[1] Serious side effects include QT prolongation, liver dysfunction, and an increased risk of death.
[13][14][needs update] The most common side effects of bedaquiline in studies were nausea, joint and chest pain, and headache.
The drug also has a black-box warning for increased risk of death and arrhythmias, as it may prolong the QT interval by blocking the hERG channel.
[16] There remains significant concern for the higher mortality in people treated with bedaquiline, leading to the recommendation to limit its use to situations where a four drug regimen cannot otherwise be constructed, limit use with other medications that prolong the QT interval, and the placement of a prominent black box warning.
[20] The onset of bedaquiline-induced mycobacterial cell death does not occur until several days after treatment, but nonetheless kills consistently thereafter.
[21] Bedaquiline was described for the first time in 2004 at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, after the drug had been in development for over seven years.
[28] The WHO TB program director has pointed out that Janssen will donate $30 million worth (30,000 treatment courses) of bedaquiline over a four-year period.
[30] The patent was supposed to expire in July 2023, but J&J's evergreening practices will not allow the distribution of generics in several countries heavily afflicted by tuberculosis.
[32] In July 2024, the Indian Patent Office’s rejected Johnson & Johnson's application for a pediatric version of bedaquiline, paving the way for more affordable generic alternatives, potentially reducing treatment costs by 80% beyond the primary patent’s expiration in July 2023.
[35] In vitro experiments have indicated that bedaquiline may also target the mitochondrial ATP synthase of malignant mammalian cells and reduce the rate of metastasis.