Local Adverse Drug Reactions in Ambulatory Asthma Patients Treated With Inhaled Corticosteroids: An Experience from a South Indian Teaching Hospital

Abstract

Objective: To determine prevalence, severity, predictability, preventability of local adverse drug reactions (ADRs) to ICS and their associated risk factors. Methods: Patients with asthma needing ICS were enrolled. Study patients were interviewed with open-ended questions to assess local ADRs to inhaled corticosteroids (ICSs) at baseline and at each follow-up visit, once per month for 3 months. Causality (Naranjo's algorithm and WHO scale), severity (Hartwig SC et al. scale), predictability (based on frequency of occurrence of ADR and history of drug exposure), and preventability (Schumock and Thornton criteria) of local ADRs were assessed. Bivariate analysis and subsequently multivariate logistic regression were used to identify the risk factors for local ADRs to ICSs. Results: A total of 243 patients (134 female) were included in the study. A total of 74 local ADRs were observed in 59 patients (prevalence 24.3%). The most common local ADRs were thirsty feeling (14.8%) followed by cough during inhalation (8.6%) and taste disturbance (4.5%). All ADRs were predictable and mild in severity. Preventability assessment found 85.1% of local ADRs as "probably preventable." Age >41 years, use of MDI with spacer, and use of budesonide were identified as the risk factors for development of ADRs to ICSs. Conclusion: Local ADRs to ICSs were commonly observed in patients with asthma (24.3%). Strategies to prevent local ADRs to ICSs should focus on patients aged >41 years, receiving budesonide, and using MDI with spacer.