Adverse drug reactions to first-line antituberculosis drugs at four DOTS centers in Goa, India

BACKGROUND: Major adverse drug reactions (ADRs) can cause significant morbidity and can compromise the treatment regimen. This can result in substantial additional cost due to added outpatient visits to the health facility or laboratory investigations or hospitalization in serious instances. Treatment is often prolonged with additional challenge of compliance. Hence, there is a need to monitor and manage these ADRs timely for better patient care and outcome. This study was carried out with the objective of studying the pattern of ADRs due to first-line antitubercular drugs and to carry out the causality and severity assessment of the reported ADRs. METHODOLOGY: A prospective observational study was conducted at four DOTS centers. All tuberculosis (TB) patients registered and receiving treatment under DOTS were enrolled for the study and were followed up at regular intervals till the end of their treatment. Patients' demographic, personal, disease, investigation, and ADRs details were entered in a predesigned patient recording form. Causality assessment of all ADRs were done using Naranjo algorithm. Severity assessment was done using modified Hartwig and Siegel scale. The study was approved by the institutional ethics committee of the institute. Statistical analysis was conducted using IBM SPSS Statistics for Windows. RESULTS: Of 186 patients, 23 patients (12.26%) developed one or more ADRs. The average number of ADRs per person was 1.43. Majority of the ADRs were reported in the 20–40 years of age group and ADRs were more likely to be among females compared to males. There was no association between type of TB, site of TB, regimen of anti-TB drugs, treatment outcomes, and ADRs. Around 84.85% and 15.15% of ADRs were classified as of mild and moderate severity, respectively, as per modified Hartwig and Siegel scale, while, as per Naranjo algorithm, 72.73% of the ADRs were classified as probable and 27.27% of ADRs as possible. No ADRs were classified as definite. CONCLUSION: Thorough understanding of the various ADRs and their management will help in the effective treatment of TB as well as designing effective counseling methods, which will help in adherence to treatment and also to have better compliance.