Analysis on Adverse Events of Treatment Medications in Patients with Nontuberculous Mycobacteria (NTM) Using the Korea Adverse Event Reporting System (KAERS)

다국어 초록 (Multilingual Abstract)

Objective: The incidence of nontuberculous mycobacteria pulmonary disease (NTM-PD) has been increasing worldwide. However, treatment options for NTM-PD have been limited by the multidrug-resistant nature of these organisms and toxicities of antibiotics.
Due to the lack of clinical safety studies related to NTM-PD treatment in Korea, the objectives of this study were to analyze NTM-PD treatment medication-related adverse events (AEs) and to identify clinical characteristics of various AEs and serious adverse events (SAEs) in medication treatments for NTM-PD patients. Methods: This study was conducted to analyze the current status of adverse event occurrences during drug treatment in domestic NTM-PD patients using the Korea adverse event reporting system database (KAERS DB) from 2017 to 2021. Results: According to the analysis of 2017-2021 KAERS DB in this study, 1,034 AEs were reported in the process of NTM-PD treatments, and the most common causative agents of AEs were ethambutol (19.2%), followed by rifampin (17.2%), azithromycin (12.6%), moxifloxacin (7.0%), clarithromycin (6.0%), levofloxacin (5.1%), amikacin (4.7%), cefoxitin (3.9%), imipenem (3.1%), linezolid (2.1%), and ciprofloxacin (0.8%). SAEs were approximately 5% of the total AEs and the most frequently reported drugs for SAEs were rifampin, ethambutol, clarithromycin, amikacin, and levofloxacin in order. AEs during NTM-PD treatments were the major causes of treatment discontinuation. Conclusion: Therefore, careful monitoring of AEs is req