Adverse Drug Reactions in Children Using Biologicals

Nair SG, Dhanish NJ, Dhanya S and Palatty LP

Published on: 2024-01-17

Abstract

Context: Biological agents play an important role in the therapy of inflammatory diseases, autoimmune disorders, malignancies, etc. Despite their therapeutic potential, they have the capability of causing adverse drug reactions (ADR). As there is no significant or published data regarding the adverse reactions in children using biologicals, this study aims to assess the occurrence of the same.

Aims: To determine the frequency of occurrence and severity of adverse drug reactions in the pediatric population by using biological agents.

Settings and Design: This was a prospective, observational study conducted in a tertiary care hospital in the Pediatrics Department and the Pharmacology Department where adverse drug reactions were being monitored and reported.

Methods and Materials: All children between one month and 18 years of age who were patients in the department of pediatrics were included and monitored for adverse effects after biologicals were administered. The ADRs were recorded based on a questionnaire provided to the healthcare workers.

Statistical Analysis Used: The questionnaires collected were analysed for various parameters like patient demographics, severity, causality, and preventability of the reactions.

Results: A total of 100 ADRs were reported in this study. Thrombophlebitis was the most reported adverse event with intravenous immunoglobulins (IV-IG) being the causative drug causing most ADRs. It was observed that most of the ADRs occurring were associated with illnesses affecting the hematological system.

Conclusions: The study concluded that ADRs caused due to biologicals were uncommon, thereby justifying their safety and efficacy for use in children.