Informed use of bedaquiline for tuberculosis

In their Viewpoint (Jan 31, p 477),1 Laia Ruiz Mingote and colleagues highlight the urgent need for additional safety data on bedaquiline, the first new tuberculosis drug to receive US Food and Drug Administration (FDA) approval in more than 40 years. Because the drug received accelerated approval b...

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Bibliographic Details
Published in:The Lancet (British edition) 2015-05, Vol.385 (9979), p.1724-1724
Main Authors: Lessem, Erica M, Bernardo, John, Reed, Caitlin, Wegener, Donna H
Format: Article
Language:English
Subjects:
Diarylquinolines - administration & dosage
Drug therapy
FDA approval
Humans
Internal Medicine
Medical research
Mortality
Mycobacterium
Tuberculosis
Tuberculosis - drug therapy
Tuberculosis, Multidrug-Resistant - drug therapy
Citations: Items that this one cites
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Summary:In their Viewpoint (Jan 31, p 477),1 Laia Ruiz Mingote and colleagues highlight the urgent need for additional safety data on bedaquiline, the first new tuberculosis drug to receive US Food and Drug Administration (FDA) approval in more than 40 years. Because the drug received accelerated approval based solely on phase 2 studies, critical safety data for bedaquiline are incomplete.
ISSN:0140-6736
1474-547X
DOI:10.1016/S0140-6736(15)60885-6