A pharmacovigilance study of antiasthmatic agents in patients of bronchial asthma at a tertiary care hospital

Background: Pharmacovigilance study reports on monitoring adverse drug reactions (ADRs) of antiasthmatic agents are scarce in India. Oral thrush, tremor and palpitations, throat irritation and cough are common adverse effects of antiasthmatics. However prevalence and severity of these adverse effects remains undetected due to lack of pharmacovigilance studies in Indian context. Objective: The present study was conducted to assess the prevalence and severity of ADRs in patients of bronchial asthma in a tertiary care teaching hospital in Pune. Materials and Methods: 50 patients irrespective of age and sex with established asthma were interviewed during the time period of January 2013 to June 2013 using structured questionnaire. The Naranjo's probability scale was used for causality & Hartwig and Seigel scale for severity assessment. Results: A total of 13 ADRs were reported in 11 out of 50 asthmatic patients. Maximum percentage of ADRs (57.1%) observed with salbutamol, followed by salmeterol (50%) beclomethasone (30%) and tiotropium (25%). According to the Naranjo's scale, 7.69 % ADRs each were found to be definite and doubtful while 30.76% possible and 53.85 % probable. Highest percentage of ADRs (84.6%) were mild (e.g., nausea, gastrointestinal distress, dryness of mouth, bitter taste, headache, cough, etc. & well tolerated by the patients, 15.4% of ADRs were classified as moderate (e.g., tremors and palpitations) on Hartwig and Seigel scale. Conclusions: Salbutamol was found to be associated with greater percentage of adverse drug reactions like bitter taste, tremors and palpitations as compared to other anti-asthmatics. 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.