Analysis of nationwide adverse event reports on Isoniazid and Rifampin in tuberculosis prevention and treatment in South Korea

Abstract

Abstract Individuals with latent tuberculosis infection (LTBI) are at risk of progressing to active tuberculosis (TB), which remains a significant cause of death globally. Although various antiTB medications—rifampin and isoniazid—exist for treating for both LTBI and active TB, pharmacovigilance studies evaluating their adverse effects are especially scare for LTBI. Given the continued status of South Korea as having the highest TB incidence among Organization for Economic Cooperation and Development countries, this study examines drug-related adverse events (AEs) and identifies novel signals associated with rifampin or isoniazid in TB prevention and treatment in South Korea using the national AE reporting system. Analyzing data from the Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KAERS DB, 2301A0006) between 2017 and 2021, we observed that rifampin was frequently listed as a suspected drug in AE reports. Serious adverse events (SAEs), including life-threatening events and hospitalizations, were observed in LTBI as well as active TB cases when rifampin was the suspected drug. Novel signals, including QT prolongation and acne, were also identified, underscoring the importance of AE monitoring in LTBI or active TB treatment.

Keywords

• Drug-related adverse event report
• Tuberculosis
• Antituberculosis drugs
• Rifampin
• Isoniazid
• Pharmacovigilance