A study to evaluate the pattern, causality, predictability, and severity of adverse drug reactions to corticosteroid therapy in pediatric idiopathic nephrotic syndrome at a tertiary care center

ABSTRACT

Background: Adverse drug reactions (ADRs) in children cannot be predicted based on those observed in adults. Systematic surveillance of ADRs in children, in particular to corticosteroids are limited. Aim and Objective: The aim of the study was to evaluate the pattern as well as causality, preventability, and severity of occurrence of ADRs due to corticosteroid therapy in pediatric idiopathic nephrotic syndrome (INS). Materials and Methods: After obtaining approval from Institutional Ethics Committee and informed consent/assent, 98 patients who developed ADRs were included in the study. Each patient’s demographic, clinical, treatment data, response pattern, and ADRs to corticosteroids as per Indian Academy of Pediatrics guidelines were noted in the pro forma. The data were analyzed using descriptive statistics. Results: Total of 148 ADRs were observed due to corticosteroids among 98 patients diagnosed with nephrotic syndrome. The most common ADR was cushingoid features (18%), followed by infections (14%), gastrointestinal symptoms (11.48%), hypocalcemia (8%), and growth retardation (7%). About 45% of the ADRs were of “possible” causality and 32% were certain. Severity assessment indicates 54% as mild and majority of ADRs were not preventable. Conclusions: This study provides data of ADRs to corticosteroid therapy in INS patients. Most of the ADRs were predictable and possibly preventable and mild, which highlights the importance of early detection and management of ADR.