ADVERSE DRUG REACTIONS ASSOCIATED WITH FIRST-LINE ANTI TUBERCULAR DRUGS IN A TERTIARY CARE HOSPITAL OF CENTRAL INDIA: A STUDY OF CLINICAL PRESENTATIONS, CAUSALITY, AND SEVERITY
Abstract
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 Objective: The objective was to study the adverse drug reactions (ADRs) associated with first-line anti-tubercular drugs for clinical presentations, causality, and severity.
Methods: A retrospective study was undertaken in a 750 bedded tertiary care teaching hospital of central India for the duration of 1 year (May 2013‑May 2014). Patients diagnosed with tuberculosis and under treatment with the first-line anti-tubercular drugs were study subjects. Causality, preventability, and severity were analyzed and other parameters such as male to female ratio, most affected system, most common class of drug, and common types of ADRs, were studied.
Results: Nearly 118 patients were started on anti-tubercular treatment of first-line drugs in the study duration. Out of these 45 patients suffered one or more ADRs with a total number of reported ADRs being 91. 57.77% were males. Maximum patients belonged to the age group of 31-40 years (26.66%). The most commonly involved system was hepatic and biliary system (53.33%) followed by gastrointestinal system (51.11%), the most common ADR observed was disturbed liver transaminases (33.33%) followed by nausea and vomiting (28.88%). Causality assessment by Naranjo's scale showed 58.2% ADRs scoring probable, 31.86% were of possible score, whereas 9.8% definite score category. Severity assessment shows 68.88% cases of mild grading, 31.11% of moderate and no case of severe grading was reported in the study duration.
Conclusions: Vigilance regarding these ADRs occurrences can result in early diagnosis and thus, proper management can be instituted earliest. This will build confidence of patients and will decrease the dropouts which in turn can result in decrease chances of developing drug-resistant strains.
Keywords: Adverse drug reactions, Multidrug resistant tuberculosis, Extensively drug-resistant tuberculosis, Causality, Naranjo's algorithm
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