Adverse effects associated with Kanamycin, Amikacin, Capreomycin and Bedaquiline -a VigiAccessTM study

Abstract

Background: Multidrug-resistant tuberculosis (MDR-TB) is a prevalent health burden, both in South Africa and globally. The treatment of MDR-TB is both complex and difficult as multiple drugs have to be used concurrently in order to achieve good treatment outcomes for patients. However, there is a lack in the evidence regarding the incidences of specific adverse effects of these drugs. Objective: The main aim/objective of this study was to investigate and compare reported specific adverse drug reactions (ADRs) associated with kanamycin, capreomycin, amikacin and bedaquiline in MDR-TB patients. Methods: Secondary data collected over a period of 12 months were sourced from a public access data base, VigiAccessTM, and analysed. Results: There was a steep increase in adverse drug reactions reported for kanamycin with the main adverse reactions being hypoacusis, deafness and tinnitus cases, along with vomiting, nausea and diarrhoea. With capreomycin, there were increases in asthenia and hypoacusis although the latter showed a plateau after some point. Rash and pruritus increased along with cases of death with amikacin and there were reports of prolonged QT interval in the electrocardiogram of patients on bedaquiline in addition to nausea, vomiting and diarrhoea. Conclusion: There are many specific adverse effects associated with kanamycin, capreomycin, amikacin and bedaquiline. The number of cases of the specific adverse effects also increased with time. Therefore, VigiAccessTM provides a good platform for reporting and awareness of specific adverse effects associated with MDR-TB therapy. This is a vital stepping stone for further research. Keywords: Kanamycin; Amikacin; Capreomycin; Bedaquiline.