ADVERSE DRUG REACTIONS WITH FIXED-DOSE COMBINATIONS IN TUBERCULOSIS PATIENTS

Background:Government of India's National Tuberculosis Elimination Program (NTEP) has startedimplementing daily fixed dose combination (FDC), anti-TB treatment regimen for drug sensitive TBpatients. This study was designed to assess the frequency, types and impactof adverse drug reactions(ADR) to category 1 anti-tubercular therapy using fixed drug combinations (FDC).Methodology:This was a hospital-based observational study in the population of rural Haryana forone year from 30thSeptember 2020 to 30thSeptember 2021 in the SGT Medical College in theDepartment of Pulmonary Medicine.Result:We encountered 384 patients who were started on ATT for the treatment of tuberculosis.Among them, 26.04% suffered from mild to life-threatening adverse drug reactions (ADR) due to theDOTS regimen. 74% of the ADR was seen in patients with pulmonary TB andthe rest withextrapulmonary tuberculosis. Among the total population treated, 18.49% suffered from ADR ofvarying severity while being treated for pulmonary TB. Similarly, 7.55% developed ADR while beingtreated for extrapulmonary TB. The most common ADR encountered was hepatitis in 39% of theaffected group.Conclusion:Adverse reactions were commoner among the elderly, and were associated withprolongation and modification of anti-tuberculosis therapy but overall treatment outcomes were notadversely affected.