Adverse Drug Reactions Experienced During Intensive Phase of Standardized Ambulatory Regimen of MDR-TB, A Cross Sectional Study

DOI: 10.21276/sjams.2017.5.9.22 Abstract: Aim of our study was to determine the adverse drug reactions experienced by the patients during intensive phase of standardized category IV regimen of multi drug resistant tuberculosis (MDR-TB). All eligible patients with MDR pulmonary -TB were followed up till the end of intensive phase to determine adverse drug reactions encountered during this period by personal interview in questionnaire format and review of medical records. Total 120 patients constituted the final study population. There were 94 (78.3%) male and 26 (21.6%) females. Mean age of cohort was 38.7 years. Total 117(97.5%) patients experienced one or more adverse drug reaction during intensive phase. 85(72.6%) patients experienced gastro-intestinal adverse effects followed by joint pain (n=66, 56.4%). Eleven (9.4%) patients experienced single adverse drug reaction, while majority of patients (n=61, 52.1%) experienced ≥4 adverse drug reaction. Thirty six (30.7%) patients pointed out a particular drug for observed side effects. Ethionamide was most common offending drug in 19 (52.7%) patients; the most common reaction was gastrointestinal side effects. Regimen was modified during intensive phase due to drug toxicity in 11 (9.1%) patients. In 4 (36.3%) patients, Kanamycin was stopped and replaced by PAS while in rest (n=7, 63.6%) drugs other than Kanamycin were stopped and replaced by PAS. In conclusion, adverse drug reactions are extremely common during intensive phase. However; in majority of patients, treatment can be continued without modification in regimen.