865-8652 0741-238X |
| DOI: | 10.1007/s12325-018-0665-5 |
| Popis: | Causality assessment is crucial to post-marketing pharmacovigilance and helps optimize safe and appropriate use of medicines by patients in the real world. Self-reported olfactory and gustatory dysfunction are common in the general population as well as in patients with allergic rhinitis and nasal polyposis. Intranasal corticosteroids, including intranasal fluticasone propionate (INFP), are amongst the most effective drugs indicated in the treatment of allergic rhinitis and nasal polyposis. While intranasal corticosteroids are associated with olfactory and gustatory dysfunction and are currently labeled for these adverse events, causality assessment has not been performed to date. Although there is no single widely accepted method to assess causality in pharmacovigilance, the Bradford Hill criteria offer a robust and comprehensive approach because nine distinct aspects of an observed potential drug–event association are assessed. In this literature-based narrative review, Hill’s criteria were applied to determine causal inference between INFP and olfactory and gustatory dysfunction. |
| Databáze: | OpenAIRE |
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