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Inhaled and Intranasal Corticosteroids and Behavioral and Psychiatric Problems: A Pharmacovigilance Analysis Using AERS Data.
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Permanent Link: http://ufdc.ufl.edu/IR00000603/00001
 Material Information
Title: Inhaled and Intranasal Corticosteroids and Behavioral and Psychiatric Problems: A Pharmacovigilance Analysis Using AERS Data.
Physical Description: Conference Papers
Creator: Ayad K Ali
Conference: 27th ICPE
Publisher: John Wiley & Sons, Ltd.
Place of Publication: USA
Publication Date: August 12, 2011
 Notes
Abstract: Background: Analysis of spontaneous reporting systems in the European Union resulted in a concern regarding the association between inhaled and intranasal corticosteroids (CS) and behavioral or psychiatric (BP) adverse events. Objectives: We conducted an analysis using the United States Adverse Event Reporting System (AERS) to assess BP safety signals associated with inhaled and intranasal CS. Methods: The AERS database is used to conduct a retrospective pharmacovigilance analysis of adverse event reports received between January 1, 2004 and March 31, 2010. Proportional Reporting Ratios (PRR) as a data mining algorithm and corresponding 95% Confidence Intervals (95%CI) are used to estimate the association between specific corticosteroids (CS) and BP adverse events. These events are identified using defined Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PT). The PRR and 95%CI are reported for individual CS by route of administration (systemic, intranasal, and orally inhaled). The reporting ratios for individual CS are compared with all CS in the drug class by route of administration. Results: A total of 2,245,691 reports for the specified exposure are identified in AERS during the study period. 68,101 reports were for CS; 78%, 11.3%, and 10.7% of the CS reports were for systemic, inhaled, and intranasal CS, respectively. Compared to all CS, inhaled and intranasal CS had higher PRR values of BP than systemic CS (1.40 95% CI 1.20–1.63; 1.71 95%CI 1.48–1.97; and 0.48 95%CI 0.43–0.54; respectively). PRR values higher than 1 are found for inhaled mometasone (2.50 95%CI 0.38–16.8); inhaled budesonide (1.20 95%CI 0.93–1.54); intranasal triamcinolone (1.24 95%CI 0.79–1.97); intranasal mometasone (1.13 95%CI 0.83–1.54); and intranasal beclomethasone (1.13 95%CI 0.79–1.61). However, all the estimates are statistically not significant. Conclusions: Compared to systemic CS, inhaled and intranasalCS are associated with higher than expected reporting of behavioral and psychiatric events, however; -except for inhaled mometasone—the PRR data mining algorithm failed to detect a safety signal (PRR 2).
Acquisition: Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Ayad K Ali.
Publication Status: Published
General Note: Citation: Pharmacoepidemiology and Drug Safety. August 2011;20(S):61Abstract No. 142.
 Record Information
Source Institution: University of Florida Institutional Repository
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution.
System ID: IR00000603:00001

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