Pattern of adverse drug reactions of antitubercular drugs in tuberculosis patients with comorbidities and risk factors in South Indian government health-care facilities

Abstract

Background: Tuberculosis (TB) is one of the common infectious diseases in India with a high socioeconomic impact. It is estimated that more than 5% of the patients on antitubercular drugs develop adverse drug reactions (ADRs) and subsequently this proportion is expected to increase with comorbidities due to drug-disease interactions and also drug-drug interactions used to treat the comorbidities. Aims and Objectives: This study aims to assess the prevalence and pattern of ADRs due to antitubercular therapy in TB patients with comorbidities and risk factors. Materials and Methods: Fifty TB patients were enrolled, their sociodemographic data, concurrent diseases, and medications other than antitubercular agents that the patients might be taking were investigated. Any adverse reaction and the steps taken toward the management of adverse reaction were immediately noted on the Suspected ADR Reporting Form. The severity of ADRs was assessed using the Naranjo scale and WHO causality assessment scale. Results: Out of 50 patients, 10 ADRs were reported, out of which seven ADRs were reported by males and two were reported by females (P > 0.05). All ADRs were from patients with pulmonary TB. The most common ADRs were gastrointestinal problems such as loss of appetite, symptoms suggestive of gastritis such as heart burns and abdominal pain. About 50% of the patients who developed ADR had diabetes as comorbidity (χ2 = 0.5208, P > 0.05) and all were having diabetes for more than 5 years duration. Conclusion: Most common comorbid condition with TB was found to be combined diabetes and hypertension.