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      Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria

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          Abstract

          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.

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          Most cited references 77

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          Under-reporting of adverse drug reactions : a systematic review.

          The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. Studies were included regardless of the methodology used or the setting, e.g. hospital versus general practice. Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%. This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals.
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            Smell and Taste Disorders, A Study of 750 Patients From the University of Pennsylvania Smell and Taste Center

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              Central Processing of the Chemical Senses: an Overview.

              Our knowledge regarding the neural processing of the three chemical senses has been lagging behind that of our other senses considerably. It is only during the last 25 years that significant advances have been made in our understanding of where in the human brain odors, tastants, and trigeminal stimuli are processed. Here we provide an overview of the current knowledge of how the human brain processes chemical stimuli based on findings in neuroimaging studies using positron emission tomography and functional magnetic resonance imaging. Additionally, we provide new insights from recent meta-analyses, based on all published neuroimaging studies of the chemical senses, of where the chemical senses converge in the brain.
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                Author and article information

                Contributors
                s.m.chandrashekhar@gsk.com
                Journal
                Adv Ther
                Adv Ther
                Advances in Therapy
                Springer Healthcare (Cheshire )
                0741-238X
                1865-8652
                2 February 2018
                2 February 2018
                2018
                : 35
                : 2
                : 173-190
                Affiliations
                ISNI 0000 0004 0393 4335, GRID grid.418019.5, GlaxoSmithKline R&D, ; Research Triangle Park Durham, North Carolina, USA
                Article
                665
                10.1007/s12325-018-0665-5
                5818548
                29396682
                © The Author(s) 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004330, GlaxoSmithKline;
                Categories
                Review
                Custom metadata
                © Springer Healthcare Ltd., part of Springer Nature 2018

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