Assessing the Frequency and Severity of Adverse Drug Reactions in Drug-Sensitive Tuberculosis Regimen: A Prospective Observational Study

Background

Tuberculosis (TB) is a significant national health issue of India, and the multidrug regimen afflicted to treat Drug Sensitive TB (DSTB) is commonly linked with Adverse Drug Reactions (ADRs) that may jeopardize the treatment adherence and the outcome.

Objectives

To assess the frequency and severity of ADRs associated with first-line anti-tubercular drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) among patients receiving treatment for DSTB.

Materials and Methods

A prospective, observational study was conducted over six months in the Department of Pulmonology, Durgabhai Deshmukh Hospital and Research Centre, Hyderabad. The study involved 60 microbiologically verified drug-sensitive patients of TB. Adverse drug reactions were observed and evaluated in terms of type, frequency, severity and causative drug. The analysis of data was done with the chi-square test and p<0.05 as the statistically significant level.

Results

Among 60 drug-sensitive tuberculosis patients, arthritis (26.7%), rash (23.3%), gastrointestinal upset (15%), and hepatotoxicity (15%) were the most common adverse drug reactions. Pyrazinamide was the most frequently implicated drug (43.3%), followed by rifampicin (25%), isoniazid (23.3%), and ethambutol (8.3%). Most ADRs were mild (41.7%), while pyrazinamide caused most moderate reactions and isoniazid and rifampicin accounted for the majority of severe ADRs.

Conclusion

Patients on first-line DSTB therapy are prone to adverse drug reactions with pyrazinamide, rifampicin and isoniazid having the highest risk especially in arthritis, rash and hepatotoxicity. Structured pharmacovigilance and early clinical monitoring are essential to detect and manage ADRs promptly and to safeguard treatment adherence.