A pharmacovigilance study on patients of bronchial asthma in a teaching hospital

Objective: The present study was conducted to monitor adverse drug reactions in patients of bronchial asthma in outpatient department and inpatient department of a university teaching hospital in South Delhi. Materials and Methods: About 200 patients irrespective of age and sex with established asthma were interviewed during the time period of January 2006 to April 2006 using structured questionnaire. Naranjo's adverse drug reaction probability scale was used to assess the adverse drug reactions. Results: A total of 15 adverse drug reactions were reported in 13 out of 200 asthmatic patients. Among the 13 patients reported with adverse drug reactions, 5 (38.5%) were male and 8 (61.5%) patients were female. Maximum percentage of ADRs (2 in 15 prescriptions, 13.3%) observed with montelukast, followed by beclomethasone (1 in 12 prescriptions, 8.3%), salbutamol (6 in 109 prescriptions, 5.5%), and ipratropium (3 in 63 prescriptions, 4.8%). Conclusions: Montelukast was found to be associated with greater percentage of adverse drug reactions as compared to other antiasthamatics. The above findings are constrained by a small sample size and need to be corroborated by conducting long- term studies using a larger sample size.