Bedaquiline’s Safety Profile Monitoring in India: Considerations for Future - A Systematic Review

Abstract

Background: Tuberculosis is still one of the top causes of infection-related death globally. Drug-resistant tuberculosis has a high mortality rate and is still a serious public health concern around the world. The appearance of multidrug-resistant and extensively drug-resistant strains of tuberculosis has increased the need for new therapeutic options against these strains. Most of the drugs used to treat them have been poorly tested and have serious negative effects. Patients with drug-resistant tuberculosis have been fighting for access to experimental medications, particularly bedaquiline. Objective: The study aimed to summarise the existing evidence of bedaquiline's safety on drugresistant tuberculosis treatment outcome and look for bedaquiline-related adverse drug reactions in the Pharmacovigilance Programme of India and World Health Organisation - Uppsala Monitoring Centre database. Methods: We searched the PubMed database for relevant studies on the safety profile of bedaquiline used in the treatment of drug-resistant tuberculosis and bedaquiline-related adverse drug reactions in the Pharmacovigilance Programme of India and World Health Organisation - Uppsala Monitoring Centre database published up to April 25, 2022. Results: A total of 190 abstracts were identified through the Pubmed database. In a list of 157 fulltext eligible articles assessed, 149 were excluded as they did not meet the inclusion criteria. The complete articles of the remaining 8 studies were further evaluated. There were 4 prospective cohorts, 2 retrospective cohorts, and 2 case series. Conclusion: Pharmacovigilance and medication safety monitoring of newer treatments, like bedaquiline, are critical for enhancing treatment support and adherence, especially among drugresistant tuberculosis patients.