Adverse drug reactions associated with Antiasthmatics among children: A Prospective study

Abstract

Background: Childhood asthma can cause bothersome daily symptoms that interfere with play, sports, school and sleep. In some children, unmanaged asthma can cause dangerous asthma attacks. The condition is a leading cause of emergency department visits, hospitalizations and missed school days. Anti-asthmatic drugs used in children may result in a beneficial and adverse drug reactions (ADR) and could contribute significantly to morbidity and mortality. Material and Methods: This is a Prospective and single centre study of children who presented to the Department of Paediatrics, Gayatri Vidya Parishad Institute of Health Care and Medical Technology over a period of 1 year. Paediatric patients of bronchial asthma (both acute and chronic cases) of either gender within the age limit of 1-13 years who attended outpatient department (OPD) as well as in patient department (IPD) were included in the study. Results: During the study period, a total of 19 ADRs were reported among 90 patients. The incidence rate of ADRs was found to be 21.1%. Our study revealed that out of 19 reported cases of ADR, 12 (13.3 %) occurred in males and 7 (7.7%) in females. The most commonly reported ADRs were 5.5% of Anorexia followed by 4.4% of palpitation, 3.3% of dryness of mouth and Headache, and least were 1.1% of oral candidiasis and nausea/vomiting. On causality assessment by WHO-UMC method, it was observed that 1 (1.1%) were certain, 7 (7.7%) were probable and maximum 11 (12.2%) was possible ADR. Assessment of severity of recorded adverse drug reactions with the help of Hartwig and Siegel scale showed that 12 (13.3%) accounted for mild reactions and 7 (7.7 %) were moderate reactions. No severe ADR were recorded during the study period. Conclusion: As compared to adults, ADRs in children can have a relatively more severe effect. Adverse drug reactions associated with anti-asthmatic drugs are quite common. This study highlights the incidence and pattern of ADRs associated with pharmacotherapy of pediatric bronchial asthma.