The quantity and severity of adverse drug reactions experienced by patients with multi-drug resistant tuberculosis in the Ugu District

MDR-TB treatment has a history of being associated with a lengthy regimen accompanied by numerous adverse drug reactions (ADRs). This notion results from the aminoglycoside-based regimen and its association with severe and long-term ADRs such as ototoxicity, renal impairment, and optic neuritis. The introduction of a shorter regimen offered a more convenient and safer regimen. Data on the safety of the short bedaquiline regimen (SBR) has rarely been explored since the widespread use of bedaquiline was recommended in 2018. This is especially important for a country like South Africa, where the factors influencing therapy outcomes are vast and multifactorial. The method employed in this study included an investigation of patient clinical charts and documentation of noted ADRs. This was deemed the most appropriate method because medical officers or doctors did not complete other data sources such as ADR reports. All patients from a three-year period diagnosed with MDR-TB were included in the study. The most documented ADRs were thrombocytopenia, hypothyroidism, prolonged QTc, gastrointestinal disturbances, and rash. Three of the 5 most common ADRs were categorized as severe. There were no ADR reports submitted for escalation to relevant authorities. New drugs to the MDR-TB regimen, bedaquiline, and linezolid were primarily responsible for most ADRs. SBR appears to be associated with more severe ADRs than initially anticipated or documented. The focus previously was on QTc prolongation. The cost, including financial, human and emotional on treating the ADRs should also be factored in when comparing to previous regimens. Based on current data, increased monitoring of baseline results and management time of ADRs is imperative in ensuring a better response to therapy. Established pharmacovigilance systems are necessary to ensure the continued safety of drugs, irrespective of the disease state or known safety profile of the drug.