Prevalence of Adverse Drug Reactions to Second Line Anti Tuberculosis Drugs in Nigeria: A Cross-Sectional Study

Introduction: Multidrug resistant tuberculosis (MDR-TB) is treated with second line antituberculosis drugs. These drugs are notorious for inflicting serious adverse drug reactions (ADRs), which many studies have shown causes a wide range of economic and health problems including death. Aim: The study examined the prevalence of ADRs, associated risk factors, socio-demographic association and outcomes among patients treated for MDR-TB at a comprehensive tuberculosis treatment center in Nigeria. Method: The study was conducted at the Government Chest Hospital, Jericho, Ibadan. We applied a retrospective assessment of patient treatment data and ADRs reports stored at the study site from March 2013 and February 2016. Subsequently, a prospective study of ADRs was conducted on patients admitted into the same hospital. Causality relationship between the drugs and the reported ADRs was determined with a specially validated tool. The outcomes assessed include recovery from the ADRs, death and permanent deafness from the ADRs. Extracted data were analyzed using SPSS version 22.0. Risk Ratio was calculated for the influence of risk factors for adverse drug reactions. Logistic regression was performed to test for the strength of relationships between risk factors and incidence of ADRs among patients. Result: Almost all the participants in this study reported adverse drug reaction [99% (118/119)]. However, ototoxicity was the most prevalent ADR (35.3%), followed by electrolyte imbalance (12.6%), gastrointestinal track (10.1%) and psychiatric disorders (10.1%). Being older than 35 years and HIV negative or having a healthy BMI were not significant risk factors for developing ADRs. Duration of ADR above one month was significantly associated with the outcome of ADR. Conclusion: Ototoxicity, electrolyte imbalance, psychiatric disorders and gastrointestinal tract problems were the most frequently reported ADRs. Healthcare providers, government and donor agencies supporting the treatment should ensure that hearing aids and other forms of support are readily made available for the affected patients.