Bedaquiline has been approved by the US Food and Drug Administration (FDA), while delamanid has been approved by the European Medical Agency (EMA).
Little data exists on the drugs’ effects and adverse events outside of a few clinical trials and WHO currently recommends that they may be added to a WHO-recommended regimen in adult patients with pulmonary TB caused by MDR organisms but only under certain conditions and must not be added alone to a failing regimen.
Any time these drugs are considered, informed consent should be obtained from the patient and there should be careful monitoring for adverse drug effects.
Delaminanid and bedaquiline in the same regimen are currently not recommended by WHO as there is no data on their use.
