A comprehensive assessment of the aDSM database was convened by WHO’s team on Pharmacovigilance, and the Global TB Programme in collaboration with TDR in 2020, in order to better understand the benefit and risk profiles of four TB medicines bedaquiline, delamanid, clofazimine and linezolid for their use in treatment of MDR-TB. The aim of the assessment was to identify for these four TB drugs any new potential “signals” and any new emerging safety concerns.
Analysis of the safety data from aDSM database was supplemented by additional safety data provided by the public portal of Eudravigilance and the WHO Global Individual Case Safety Report database (VigiBase). The outcomes of the assessment were reviewed by the WHO Advisory Committee on Safety of Medical Products (ACSoMP) in its 17th meeting on 27-29 October 2020. The main finding of the assessment, reviewed and agreed by the committee, confirmed the current safety profiles of the four reviewed TB drugs and no regulatory action (i.e. labelling change) is considered necessary at present regarding the TB drugs of interest. However, the assessment also pointed out some “potential signals of emerging risks” in relation to these medicines and therefore, the committee recommended the continuation of active monitoring following the WHO aDSM framework by countries. Following the outcomes of the assessment, the data in the Global aDSM database will be archived and securely stored by WHO’s Global Tuberculosis Programme. To strengthen country-based monitoring and pharmacovigilance systems in line with committee recommendations, WHO will continue to support national TB programmes in the implementation of the aDSM framework and to use VigiBase for individual case safety reporting, the usual route used by the national pharmacovigilance authorities.