I Gusti Agung Ayu Putu Sri Darmayani1, Purwantyastuti Ascobat2
1Program Pendidikan Dokter Spesialis Farmakologi Klinik, FKUI
2Departemen Farmakologi dan Terapeutik, FKUI
Bedaquiline is a new antibiotic particularly developed for the treatment of drug-resistant tuberculosis. Based on the results of studies during drug development, the safety aspect of bedaquiline to the heart was a major concern, since it caused prolongation of QT interval. However, this safety concerns were obtained by observing only small number of patients with incomplete cardiac safety monitoring data. Additional safety data of the heart needs to be systematically collected after the drug is widely used as a programmatic drug. Services and patient safety will be enhanced by implementing active drug safety monitoring (aDSM) from WHO.
Keywords: Bedaquiline, prolongation QT interval, safety profile