Despite the lack of a Phase III clinical trial report of bedaquiline, the newly discovered drug for treatment of multidrug-resistant tuberculosis (MDR-TB), the World Health Organization (WHO) on Thursday issued an interim policy guidance notification on the use of the drug. Bedaquiline was discovered after a fifty year lull in development of drugs against TB – a period during which drug resistance of the disease made treatment difficult.
| Conditions for use of bedaquiline
- Treatment to be closely monitored for effectiveness and safety, using protocols approved by relevant national authorities
- Proper patient inclusion; caution when used in elderly, HIV infected. Not to be administered to pregnant women and children
- Patients to be made aware of potential benefits and harsm; to give documented informed consent
- Adherence to WHO recommendations, particularly inclusion of four effective second-line drugs
- Active pharmacovigilance to detect and manage adverse drug reactions
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Lack of complete data
One of few drugs effective