Frequency of Adverse Effects of Fixed Dose Combinations, in Tuberculosis and there Effects on Treatment Outcome

This study was designed to assess the frequency, types and impact of adverse drug reactions (ADR) to category 1 anti-tubercular therapy using fixed drug combinations (FDC). Patients with tuberculosis started on anti TB treatment from 01st of July 2011 to 30th of June 2012 were recruited Methodology: Patients were followed up for development of ADR. Frequency of ADR, number of patients who required prolongation of therapy, who had alternate regimes, and there treatment outcome were recorded. Results: Out of 280 patients with tuberculosis 67 (24%), 37 (55.2%) males, 30 (44.8%) females ADR. Thirty three out of 74 (44%) of total population above the age of 60 had ADR, while only 34 out of 206 (16.5%) of patients below the age of 60 had ADR (Chi= 23, p <0.0001). Incidence of ADR were - Dyspeptic symptoms 31(11.1%), itching 20 (7.1%), hepatitis 9 (3.2%), arthralgia 1 (0.4%), vertigo 1 (0.4%), peripheral neuropathy 1 (0.4%), visual impairment 1 (0.4%), rash 1 (0.4%). Out of 27 patients who had prolongation of therapy 22 (81.4%) were due to ADR (Chi = 54, p <0.0001). Nine (3.2%) were given alternate regimes (Fishers exact p = 0.000017) [6 hepatitis, 1 rash, 1 vertigo, 1 visual impairment]. None of the patients with ADR had relapses or treatment failures. Conclusion: Adverse reactions were commoner among the elderly, and were associated with prolongation and modification of anti tuberculosis therapy but over all treatment outcomes were not adversely affected. SAARC J TUBER LUNG DIS HIV/AIDS, 2015 XII (2),Page: 8-12