Pharmacovigilance Study of Antiasthmatic Agents in Patients of Bronchial Asthma at a Tertiary Care Centre.

Abstract

Background: Bronchial asthma is one of the most common chronic disease in the world affecting around 334 million people. Management of bronchial asthma includes multidrug therapy for long duration, which leads its association with adverse drug reactions (ADRs). Pharmacovigilance studies of antiasthmatic agents are scare in india.Therefore, the present study was planned to monitor and evaluate adverse drug reactions associated with antiasthmatic agents. Objectives: The present study was conducted to evaluate the pattern, causality and severity analysis of adverse drug reactions associated with antiasthmatic agents in a tertiary care centre. Materials and Methods: 150 patients of either gender, ageing above 18 years with established bronchial asthma attending outpatient and inpatient department of medicine at a tertiary care centre interviewed during the time period of October 2016 to February 2017.Central Drugs Standard Control Organisation (CDSCO) ADR forms were filled. World Health Organisation-Upasala Monitoring Centre (WHO-UMC) causality categories were used for assessment of causality. Severity of ADRs was assessed by using Hartwig and siegel scale. Results: A total 33 ADRs were reported in 23 patients out of 150 bronchial asthma patients. Among the 23 patients reported with ADRs 10 (43.47%) were male while 13 (56.52%) were female. Oral thrush was most common ADR (33.33%) followed by palpitation (15.15%), sore throat (12.12 %), running nose, tremors (each 9.09%), dry mouth, GI distress, bitter taste (each 6.06%) and headache (3.03%) among the patients of bronchial asthma receiving antiasthmatic agents. Most ADRs were associated with inhalational Beclomathasone (58.33%) followed by inhalational budesonide (25%), montelukast (23.07%), salbutamol (18.75%), theophylline (14.29%), ipratropium (7.4%) and salmeterol (02.22%). According to WHO-UMC categories 48.57% ADRs were found to be probable while 51.42% were possible. Highest percentage of ADRs 75.79% were classified as mild and 24.24% were moderate on Hartwig and Siegle scale. Conclusion: Results of our study highlighted the need for ADR monitoring of antiasthamatics in asthma patient. Patients receiving inhalational steroids needs to be proper councelling and also written